Job summary
Band 6 Quality Control Releasing Officer Pharmacy QC Laboratory
We have been successful in developing a new role within our Pharmacy Quality Team and are looking for a Quality Control releasing officer to join us. Working with the team the post holder will provide a assess and release process for all medicinal products manufactured within this large Trust and for other NHS Trust which we provide a Quality Assurance service for re the approval or rejection of raw materials , manufactured finished products produced in our Sterile, non-sterile and CIVAS suites, unlicensed medicines and packaging materials. The postholder will keep appropriate records and be responsible for the generation of certificates of Conformity and Certificates of Analysis for products released for internal and external clients.
Main duties of the job
The post holder will be required to work closely with the Head of Pharmaceutical Quality to maintain the integrated Quality systems across Quality Control Services as required by the ML(specials), MA(IMP) licenses and NHS guidance and will assist to develop, deliver and maintain the reliability and capabilities of the Quality unit.
The ideal candidate will hold a BSc or HND in relevant sciences with full membership of the relevant professional body. They should have proven experience of working in a QC Laboratory ideally linked to an MHRA Licensed Pharmacy Manufacturing Unit and QA Department with analytical experience using relevant analytical equipment and methods. She/he will be confident, have a proactive attitude and have the ability to forge relationships with a wide range of staff both within and beyond the Pharmacy Quality Control and Pharmacy Manufacturing Units.
About us
Our trust has around 10,000 staff serving 1.6 million patients. It comprises Barnet Hospital, Chase Farm Hospital, the Royal Free Hospital and more than 30 services in the community. This large scale organisation provides an unprecedented opportunity for us to continue our pioneering work, particularly in finding ways to deliver even better care to our patients. In addition to the above specialities, the Trust is a centre for renal, liver, oncology, infectious disease and haemophilia which are all underpinned by a strong research agenda, the Royal Free is renowned for providing excellent patient care.
On the Hampstead site we host one of the most extensive manufacturing suites in the NHS which supplies high quality bespoke products to both Primary and Secondary Care and Research organisations. The facility has an MHRA Manufacturer "Specials" Licence (MS), a Wholesale Distribution Authorisation (WDA(H)) and a Manufacturer Licence for Investigational Medicinal Products (Clinical Trials) (MIA(IMP)). At Barnet we have a manufacturing unit supplying products for Royal Free London patients.
Job description
Job responsibilities
1. QUALITY CONTROL RESPONSIBILITY
- To act as a Releasing Officer responsible for the approval or rejection of raw materials, manufactured finished products (Sterile, Non-sterile products and CIVAS) and packaging materials and to keep appropriate records and generate Certificates of Conformity and Certificates of Analysis for external clients.
- As a Releasing Officer be responsible for the review of documentation and physical stock in the Production Units, and release or reject batches for sale or use within the trust.
- Responsible for the approval or rejection of all purchased non-licensed pharmaceuticals, and for writing their testing specifications, under the direction of the Head of Quality and Quality Control Laboratory Manager.
- To evaluate batch manufacturing records and batch packing records, alongside Quality Control test results, prior to release or rejection of a batch.
- To write, and review the testing specification for raw material, packaging components and finished products for the Quality Control Laboratory.
- To assist in ensuring the manufacturing environment and equipment is monitored and calibrated appropriately, to ensure compliance with local and regulatory guidelines.
- In conjunction with other staff, be responsible for carrying out the environmental monitoring programme, in the units and at the establishments for which the laboratory provides a service.
- To assist the Head of Quality and Quality Control Laboratory Manager in setting up Technical Agreements with internal and external clients.
- To assist in the maintenance and development of the Quality Management Systems across the Quality and Production departments, including but not limited to writing, reviewing and updating department procedures and policies and maintaining the departments change control, deviation, complaints, recall and corrective action and preventative action (CAPA) systems after appropriate training..
- To ensure all necessary testing is carried out, according to the approved written specifications or Pharmacopeial monographs.
- To be familiar with the chemical and microbiological testing carried out in the Quality Control Laboratory.
- Staff Supervision and Training
- To assist in the training of the laboratory technical staff To undertake testing, method development and ensure that activities undertaken meet current GMP guidelines, Health and Safety, COSSH.
- To assist in managing staff assigned to the QA/QC Department including attendance monitoring
- To participate in the training of pharmacists, chemists, pre-registration pharmacy graduates, technicians and student technicians with the QA department and external to the trust as necessary.
- To assist in the competency checks of QC/QA Staff, and assessment before the signing off Training Records by Quality Control manager or Head of Pharmaceutical Quality.
3. Resource Management - To assist in the planning for equipment procurement and ensure that equipment is adequately qualified and maintained and its performance continuously verified.
- To manage analytical testing by Quality Control staff using instrumental methods including HPLC/UHPLC, LC, FTIR, UV-visible spectroscopy, Atomic Spectrometry, ICP and classical methods of analysis.
4. Research and Development (including Clinical Trials)
- To provide support to the development, formulation and validation of new products in response to clinical trial or clinical need and risk management in accordance with client and trust objectives.
- To assist in the review of trial documentation . To ensure that all IMP pre-releases (licensed and unlicensed) follows the principle of GMP and GCP.
- To assist in review of IMP production documentation per GCP and trail specific PSF and pharmacy manual
- To assist in the response to audit deficiencies in a timely manner
- To assist and undertake assigned stability studies where required in line with current ICH guidelines or equivalent.
- To assist in the rolling programme to investigate the validation and possible extension of current expiry dates attributed to manufactured batches.
5. CLINICAL SERVICES
- To assist in the provision of expert pharmaceutical QC/QA advice where applicable manufactured products released by QC.
- To assess the suitability of unlicensed medicines purchased by the trust and release for use as appropriate
- To assist in responding to MHRA drug alerts,
- To assist in the temperature monitoring and mapping of relevant drug storage areas and communication of results and excursions to relevant areas of the trust
6. PROFESSIONAL RESPONSIBILITIES
- To remain on the relevant Professional register.
- To undertake GCP and GMP training as required.
- To maintain 100% MAST record.
- To complete CPD where applicable.
Business and Intellectual Property
- To assist in the costing of new product testing undertaken by the laboratory.
- To help identify issues of intellectual property
- Other Duties
To undertake other duties as requested by the Head of Laboratory and the Head of Pharmaceutical Quality.
To work across sites and contracted clients when required.
GENERAL RESPONSIBILITIES
Infection Control
Infection control is everyones responsibility. All staff, both clinical and non clinical, are required to adhere to the Trusts Infection Prevention and Control policies and procedures and the Health Act (2006) Code of Practice for the prevention and control healthcare associated infections and make every effort to maintain high standards of infection control at all times thereby reducing the risk of Healthcare Associated infections.
To work in collaboration with the Infection Control Team.
- To ensure that all relevant monitoring data and issues are provided to the Directorates Governance structures when requested..
- To ensure attendance of relevant infection control-related educational sessions when requested..
Health and Safety at Work
The post holder is required to:
- Take reasonable care for the health and safety of himself/herself and other persons who may be affected by their actions or omissions at work.
- Co-operate with the employer in ensuring that all statutory and other requirements are complied with.
- To improve understanding of hazards specific to Aseptic service & COSHH materials and highlight ways of reducing risks to staff.
Confidentiality & Data Protection
The post holder has a responsibility to comply with the Data Protection Act 1998 and maintain confidentiality of staff, patients and Trust business.
You should disclose information only to authorised persons or organisations as instructed. Breaches of confidentiality in relation to information will result in disciplinary action, which may include dismissal. Employees are expected to comply with all Trust policies and procedures and to work in accordance of the Data Protection Act 1998.
Sustainability
The Trust places great importance on sustainable development, reducing their carbon footprint and maximising the positive social, economic, and environmental outcomes of Trust actions and activities. As an employee it will be your responsibility to minimise your environmental impact, use resources efficiently, saving energy by switching off unnecessary equipment, reducing waste generation, using recycling/redistribution facilities, minimising travel, and saving water when possible. If your role involves purchasing/ordering supplies, you must consider the environmental impacts and purchase optimal sustainable products and services.
Job description
Job responsibilities
1. QUALITY CONTROL RESPONSIBILITY
- To act as a Releasing Officer responsible for the approval or rejection of raw materials, manufactured finished products (Sterile, Non-sterile products and CIVAS) and packaging materials and to keep appropriate records and generate Certificates of Conformity and Certificates of Analysis for external clients.
- As a Releasing Officer be responsible for the review of documentation and physical stock in the Production Units, and release or reject batches for sale or use within the trust.
- Responsible for the approval or rejection of all purchased non-licensed pharmaceuticals, and for writing their testing specifications, under the direction of the Head of Quality and Quality Control Laboratory Manager.
- To evaluate batch manufacturing records and batch packing records, alongside Quality Control test results, prior to release or rejection of a batch.
- To write, and review the testing specification for raw material, packaging components and finished products for the Quality Control Laboratory.
- To assist in ensuring the manufacturing environment and equipment is monitored and calibrated appropriately, to ensure compliance with local and regulatory guidelines.
- In conjunction with other staff, be responsible for carrying out the environmental monitoring programme, in the units and at the establishments for which the laboratory provides a service.
- To assist the Head of Quality and Quality Control Laboratory Manager in setting up Technical Agreements with internal and external clients.
- To assist in the maintenance and development of the Quality Management Systems across the Quality and Production departments, including but not limited to writing, reviewing and updating department procedures and policies and maintaining the departments change control, deviation, complaints, recall and corrective action and preventative action (CAPA) systems after appropriate training..
- To ensure all necessary testing is carried out, according to the approved written specifications or Pharmacopeial monographs.
- To be familiar with the chemical and microbiological testing carried out in the Quality Control Laboratory.
- Staff Supervision and Training
- To assist in the training of the laboratory technical staff To undertake testing, method development and ensure that activities undertaken meet current GMP guidelines, Health and Safety, COSSH.
- To assist in managing staff assigned to the QA/QC Department including attendance monitoring
- To participate in the training of pharmacists, chemists, pre-registration pharmacy graduates, technicians and student technicians with the QA department and external to the trust as necessary.
- To assist in the competency checks of QC/QA Staff, and assessment before the signing off Training Records by Quality Control manager or Head of Pharmaceutical Quality.
3. Resource Management - To assist in the planning for equipment procurement and ensure that equipment is adequately qualified and maintained and its performance continuously verified.
- To manage analytical testing by Quality Control staff using instrumental methods including HPLC/UHPLC, LC, FTIR, UV-visible spectroscopy, Atomic Spectrometry, ICP and classical methods of analysis.
4. Research and Development (including Clinical Trials)
- To provide support to the development, formulation and validation of new products in response to clinical trial or clinical need and risk management in accordance with client and trust objectives.
- To assist in the review of trial documentation . To ensure that all IMP pre-releases (licensed and unlicensed) follows the principle of GMP and GCP.
- To assist in review of IMP production documentation per GCP and trail specific PSF and pharmacy manual
- To assist in the response to audit deficiencies in a timely manner
- To assist and undertake assigned stability studies where required in line with current ICH guidelines or equivalent.
- To assist in the rolling programme to investigate the validation and possible extension of current expiry dates attributed to manufactured batches.
5. CLINICAL SERVICES
- To assist in the provision of expert pharmaceutical QC/QA advice where applicable manufactured products released by QC.
- To assess the suitability of unlicensed medicines purchased by the trust and release for use as appropriate
- To assist in responding to MHRA drug alerts,
- To assist in the temperature monitoring and mapping of relevant drug storage areas and communication of results and excursions to relevant areas of the trust
6. PROFESSIONAL RESPONSIBILITIES
- To remain on the relevant Professional register.
- To undertake GCP and GMP training as required.
- To maintain 100% MAST record.
- To complete CPD where applicable.
Business and Intellectual Property
- To assist in the costing of new product testing undertaken by the laboratory.
- To help identify issues of intellectual property
- Other Duties
To undertake other duties as requested by the Head of Laboratory and the Head of Pharmaceutical Quality.
To work across sites and contracted clients when required.
GENERAL RESPONSIBILITIES
Infection Control
Infection control is everyones responsibility. All staff, both clinical and non clinical, are required to adhere to the Trusts Infection Prevention and Control policies and procedures and the Health Act (2006) Code of Practice for the prevention and control healthcare associated infections and make every effort to maintain high standards of infection control at all times thereby reducing the risk of Healthcare Associated infections.
To work in collaboration with the Infection Control Team.
- To ensure that all relevant monitoring data and issues are provided to the Directorates Governance structures when requested..
- To ensure attendance of relevant infection control-related educational sessions when requested..
Health and Safety at Work
The post holder is required to:
- Take reasonable care for the health and safety of himself/herself and other persons who may be affected by their actions or omissions at work.
- Co-operate with the employer in ensuring that all statutory and other requirements are complied with.
- To improve understanding of hazards specific to Aseptic service & COSHH materials and highlight ways of reducing risks to staff.
Confidentiality & Data Protection
The post holder has a responsibility to comply with the Data Protection Act 1998 and maintain confidentiality of staff, patients and Trust business.
You should disclose information only to authorised persons or organisations as instructed. Breaches of confidentiality in relation to information will result in disciplinary action, which may include dismissal. Employees are expected to comply with all Trust policies and procedures and to work in accordance of the Data Protection Act 1998.
Sustainability
The Trust places great importance on sustainable development, reducing their carbon footprint and maximising the positive social, economic, and environmental outcomes of Trust actions and activities. As an employee it will be your responsibility to minimise your environmental impact, use resources efficiently, saving energy by switching off unnecessary equipment, reducing waste generation, using recycling/redistribution facilities, minimising travel, and saving water when possible. If your role involves purchasing/ordering supplies, you must consider the environmental impacts and purchase optimal sustainable products and services.
Person Specification
Education & professional Qualifications
Essential
- Bsc, HND in relevant sciences
- Full membership of a relevant Professional Body or eligible to register
- Mandatory CPD to maintain fitness to practice
Royal Free World Class Values
Essential
- Demonstrable ability to meet the Trust Values
Experience
Essential
- 3-5 years experience of good performance in previous jobs within a modern Pharmaceutical Control laboratory working under GMP conditions and safe Laboratory practice.
- Knowledge and / or Analytical experience using UV, IR and HPLC methods and validation of analytical methods
- Previous experience assisting in or validation of pharmaceutical manufacturing processes, equipment and products
- Experience of training and supervising staff within a Pharmaceutical Quality Control Laboratory
- Demonstrated experience & ability to undertake technical projects
- Practical knowledge of and commitment to the principles of cGMP, GLP, QA and all current legislation and regulations and ability to apply this knowledge run Laboratory Services
- Demonstrated knowledge of principals and practices of formulation, stability, of products and manufacturing processes
- Knowledge of COSHH and health and safety at work
- Practical knowledge on the analysis of pharmaceutical manufactured products and ability to identify and manage associated risks
- Demonstrated knowledge of Pharmaceutical microbiology
- Willingness to undertake training in medical gas testing
Desirable
- Experience in a QC Laboratory linked to an MHRA or Licensed manufacturing unit
Person Specification
Education & professional Qualifications
Essential
- Bsc, HND in relevant sciences
- Full membership of a relevant Professional Body or eligible to register
- Mandatory CPD to maintain fitness to practice
Royal Free World Class Values
Essential
- Demonstrable ability to meet the Trust Values
Experience
Essential
- 3-5 years experience of good performance in previous jobs within a modern Pharmaceutical Control laboratory working under GMP conditions and safe Laboratory practice.
- Knowledge and / or Analytical experience using UV, IR and HPLC methods and validation of analytical methods
- Previous experience assisting in or validation of pharmaceutical manufacturing processes, equipment and products
- Experience of training and supervising staff within a Pharmaceutical Quality Control Laboratory
- Demonstrated experience & ability to undertake technical projects
- Practical knowledge of and commitment to the principles of cGMP, GLP, QA and all current legislation and regulations and ability to apply this knowledge run Laboratory Services
- Demonstrated knowledge of principals and practices of formulation, stability, of products and manufacturing processes
- Knowledge of COSHH and health and safety at work
- Practical knowledge on the analysis of pharmaceutical manufactured products and ability to identify and manage associated risks
- Demonstrated knowledge of Pharmaceutical microbiology
- Willingness to undertake training in medical gas testing
Desirable
- Experience in a QC Laboratory linked to an MHRA or Licensed manufacturing unit
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
