Job summary
We are looking for a motivated individual with excellent communication, interpersonal and organisational skills who is dedicated to working as part of the team.
Key duties of the role include:
- 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 and developing the department's documentation systems.
- To act as a QA/QC Officer responsible for the approval or rejection of raw materials, intermediates, hospital-manufactured finished products, commercial products and packaging materials and to keep appropriate records, including maintaining electronic records on the quality system and generation of Certificates of Conformity and Certificates of Analysis for external clients.
You will also contribute to the operations of the departments Pharmaceutical Quality System and assist with the provision of expert advice on all Quality matters that support the wider Pharmacy department.
Main duties of the job
- Management and maintenance of a comprehensive documentation control system across RFH Technical Services.
- Leading the implementation of eQMS for effective document control and quality management.
- Assisting in transferring documents from the current filing system to the eQMS electronic Quality Management System.
- Management of the review and approval process for all GMP documents.
- Supporting the QA team in delivering high-quality services in accordance with the Medicines Act and Trust licenses.
- Assisting in developing the QA service and provide expert advice on QA matters, with emphasis on Quality Control activity.
- Ensuring GMP activities align with regulatory and legal requirements and comply with current GMP, company SOPs, and Health and Safety policies/SOPs.
- Collaborating with other staff responsible for the environmental monitoring program.
- Undertaking additional duties as required by the Head of Quality.
About us
Our trust has around 10,000 staff serving 1.6 million patients. It comprises Barnet, Chase Farm and Royal Free Hospitals and more than 30 services in the community. Our mission is to deliver world class care and expertise in our clinical services, underpinned by world class teaching and research.
The Trust takes pride as one of the major specialist centres for infectious diseases, liver and renal transplants, breast and plastic surgery, myeloma, and neuroendocrine tumours. Working in one of the main speciality centres brings exciting opportunities to see a range of patients at different levels of complexities. Everyone is welcome at Royal Free London NHS Foundation Trust. We're proud of our diversity and we continue to undertake new initiatives to advance equality for LGBT+, BME, gender equality, staff carers and people with disabilities and lived experiences to promote good relations and understanding between our staff.
The Pharmacy department is a friendly, progressive, and expanding unit dedicated to providing the highest standards of pharmaceutical care and service in this internationally renowned teaching hospital. Quality improvement and cost-effective, safe use of medicines is at the forefront of everything we do.
Job description
Job responsibilities
The responsibilities include:
Quality Management and Documentation Control:
- Manage and maintain a comprehensive documentation control system across RFH Technical Services.
- Lead the implementation of eQMS for effective document control and quality management.
- Assist in transferring documents from the current filing system to the eQMS electronic Quality Management System.
- Oversee the day-to-day operation of eQMS.
- Utilize eQMS for maintaining version control of all GMP documents.
- Manage the review and approval process for all GMP documents.
- Drive the development and review of new and updated documents.
- Provide reports to Unit Managers on GMP documentation status, escalating concerns to the QA Specialist and the Head of Quality.
Quality Assurance:
- Be an integral part of the Quality Assurance team, fulfilling QA responsibilities as needed.
- Support the QA team in delivering high-quality services in accordance with the Medicines Act and Trust licenses.
- Assist in developing the QA service and provide expert advice on QA matters, with emphasis on Quality Control activity.
- Contribute to drug defect investigations, drug recalls, and investigation of patient complaints regarding Trust-manufactured products.
- Undertake validation reviews and stay updated on the latest QA guidelines.
- Ensure GMP activities align with regulatory and legal requirements and comply with current GMP, company SOPs, and Health and Safety policies/SOPs.
- Utilize the deviation reporting system and change control system, analyzing and trending data.
- Conduct internal audits of the Quality Control department and documentation control systems.
- Collaborate with other staff responsible for the environmental monitoring program.
Quality Control:
- Release raw materials and containers used in the manufacture of medicinal products.
- Undertake additional duties as required by the Quality Control Manager.
- Conduct QC research projects as needed.
- Support the laboratory's quality control activities, covering tasks during illness and annual leave.
- Manage the approval of starting material suppliers.
- Write departmental procedures in line with current guidelines.
Staff Supervision and Training:
- Introduce an ongoing training program for new users of eQMS.
- Assist in the training of pharmacists, chemists, pre-registration pharmacy graduates, technicians, and student technicians within and external to the trust, as necessary.
Education and Training/Research and Development Responsibilities:
- Investigate and implement the use of an electronic archiving system.
- Undertake continuous professional development.
Job description
Job responsibilities
The responsibilities include:
Quality Management and Documentation Control:
- Manage and maintain a comprehensive documentation control system across RFH Technical Services.
- Lead the implementation of eQMS for effective document control and quality management.
- Assist in transferring documents from the current filing system to the eQMS electronic Quality Management System.
- Oversee the day-to-day operation of eQMS.
- Utilize eQMS for maintaining version control of all GMP documents.
- Manage the review and approval process for all GMP documents.
- Drive the development and review of new and updated documents.
- Provide reports to Unit Managers on GMP documentation status, escalating concerns to the QA Specialist and the Head of Quality.
Quality Assurance:
- Be an integral part of the Quality Assurance team, fulfilling QA responsibilities as needed.
- Support the QA team in delivering high-quality services in accordance with the Medicines Act and Trust licenses.
- Assist in developing the QA service and provide expert advice on QA matters, with emphasis on Quality Control activity.
- Contribute to drug defect investigations, drug recalls, and investigation of patient complaints regarding Trust-manufactured products.
- Undertake validation reviews and stay updated on the latest QA guidelines.
- Ensure GMP activities align with regulatory and legal requirements and comply with current GMP, company SOPs, and Health and Safety policies/SOPs.
- Utilize the deviation reporting system and change control system, analyzing and trending data.
- Conduct internal audits of the Quality Control department and documentation control systems.
- Collaborate with other staff responsible for the environmental monitoring program.
Quality Control:
- Release raw materials and containers used in the manufacture of medicinal products.
- Undertake additional duties as required by the Quality Control Manager.
- Conduct QC research projects as needed.
- Support the laboratory's quality control activities, covering tasks during illness and annual leave.
- Manage the approval of starting material suppliers.
- Write departmental procedures in line with current guidelines.
Staff Supervision and Training:
- Introduce an ongoing training program for new users of eQMS.
- Assist in the training of pharmacists, chemists, pre-registration pharmacy graduates, technicians, and student technicians within and external to the trust, as necessary.
Education and Training/Research and Development Responsibilities:
- Investigate and implement the use of an electronic archiving system.
- Undertake continuous professional development.
Person Specification
Education & professional Qualifications
Essential
- Undergraduate or postgraduate degree in a Science related discipline or equivalent.
- Mandatory CPD to maintain fitness to practice
Desirable
- Specialist higher degree (Masters) or Diploma in Pharmacy and/or Technical Services related subject
- Full membership of a relevant Professional Body
Values
Essential
- Demonstrable ability to meet the Trust Values
Experience & Skills
Essential
- Relevant experience in the pharmaceutical industry or biotechnology industry with a thorough knowledge of Quality Management Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
- Evidence of management and support of QMS, including the documentation systems.
- Use and management of electronic documentation systems.
- Knowledge of COSHH and health and safety at work.
- Able to accurately follow written procedures and complete documentation accurately with attention to detail.
- Demonstrates ability to perform accurate complex calculations and numeracy skills.
- Ability to plan, prioritise, work unsupervised, to organise own time and work effectively in stressful situations.
- Able to communicate complex information effectively using clear and spoken English (verbal and written).
Desirable
- Experience of aseptic, and/or sterile/nonsterile manufacture.
- Experience in quality assurance /manufacturing (MS / Licensed /Section 10 manufacturing unit).
- Practical knowledge of and commitment to the principles of cGMP, GLP, QA and all current legislation and regulations and ability to apply this knowledge.
- Demonstrated knowledge of pharmaceutical microbiology.
Person Specification
Education & professional Qualifications
Essential
- Undergraduate or postgraduate degree in a Science related discipline or equivalent.
- Mandatory CPD to maintain fitness to practice
Desirable
- Specialist higher degree (Masters) or Diploma in Pharmacy and/or Technical Services related subject
- Full membership of a relevant Professional Body
Values
Essential
- Demonstrable ability to meet the Trust Values
Experience & Skills
Essential
- Relevant experience in the pharmaceutical industry or biotechnology industry with a thorough knowledge of Quality Management Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
- Evidence of management and support of QMS, including the documentation systems.
- Use and management of electronic documentation systems.
- Knowledge of COSHH and health and safety at work.
- Able to accurately follow written procedures and complete documentation accurately with attention to detail.
- Demonstrates ability to perform accurate complex calculations and numeracy skills.
- Ability to plan, prioritise, work unsupervised, to organise own time and work effectively in stressful situations.
- Able to communicate complex information effectively using clear and spoken English (verbal and written).
Desirable
- Experience of aseptic, and/or sterile/nonsterile manufacture.
- Experience in quality assurance /manufacturing (MS / Licensed /Section 10 manufacturing unit).
- Practical knowledge of and commitment to the principles of cGMP, GLP, QA and all current legislation and regulations and ability to apply this knowledge.
- Demonstrated knowledge of pharmaceutical microbiology.
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).
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).
