Job summary
An exciting opportunity has arisen for a Lead Technician - Validation and Quality Assurance to join our specialist team within the MHRA licenced Pharmacy Aseptic Services Unit at the Royal Surrey County Hospital.
This post offers a unique chance to play a pivotal role in the development of our new state-of-the-art aseptic unit, designed to support the safe manufacture of cytotoxic chemotherapy, monoclonal antibodies, clinical trials and gene therapy. The successful candidate will provide subject matter expertise in validation, qualification, and quality assurance, ensuring the unit operates to the highest GMP standards.
We are seeking an individual who is highly motivated, detail-oriented and organised, with proven experience in validation within a pharmaceutical or aseptic environment. The post holder should demonstrate excellent interpersonal and communication skills, with the ability to manage multiple priorities and contribute to the training and development of staff. A commitment to continuous professional development and to driving quality improvement is essential.
Main duties of the job
This role provides key Validation Subject Matter Expertise to ensure that the Pharmacy Aseptic Manufacturing Unit has the appropriate validated processes and qualified equipment in place to provide assurance that the unit manufactures sterile products. This subject matter expert is key to ensuring the department is compliant with the regulatory requirements of EU GMP.
Currently, the Trust is undertaking the build of a new aseptic unit, incorporating state-of-the-art cleanroom design and monitoring for aseptically manufactured products prepared under an MS licence for Systemic Anti-Cancer Therapy (SACT) products and aseptic clinical trials. The successful post holder will be critical to the delivery of the new aseptic unit project, providing technical expertise and oversight to the design, validation and start-up of the facility prior to opening.
About us
Royal Surrey is a compassionate and collaborative acute and community Trust. Recognising that our 5000 colleagues are our greatest strength, we offer a comprehensive health and wellbeing program along with a commitment to developing and advancing your career. Our diverse and welcoming Royal Surrey family will ensure you that you feel valued from your initial interview through your entire tenure.
We are clinically led and provide joined up care by bridging the gap between hospital and community services alongside regional specialist cancer care. Our main acute hospital site is in Guildford with community hospital sites at Milford, Haslemere and Cranleigh. We provide adult community health services in homes across Guildford and Waverley.
The Care Quality Commission (CQC) have given us an overall rating of Outstanding.
Royal Surrey has a strong reputation and history to build on. We are proud of our achievements and we are investing in our colleagues through our commitment to supporting professional development as well as investing more than £45 million in our physical environment and new equipment in the next few years. There has never been a better time to join us.
Although it isn't the Trusts normal practice, adverts may close early, so you are encouraged to submit an application as soon as possible.
A video about the Royal Surrey - https://www.youtube.com/watch?v=R96pMboIYdo
Job description
Job responsibilities
Responsible for ensuring equipment is suitable for its intended use through the development and execution of qualification documentation including facilities, utilities, equipment, and automation. Responsible for the creation and review of validation and qualification documentation. Provide Subject Matter Expertise with respect to validation of processes that support sterility assurance of aseptically prepared product. Review validation practices and processes in manufacturing facilities to ensure the approach taken is in line with industry best practice and meets regulatory requirements. Contribute to the management of all aspects of the units Planned Preventative Maintenance (PPM), calibration and validation programmes, ensuring that the activities are completed in accordance to schedules and meet regulatory requirements, and to provide reporting data. Participate in final checking and release activities of aseptically manufactured products and unlicensed medicines. Provide subject matter expert advice for the investigation of quality exception events and support the implementation of CAPA actions. Responsible for the direct line management of a limited number of pharmacy technicians and assistants. Responsible for providing support for the coordination and prioritisation of the Aseptic Unit workload. Responsible for ensuring compliance with departmental procedures, hospital policy and regulations including but not limited to EU GMP and MHRA licence requirements.
The post holder is required to support the documentation system and Pharmaceutical Quality System (PQS) by ensuring all validation activities comply with regulatory requirements and internal standards. Key responsibilities include: Assisting in the development, review, and maintenance of Standard Operating Procedures (SOPs), validation protocols, reports, and related documentation to ensure accuracy and completeness within the PQS framework, with a particular focus on validation activities. Performing or assisting with risk assessments related to equipment and processes to identify potential validation impacts and mitigation strategies. Ensuring that all documentation generated during validation is controlled, traceable, and archived according to the documentation system policies. Assist the Quality Controller with maintaining the site master file. Collaborating with cross-functional teams to identify validation needs and support continuous improvement of the PQS. Supporting the management and documentation of Pharmaceutical Quality System (PQS) items such as Change Control (CC), Corrective and Preventive Actions (CAPA), and Complaints, etc ensuring appropriate validation-related actions are initiated and tracked. Monitoring compliance with Good Manufacturing Practices (GMP) and other relevant regulatory guidelines throughout validation processes. Supporting audits and inspections related to validation activities by providing required documentation and evidence of compliance.
Responsible for the lifecycle of all validation activities undertaken in the aseptic pharmacy and the manufacturing unit including but not limited to: Development of validation approaches and documentation for facility, instrumentation, utilities and equipment. Development and maintenance of the Validation Master Plan (VMP). Perform/support temperature and humidity mapping studies for all the temperature controlled areas including fridges, freezers, incubators, rooms. Undertake/coordinate process validations including sterility, decontamination and cleaning validations as necessary. Creating, populating, and maintaining databases for tracking validation activities, test results, or validated systems. Decommissioning of facility, utility, and equipment including computerised systems. Ensuring the obsoleting of associated documentation such as SOPs, Forms and validation templates. Migration, archival and destruction requirements for historic data and records.
Deputise for the Chief Technician Quality Assurance for staff management and quality control responsibilities when required. Develop and maintain a strong working knowledge of all work, processes and procedures undertaken within the aseptic services department, other areas of Pharmacy and related disciplines. Propose changes to departmental policies and procedures and assist in the implementation of these. Propose and implement improvements to planned preventative maintenance and validation programs.
Be a signatory for the departmental keys. Take responsibility for the security of the Pharmacy department whilst in possession of the keys. Log all consumables transferred into the Aseptic Unit according to departmental procedures. Be responsible for minimising drug wastage by ensuring drugs are prepared within the correct time frame ensuring drugs are available and suitable for use at the agreed time of administration. Participate in the management of aseptic stock, ensuring the electronic stock management system is updated appropriately.
Ensure products are prepared in a timely manner in order to meet agreed turnaround times for wards and external customers. Prioritise workload accordingly. Accurately label aseptically prepared products. Responsible for the final check and release of licensed aseptic products, having completed the appropriate accreditation, providing high quality, sterile products in a ready to use form. As part of the final check / release role ensure environmental monitoring, cleaning and operator validations have been undertaken. Take action to resolve any out of specification results before products are released.
Job description
Job responsibilities
Responsible for ensuring equipment is suitable for its intended use through the development and execution of qualification documentation including facilities, utilities, equipment, and automation. Responsible for the creation and review of validation and qualification documentation. Provide Subject Matter Expertise with respect to validation of processes that support sterility assurance of aseptically prepared product. Review validation practices and processes in manufacturing facilities to ensure the approach taken is in line with industry best practice and meets regulatory requirements. Contribute to the management of all aspects of the units Planned Preventative Maintenance (PPM), calibration and validation programmes, ensuring that the activities are completed in accordance to schedules and meet regulatory requirements, and to provide reporting data. Participate in final checking and release activities of aseptically manufactured products and unlicensed medicines. Provide subject matter expert advice for the investigation of quality exception events and support the implementation of CAPA actions. Responsible for the direct line management of a limited number of pharmacy technicians and assistants. Responsible for providing support for the coordination and prioritisation of the Aseptic Unit workload. Responsible for ensuring compliance with departmental procedures, hospital policy and regulations including but not limited to EU GMP and MHRA licence requirements.
The post holder is required to support the documentation system and Pharmaceutical Quality System (PQS) by ensuring all validation activities comply with regulatory requirements and internal standards. Key responsibilities include: Assisting in the development, review, and maintenance of Standard Operating Procedures (SOPs), validation protocols, reports, and related documentation to ensure accuracy and completeness within the PQS framework, with a particular focus on validation activities. Performing or assisting with risk assessments related to equipment and processes to identify potential validation impacts and mitigation strategies. Ensuring that all documentation generated during validation is controlled, traceable, and archived according to the documentation system policies. Assist the Quality Controller with maintaining the site master file. Collaborating with cross-functional teams to identify validation needs and support continuous improvement of the PQS. Supporting the management and documentation of Pharmaceutical Quality System (PQS) items such as Change Control (CC), Corrective and Preventive Actions (CAPA), and Complaints, etc ensuring appropriate validation-related actions are initiated and tracked. Monitoring compliance with Good Manufacturing Practices (GMP) and other relevant regulatory guidelines throughout validation processes. Supporting audits and inspections related to validation activities by providing required documentation and evidence of compliance.
Responsible for the lifecycle of all validation activities undertaken in the aseptic pharmacy and the manufacturing unit including but not limited to: Development of validation approaches and documentation for facility, instrumentation, utilities and equipment. Development and maintenance of the Validation Master Plan (VMP). Perform/support temperature and humidity mapping studies for all the temperature controlled areas including fridges, freezers, incubators, rooms. Undertake/coordinate process validations including sterility, decontamination and cleaning validations as necessary. Creating, populating, and maintaining databases for tracking validation activities, test results, or validated systems. Decommissioning of facility, utility, and equipment including computerised systems. Ensuring the obsoleting of associated documentation such as SOPs, Forms and validation templates. Migration, archival and destruction requirements for historic data and records.
Deputise for the Chief Technician Quality Assurance for staff management and quality control responsibilities when required. Develop and maintain a strong working knowledge of all work, processes and procedures undertaken within the aseptic services department, other areas of Pharmacy and related disciplines. Propose changes to departmental policies and procedures and assist in the implementation of these. Propose and implement improvements to planned preventative maintenance and validation programs.
Be a signatory for the departmental keys. Take responsibility for the security of the Pharmacy department whilst in possession of the keys. Log all consumables transferred into the Aseptic Unit according to departmental procedures. Be responsible for minimising drug wastage by ensuring drugs are prepared within the correct time frame ensuring drugs are available and suitable for use at the agreed time of administration. Participate in the management of aseptic stock, ensuring the electronic stock management system is updated appropriately.
Ensure products are prepared in a timely manner in order to meet agreed turnaround times for wards and external customers. Prioritise workload accordingly. Accurately label aseptically prepared products. Responsible for the final check and release of licensed aseptic products, having completed the appropriate accreditation, providing high quality, sterile products in a ready to use form. As part of the final check / release role ensure environmental monitoring, cleaning and operator validations have been undertaken. Take action to resolve any out of specification results before products are released.
Person Specification
Qualifications
Essential
- Bachelor of Science degree in pharmacy, engineering or related scientific discipline and/or extensive experience to equivalent level working in a pharmaceutical validation role.
Desirable
- Master's degree in science or engineering subject or other postgraduate qualification relevant to pharmaceutical science e.g. PTQA.
- Registered with relevant professional body.
Knowledge and Experience
Essential
- Quality and compliance experience within a GMP manufacturing environment, with an element of writing of qualification / validation protocols and reports
- Previous experience of working at supervisory / management level.
- Proven experience of writing and reviewing protocols, reports and procedures.
- Proficient in using computerised systems for entering, tracking, and analysing validation data, including trending and reporting functionalities.
- Hands-on experience operating pharmaceutical isolators with integrated gassing systems used for aseptic processing.
- Direct involvement in the commissioning and qualification of cleanroom environments and associated production equipment.
- Experience with Quality Management Systems (QMS), including documentation control, audit readiness, and continuous improvement practices
- In-depth knowledge and applied understanding of GMP, cleanroom protocols, and validation principles.
Desirable
- Previous experience participating in internal and external audits.
Person Specification
Qualifications
Essential
- Bachelor of Science degree in pharmacy, engineering or related scientific discipline and/or extensive experience to equivalent level working in a pharmaceutical validation role.
Desirable
- Master's degree in science or engineering subject or other postgraduate qualification relevant to pharmaceutical science e.g. PTQA.
- Registered with relevant professional body.
Knowledge and Experience
Essential
- Quality and compliance experience within a GMP manufacturing environment, with an element of writing of qualification / validation protocols and reports
- Previous experience of working at supervisory / management level.
- Proven experience of writing and reviewing protocols, reports and procedures.
- Proficient in using computerised systems for entering, tracking, and analysing validation data, including trending and reporting functionalities.
- Hands-on experience operating pharmaceutical isolators with integrated gassing systems used for aseptic processing.
- Direct involvement in the commissioning and qualification of cleanroom environments and associated production equipment.
- Experience with Quality Management Systems (QMS), including documentation control, audit readiness, and continuous improvement practices
- In-depth knowledge and applied understanding of GMP, cleanroom protocols, and validation principles.
Desirable
- Previous experience participating in internal and external audits.
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).
