Job description 2021-02-23
Job description
Job title Head of Quality Control
Division Quality
Career Level 1
Responsible to Director of Quality
INTRODUCTION
Porton Biopharma Ltd, Porton Down is a medium sized life-science company performing a
range development and manufacturing roles for biopharmaceuticals. This also includes all
associated support functions from logistics through to engineering, quality control / quality
assurance, regulatory affairs and management. The Company manufactures two licensed
products, Erwinase® and the UK’s Anthrax Vaccine as well as providing R&D services for
product development. JOB SUMMARY To lead and manage a team engaged in Quality Control in both Analytical Chemistry and
Microbiology testing in line with regulatory requirements, safety standards and within budget
constraints. To ensure that changes in world-wide pharmaceutical regulations are recognized
and incorporated into QC working practices. Communication and key working relationships Internal Director of Quality Director / Deputy Manager of Pharmaceutical Production Quality Managers Qualified Persons Validation Manager Regulatory Affairs Operations Project Management Capital Projects Management External MHRA (Medicines and Healthcare Regulatory Agency DEFRA (Department for Environment Food and Rural Affairs) NIBSC (National Institute for Biological Standards and Control) Commercial customers FDA (Food and Drug Administration of America)
MAIN DUTIES AND RESPONSIBILITIES
To ensure that all testing is carried out with properly developed validated and approved methods. To ensure that the facilities are maintained to meet all necessary operational standards and regulations. To lead the regular review of Safety standards for the QC laboratories and related equipment. Utilising input from relevant functions, Operational Project and Production management, take all decisions relating to the routine operations of the facilities. To ensure sufficient suitably trained staff are in place to carry out the testing and supervision of the testing, procedures and equipment. To lead the training, management, appraisal and mentoring of staff to ensure performance, safety and training standards are achieved. To review and implement an organisation structure and work patterns fit to meet the needs of process and production and where necessary propose and implement change. To recruit suitable staff and to plan staff development succession planning to meet current and future needs of the process and production. To act as the lead expert on Analytical Methodology and ensure that all laboratory practices, methods and reporting procedures are compliant with Pharmacopoeias and
international guidelines as developed by ICD and applicable ISO standards. To manage the capacity for all Quality Department Testing through the Capacity and Demand Manager to meet agreed dates for completion. To ensure that all processes and procedures are documented and current for the operation of the facility. To monitor performance and capacity of test equipment and via contribution to the Pharmaceutical Operations Budgets, recommend and provide justification for new
investment. Other
The above is only an outline of the tasks, responsibilities and outcomes required of the role. You will carry out any other duties as may reasonably be required by the directorate. The job description and person specification may be reviewed on an ongoing basis in accordance with the changing needs of the organisation. Professional development You should pursue a programme of continuous professional development in accordance with any relevant professional registration or statutory requirements, while maintaining appropriate awareness of service provider requirements. You should adhere PBL values and behaviors: Passion Respect Integrity Diligence Excellence in Execution (E²)
Person specification
Essential Desirable
Eligibility Current, valid Right to Work in the UK A good standard of written and spoken English Language
Qualification Educated to degree level in relevant a life science subject or
equivalent level qualification or significant experience o working
at a similar level in specialist area. Knowledge and experience
Experience as defined by type/level (not length) Substantial knowledge and understanding of MHRA and FDA
regulatory requirements in relation to QC
Extensive management experience of pharmaceutical QC
laboratories Experience of in-process and final product QC testing of
biopharmaceutical products Experience of analytical method development and validation Skills and capabilities Problem solving skills and ability to respond to sudden
unexpected demands Demonstrated capability to plan over short, medium and long-
term timeframes and adjust plans and resource. Comprehensive experience of project principles techniques
and tools such a Prince 2 and Managing Successful Projects Must be able to priorities own work effectively and be able to
direct activities of others. Experience of managing and
motivating a team and reviewing performance of the
individuals. Equality and diversity
An understanding of and commitment to equality of opportunity and good working relationships, both in terms of day-to-day working practices, but also in relation to management systems
range development and manufacturing roles for biopharmaceuticals. This also includes all
associated support functions from logistics through to engineering, quality control / quality
assurance, regulatory affairs and management. The Company manufactures two licensed
products, Erwinase® and the UK’s Anthrax Vaccine as well as providing R&D services for
product development. JOB SUMMARY To lead and manage a team engaged in Quality Control in both Analytical Chemistry and
Microbiology testing in line with regulatory requirements, safety standards and within budget
constraints. To ensure that changes in world-wide pharmaceutical regulations are recognized
and incorporated into QC working practices. Communication and key working relationships Internal Director of Quality Director / Deputy Manager of Pharmaceutical Production Quality Managers Qualified Persons Validation Manager Regulatory Affairs Operations Project Management Capital Projects Management External MHRA (Medicines and Healthcare Regulatory Agency DEFRA (Department for Environment Food and Rural Affairs) NIBSC (National Institute for Biological Standards and Control) Commercial customers FDA (Food and Drug Administration of America)
MAIN DUTIES AND RESPONSIBILITIES
To ensure that all testing is carried out with properly developed validated and approved methods. To ensure that the facilities are maintained to meet all necessary operational standards and regulations. To lead the regular review of Safety standards for the QC laboratories and related equipment. Utilising input from relevant functions, Operational Project and Production management, take all decisions relating to the routine operations of the facilities. To ensure sufficient suitably trained staff are in place to carry out the testing and supervision of the testing, procedures and equipment. To lead the training, management, appraisal and mentoring of staff to ensure performance, safety and training standards are achieved. To review and implement an organisation structure and work patterns fit to meet the needs of process and production and where necessary propose and implement change. To recruit suitable staff and to plan staff development succession planning to meet current and future needs of the process and production. To act as the lead expert on Analytical Methodology and ensure that all laboratory practices, methods and reporting procedures are compliant with Pharmacopoeias and
international guidelines as developed by ICD and applicable ISO standards. To manage the capacity for all Quality Department Testing through the Capacity and Demand Manager to meet agreed dates for completion. To ensure that all processes and procedures are documented and current for the operation of the facility. To monitor performance and capacity of test equipment and via contribution to the Pharmaceutical Operations Budgets, recommend and provide justification for new
investment. Other
The above is only an outline of the tasks, responsibilities and outcomes required of the role. You will carry out any other duties as may reasonably be required by the directorate. The job description and person specification may be reviewed on an ongoing basis in accordance with the changing needs of the organisation. Professional development You should pursue a programme of continuous professional development in accordance with any relevant professional registration or statutory requirements, while maintaining appropriate awareness of service provider requirements. You should adhere PBL values and behaviors: Passion Respect Integrity Diligence Excellence in Execution (E²)
Person specification
Essential Desirable
Eligibility Current, valid Right to Work in the UK A good standard of written and spoken English Language
Qualification Educated to degree level in relevant a life science subject or
equivalent level qualification or significant experience o working
at a similar level in specialist area. Knowledge and experience
Experience as defined by type/level (not length) Substantial knowledge and understanding of MHRA and FDA
regulatory requirements in relation to QC
Extensive management experience of pharmaceutical QC
laboratories Experience of in-process and final product QC testing of
biopharmaceutical products Experience of analytical method development and validation Skills and capabilities Problem solving skills and ability to respond to sudden
unexpected demands Demonstrated capability to plan over short, medium and long-
term timeframes and adjust plans and resource. Comprehensive experience of project principles techniques
and tools such a Prince 2 and Managing Successful Projects Must be able to priorities own work effectively and be able to
direct activities of others. Experience of managing and
motivating a team and reviewing performance of the
individuals. Equality and diversity
An understanding of and commitment to equality of opportunity and good working relationships, both in terms of day-to-day working practices, but also in relation to management systems
