QA Team Lead GMP
Pharmaceutical Manufacturer seeks an experienced QA Team Lead for its Hertfordshire based manufacturing facility.
About the role:
Act as the Quality Management System specialist and be responsible for the daily operational activities of the Quality Assurance function which ensure the quality, safety and efficacy of released API's, excipients and food/beverage ingredients in accordance with EU GMP and BRC food standards and to provide leadership to develop staff and QMS, in line with the corporate vision for the site.
Duties may include:
Responsible for the management of a team of QA Officers
Deputise for the Head of Quality for Quality Assurance.
Responsible for the day-to-day operational functions of the QA team to ensure flow of products through the product lifecycle and batch review processes to meet compliance and commercial requirements. Key performance indicators include OTIF and BRFT.
Act as the site QMS Specialist championing improvements through risk management and root cause analysis. Provide training across site as required.
Responsible for the functional performance of the QMS, providing quality oversight to key stakeholders including the board.
Responsible for the management of the audit program including internal and external audits. Act as the audit lead when hosting external customer audits and support regulatory audits.
Responsible for external communication with regulatory bodies.
Skills and experience:
Extensive QMS knowledge including its management and improvement.
Qualification and Validation knowledge
Experience in hosting and conducting external audits, in a heavily regulated environment.
Expert knowledge of current GMP requirements
Awareness of Lean/Six sigma (preferred green belt certified)
Eligible to be a responsible person for controlled drugs.
Desirable: Supervisory experience
Desirable: Awareness of food safety and/or BRC requirements.
Good communicator across all levels and across departments, collaborative.
Proven track record of delivering improvements to processes & problem solving
Proven track record in positively influencing the performance of teams
About the role:
Act as the Quality Management System specialist and be responsible for the daily operational activities of the Quality Assurance function which ensure the quality, safety and efficacy of released API's, excipients and food/beverage ingredients in accordance with EU GMP and BRC food standards and to provide leadership to develop staff and QMS, in line with the corporate vision for the site.
Duties may include:
Responsible for the management of a team of QA Officers
Deputise for the Head of Quality for Quality Assurance.
Responsible for the day-to-day operational functions of the QA team to ensure flow of products through the product lifecycle and batch review processes to meet compliance and commercial requirements. Key performance indicators include OTIF and BRFT.
Act as the site QMS Specialist championing improvements through risk management and root cause analysis. Provide training across site as required.
Responsible for the functional performance of the QMS, providing quality oversight to key stakeholders including the board.
Responsible for the management of the audit program including internal and external audits. Act as the audit lead when hosting external customer audits and support regulatory audits.
Responsible for external communication with regulatory bodies.
Skills and experience:
Extensive QMS knowledge including its management and improvement.
Qualification and Validation knowledge
Experience in hosting and conducting external audits, in a heavily regulated environment.
Expert knowledge of current GMP requirements
Awareness of Lean/Six sigma (preferred green belt certified)
Eligible to be a responsible person for controlled drugs.
Desirable: Supervisory experience
Desirable: Awareness of food safety and/or BRC requirements.
Good communicator across all levels and across departments, collaborative.
Proven track record of delivering improvements to processes & problem solving
Proven track record in positively influencing the performance of teams