Pfizer Senior Quality Specialist in Hurley, United Kingdom
Senior Quality Specialist - Batch Release
To provide Quality supervision and support to the Quality Assurance (Batch Release) group in order to ensure business requirements and market needs are met, including agreement and supervision of batch release activities.
To provide Technical Expertise in issue resolution and impact assessment for aseptically manufactured and terminally sterilized products, relating to production activities, operator interventions, environmental monitoring and support activities.
To provide support to maintain appropriate compliance oversight for the Batch Release group, including but not limited to: batch document review, support document review/approval, investigation support, review and approval, and support documentation where required.
To ensure Quality Systems supporting Batch Release are operating effectively and utilised in order to support effective and robust decision making.
To act as the Subject Matter Expert for Production Processes within the Batch Release group, supporting QAOs, QPs, Supply Chain, Above Market Planners, Logistics, Customer Service and L-AQO
To liaise with PGS sites and third party contractor CMOs as required as part of the Batch Release process for release of medicinal products.
To act as primary contact for routine Batch Release activities internally and externally.
To support site inspections (internal and external).
To improve and implement Quality Systems and Compliance within Batch Release and across site as necessary in line with corporate and regulatory requirements.
To act a key pillar in the Batch Release On-boarding programme by providing training and coaching to new team members, and to support routine refresher training activities on Quality and Compliance matters.
To lead Continuous Improvement initiatives.
To work independently on technical support and troubleshooting activities within the Batch Release Team.
To ensure batch review activities are ensuring compliance to the site MIA and product Market Authorisations.
To ensure that the Quality Systems within Batch Release are implemented in compliance with regulatory/corporate expectations in order to support decision-making.
To review, challenge and improve Quality Systems and Procedures to ensure Continuous Improvement; to take part in effective training and roll-out of Quality Systems and procedures.
To ensure that all metrics required by site and corporate procedures are gathered, assessed and reported in a timely fashion.
To ensure that all inspection issues raised by internal (site and Corporate) and external bodies are comprehensively resolved to the agreed timescales; to support site permanent inspection readiness.
To ensure that appropriate assistance is provided within QA Operations and across other service departments in order to resolve issues.
To liaise with and provide technical support to QA Operations and external parties as required.
To liaise with PGS sites and contract laboratories for routine testing and release activities and to ensure Continuous Improvement in site related Batch Release processes.
To resolve any Batch Release related issues through appropriate investigation, risk assessment or collaboration across the network and externally as required.
To lead Quality/ CI Projects and provide Quality support to projects across the Hurley and Zaventem Site.
To resolve issues through appropriate investigation and risk assessment.
To carry out Supplier or Vendor Quality audits as required.
Required skills and experience:
A minimum degree in life sciences, preferable with MSc in life sciences.
Extensive experience in the life sciences / GMP environment.
Experience of production environment with broad experience across production activities; ideally with dosage form experience of injectable products.
Closing date: April 30th.
All applicants must have the relevant authorisation to live and work in the UK.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.