Senior Quality Specialist

A global pharmaceutical giant is looking for a Senior Quality Specialist to join their team in Maidenhead, UK on a contract basis.

Job Role:

• 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 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.

Role Responsibilities:

• 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 resolve any Batch Release related issues through appropriate investigation, risk assessment or collaboration across the network and externally as required.
• To resolve issues through appropriate investigation and risk assessment.
• To carry out Supplier or Vendor Quality audits as required.

Education, Skills and Experience:

• Degree in a science-based subject, preferably Biological Sciences, Chemistry, Biochemistry, Pharmacy or Microbiology.
• Experience working in a GXP environment.
• Direct experience of Batch Release in a virtual environment would be an advantage.
• Extensive knowledge of cGMP and its implementation by EMEA and FDA authorities.
• Extensive knowledge of corporate quality systems that are applicable to the quality unit and the production operations serviced.
• Good understanding of analytical techniques utilized in the QC unit, when appropriate
• Thorough understanding of applicable corporate systems used within the area (training provided).
• Frontline exposure to MHRA/EMEA inspections (FDA would also be an advantage).

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Caleb Mensah on +44 203 854 1080 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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