Proclinical is advertising a vacancy for a Senior Production Specialist position with one of the most prestigious pharmaceutical companies in the world. This internationally recognised organisation specialises in developing and producing medicines and vaccines for a wide range of therapeutic areas including oncology, cardiology and immunology. This is a brilliant opportunity to work alongside a historic and innovative company in their office in Berkshire.
The Senior Production Specialist will provide Technical Expertise in issue resolution and impact assessment for aseptically manufactured and terminally sterilized products, including deviation impact assessment, assembly, cleaning, processing, full batch review, and compliance to module 3 regulatory dossiers. Furthermore, they will be the Subject Matter Expert for Production Processes within the Batch Release group, supporting QAOs, QPs, Supply Chain, Above Market Planners, Logistics, Customer Service, and Markets. Finally, the Senior Production Specialist will provide support to maintain appropriate compliance oversight for the Batch Release group.
Job Responsibilities:
- Working independently on production/technical support and troubleshooting activities within the Batch Release Team.
- Liaising with and providing production technical support to Quality Operations and external parties as required.
- Carrying out Supplier or Vendor Quality audits and technical visits as required.
- Ensuring batch review activities are ensuring compliance to the site MIA and product Market Authorisations.
- Ensuring that the Quality Systems within Batch Release are implemented in compliance with regulatory/corporate expectations in order to support decision-making.
- Reviewing, challenging, and improving Quality Systems and Procedures to ensure Continuous Improvement; taking part in effective training and roll-out of Quality Systems and procedures.
- Ensuring that all metrics required by site and corporate procedures are gathered, assessed, and reported in a timely fashion.
- Ensuring that all inspection issues raised by internal (site and Corporate) and external bodies are comprehensively resolved to the agreed timescales; supporting site permanent inspection readiness.
- Ensuring that appropriate assistance is provided within QA Operations and across other service departments in order to resolve issues.
- Liaising with PGS sites and contract laboratories for routine testing and release activities and ensuring Continuous Improvement in site related Batch Release processes.
- Resolving any Batch Release related issues through appropriate investigation, risk assessment, or collaboration across the network and externally as required.
- Liaising Quality/ CI Projects and providing Quality support to projects across the Hurley and Zaventem Site.
- Resolving issues through appropriate investigation and risk assessment.
Skills and Requirements:
- Degree in science-based subject, preferably Biological Sciences, Chemistry, Biochemistry, Pharmacy, or Microbiology.
- Qualification as a Lead Auditor.
- At least 5 years of experience working in a sterile GXP production environment, though 8 years is preferred.
- At least 5 years of direct experience with a multi-dose GXP production environment.
- Extensive knowledge of cGMP and its implementation by EMEA and FDA authorities.
- Auditing Frontline exposure to MHRA/EMEA inspections (FDA would also be an advantage).
- An extensive knowledge of corporate quality systems that are applicable to the quality unit and the production operations serviced.
- Good understanding where appropriate of analytical techniques utilized in the QC unit.
- A thorough understanding of applicable corporate systems used within the area (training can be provided).
- The ability to lead CI teams using DMAIC methodology would be an advantage.
- The ability to complete complex risk assessments.
- The ability to lead complex investigations through to true root cause and provide appropriate CAPA.
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 contact Caleb Mensah at +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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