Job Title: Senior R&D QA Steriles Specialist
SRG is currently working with a leading pharmaceutical organisation located in Runcorn who are currently looking for a QA Specialist to provide expertise in QA to the New Product Development and Technical Support functions.
In this role, you will provide the oversight to ensure new products and processes are designed, developed and introduced to the respective manufacturing site in compliance with current Good Manufacturing Practices.
In particular, to provide ongoing expert advice and problem solving on aseptic processing manufacturing, filling and packaging activities; facilitating the development of robust policies, processes and procedures in support of the Production processes to ensure compliance with global, site and regulatory expectations.
- To support activities within the Generic R & D (New Product Development) Department, Technical Support functions and external Teva partners, to ensure that current Good Manufacturing Practices, Teva Global Policies and Standards and relevant Regulatory Authority requirements are met.
- Review R&D QA systems and processes to ensure best practice, using continuous improvement to suggest system improvements.
- To review and approve all documentation generated in support of new products and processes to ensure compliance with regulatory requirements.
- To assess current and developing regulations and regulatory position in order to develop and implement changes within the business to ensure continued compliance.
- Ensure all OOS results and unplanned deviations with respect to NPD are fully investigated and documented and any corrective and preventative actions identified are implemented.
- Understanding of Teva pharmaceutical development process (including the QMS), and contributing to Quality related decisions that affect product development.
- Minimum degree qualified in a pharmaceutical discipline with evidence of ongoing professional development.
- Experience in a QA managerial/Microbiologist position within a similar steriles environment MUST have steriles (liquids) experience
- Minimum of 2 years in a Quality Assurance role in a modern manufacturing/R&D environment within the pharmaceutical industry.
- Experience in steriles operations to EU and FDA standards.
- Strong experience of new product introduction from development to final approval. Experience with reviewing and assessing the suitability of new product licence dossiers/submissions.
- Experience with Regulatory inspections (either hosting or being a key presenter).
If you would like to apply for this position, please use the link provided. Alternatively please email a copy of your CV to firstname.lastname@example.org For more information regarding this position or any others, please call Emma on 0161 868 2222
SRG is the UK's number one recruitment company specialising in the scientific, engineering, clinical, pharmaceutical, food/FMCG, energy & renewables, biotech, chemical and medical device sectors.
As scientists ourselves, our specialist sector knowledge and our passion are second to none. It's this combination that makes us different. We're committed to providing outstanding temporary, contract and permanent career opportunities of all levels for our candidates and a comprehensive range of expert strategic recruitment services for our clients.
If you have a scientific background and this position is not relevant / suitable for you, please feel free to get in touch or visit www.srg.co.uk to view our other vacancies.
Key words: Quality / QA / Pharmaceuticals / GMP / Steriles / Sterilisation / NPD / Regulatory / Regulations / OOS / QMS
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