Provide quality oversight on design and qualification activities as part of the introduction of new equipment and modification of existing equipment in order to facilitate new product introductions.
- Supporting the qualification and validation activities and agreeing best practices in line with applicable GMP Regulations.
- Quality SME for the execution and reporting phases of the qualification and validation activities associated with the facility.
- Review and Approve all documentation where required specific to Qualification / Validation activities.
- Ensure any investigations / deviations associated with the validation activities are thoroughly investigated and closed in a timely manner
- Oversee the Project Change Management Process and approve Project Change Requests where required.
- Minimum of 10 years’ experience in a QA/Validation related position within the pharmaceutical or life-sciences industry.
- Strong experience with Validation in project related activities i.e. Experience of the Validation lifecycle particularly the qualification of process equipment, utilities and HVAC associated within a Drug Substance facility.
- Strong experience in Validation to ensure compliance to Annex 15, EU regulations, applicable US FDA Guidelines and ASTM E2500
- Strong experience of Computer System Validation regulations in line with 21 CFR Part 11, Annex 11 and Annex 15.
- Knowledge and understanding of EU and US cGMP regulations with respect to the validation, production and testing of pharmaceutical and/or biological products.
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