Reporting to tech transfer QO Lead, the QA specialist will be responsible for all QA activities associated with the technical transfer of a number of new processes. These will include (but not limited to): Purchased material qualification, equipment C+Q support, documentation GMP review, QC, etc.
* Product release including incorporation of Lean/Agile principles to ensure efficient documentation review, batch approval/release and labelling.
* Review and approval of quality related documentation including: master batch records, cleaning records, SOPs, change controls, LIRs, and quality actions ensuring adherence to cGMPs, regulatory filing and site procedures
* Ensure production equipment is inspected during cleaning and conduct swabbing, if required
* Be an active member of process teams with a focus on ensuring quality and cGMP compliance, effective deviation investigations and continuous improvement in all aspects of operations
* Lead and/or participate in X-Matrix projects
* Lead the compilation and approval of Annual Product Reviews as per Site Schedule.
* Lead/participate in internal audits to ensure that site maintains high standards and strong quality systems
* Preparation for and take part in external regulatory and corporate quality audits, as required.
* Provide training, support and advice to colleagues on-site to facilitate cGMP improvement and best practice.
* Support other Quality Systems, as required, including supplier management/qualification; equipment, process and cleaning validation and Site Quality Review Team.
* BSc in Chemistry or equivalent.
* Thorough working knowledge of GMP's and regulatory expectations for manufacturing of APIs.
* Minimum of 1 year of experience working in Quality Assurance in the pharmaceutical manufacturing industry, across the main areas of responsibility of the role.
* The ideal candidate will be a self starter with the ability to work on their own initiative and within teams.
* Strong communication and organizational skills are important.
* Excellent ability to deliver results, with strong interpersonal and influencing skills.
* Ability to build relationships internally and externally.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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The Life Science Specialists