Senior Quality Assurance Specialist
Website Wasdell Group
Due to further expansion of the Quality department, Wasdell are looking for an experienced 'Senior QA Specialist' to join our headquarters in Swindon.
The Wasdell Group provides the pharmaceutical and nutraceutical industries with solutions to a range of outsourcing requirements. Established in 1971, with multiple sites in the United Kingdom and employing over 500 people, the group offers an impressive range of technical, manufacturing, packaging and storage/distribution services.
This is a full-time role working five days per week, Monday to Friday 8-5pm.
- Deputise for the QA Manager during occasional short term absence.
- Preparation of Master Batch Records for selected licensed medicines, Investigational Medicinal Products (IMP) and associated revisions.
- Technical Dossier and Product Specification File (PSF) preparation and maintenance.
- Training / supervision of production and QA staff in clinical trial / commercial packaging and labelling activities as appropriate.
- Support the New Product Introduction (NPI) process and support general customer requests in order to deliver new products/ projects.
- Represent Quality for site projects, incudes liaising with all departments at Swindon and as appropriate with other sites.
- Review of batch documentation for completed batches prior to QP / Head of Quality / QA Manager Release.
- Carry out investigations into customer complaints and deviations and replying on behalf of the company.
- To approve Master Packaging Instructions and Standard Operating Procedures (SOPs).
- Liaise with production on day to day quality issues.
- Supporting Regulatory and Customer audits.
- Assist in validation and qualification activities where required.
- Internal and external auditing.
- Preparation and update of Quality System SOPs.
- Completion of CAPAs assigned.
- Completion of Change controls assigned.
The Senior Quality Assurance Specialist has responsibility for driving new projects and new business activities involving QA department. This includes but is not limited to:
- Oversight of clinical trial / commercial packaging and labelling activities at Swindon. This includes the generation of the MBRs, PSF and Technical Dossier creation & maintenance and training / supervision of staff in these activities.
- Oversight of serialisation activities at Swindon. This includes maintenance of relevant QA SOPs and training of QA staff.
- Technical QA input into new business / products /projects at Swindon.
If you are interesting in hearing more about the role and would like to apply, please send your CV by applying below.
Look forward to hearing from you.
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