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A generic pharmaceutical company in London is looking for maternity cover (12 Months) for a Senior QA Officer.
Responsibilities will be focused on artwork component management for marketed products, master document approval (BPRs) and change control handling.
Main accountabilities/ activities:
- Artwork management for marketed products, (including artwork approval coordination (with RA dept and contract manufacturers (CMOs)), artwork implementation management (with commercial dept and CMO), artwork log maintenance, artwork change impact assessment and artwork component periodic reviews)
- Review and approval of Batch Packing Record master documents, for allocated CMO(s)
- Handling allocated change requests and change controls - mostly likely to be product safety or artwork change related.
- Perform a defined set of pre-release checks per batch for allocated batches, prior to presenting the batch documentation to the UK QP for batch review and certification.
- Coordinating with third party batch release site for EU batch release, including maintaining product reference files and provision of all documentation required for QP review and batch release.
- Assist with other aspects of the Company’s Quality Management System, as required by the QA department workload.
KNOWLEDGE / EXPERIENCE / REQUIREMENTS
- 3-5 years’ experience in pharmaceutical Quality Assurance.Ideally with experience in the areas of pharmaceutical packing or artwork management
- Bachelor’s degree in a relevant science field, (e.g. chemistry, pharmacy)
- Good IT and computer skills, including with standard software packages (Word, Excel, Acrobat etc). Ideally experience using an electronic quality management system.
- Ability to understand and work following written procedures, with a logical and methodical approach to performing duties.
- Good organisational skills with good attention to detail and ability to learn processes quickly
- Good interpersonal, communication and team working skills.
Skills: QA, Batch documentation, artwork component management, CMO, Science Degree, Pharmaceutical, Quality Management System,
To apply for this position, candidates must be living in the UK and eligible to and work
