QA Documentation Specialist (GMP/QMS)

Bimeda, Inc.; United Kingdom; Remote; GBP 32,000 - 52,000; Full time

Job summary

Bimeda is seeking a QA specialist in the United Kingdom to effectively maintain site QA / QMS documentation systems and QC testing activity for materials and finished product.

The role covers review of release documentation, management of the retain room, SOP development support, and generating CoC/CoA for batches, while ensuring GMP/GDP and cGMP compliance across packaging and production records.

Qualifications

• Experience in GMP/GDP or Food Manufacture.
• Proficient in Microsoft Office.
• Self-initiating / self-directed.
• Problem solving using robust tools.
• Thorough and detail oriented.
• 2+ years’ experience within GMP Manufacturing.
• Understanding of quality systems and cGMPs.
• Previous lab environment experience.

Responsibilities

• Maintain site QA / QMS documentation systems.
• Review Bimeda and third-party product release documentation and maintain MRP inventory status.
• Maintenance of finished product retains and the retain room including annual inspections.
• Complete incoming inspection and verification checks for receipt of human pharmaceutical product.
• Assist in the preparation of QA SOPs and issue control for SOPs.
• Assist in generation and maintenance of packing, artwork and material specifications.
• Generate and maintain artwork specification files and artwork update requests.
• Responsible for incoming QC inspection of all packaging components and materials.
• QA Batch review of production dispensing / packing records and manufacturing records.
• Review third party QC testing reports and generate batch CoC and inventory release.
• Primarily responsible for packaging line set up approval and packed stock pallet checks.
• Complete in-house QC testing reports and draft CoA for batch testing.

Skills

Analytical thinking

Collaboration

Effective communication

Judgement

Process improvement

Tools

Microsoft Office

Job description

Bimeda is seeking a QA specialist in the United Kingdom to effectively maintain site QA / QMS documentation systems and QC testing activity for materials and finished product.

The role covers review of release documentation, management of the retain room, SOP development support, and generating CoC/CoA for batches, while ensuring GMP/GDP and cGMP compliance across packaging and production records.