GMP QA Documentation Specialist

Mennonite Economic Development Associates (MEDA); Wales; On-site; GBP 35,000 - 50,000; Full time

Job summary

Bimeda is seeking a QA Documentation Specialist to maintain site QA/QMS documentation and oversee archival processes in a regulated environment. You will review release documentation, manage SOPs, and contribute to batch release activities with a focus on accuracy and compliance.

The role involves handling CoC/CoA generation, packaging specifications, and line setup approvals. Strong analytical skills and meticulous attention to detail are essential for success.

Qualifications

• Experience in regulated environments (GMP/GDP or food manufacture).
• Strong analytical and quantitative skills.
• Proficiency with Microsoft Office suite.
• Self-initiating and able to work independently.
• Attention to detail and thorough documentation practices.

Responsibilities

• Maintain site QA/QMS documentation systems and archive materials.
• Review Bimeda and third-party release documentation; ensure QMS accuracy.
• Perform incoming inspections and QA reviews for batch releases.
• Develop and maintain SOPs; issue controlled documents.
• Prepare CoC/CoA drafting for finished products and packaging specs.
• Oversee packaging line setup approvals and inventory release checks.

Skills

Analytical thinking

Collaboration

Effective communication

Judgement

Process improvement

Tools

Microsoft Office

Job description

Bimeda is seeking a QA Documentation Specialist to maintain site QA/QMS documentation and oversee archival processes in a regulated environment. You will review release documentation, manage SOPs, and contribute to batch release activities with a focus on accuracy and compliance.

The role involves handling CoC/CoA generation, packaging specifications, and line setup approvals. Strong analytical skills and meticulous attention to detail are essential for success.