GMP QA Specialist – Batch Release & Quality Compliance

Advanced Resource Managers Ltd; Ware; On-site; GBP 28,000 - 45,000; Full time

Benefits offered by this job

Contract position in GMP environment

Job summary

Advanced Resource Managers Ltd. is seeking an experienced QA Specialist to review and approve GMP documentation for Investigational Medicinal Products at a client facility in Hertfordshire. The role focuses on batch release, QMS records, and CAPA actions within a high-pressure environment.

The ideal candidate will have a Bachelor's degree and 5+ years in a similar QA/QAQC role, with strong GMP knowledge and the ability to drive process improvements in a packaging/third-party setting.

Qualifications

• Bachelor's degree or equivalent work experience in QA/Manufacturing/Pharmaceuticals.
• Experience QA review of GMP documentation and batch release processes.
• Ability to interpret GMP principles and make quality decisions under pressure.
• Experience with QMS activities (deviations, complaints, change controls).

Responsibilities

• Serve as Batch Release Officer for review and release of GMP documentation for dosage forms and clinical trial packs.
• Assess Quality QMS Records and recommend CAPAs.
• Follow up on implementation of recommendations.
• Review and Approve GMP documentation (Packaging Specifications, Quality Agreements, Change Controls).
• Provide advice and support on quality matters and process improvements.
• Develop processes for Quality R&D Packaging Third Party group and related areas.
• Support Packaging Third Party Qualification.
• Participate in or lead improvement initiatives.

Skills

QA review

GMP knowledge

Attention to detail

Communication

Ability to work under pressure

Education

Bachelor's degree

Job description

Advanced Resource Managers Ltd. is seeking an experienced QA Specialist to review and approve GMP documentation for Investigational Medicinal Products at a client facility in Hertfordshire. The role focuses on batch release, QMS records, and CAPA actions within a high-pressure environment.

The ideal candidate will have a Bachelor's degree and 5+ years in a similar QA/QAQC role, with strong GMP knowledge and the ability to drive process improvements in a packaging/third-party setting.