Quality Assurance Specialist

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

Are you an experienced Quality Assurance Specialist with a background in the review and approval of GMP documentation? If so, this role could be for you!

Our leading CRO client is recruiting for a QA Specialist to be based at their clients facility in Hertfordshire.

The successful candidate will have a crucial role in ensuring quality and compliance of investigational medicinal products used worldwide.

This position is offered on a 12 month contract basis initially, inside IR35, working 37 hours per week.

Responsibilities:

• Serve as a Batch Release Officer for the review and recommended release of documentation for a range of dosage form batches and finished clinical trial packs of Investigational Medicinal Products.
• Assessment of Quality QMS Records (e.g. deviations and third party or internal complaints) and make recommendations for corrective and preventative actions.
• Follow up on the implementation of those recommendations.
• Review and Approve GMP documentation, which may include Packaging Specifications, Quality Agreement, Change Controls and other controlled documents
• Provide advice and support to business partner areas relating to quality matters and process improvement.
• Develop and incorporate effective processes and procedures in Quality R&D Packaging Third Party group and may contribute to business processes and procedures outside of quality
• Support Packaging Third Party Qualification
• Participate in or lead improvement initiatives

Education and Experience:

• Bachelor's degree or equivalent work experience such as 5+ years in similar position
• Experience of QA review of GMP Manufacturing / Packaging Documentation / laboratory records of pharmaceutical dosage forms which may include sterile products and/or review and approval of GMP documentation within a Quality Assurance / Quality Control role.
• Experience of knowledge of GMP principles and being a decision maker using this knowledge,
• Experience leading or participating in QMS activities (e.g. Quality Deviations, third party/Internal Complaints, Change Controls and inspections/audits and root causing).
• Experience working in high pressure environments where there are likely to be conflicting priorities.
• Knowledge of the R&D process, particularly with respect to clinical trials manufacturing and packaging.
• Strong attention to detail.
• Good communication skills with the ability to build relationships and trust.