Quality Assurance Specialist

Industry Sector Pharmaceutical
Profession QA & Regulatory
Location UK, South East
Salary Competitive


Quality Assurance Specialist

Location: Oxfordshire

Sector: Pharmaceutical

Our client is a leading Pharmaceutical CRO based in Oxfordshire and is now seeking an experienced QA professional to join the company and support with the provision of Quality Assurance guidance and coaching to ensure compliance and adherence to cGMP.

The role:

Responsibilities will include:

·      Generation and monitoring of KPI’s.
Maintenance of QMS.
QC method and equipment validation, qualifications, deviations and calibration.
Data integrity reviews.
Issue documentation and carry out biennial document reviews.

·      Product Quality Reviews.

·      Production batch record reviews.

·      Prepare COA/GMP statements, BSE/TSE and other certifications and statement of results.

·      Raw material code assignment and risk assessments.

·      Manufacturing cleaning and decontamination certificates.

·      Review production logbooks in line Quality standards.

·      Review and approval of production equipment (changes, deviations, qualifications, and calibration).

·      Monitor water plant results and generate annual environmental monitoring reports.


Experience expectations:

Suitable applicants will have;

·      Experience within a QA role for a minimum of 2 years, preferably within a cGMP environment, such as an API manufacturer/CMO.

·      Previous experience writing, reviewing and approving documentation and practices for QMS

·      Knowledge and experience of working with quality programs such as cGMP/ICH Q7 and maintain cGMP compliance.

·      The ability to coordinate multiple priorities in a fast paced environment.

·      Work effectively and efficiently in a cross functional team environment.

·      Solid organizational, analytical and problem solving skills, with the ability to troubleshoot and resolve problems.

·      Strong communication skills with the ability to interact with all levels throughout the organization.

·      Demonstrated excellent interpersonal skills and flexibility.


The Package:


Our client offers an opportunity to work for a leading Pharmaceutical company on a permanent basis with a competitive annual salary and benefits package.

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