Quality Assurance Executive
Permanent position
Manchester
Salary negotiable + bonus
Cpl Life Sciences are partnering with a large pharmaceutical company to recruit for a Quality Assurance Executive. The purpose of this job is to assist the Head of Regulatory and Pharmacovigilance in the maintenance and application of the company QMS. The successful candidate will also review and maintain the product quality records for commercial release of batches of company products in compliance with current GMP, GDP and product licenses.
Key Responsibilities:
- Undertake annual reviews of products according to current legislation surrounding quality aspects, stability data and reports.
- Compile and review all batch release documentation in preparation for QP review and release.
- Carry out annual compliance audits, liaising with manufacturers and distribution, checking test reports.
- Support the Head of Regulatory & Pharmacovigilance and the Technical Director with the internal audit program, performing audits and compiling reports.
- To assist in the implementation, maintenance and continuous improvement of the Quality Management System at local level in compliance with applicable regulatory requirements and company quality standard (corporate and local).
- To provide relevant quality related training to all staff (where applicable).
- Check for all deviations; document and investigate any occurrences.
- Develop and maintain SOPs for the Quality Assurance department and ensure compliance.
- Oversee all complaints regarding product quality, supporting investigations and providing feedback
- Ensure product stability tests are carried out each year, checking they remain within specification, passing to the Head of Regulatory & Pharmacovigilance and the Technical Director should any issues arise.
- Produce annual report of all product returns, complaints, deviations and defects.
- Provide monthly quality KPI updates to the Technical Director and Head of Regulatory & Pharmacovigilance.
- Keep up to date with the latest guidelines and legislation (including monitoring regulatory websites), advising colleagues on implications of any changes.
Key Requirements:
- Life Sciences or Pharmacy degree or 5+ years' experience in Quality Assurance or Quality Control
- Experience of working in a pharmaceutical quality assurance position
- Strong IT skills, including MS Excel, Word and Powerpoint
- High standard of literacy and written communication.
If you're interested then please apply or send your CV to