Job Title
A Quality Assurance Specialist is required to work in the pharmaceutical industry. The successful candidate will be responsible for ensuring the quality of drug substances, drug products, and packaged finished goods.
The role involves reviewing and approving production and analytical documentation, performing complaints and deviation investigations, change controls and CAPAs, creating and maintaining SOPs, compiling data for reports and presentations, completing audits, and supporting product recalls and stock recoveries.
Requirements
* A degree in a science or engineering discipline plus industrial experience or considerable industrial experience.
Responsibilities
* Review and approve production and analytical documentation.
* Perform and review complaints and deviation investigations, change controls and CAPAs.
* Create and maintain assigned SOPs.
* Compile data for reports and presentations.
* Complete audits to ensure compliance to SOPs, GMPs and applicable regulations.
* Support product recalls and stock recoveries as appropriate.
* Actively communicate and collaborate with functional areas.
* Identify compliance gaps and make recommendations for continuous improvement.
* Assist in the induction process for new starters and training of other staff.