QA / Quality Assurance Specialist - Pharmaceutical (various levels)
Salary: Competitive, depending on experience
Our Client, a global Pharmaceutical company are expanding and looking for a number of QA Specialists to work at their modern facility in the Bedfordshire area.
Working to GMP, Pharmaceutical standards this person will…
- Ensuring QA regulatory compliance and product quality requirements are met/ as per QMS and MHRA standards.
- QMS maintenance - CAPAs, deviations, change controls, investigations etc
- Assisting and participating in internal/external audits
- Ensuring Manufacturing, QA, QC documents are reviewed at all times
- OOS management and ensuring QC documentation are reviewed and complied as per standards
- Participating in regular In-process QA checks for manufacturing / packing activities
- Reviewing Quality systems documentation
- Preparing, reviewing and amending SOPs & verifying up to date documentation as per GMP requirements.
- Participating in investigation of customer complaints, deviations etc.
- Ensuring timely approvals of batch release.
- Handling of controlled drugs.
- Warehouse temperature monitoring and downloading reports, file and inspect all claims, damages and audit returns & rejects.
- Will hold a Degree in a relevant Scientific discipline
- Will have worked in a GMP - Pharmaceutical regulated QA environment
- Will have a sound knowledge and experience implementing new ideas and changes to a QMS within Pharmaceutical or Medical Devices - industries.
- Will have experience using/ implementing CAPA
- Will have experience in dealing with complaints and deviations
- Will have auditing experience within Pharmaceutical or Medical Devices- industries
- Strong interpersonal skills with the ability to communicate information clearly and maturely across a range of departments
- Sound technical writing and report writing skills; with extended experience in Microsoft Office based applications/ programs.