Description
A global pharmaceutical organisation based in the North Home Counties is seeking a QA Associate for a 6 month contract.Under general direction of the Senior Manager QA, The QA officer will be responsible for the maintenance of the Quality Assurance activities and the Quality Management System (QMS). In addition to ensuring site compliance to standard operating procedures and company policies, the QA officer will also be responsible for auditing approved vendors and suppliers to ensure appropriate quality and regulatory requirements are being met. The role will require the post-holder to provide 'day-to-day' QA support to staff at the site, giving guidance and advice as appropriate.
Under general direction of the Senior Manager QA, The QA officer will be responsible for the Key Responsibilities:
- Manage programme of internal and external audits
- Provide QA support for incident investigations (e.g. deviations and out-of-specification (OOS) results), change control and CAPA
- QA review and approve laboratory testing results (e.g. QC, stability) and equipment calibration and maintenance records
- QA review and approve controlled documentation (e.g. SOPs, reports and protocols)
Other Responsibilities:
- Generation and update of QA procedures
- Staff training in QA procedures.
- Participate in readiness for regulatory inspection
- Provide QA support for the development of new processes or testing methods
- Other duties, as assigned.
Preferred Qualifications: Minimum of a BSc in a relevant science/engineering discipline.
- 5+ years experience in Quality Assurance within the pharmaceutical / biotechnology industries
- Technical understanding of routine QC testing methods
- Experienced auditor (both suppliers/contractor and internal audits)
- Good knowledge of cGMP requirements and current industry practices.
- Good knowledge of European and US Pharmacopoeias
- Strong communication and interpersonal skills.
- Demonstrate ability to work in a cross-functional team environment.
- The ideal candidate will possess excellent planning and coordination skills and be able to readily adapt to changes in priorities and project schedules.
If you are interested in this opportunity please contact Hemish Ilangaratne on immediately.
To find out more about Real please visit www.realstaffing.com