Quality Assurance Operations (Hybrid)
RK22264, Contract – 11 months
We are currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties:
1. Lead, facilitate and participate daily on cross-functional teams to collaboratively address compliance issues and achieve project milestones.
2. Participate in investigations and risk assessments related to deviations/complaints and changes, ensuring appropriate actions are implemented timely.
3. Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPs and related documentation for compliance to GMP and site requirements at the facility.
4. Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals and commercial/clinical operations at the facility.
5. Complete QA operational duties related to product disposition including incoming material release and the performance of detailed review of eBR prior to QP release.
6. Evaluate new and prospective regulatory guidance and industry best practice and determine impact on Quality systems, identifying and implementing appropriate updates where required.
7. Assist in the development of training curricula and records for the QA Operations Group, providing SME training on Quality Assurance SOPs as required.
8. Assist in the creation and maintenance of QA policies, SOPs and reports in line with site requirements.
9. Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.
10. Participate in and support risk management activities in line with relevant guidance and best industry practice.
11. Assist in the execution of the internal audit programme including the performance of audits as required.
12. Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture.
13. Ensure the escalation of compliance risks to management in a timely manner.
Experience and Education:
1. Degree qualification (Science/Quality/Technical).
2. 8-10 years' experience, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry.
3. Project Manager capability with significant understanding of Operations.
4. Demonstrated experience in QRM, Investigations, Problem solving as a Quality SME.
5. Strong written and verbal communication skills.