Job Title: Quality Assurance Operations (Hybrid)
RK22264
Contract – 11 months
{company}
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About the Opportunity
We are currently recruiting for a talented Quality Assurance professional to join an award-winning Pharmaceutical organization.
Duties:
1. Lead and facilitate daily cross-functional teams to address compliance issues and achieve project milestones.
2. Participate in investigations and risk assessments related to deviations/complaints and changes, ensuring timely implementation of actions.
3. Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPs and related documentation for compliance to GMP and site requirements.
4. Ensure QA oversight of qualification/validation, technical transfers, regulatory approvals and commercial/clinical operations.
5. Complete QA operational duties related to product disposition, including incoming material release and eBR review.
6. Evaluate new regulatory guidance and industry best practice, identifying updates to Quality systems as required.
7. Assist in developing training curricula and records for the QA Operations Group, providing SME training on Quality Assurance SOPs.
8. Support the creation and maintenance of QA policies, SOPs and reports in line with site requirements.
9. Drive continuous improvement by identifying and implementing efficiencies and quality improvements.
10. Participate in risk management activities in line with relevant guidance and best practice.
11. Execute the internal audit programme, including audits as required.
12. Foster strong relationships with management and colleagues, driving a safe and compliant culture.
13. Escalate compliance risks to management in a timely manner.
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Requirements:
* Degree qualification in Science, Quality or Technical field.
* 8-10 years' experience in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry.
* Project Manager capability with significant understanding of Operations.
* Demonstrated experience in QRM, Investigations, Problem solving as a Quality SME.
* Strong written and verbal communication skills.