Responsibility for carrying out tasks pertaining to compliance and product quality. Providing Quality oversight and ensuring compliance with regulatory requirements (GMP & controlled substances). This role is required to partner with relevant departments to ensure that key quality systems are operated and maintained in a compliant manner. This can include but is not limited to batch disposition, documentation management and approval, product record review, investigations, complaints, change control, audits, quality agreements, stability, QA support for validation activities, supplier management and regulatory support.
1. Ensure strict adherence to site policies/procedures, cGMP and environmental, health and safety regulations.
2. Ensure area of responsibility is maintained in a constant state of compliance and audit readiness in line with current regulations, PQS, and business needs. All related procedures and documentation are maintained accordingly.
3. Safety and housekeeping considerations
4. Execute responsibilities in line with Right First Time principles
5. Ensure resolution of and/or appropriate escalation of issues
6. Demonstrating company values and company competencies
7. Ensure that all department metrics are adhered to and reported on time.
8. Provide subject matter expertise and support for systems, technologies and products.
9. Identify Continuous Improvement opportunities and progress Continuous Improvement projects.
10. Participate in decision making in consultation with relevant stakeholders
11. Support the introduction of new products.
12. Authors, tracks, review for adequacy and/or ensure timely closure of commitments (Regulatory Agency, investigation, audit, PRR, and other).
13. General support of the Quality Systems and compliance monitoring through the following; internal and external audits and dealing with queries from other functions.
14. Compilation and approval of relevant PRR sections (where required)
15. Trend reviews and SQRT (Site Quality Review Team) updates (where required)
16. Training for system users / participants
17. Area/departmental weekly/monthly reporting.
- BSc or other
- 3 years previous Pharma industry experience in a similar role (research and/or industry) is preferred.
- Experience in dealing with Regulatory compliance desired.
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The Life Science Specialists