QA Analyst, Leinster
In partnership with its client Kenny-Whelan & Associates is currently seeking QA Analysts for a number of clients in the Leinster area.
For further information please contact Nell Ní Chiobháin on 0214665411 or [email protected] to find out more!
Award winning leading pharmaceutical company.
Supervision and maintenance of quality systems managed by the quality department.
Role has responsibility for carrying out tasks pertaining to compliance and product quality. Providing Quality oversight and ensuring compliance with regulatory requirements (GMP & controlled substances). These roles are 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 material /component/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.
General scope of responsibilities:
- Ensure strict adherence to site policies/procedures, cGMP and environmental, health and safety regulations.
- 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.
- Ensure resolution of and/or appropriate escalation of issues.
- Provide subject matter expertise and support for systems, technologies and products.
- Support the introduction of new products.
- Authors, tracks, review for adequacy and/or ensure timely closure of commitments (Regulatory Agency, investigation, audit, PRR, and other).
- General support of the Quality Systems and compliance monitoring through the following; internal and external audits and dealing with queries from other functions.
- Compilation and approval of relevant PRR sections (where required)
- Trend reviews and SQRT (Site Quality Review Team) updates (where required)
- Training for system users / participants
- Area/departmental weekly/monthly reporting. Minimum Qualification Requirements
• Third level qualification /degree in a science/technical field is preferred. Exceptions may be considered where relevant experience and correct attitude and behaviours exist (this may be supplemented by further education in parallel).
• 3 years previous Pharma industry experience in a similar role (research and/or industry) is preferred.
Exceptions maybe considered e.g. Food, veterinary.
Experience in dealing with Regulatory compliance desired.
All applications will be treated with the strictest confidence
For further information please contact Nell Ní Chiobháin on 0214665411 or send your updated CV to [email protected]
Keywords: QA, Quality Assurance, Document control, Chemist, Kildare, Carlow, Leinster, cGMP, GLP, RFT