PE Global are currently recruiting for a Quality Specialist – Quality Systems for our client site in Tipperary:
11 month initial contract
Role Description
The Quality Specialist – Quality Systems supports the Quality Systems activities in both the Drug Substance and Drug Product facilities. The Quality Specialist participates as a member of the Quality Systems Team.
Role Functions
1. Sub System Ownership: Complete sub system ownership responsibilities as per the site System Ownership list.
2. Quality SME for Process, Cleaning, Water, Equipment: Provide leadership regarding validation standards required for a Drug Substance and Drug Product pharmaceutical facility.
3. Participate in and support the site PVC (Process Validation Committee), WVC (Water Validation Committee), CVG (Cleaning Validation Group), and Equipment Qualification Validation Committee (EQVC).
4. Approval of all validation documentation and ensuring compliance to MMD policies, procedures, and guidelines.
5. Support the implementation of site or capital projects by defining validation requirements and providing technical assistance as a member of the project teams.
6. Develop Validation Summary Reports and assist in developing overall Quality plans for major projects.
7. Work with other areas in the company and industry to predict future trends in validation and to determine best practices.
8. SAP Quality Process Steward
9. Quality SME for Change Control: Principal Quality contact for all site change requests impacting processing.
10. Provide Quality and change analyst review for all change requests through all stages of the change control process.
11. Support and approve the systems supporting laboratory functions, instrumentation, and GLIMS.
12. Review and approval of stability reports for accuracy and to support OOS and investigations as appropriate.
13. Manage the site inventory of Quality Agreements to ensure all required relationships are current and approved.
14. Manage the system ensuring that Annual Reviews (AR/APR/PQR) for products and systems are completed to meet the Annual Review schedule.
15. Create, review, and approve Site Quality documentation including Site Master File, Validation Master Plan, policies or procedures.
16. Manage the annual quality council schedule, including the monthly quality council agenda, minutes, and action follow-up.
17. Participate in the investigation and review of any internal/external customer complaints in accordance with agreed lead-times.
18. Review and ongoing maintenance of site licenses.
19. Support the internal GMP walk-down and scheduled audits program.
20. Support hosting of site Regulatory Inspections.
Experience, Knowledge & Skills
1. Site quality policies, procedures, and guidelines related to the Quality Assurance function and plant quality systems.
2. Relevant GMP standards.
3. Validation principles and guidelines.
4. System Development Life Cycle.
Qualifications & Education
Minimum of Degree or post-graduate qualification in Science, Pharmacy, or Engineering field.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Audrey on 021- 4297900, or alternatively send an up-to-date CV to audrey.mccarthy@peglobal.net
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