Company Overview
Pinewood Healthcare is a leading developer, manufacturer, and marketer of healthcare products, employing over 320 people across Tipperary and Dublin. Established in 1976, it initially served the renal care market in Ireland and has evolved under Irish ownership until its acquisition by the Wockhardt Group in 2006. Wockhardt, headquartered in Mumbai, India, is a global pharmaceutical and biotechnology company with over 7,000 employees across 27 countries, including manufacturing and research facilities in India, the USA, UK, and Ireland.
Key Responsibilities
1. Originating, approving, and issuing production documentation for manufacturing and packaging.
2. Creating and approving Standard Operating Procedures (SOPs) in compliance with cGMP requirements.
3. Reviewing SOPs according to the review schedule.
4. Issuing stability documentation, approving testing protocols, and reviewing stability reports.
5. Reviewing validation protocols and reports, including process, cleaning, and equipment validation.
6. Reviewing product development documents.
7. Providing cGMP training.
8. Conducting internal and external audits.
9. Investigating deviations and out-of-specification results.
10. Handling customer complaints investigations.
11. Proofing and approving artwork.
12. Maintaining ISO standards.
13. Liaising with customers for contract-manufactured products.
14. Reviewing batch documentation.
15. Participating in projects related to quality standards and requirements as assigned by the QA/QC Manager.
16. Investigating internal comments.
17. Managing change control, vendor certification, and supplier approvals, including raw material review.
18. Monitoring temperature controls.
19. Preparing CAPA reports.
20. Managing APRs and FPS approvals.
21. Supporting elemental impurities, excipient risk assessments, PQR reporting, and production support.
Key Requirements
1. Degree in Chemistry, Pharmacy, Biological Science, or related field, with experience in the pharmaceutical industry, preferably within QC or QA.
2. Excellent organizational and time-management skills.
3. Ability to collaborate effectively with internal and external stakeholders.
4. Strong written and verbal communication and interpersonal skills.
5. Problem-solving skills and resourcefulness.
6. Ability to work independently and as part of a team.
7. Critical thinking skills.
8. Comfortable working in a busy, regulated manufacturing environment.
9. Adaptability to a professional, team-based setting.
#J-18808-Ljbffr