Irish Oxygen Company Ltd dates its origins back to Cork in 1949. Since then Irish Oxygen has developed a reputation second to none, producing and distributing industrial gases for industry, laboratories, agriculture, education and DIY users. In 2016 Irish Oxygen partnered with SOL Group to produce medical gases, and now supply medical gas to many of Ireland's Hospitals and Medical facilities.
General Responsibilities
1. Own, review and approve SOPs and other GDP/GMP documentation and records, ensuring that Corporate, Site and Regulatory requirements are met.
2. Perform review and approval of validation documentation.
3. Lead and participate in internal and external audits as needed.
4. Maintain a close contact and familiarity with IOC & SOL Group Quality systems and programs utilized at other SOL Group sites.
5. Provide guidance and direction to Quality, Production, Warehouse/Distribution and Supply Chain staff in regard to compliance with quality policies, standards and procedures.
6. Evaluate and assess change control records, non-conformances and CAPAs.
7. Participate in global Quality initiatives as a site subject matter expert.
8. Participate or lead projects and improvement efforts including product launches.
9. Support the evaluation of quality and distribution complaints.
10. Assist during regulatory inspections and respond to inquiries from regulatory bodies.
11. Perform required activities as outlined by company procedures as QA staff, particularly where the role of Qualified Person (QP) is specified.
12. Certify in a register or equivalent document, that each production batch has been manufactured and checked in compliance with laws in force in Ireland, is in accordance with the requirements of the marketing authorization and with EU Good Manufacturing Practice (GMP).
13. Ensure batches of medicinal products are distributed as per the Manufacturing Importation Authorisation and EU Good Distribution Practice (GDP) as per Directive 2001/83/EC and guidance 2013/C 343/01.
14. Investigational Medicinal Products QP (Directive 91/356/EEC and Directive 2001/20/EC).
Requirements
1. Basic Qualifications for QA: University degree in a scientific or engineering area.
2. Knowledge of the processes involved in manufacturing (GMP), warehousing, supply chain, equipment engineering principles and validation.
3. Familiarity with applicable regulatory requirements.
4. Experience working in the pharmaceutical or Biotechnology Industry an advantage.
5. Potential for progression as a QP possible.
What you should expect
1. A chance to join a small but rapidly expanding company.
2. A warm friendly working environment.
3. Opportunities for further growth and progression within the Group.
4. A competitive salary (DOE).
Job Types: Full-time, Permanent
Pay: €40,000.00-€50,000.00 per year
Benefits:
* Company pension
* On-site parking
* Sick pay
Language:
* English (required)
Work authorization:
* Ireland (required)
Work Location: In person
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