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Details
Quality Assurance Specialist/Manager
| Reference: | A015435 | Location: |
Dublin |
| Qualification: | Degree | Experience: | 4-5 Years |
| Job Type: | Permanent | Salary: | Not Disclosed |
May be suitable for:
QA Executive, QA Manager, QA Specialist, QA Supervisor, Quality Manager, Quality Specialist
Quality Assurance Specialist/Manager
Our client, a pharmaceutical organisation, are currently recruiting for a Quality Specialist/Manager to join their team on a permanent basis. As Quality Assurance Specialist/Manager you will play a key role in ensuring compliance with Good Distribution Practice (GDP) requirements and supporting quality activities across the organisation and its affiliates. You will work closely with cross-functional teams including Regulatory Affairs, Pharmacovigilance, Medical Affairs, and Supply Chain, as well as with external partners and regulatory authorities. This is a permanent role with hybrid working.
Responsibilities
- Support and maintain the Pharmaceutical Quality System (PQS)
- Assist with quality documentation (Quality Manual, policies, SOPs)
- Support quality training systems and records
- Participate in internal and external audits (GDP; GMP desirable)
- Support quality activities including deviations, CAPAs, change controls, complaints, recalls, and incidents
- Contribute to Quality Management Reviews through data collection and reporting
- Maintain technical product files
- Provide day-to-day QA support and act as quality contact when required
- Support artwork approval processes
- Already be a qualified Responsible Person (RP) or demonstrate interest in developing toward a Responsible Person (RP) role
Requirements
- Scientific degree (pharmacy degree strongly preferred)
- Minimum 4 years’ experience in a QA or related role within the pharmaceutical sector
- Strong knowledge of GDP regulations for medicinal products
- Experience with GDP audits (hosting and performing)
- Knowledge of GMP (EudraLex Volume 4)
- GMP audit experience
- Familiarity with Microsoft 365
- Self-motivated, organised, and able to work independently
- Strong communication and collaboration skills
- Comfortable working in a fast-paced environment
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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