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Details
QA Specialist (hybrid)
Reference: | RK8318 | Location: |
Cork |
Qualification: | Degree | Experience: | 3-4 Years |
Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
May be suitable for:
QA Specialist
QA Specialist (hybrid)
RK8318
Contract – 12 months
Cork
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties:
- Batch Record Review & material release to ensure compliance with GMP requirements.
- Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints.
- Carries out tasks related to the management of batch records design and approval.
- Carries out administration of the SAP Quality Management Module.
- Carries out tasks relating to the management of site change control systems.
- Compiles Annual Product Reviews.
- Supports all validation activities on site as described in the Site Validation Master Plan.
- Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).
- Supports system qualification and process validation activities.
- Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance
- Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site.
- Participates in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI)
- Perform GMP audits on-site and vendor facilities as required.
- Performs on the floor walkdowns regularly to ensure process and facilities are maintained to GMP standards.
- Carries out tasks related to the administration of site supplier approval process.
Experience and Education:
- Bachelors Degree in a scientific/technical discipline required
- 3-5 years’ experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
- Experience in auditing of external suppliers, contractors and vendors
If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or [email protected] for further information.
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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
Valid XHTML - CSS