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Details
QA Operations Specialist
| Reference: | RK25901 | Location: |
Dublin |
| Qualification: | Degree | Experience: | 4-5 Years |
| Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
May be suitable for:
QA Specialist
QA Operations Specialist
Shift - Days
RK25901
Contract 11 months
Dublin
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. 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.
Key Responsibilities:
- Responsible for review/approval of new and updated Master Batch Records / Electronic Batch Records
- Review and approve production documentation such as executed electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures
- Provides presence on the shop floor to support compliance and data integrity
- Review and approve new and updated SOPs/ Work Instructions and Controlled Job Aides
- Actively participates in the Tier process and uses this forum to make issues visible and to partner with the functional area on resolution
- QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.
- Will serve as the Quality SME for Performance qualification (PQ) activities across the site including but not limited to: Equipment, Facility and Utility PQ studies, Cleaning Validation, SIP, process validation
- Participates as the quality member on cross functional projects
- Support sustaining activities such as Change Management, Deviations, CAPAs, Equipment Requalification and Periodic review, Site Maintenance & Calibration Program
- Provides support to internal audits and regulatory inspections
- Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans
- Drive continuous improvement and utilise problem solving tools and Production Systems Participate in continuous improvement initiatives to enhance operational efficiency and resolve issues
Education and Experience:
- 5 years of relevant post-degree work experience in GMP Manufacturing, Quality Assurance or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations.
- Bachelor degree, in a scientific or engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience
- Understanding of QA operations an advantage as well as Regulatory agency engagement.
- Experience working on manufacturing shop floor
- Familiarity with GMP documentation review and/or shop floor auditing
If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
Manufacturing Executive Mayo Academic Connected Health IT Microbiology Diagnostics Scientific Dublin Engineering Packaging Engineer Medical Device Quality Assurance Biopharmaceutical Validation Engineer Pharmaceutical Supply Chain Sales and Marketing Scientist Quality Engineering Pharma Sales Allied Healthcare Sales and Marketing Chemistry Biotechnology Supply Chain Life Science Clinical Research PhD Limerick Medical Affairs Laboratory Scientist Project Manager Cork Academic Product Development Engineer Cork City Quality Control
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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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