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Details
Associate Quality Specialist
| Reference: | RK26071 | Location: |
Tipperary |
| Qualification: | Degree | Experience: | 2-3 Years |
| Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
May be suitable for:
QA Analyst
Associate Quality Specialist
Onsite
RK26071
Contract 11 months
Tipperary
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Tipperary. 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:
- Participate as functional expert in the cross functional team that manages production right first time.
- Review and approve batch, cleaning and testing documentation.
- Ensure that all Laboratory Out of Specification (OOS) and process deviations are documented, assessed and associated CAPA identified.
- Provide support to deviation investigations and process performance monitoring.
- Perform trending on deviations raised as required to identify improvement initiatives.
- Provide detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed.
- Provide guidance on quality requirements to maintain validation status, including participation in process/product Risk Assessments.
- Provide feedback on re-occurring issues ensuring continuous improvement to systems/processes.
- Ensure changes controls raised are documented, assessed and completed.
- Prepare Annual Process and System Reviews.
- Act as lead/team auditor to support the internal GMP walkdown and scheduled audits.
- Participate in the generation and communication of quality metrics.
- Creation, review and approval of quality procedures as required.
Education and Experience:
- Degree or post-graduate qualification in Science, Pharmacy or equivalent.
- Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise).
- Spray drying experience desirable.
- Knowledge and demonstrated expertise in Lean / Continuous Improvement.
- Experience and knowledge of GMP Requirements for Electronic /paper free operations.
- Experience in High potency manufacturing desirable.
If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
Life Science Scientist Medical Affairs Validation Engineer Sales and Marketing Microbiology Engineering Clinical Research Academic Diagnostics IT Scientific Pharmaceutical Chemistry Medical Device Product Development Engineer Limerick Cork City Quality Assurance Mayo Supply Chain Connected Health Dublin Biopharmaceutical Cork Pharma Sales Project Manager Allied Healthcare Quality Control Supply Chain Academic Quality Engineering Packaging Engineer Biotechnology Sales and Marketing Laboratory Scientist Manufacturing Executive PhD
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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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