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Details
QC Bioassay Analyst (shift)
Reference: | RK20672 | Location: |
Carlow |
Qualification: | Degree | Experience: | 2-3 Years |
Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
May be suitable for:
QC Analyst
QC Bioassay Analyst (shift)
RK20672
11 Months
Carlow
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. 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:
- Perform and review a range of techniques such as immunoassays, cell-based potency bioassays and aseptic techniques as part of routine and non-routine testing and project work to ensure processes and end products comply with corporate and regulatory requirements to facilitate product release.
- Work as directed by the Bioassay Manager / Associate Director, according to Company safety policies, cGMP and cGLP.
- Required to drive compliance with our Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
- Required to comply with our Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
- Ensure that all Quality Systems within the department are adhered to on a daily basis.
- Operate as part of the QC team performing the allocated testing and laboratory-based duties.
- Ensure timely completion of all assigned data processing and reviewing.
- Ensure timely completion of Laboratory Investigation Reports and deviations through site procedures
- Participate in the timely generation of trend data, investigations, nonconformances, validation protocols, reports in support of method validation/verifications and equipment qualifications.
- Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc.
- Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved.
- Review, approve and trend test results where applicable,
- Participate in the laboratory aspects of OOS investigations.
- Provide support with audit/inspection requirements to ensure department compliance/readiness.
- Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why's etc,
Education and Experience :
- Bachelor’s Degree or higher preferred; ideally in a science related discipline.
- Laboratory Quality Systems experience
- Understanding of Lean Six Sigma Methodology preferred.
- Immunoassay and cell culture experience preferable
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
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