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Details
Senior Associate Quality Control NPI
Reference: | RK2498 | Location: |
Dublin |
Qualification: | Degree | Experience: | 4-5 Years |
Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
May be suitable for:
QC Analyst
Senior Associate Quality Control NPI
RK2498
12 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.
Duties:
- With a high degree of technical flexibility, work across diverse areas within QC
- Plan and perform analyses with great efficiency and accuracy.
- Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
- Report, evaluate, back-up/archive, trend and approve analytical data.
- Troubleshoot, solve problems and communicate with stakeholders.
- Initiate and/or implement changes in controlled documents.
- May train others as necessary
- Participate in audits, initiatives and projects that may be departmental or organizational in scope.
- Write protocols and perform assay validation and equipment qualification/ verification.
- Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
- May contribute to regulatory filings.
- May conduct lab investigations as necessary.
- Evaluate lab practices for compliance on a continuous basis.
- Approve lab results
- May represent the department/organization on various teams
- May interact with outside resources.
- Create APPX data files and randomisation memo to facilitate data analysis.
- LIMS data coordination of commercial and import testing on site where applicable
- May provide technical guidance. May contribute to regulatory filings.
- May represent the department/organization on various teams. May train others.
- May interact with outside resources
Education and Experience :
- Bachelor’s degree in a Science related field is required.
- 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry,
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
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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