|Role Type||Fixed Term Contract|
Senior QC Analyst (Verifer)
Job ID: JOB-11666
Senior QC Analyst (Verifier)
My client is a Sligo-based Pharmaceutical company with sites around the world! There is a new 1 year fixed term contract position available for a Senior QC Analyst who will join a well-established team.
As a new Snr QC Analyst (Verifier), you will provide an effective testing and analytical service to the plant, ensuring that products manufactured are tested to specification on time and plant quality and safety goals are met. Joining a talented and high performing team, you will take responsibility for supporting the QC lab on all administration, verification, and investigation type activities.
Key responsibilities include:
- Ensure Laboratory Documentation and Computerized Systems compliance with Data Integrity policies and regulatory requirements.
- Understand regulations and business processes required to maintain Laboratory data Integrity.
- Report generation for annual PQR & periodic Stability studies.
- Filing, archiving and control of all Analytical data.
- Change control – update redlined procedures.
- Generation and management of all QC related regulatory requests.
- Completion of documentation audits ensuring that the QC Lab has the most up-to-date revisions of all documents.
- Timely completion of all QC related Policy and period reviews.
- Review/Verification of analytical data and batch records as required.
- Support trending activities on release data using Minitab, Cognos, Discoverant.
- Support data compilation for PPQ and lifecycle validation documentation.
- Support all Laboratory Investigation activities as required through Soltraqs.
- SME on QC laboratory-related systems, e.g. LIMs, Cognos, Mini Tab & Discoverant.
- Provide Support to QC supervisors and Laboratory Manager for all administration related activities.
Qualifications & Experience:
- 3rd level qualification in a relevant Science discipline.
- Experience in a similar role within the Pharmaceutical industry essential.
- Capable of collating and controlling laboratory documentation & information on site.
- Detailed Knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry.
For more information on this role in Sligo please contact Clara Burke on 086816823 or email@example.com
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