Associate QC Manager - Raw Materials

Competitive
Permanent
Limerick
12 May 2020
BBBH759407

QC Chemistry Manager role available in Limerick

Fantastic opportunity to join an ever-growing company based in Limerick. If you are looking for an opportunity to join one of Ireland's leading pharmaceuticals, this could be the role for you.

The QC Manager will be responsible for the QC Raw Materials laboratory team and has technical responsibility for all chemical aspects of QC testing.

This is a permanent position. All interviews will be done virtually for this role.

Essential Duties and Responsibilities include, but are not limited to, the following:

  • Coordinates with members of Facilities, Manufacturing, Stability, and Business Ops to provide analytical support.
  • Manages QC Analysts, distributes work load, and monitors progress.
  • Manages product testing to ensure efficient and compliant operations.
  • Reviews test reports.
  • Ensures QC Analysts receive proper training.
  • Attends meetings to keep informed of manufacturing priorities.
  • Ensures that safety standards are maintained.
  • Ensures compliance with applicable cGMP regulations and SOPs.
  • Investigates atypical and OOS test results as necessary.
  • Manage assay transfer internally from R&D to the QC laboratory or from PAS to the QC Laboratory.
  • Manage assay transfer externally from QC laboratory to contract labs, includes audits if needed
  • Manages QC projects including analytical commitments for Regulatory filing, follow-up actions for general GMP inspections and its readiness.
  • Track and coordinate major analytical investigation
  • Track and monitor timeline of analytical validation projects.
  • Monitor the team performance for Compliance events, track, assist and organize continuous improvement events.
  • Interact with Regulatory Agencies as needed to ensure cGMP compliance.
  • Special projects as assigned.
  • Performs personnel management functions including time sheet submissions, scheduling of vacations, personnel development/feedback, and performance evaluations

Education and Experience:
* Requires BSc/BA in Life Sciences or related field with 6+ years of relevant experience, preferably in the pharmaceutical or biotechnology industry. Previous supervisory/ leadership experience in a laboratory environment is required.
* Thorough understanding of Analytical Testing in a cGMP environment for Raw Materials, Wet Chemistry and HPLC assays.

If you are interested in learning more, please apply below or email me at jfitzpatrick@morganmckinley.com

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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Cork 353 (0) 21 2300300 | jfitzpatrick@morganmckinley.com