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Pharma-Cruiting Executive Search is seeking an experienced Senior Quality Assurance Specialist, CMC Services for our CRO client serving the pharmaceutical industry in the Greater Philadelphia area.

The Senior Quality Assurance Specialist, CMC Services candidate will be responsible for ensuring the implementation of quality system for the CMC services department – analytical services laboratory and CTM manufacturing. Complies with all relevant cGMP/GLP regulatory requirements while carrying out assigned tasks.

Senior Quality Assurance Specialist, CMC Services – Responsibilities:

  • Reviews and approves method validation and stability protocols, and reports.
  • Reviews and approves CTM specifications, raw material, finished product COAs, batch records, and related documents
  • Conducts vendor qualification as assigned.
  • Performs internal systems audits and issues audit reports.
  • Facilitates OOS investigations, reviews and approves completed investigation reports.
  • Facilitates manufacturing deviations and investigations.
  • Monitors compliance to DEA license requirements.
  • Monitors and tracks corrective and preventive (CAPA) investigations and commitments to internal, client, and regulatory audits.
  • Complies with all relevant cGMP/GLP regulatory requirements while carrying out assigned tasks.

Requirements:

  • Bachelor’s degree in Chemistry, or related discipline (QA/RA), with at least 5 years relevant experience in pharmaceutical or related industry

Email ruth@pharmacruiting.com to apply

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