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Pharmaceutical Quality Assurance Manager

Pharmaceutical Quality Assurance Manager

Pharmaceutical Quality Assurance Manager

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Accentuate Staffing is recruiting for a Pharmaceutical Quality Assurance Manager for an established pharmaceutical client.  It’s a full time, perm role in the Durham, NC area with lots of growth opportunities.

Responsibilities:

  • Develop Site Quality Road Map for the initiation of Manufacturing GMP Quality Systems Establishing and maintaining Site SOPs in collaboration with Mfg. staff
  • Create and maintain Site Master Validation Plan
  • Review of Batch Records and approve product disposition Review of analytical, stability test methods, protocols & reports
  • Release of raw materials, components, in-process materials and finished products Review and approve investigation reports as applicable
  • Assist in operational investigations to ensure timely completion
  • Mentoring, coaching and training of department employees

Requirements:

  • Minimum 10 years’ experience in Pharmaceutical Manufacturing QA position
  • Experience with MDI/Derma/Transdermal product manufacturing and testing is required.
  • Experience with Collection, issuance, destruction, and inventories of all DEA Regulated Controlled Substance /List Chemicals located within WHS Controlled Substance Vault/Cages
  • Must be able to review and write SOPs, review test methods, method validation protocols and reports as per FDA and ICH guidelines.
  • Have ability to communicate effectively orally and in writing
  • Have ability to motivate personnel to work together
  • Experience with analytical, stability protocols, reports, batch records, change control, investigations, deviations and other relevant GMP documentation
  • Possess organization skills
  • Possess analytical mind to deal with issues and offer solutions
  • Must be extremely reliable and committed
  • Good oral and written communication skill and working in a team environment.

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