QA Manager

QA Manager

QA Manager

Accentuate Staffing is partners with an expanding pharmaceutical company in the RTP area who is looking to expand there manufacturing team and has multiple QA Manager positions open!

Responsibilities:

  • Will manage up to 5 people
  • 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
  • Develop Site Quality Road Map for the initiation of Manufacturing GMP Quality Systems Establishing and maintaining Site SOPs in collaboration with Mfg. staff
  • Facilitate vendor audits

Requirements:

  • Minimum 10 – 15 years’ experience in Pharmaceutical Manufacturing QA position
  • 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.
  • Experience with analytical, stability protocols, reports, batch records, change control, investigations, deviations and other relevant GMP documentation
  • Possess organization skills
  • Experience on deviation investigations for manufacturing and laboratory
  • Ability to train personnel on GMP regulations and requirements
  • Technical writing skill
  • Familiarity with cGMP regulations, FDA guidance documents and QbD