QA Manager
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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
