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.
