Manufacturing Quality Specialist
3 giorni fa
The Quality Ops Advisor will be responsible for managing operational activities and responses to issues in accordance with Good Manufacturing Practices (GMP) and the company's related procedures. This includes ensuring plant compliance for batch release and quality shopfloor for the site, and possessing cross-functional knowledge and skills to manage operations with responsibility and diplomacy.
Main Responsibilities:
- Lead and support deviation response and investigations.
- Provide responsibility for other quality, product, and/or compliance activities as assigned.
- Serve as delegate/designee in absence of Quality Ops End to End Lead as needed.
Essential Requirements:
- Bachelor's degree in pharmacy, chemistry or related scientific discipline and/or 3+ years in pharmaceutical industry; Operational Quality experience/ Laboratory experience.
- Minimum of 3 years' management experience.
- Knowledge of cGMP's/FDA and other Regulatory requirements such as ICH Guidelines.
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