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Quality Management Systems Manager
hace 1 mes
Centrient Pharmaceuticals is a leading manufacturer of beta-lactam antibiotics and a provider of next-generation statins and anti-fungals. We produce and sell intermediates, active pharmaceutical ingredients, and finished dosage forms. Our commitment to Quality, Reliability, and Sustainability drives our work, and we strive to meet our customers' needs. As a Quality Management Systems Manager, you will play a crucial role in defining and implementing a clear and robust document hierarchy for global documents. Your responsibilities will include designing and drafting global quality procedures, revising the Quality manual and other GxP documents, and ensuring that procedures are current and suited to evolving GMP and regulatory requirements.
Key Responsibilities:- Define and implement a clear document hierarchy for global procedures and policies.
- Design and draft global quality procedures that are aligned to current regulatory expectations.
- Revise or revisit Quality manual and other GxP documents, standardize, harmonize, and/or simplify as required.
- Ensure that procedures are current and suited to evolving GMP and regulatory requirements.
- Timely revision and updating of global documents.
- Support development and continuous improvement of Centrient Quality Systems.
- Support leadership teams in regulatory inspections and customer audits.
- Support effective training of global procedures across Centrient Sites.
- Lead and/or support GxP quality audits and monitor corporate annual audit plan.
- Bachelor or postgraduate degree in Science, Pharmacy, or related field of study.
- +8 - 10 years of industry experience.
- Advanced level of English language (written and spoken).
- In-depth knowledge of cGMP and regulatory requirements.
- Proven skills in technical writing.
- Prior experience in similar roles with good organization skills.
- International exposure and ability to manage cultural differences.
- Ability to obtain commitment on required actions.
- Resourceful in finding and keeping abreast of the latest developments in the cGMP and regulatory environment.
