Quality Management Systems Specialist
hace 4 semanas
Job Title: QMS Manager
About the Role:
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 towards a sustainable future. We actively participate in the fight against antimicrobial resistance.
Main Responsibilities:
Define and implement a clear document hierarchy for global procedures and policies. Design and draft global quality procedures that align with current regulatory expectations. Revise or revisit the Quality manual and other GxP documents, standardizing, harmonizing, and simplifying as required. Ensure 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.
Requirements:
Bachelor or post-graduate 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.
What We Offer:
A local contract in a challenging, comprehensive, operational environment with many opportunities for personal input and growth. Plenty of discussions with other professionals in a flat organization.
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