A biotechnology firm in Singapore is seeking a Quality Manager to oversee the establishment and maintenance of a comprehensive quality management system. This role involves ensuring compliance with regulatory guidelines, managing the entire lifecycle of GMP documentation, and conducting regular quality metrics reviews. The ideal candidate should have at least 8 years of experience within production or quality management, with proficiency in English and familiarity with FDA/GMP regulations. Excellent cross-functional communication and leadership skills are essential.
Qualifikationen
Bachelor's degree or higher in a relevant field.
At least 8 years of experience in production/quality management.
5 years minimum in QA or compliance QA.
Familiarity with regulatory GMP requirements.
Experience in setting up quality systems for new sites preferred.
Experience leading audits preferred.
Aufgaben
Establish and maintain an effective quality system.
Manage GMP documentation lifecycle.
Conduct training initiatives for personnel.
Oversee quality events management.
Implement Quality Risk Management Plan.
Lead internal and external audits.
Handle product complaints and recalls.
Kenntnisse
Cross-functional communication
Learning ability
Proficient in English
Skilled in Microsoft Word
Skilled in Excel
Skilled in PowerPoint
Experience with TrackWise
Experience with SAP
Ausbildung
Bachelor's degree in Biologics, Pharmacy, Pharmaceutical Engineering or related fields
Tools
TrackWise
SAP
Jobbeschreibung
A biotechnology firm in Singapore is seeking a Quality Manager to oversee the establishment and maintenance of a comprehensive quality management system. This role involves ensuring compliance with regulatory guidelines, managing the entire lifecycle of GMP documentation, and conducting regular quality metrics reviews. The ideal candidate should have at least 8 years of experience within production or quality management, with proficiency in English and familiarity with FDA/GMP regulations. Excellent cross-functional communication and leadership skills are essential.
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