Oversee the day-to-day operations of the QC Operations team to ensure efficient, high-quality, and cost-effective performance.
Manage functional areas including sample management, raw and packaging material sampling, instrument and equipment management, daily operation of computerized/electronic systems, and overall QC operational support.
Ensure GMP compliance, data integrity, and EHS compliance in all routine operational activities.
Provide support and guidance for investigations arising from operational activities and assist in the development and implementation of appropriate CAPAs.
Supervise training, performance evaluation, and personnel management within the team coach, develop, and support team members to fully realize their potential.
Manage the QC operational budget and related cost control activities.
Coordinate and support GMP inspections and audits conducted by regulatory authorities and customers.
Requirements:
Master Degree or above in pharma/ chemistry or any sciences related course
Min 15 years in biotech or biopharma industry
A good understanding of the overall view of drug development process.
A thorough understanding of the principles and management of cGMP compliance, and strong quality minds.
Comprehensive knowledge in FDA, EMA, NMPA, ICH, WHO technical guideline and USP, Eur.P, Ch P pharmacopoieas.
Comprehensive knowledge in IND/IMPD, NDA and ANDA filing
