Senior Quality Control Manager
6 days ago
WUXI XDC SINGAPORE PRIVATE LIMITED is seeking an experienced Senior Quality Control Manager to join our team. This role is responsible for leading the routine operation of QC lab, ensuring business delivery at the right quality, cost and speed.
About the Role
The successful candidate will have a Bachelor's degree or above in pharmacy, chemistry, biochemistry, analytical chemistry or other related disciplines. A minimum of 7 years of experience in biotech or biopharma industry is required. A good understanding of the overall view of the drug development process and comprehensive knowledge of FDA, EMA, NMPA, ICH, WHO technical guidelines, and USP, Eur.P, ChP pharmacopoeias are essential.
Key Responsibilities
- Manage the routine operation of QC team to ensure business delivery at the right quality, cost and speed.
- Lead the team to comply with internal requirements in all aspects via end-to-end quality control system oversight.
- Ensure all activities in QC team performed with compliance of cGMP, data integrity and EHS requirement.
- Provide support and technical directions for any technical/experiment work required during investigation and definition of corrective and preventive actions.
- Oversight of the training, evaluation and management of the staff in QC lab. Coaching, developing and supporting them in reaching their full potential.
- Responsible for the GMP audit from regulatory authorities and clients. Reply to audit reports and create CAPAs.
Requirements
- Bachelor's degree or above in pharmacy, chemistry, biochemistry, analytical chemistry or other related disciplines.
- Minimum 7 years of experience in biotech or biopharma industry.
- Comprehensive knowledge of IND/IMPD, NDA, and ANDA filing.
Salary Information
This role offers an estimated annual salary range of SGD $120,000 - SGD $180,000 depending on experience, plus additional benefits.
About WUXI XDC SINGAPORE PRIVATE LIMITED
We are a reputable biotech company with a strong commitment to delivering high-quality products and services.
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