Assoc. Spclst, Quality Assurance
On-site · Singapore, Singapore
Job Summary
Assoc. Specialist, Quality Assurance responsible for Batch Review/Batch Disposition and closing batch records; collaborates with Operations to improve batch record errors; performs batch disposition in SAP and issues related documentation; coordinates with Qualified Person/Qualified Release Personnel; participates in investigations for Deviation/OOS/Customer Complaints and tracks CAPAs; provides training and serves as SME for batch review; participates in change control and reviews related documentation; reviews and approves SOPs, forms, cleaning protocols, and related records; works with multiple functions to address audit issues and promote cGMP awareness; contributes to continuous improvement and compliance initiatives within Singapore manufacturing operations; requires a Bachelor's degree in relevant science/engineering fields and strong GMP/compliance knowledge.
Required Qualifications
- Bachelor's Degree in Science/ Life Science, Pharmaceutical Science or Engineering or proven relevant experience
- Good knowledge and understanding of GMP and application of pharmaceutical regulatory requirements
- Strong preference for previous quality / compliance experience, and previous complaint experience
- Minimum of 1-3 years experience within the pharmaceutical industry
- Requires ability to identify and implement continuous improvement initiative
- Excellent problem solving skills, based on science, facts, data and understanding of regulatory requirements
- Strong demonstrated interpersonal, communication, collaboration and leadership skills; and ability to work in a multi-cultural environment
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