Associate Specialist, QA
(12 month contract)
About the Company:
Our client is a US healthcare and a leading global biopharmaceutical company. They have a revenue of US $40.1 billion, with more than 69,000 employees across 140 countries with a heritage of more than 125 years. Our client is committed to provide patients and customers with a reliable supply of high-quality, safe, and effective medicines and vaccines. Their global supply strategy relies on manufacturing capabilities and expertise to achieve this mission
Primary Responsibilities:
In this role, you will be responsible for all or subset of the key responsibilities below:
- Reviews and closes batch record
- Collaborates with Operations team to improve the batch record errors which includes trending analysis
- Performs batch disposition in SAP system and issues related batch disposition documentation
- Communicates to Qualified Person/Qualified Release Personnel on any information that may result in revoking of released status of any shipped material
- Discussion with Qualified Person/Qualified Release Personnel periodically related to batch disposition
Requirements:
- Diploma or Bachelor’s degree in Science/ Life Science, Pharmaceutical Science or Engineering or any other relevant field
- Minimum 1 year of applied professional work experience in quality assurance / batch record reviews in pharmaceutical manufacturing environment.
- Good knowledge and understanding of GMP and application of pharmaceutical regulatory requirements.
Reg No: R22104540
EA License no: 94C3609
