
Senior Quality Assurance Manager
3 days ago
USV, a top pharmaceutical company in India, excels in the diabetes and cardio sectors. We have a presence in over 65 countries with our dynamic team of over 7000 professionals across generations.
We are committed to brand building as evident in our popular products like Glycomet GP, Ecosprin AV, Jalra, Tazloc, Glynase, MVI, and more.
Candidates will play a key role in shaping the future of healthcare by driving quality management and regulatory compliance initiatives.
Job Title: Manager / Sr. Manager (Quality Assurance)
Key Responsibilities:- Audit handling experience for regulatory agencies audits like USFDA, EMA, ANIVSA, CDSCO, etc.
- Technical knowledge and well-versed with regulatory & cGMP requirements.
- Monitoring and Assessment of Quality Management System (QMS) for manufacturing sites and R&D functions.
- Hands-on experience in industry software like TWD, SAP HANA, LIMS, DMS, etc.
- Review of Customer Complaints, Risk Assessments, Deviations, CAPAs, Investigations, Recalls, etc. - QMS
- Handling of Customer Quality agreements and coordination with cross-functional teams till execution.
- Tracking of CQA SOPs as per review date, maintaining SOP Periodic Review Tracker and master SOP list.
- Preparation/Revision of CQA SOPs and making them effective after completion of training.
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