| Position | Manager / Sr. Manager - CQA (API) |
| Posted | 2025 September 15 |
| Expired | 2025 October 15 |
| Company | USV PRIVATE LIMITED |
| Location | Mumbai, Mahārāshtra | IN |
| Job Type | Full Time |
Latest Job Information from Company USV PRIVATE LIMITED as position Manager / Sr. Manager - CQA (API). If Job Vacancy Manager / Sr. Manager - CQA (API) in Mumbai, Mahārāshtra matches your criteria, please send your latest application/CV directly through the latest and most updated job site Jobkos.
Every job may not be easy to apply for, because as a new candidate / prospective employee must meet several qualifications and requirements according to the criteria sought by the Company. Hopefully the career information from USV PRIVATE LIMITED as the position Manager / Sr. Manager - CQA (API) below matches your qualifications.
USV, a top-15 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 7,000 across generations. Our commitment to brand building is evident in our popular products like Glycomet GP, Ecosprin AV, Jalra, Tazloc, Glynase, MVI and more.
Join USV and be part of our journey as we continue to innovate, transform lives, and shape the future of healthcare. Job Title: Manager / Sr. Manager (Quality Assurance)Designation
Manager
To: AVPDirect Reportees: NoLocation: HO @ Govandi, MumbaiWorking Days: 5 days from Office + Alternate Saturdays
Working (sometimes 2-3 days in a month to sites depends on work)Job Responsibilities:Must have audit handling experience for regulatory agencies audits like USFDA, EMA, ANIVSA, CDSCO etcMust have 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.
Tracking of CQA SOPs as per the review date, by maintaining the SOP Periodic review tracker and master SOP list. Preparation/Revision of CQA SOPs and making master, effective after completion of training. Review of Master formula and technology transfer documents for API sites.
To provide training of SOPs, cGMP, or other modules as per the requirement. Review of SOPs related to various departments. Scheduling and participation in self-audits (Sites and corporate functions).
Regulatory and customer audit support to sites. Review of Specifications for raw material, intermediate, finished API, working standard, GTPs of API Sites. Handling Customer Questionnaires, Regulatory Agencies Questionnaires and Customer queries as per the requirement.
Participation in Quality related meetings. Education: Min. Qualification Required
/M.Pharm/M.Sc. Experience: Minimum 13-17 years
After reading and understanding the criteria and minimum qualification requirements explained in the job information Manager / Sr. Manager - CQA (API) at the office Mumbai, Mahārāshtra above, immediately complete the job application files such as a job application letter, CV, photocopy of diploma, transcript, and other supplements as explained above. Submit via the Next Page link below.
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