Manager / Sr. Manager - CQA (API)

3 weeks ago

Mumbai, Maharashtra, India USV PRIVATE LIMITED Full time

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 / Sr. Manager - CQA - API

Department/Function: Operations

Reporting To: AVP

Direct Reportees: No

Location: HO @ Govandi, Mumbai

Working Days: 5 days from Office + Alternate Saturdays - 1st, 3rd & 5th Working (sometimes 2-3 days in a month to sites depends on work)

Job Responsibilities:

  1. Must have audit handling experience for regulatory agencies audits like USFDA, EMA, ANIVSA, CDSCO etc
  2. Must have technical knowledge and well versed with regulatory & cGMP requirements
  3. Monitoring and Assessment of Quality Management System (QMS) for manufacturing sites and R&D functions.
  4. Hands on experience in industry software like TWD, SAP HANA, LIMS, DMS etc.,
  5. Review of Customer Complaints, Risk Assessments, Deviations, CAPAs, Investigations, Recalls etc. - QMS
  6. Handling of Customer Quality agreement and co-ordination with cross functional team till execution of the agreement.
  7. Tracking of CQA SOPs as per the review date, by maintaining the SOP Periodic review tracker and master SOP list.
  8. Preparation/Revision of CQA SOPs and making master, effective after completion of training.
  9. Review of Master formula and technology transfer documents for API sites.
  10. To provide training of SOPs, cGMP, or other modules as per the requirement.
  11. Review of SOPs related to various departments.
  12. Scheduling and participation in self-audits (Sites and corporate functions).
  13. Regulatory and customer audit support to sites.
  14. Review of Specifications for raw material, intermediate, finished API, working standard, GTPs of API Sites.
  15. Handling Customer Questionnaires, Regulatory Agencies Questionnaires and Customer queries as per the requirement.
  16. Participation in Quality related meetings.

Education: Min. Qualification Required - B.Pharm./M.Pharm/M.Sc.

Experience: Minimum 13-17 years

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