Quality Assurance Associate

4 weeks ago


Mumbai, Maharashtra, India Indian Institute of Technology Bombay Development and Relations Foundation (IITB DRF) Full time

About IIT B

Indian Institute of Technology Bombay (IIT B) is a premier educational institute in India. The institution has established a flexible GMP facility (10X GMP Facility) to support innovations in novel drug and device development. This facility is designed to manufacture early-stage clinical supplies of drugs and devices.

The Facility

The Good Manufacturing Practice facility at IIT Bombay is intended to serve as a catalyst for stimulating translational research. It will enable Good Manufacturing Practice grade production of nanomaterials and formulations for pre-clinical testing. The facility will also act as a nodal center for nanomaterial research and attract the participation of faculty from other departments.

Job Summary

The incumbent shall execute the QA & RA programs developed by the Head In charge and the QA Lead at the IIT B GMP facility. The person shall maintain all the records and support in development of certain documentation and SOP's pertaining to the operation of the pilot GMP facility.

Responsibilities

  • Execute the quality and compliance aspects (based on pharma, biological and medical devices) of the 10X GMP facility.
  • Support the qualification of the facility, equipments and supporting infrastructure as guided by the Facility in charge and QA Lead.
  • Execute the ongoing compliance activities in all Good Manufacturing Practice operations of the pilot facility.
  • Responsible for successful outcomes from all 3rd party and regulatory & QMS audits of the Good Manufacturing Practice manufacturing operations of the facility.
  • Responsible for QA & RA deliverables and metrics for timely execution of all quality reviews, batch releases, CAPAs, change controls etc.

Requirements

  • Master's degree in life science or pharmaceutical (M.Sc.; Biomedical PG, M. Pharm) field.
  • 4 - 6 years' industry experience in Good Manufacturing Practice manufacturing or QA / RA functions of pharmaceutical &/or medical device industry.

Desired Profile

  • Experience with devices and diverse drugs (biologics, small molecule).
  • Experience in commissioning and qualification / validations of new facilities (in accordance with various ISO classes) & equipments.
  • Understanding or experience in handling phase-appropriate Good Manufacturing Practice operations for clinical manufacturing of novel drugs or devices.

Additional Desired Qualification & Experience

  • Fair understanding & Knowledge of Drugs & Cosmetics Act and Medical Device Regulations 2017 (India).
  • Familiar with ISO 9001:2015 and / or ISO 13485:2016.


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