The Good Manufacturing Practice facility set up at IIT Bombay will not only enable Good Manufacturing Practice grade production of nanomaterials and formulations for pre-clinical testing but also act as a catalyst for stimulating translational research at IIT Bombay. The facility is expected to serve as a nodal center for nanomaterial research and attract the participation of faculty from other departments including Chemical Engineering, Material Science & Metallurgy, and Chemistry.

Role: Execute the QA & RA programs developed by the Head In charge and the QA Lead at the IIT B GMP facility. Maintain all the records and support in development of certain documentation and SOP’s pertaining to the operation of the pilot GMP facility. Develop and execute training programs for the project scientist quality systems, policies and regulatory requirement.

• 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.

• Support the phase-appropriate QA program for a diverse early clinical manufacturing setting, adopting necessary flexibility while maintaining compliance in line with regulations.

• Execute the ongoing compliance activities in all Good Manufacturing Practice operations of the pilot facility covering production operations, QC, engineering, warehouse and any other support functions, including appropriate controls on any shared space, utilities or manpower resources.

• 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.

• Liase with appropriate Central and State regulatory authorities for regulatory submissions and approval as appropriate.

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

• Experience with devices and diverse drugs (biologics, small molecule).

• Experience in commissioning and qualification / validations of new facilities (in accordance to various ISO classes) & equipment.

• Experience in handling phase-appropriate Good Manufacturing Practice operations for clinical manufacturing of novel drugs or devices.

• Exposure to development QA program in a manufacturing environment.

• Interpersonal skills and ability to work with cross functional teams within and outside the organization, including R&D scientists.

• A flexible, open-minded approach to learn new topics and provide solutions in a diverse, innovation-based setting.

• Fair understanding & Knowledge of Drugs & Cosmetics Act and Medical Device Regulations 2017 (India).

• Familiar with ISO 9001:2015 and / or ISO 13485:2016

The position is contractual for a period of 1 year but renewable as per institute’s guidelines and tenable only for the duration of the project. The selection committee may offer lower or higher designation and lower or higher salary depending upon the experience and performance of the candidate in interview.

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