About:

Indian Institute of Technology Bombay is a premier educational institute in India. In order to support innovations in novel drug and device development happening within the IIT Bombay R&D laboratories and other academic institutions and startups, IIT Bombay is setting up a flexible pilot GMP facility suitable for manufacturing of early-stage clinical supplies of drugs and devices. The facility is intended to support a diverse range of product types. 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 centre for nanomaterial research and attract the participation of faculty from other departments including Chemical Engineering, Material Science & Metallurgy, and Chemistry.

Summary:

The person will establish and manage the QA system for the Pilot Good Manufacturing Practice facility. The responsibility will initially include qualification of the facility currently under construction, establishing all systems, and subsequently keeping the facility maintained and all operations in a state of compliance. The position is based in Bombay on IIT campus and offers an opportunity to demonstrate individual initiative and leadership, and work with leading researchers working on innovative technologies.

Primary responsibilities:

- Lead the quality and compliance aspects of the facility currently under construction, starting with design, build and procurement of the facility and equipment, through commissioning and qualification of the facility and supporting infrastructure.

- Build and lead a compact QA and maintenance team and maintain a high performance, high morale, collaborative team environment.

- Establish a phase-appropriate QA system for a diverse early clinical manufacturing setting, adopting necessary flexibility while maintaining compliance in line with regulations.

- Supervise ongoing compliance 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.

- Advise the researchers on the appropriate level of documentation of the R&D activities happening prior to the Good Manufacturing Practice batches, and train them on Good Manufacturing Practice systems to enable them to carry out operations within the facility.

- Responsible for successful outcomes from all 3rd party and regulatory audits of the Good Manufacturing Practice manufacturing operations of the facility.

- Responsible for QA deliverables and metrics for timely execution of all quality reviews, batch releases, CAPAs, change controls, etc.

Qualifications:

Master's degree in life science or pharmaceutical field and 10 years' industry experience in Good Manufacturing Practice manufacturing or QA functions.

1. Prior experience should preferably include the following:

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

b. Experience in commissioning and qualification of new facilities.

c. Understanding or experience in handling phase-appropriate Good Manufacturing Practice operations for clinical manufacturing of novel drugs or devices.

d. Exposure to development QA.

2. Important and necessary soft skills:

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

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

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.