Quality Assurance Officer Job in Bigtec Labs

We are seeking an experienced quality assurance specialist preferably with Biology background to work in a research and development environment. The ideal candidate is an exceptionally organized, methodical professional with the experience necessary to take our product development to the next level with respect to the accuracy, security, and safety. You will be charged with developing a complete QA program that not only safeguards the quality of our products but also fosters a quality culture, in which all employees become actively engaged in guaranteeing quality in research and development activities. Prior experience with ISO13485 will be an added advantage.

Responsibilities

• Review & approve batch records, packaging records, CofAs, stability data, expiry dating etc.
• Support clinical supplies / pilot batches activities, including providing formal approval and release for clinical supplies / pilot batches and registration samples.
• Manage QA systems such as Change Control, Planned / Unplanned Deviation, Lab investigations, and CAPAs for R&D (Global Product Development).
• Perform cGMP audit of internal R&D facilities and operations as well as 3rd Party vendors and follow up with corrective action.
• Support Health Authorities audits evaluate and follow up on the appropriateness and completeness of corrective action plans until closure.
• Participate in development of GMP training program, on job documentation training for R&D personnel and provide on-going GMP training to the R&D associates.
• Prepare Quality Agreement with new 3rd party / contract labs as required by the development team.
• Perform routine GMP rounds / visits to the laboratory & manufacturing area, ensure compliance, perform line clearance, review batch records online, perform AQL checks, in-process checks,
• Prepare technical reports.

Other Information

• Experience: 2 to 3 years of experience in QA with ISO 13485 and ISO 9001.
• Industry: Medical and defense electronics
• Role: Quality Assurance Officer
• Employment Type: Permanent Job, Full Time
• Job Location: Bangalore
• Contact Mail Id: [email protected]
• Interview Location: Bigtec Labs