Ramaprasath Gj

About Ramaprasath Gj

Experienced Quality Assurance (QA),CQV and Quality Control (QC) professional with over 28 years in biologics, pharmaceuticals and API, specializing in equipment lifecycle management, facility qualification, and compliance with regulatory standards and project management. Proven expertise in commissioning, qualification, and validation (CQV) for greenfield and brownfield projects and supporting successful audits across international locations. Skilled in leading teams to ensure adherence to cGMP, FDA 21 CFR Part 11, EuGMP and GAMP. Successfully represented the quality team during USFDA, TGA, EMA and various other regulatory audits. Adept at developing and implementing quality systems, Computer system validation (CSV) for laboratory and manufacturing process systems, stability programs and digitization. Recognized for contributions to industry standards and innovative solutions in equipment and process support, as well as for leadership in high-stakes regulatory audits. ISO 9001:2015 Lead Auditor. Experienced Quality Assurance (QA) and Quality Control (QC) professional with over 28 years in biologics, pharmaceuticals and API, specializing in equipment lifecycle management, facility qualification, and compliance with regulatory standards and project management. Proven expertise in commissioning, qualification, and validation (CQV) for greenfield and brownfield projects and supporting successful audits across international locations. Skilled in leading teams to ensure adherence to cGMP, FDA 21 CFR Part 11, EuGMP and GAMP Successfully represented the quality team during USFDA, TGA, EMA and various other regulatory audits.Adept at developing and implementing quality systems, Computer system validation (CSV) for laboratory and manufacturing processes, stability programs and digitization. Recognized for contributions to industry standards and innovative solutions in equipment and process support, as well as for leadership in high-stakes regulatory audits. Key highlights of my career include: Leading the design,commissioning and Qualification of state-of-the-art QC analytical and microbiology labs.Executing qualification and validation of upstream and downstream equipment, ensuring alignment with 21 CFR Part 11 and GAMP standards. Successfully navigating high-stakes audits and maintaining adherence to cGMP, ICH guidelines, and ISO standards. Training and mentoring teams to foster a culture of compliance and continuous improvement.

Experience

1. Senior Manager

   Biocon Biologics

   Apr 2021 — Present

Education

• Madurai Kamaraj University

  M.Sc, Chemistry

• University of Madras

  BSc, chemistry

  1990 — 1993

• Indira Gandhi National Open University

  MBA, OR

  1999 — 2002