Balachandra Nadig ASQ CPGP

Responsible for Quality (QA& QC) and Operations (Engineering, Projects, Logistics and Technical Operations)

Responsible for Compliance function of Covid 19 vaccine manufacturing operations in a CMO

Responsible for setting up Quality and GMP in CDMO

I am an independent Pharmaceutical cGMP and Quality consultant offering, 1. Vendor Quality Audit services for vendors based in APAC. 2. Internal Audits 3. Mock Audits prior to facing regulatory inspections 4. Due Diligence Audits for Contract Manufacturing 5. For Cause Audits of Vendors 6. Audit training

Responsible for leading Global Audit & Compliance Program for External suppliers, Service providers, Group Internal and Corporate audits.

- Responsible for defining and developing a GMP auditing and advisory practice - Developed offerings for GMP assessments covering own sites, contract manufacturing, and vendors - Recruited team across India offices and trained on Risk Based GMP auditing process - Business Development and Marketing of the new services by participation in industry events

- Responsible for QMS implementation, ISO (9000, 22000) sustenance, regulatory compliance, GMP trainings, Process Assurance, Customer Complaints (National Cell) & Site Risk Management (RMPO). - Responsible for Quality Metrics of the site and taking corrective actions in case of deviations - Successfully executed the Quality as Competitive Advantage project, awarded Rajiv Gandhi National Quality Award 2009 for large scale manufacturing sector. - Awarded Golden Peacock National Quality Award 2011 under large scale health care sector. - Led internal audit program improvement project as team leader. (L1 & L2 improvement) - Attended GSK Auditor Certification Program, completed training.

Responsible for Business Development, organising and conducting cGMP audits and trainings in Southeast Asia Pacific region.

Was responsible for QA activities of Biologics Pilot Plant, including qualification documentations, FAT & SAT of critical equipments and QA documentations.

Recepient of National Merit Scholarship Qualified in Graduate Aptitide Test in Engineering (GATE 1994)