Managing the entire gamut of QC Operations including resolving the problems and updating the same periodically with the actions/RCA to be undertaken throughout
Adhering to SOPs and appraising technical specifications/batch manufacturing records / analytical reports/validation protocols, validation reports and other quality documents / change-control documents
Extending complete support to regulatory submissions and quality Assurance activities
Assessing release/reject Raw materials, Excipients, packing materials, in-process release, finished goods, and stability samples etc…
Directing complete array of quality Control functions across the manufacturing facility for regulatory compliance
Closely monitoring Out-of-Specification (OOS) investigations and conclusions.
Investigating non-conformance, market complaint, lab incidence, returned goods, product recall, and their impact assessments, studying its reports and monitoring the implementation of Corrective and Preventive Action (CAPA)
Experience
Six-Sigma Green Beltcertified Life Sciences professional with nearly 20 years of experience showcased by an illustrated career in Pharmaceutical Quality Management; currently associated with M/s Sanofi Healthcare India Pvt. Ltd. as Head of the Quality Control Department
Expertise in Quality Management Systems including Deviation Management, Change Management, Risk Assessments, CAPA, and Pharmaceutical Technical Complaints; also ensured timely initiation, investigation, RCA & implementation of appropriate CAPA for lab quality notifications such as incident, Deviation, OOS, OOT, OOC, and change control
Supported the QA team in the investigation of market complaints & withdrawals
