Rakesh Purohit

Pharmaceutical Quality & Compliance Leader with 28+ years of experience driving enterprise-wide Quality Assurance, Regulatory Compliance, and Audit Excellence across global API manufacturing environments. Leaded QA, RA, Audit & Compliance for 6 manufacturing blocks at one of the largest API sites in DRL with a strong track record of delivering zero-observation USFDA inspections and sustaining global regulatory readiness. Recognized for building inspection-ready organizations, institutionalizing robust QMS frameworks, and leading quality culture transformation initiatives that embed compliance into operations at scale.

Manager- QA, RA, Audit & Compliance - Dr. Reddy's Laboratories - Srikakulam, Vishakapatnam

(2016-10 - 2026-03)

Overall responsibility for tracking, monitoring, and compliance of QAMS activities. Led multiple global regulatory audits (USFDA, Health Canada, EDQM, Korea MFDS) with consistent success, with three USFDA audits closed with zero-observations. Directed site-wide QA strategy across 6 blocks, ensuring compliance across a large-scale API manufacturing setup.

Built and sustained audit-ready teams, enabling continuous readiness for regulatory and customer inspections. Drove quality culture transformation (SuCCEED program) impacting mindset, accountability, and audit preparedness across teams. Established risk-based internal audit frameworks, improving audit effectiveness and compliance coverage.

Strengthened CAPA systems and investigation frameworks, enhancing root cause accuracy and closure effectiveness. Led 2–5 customer audits per month, ensuring high responsiveness and compliance credibility. Performed project management for cultural transformation initiative SuCCEED (Sustained Compliance through Culture, Excellence & Empowerment at Dr Reddy's) with eight different work streams.

Led annual internal audit planning by conducting comprehensive risk assessments and prioritizing critical

• Review and approval of Annual Product Quality Review (APQR / APR) reports
• Change Controls verification and approvals
• Handling and oversight of Deviations, OOS / OOT investigations and Market complaints
• Evaluation of investigations for root cause analysis and CAPA effectiveness
• CAPA tracking, effectiveness monitoring, and closure verification
• Review, verification, and approval of Quality Risk Assessments
• Internal audits & Global team audits
• Trainings to SMEs to be prepared for audit facing skills
• Handling of Market complaints
• Verification and approvals of Standard Operation Procedures
• Lead site-level regulatory compliance activities, ensuring adherence to applicable national and international regulatory standards
• Developed risk‑based audit schedules by analyzing past NCR trends, customer feedback, and regulatory requirements, ensuring alignment with GMP standards

Manager- QA - Lupin Limited - Bhopal, Madhya Pradesh

(2013-05 - 2016-10)

QA lead for two regulatory audits i.e USFDA & WHO GMP. Managed customer audits averaging 2 per month.

• Handling audits and tracking CAPAs against the audit responses
• Handling of Qualification & Validation activities
• Release of finished products (API) & saleable intermediates
• Handling of Retention samples and self inspection audits
• Responsible for review and approval of process & cleaning validations protocol and reports
• Review and approval of SOPs, BPCRs, MPCRs, specifications and test methods
• Responsible for the verification of equipment qualification & re-qualification
• Updation of SMF and validation activity as per VMP
• Evaluation of water quality and trend analysis

Manager- QA - Saurav Chemicals Ltd. - Mohali, Punjab

(2009-08 - 2013-05)

Led as Site QA Head, the GMP inspections conducted by the German Health Authority (March 2011) and Lagesco Berlin (August 2012).

Dy. Manager-QA - CTX Life Sciences Pvt. Ltd. - Surat

(2007-11 - 2009-08)

Led as Auditee for the pre‑approval inspection (PAI) conducted by the Mexican Health Authority in 2009, in addition to multiple customer audits.

Asst. Manager-QA - Cadila Pharmaceutical Ltd. - Ankleshwar

(2005-07 - 2007-11)

Officer- QC - Glenmark Pharmaceutical Ltd. - Ankleshwar

(2004-04 - 2005-07)

Faced the FDA as Section Head of QC, presenting API testing and stability in 2004.

• Analysis, Review & Release of APIs, Intermediates, Raw materials and Stability samples
• Conducting vendor audits for critical raw materials & tracking of Approved Vendors
• Performing chemical and instrumental analysis of finished and intermediate products
• Evaluation of Holding time studies and Stability studies
• Conducting training programs related to SOP compliance and Good laboratory practices
• Calibration of Instruments against the defined schedule
• Handling of Working standard & Qualification
• Control samples management and issuing based on market complaint assessment
• Procurement of the instruments as per process requirements
• Schedule planning for lean daily management for timely releasing of the samples

Sr. Chemist- QC - Zydus Cadila Health Care Ltd. - Ankleshwar

(2002-08 - 2004-03)

• Analysis, Review & Release of APIs, Intermediates, Raw materials and Stability samples
• Conducting vendor audits for critical raw materials & tracking of Approved Vendors
• Performing chemical and instrumental analysis of finished and intermediate products
• Evaluation of Holding time studies and Stability studies
• Conducting training programs related to SOP compliance and Good laboratory practices
• Calibration of Instruments against the defined schedule
• Handling of Working standard & Qualification
• Control samples management and issuing based on market complaint assessment
• Procurement of the instruments as per process requirements
• Schedule planning for lean daily management for timely releasing of the samples

Sr. Chemist- Production - IPCA Laboratory Ltd. - Ratlam, Madhya Pradesh

(1997-08 - 2002-08)

Worked as Shift Chemist, managing end‑to‑end production operations. Last 2 years responsible for testing of inprocess QC samples for LOD, water content by KF and RS by HPLC. Additionally performing stability samples as per stability analysis plan.

• Production planning
• Raw material issuance
• Manufacturing as per Batch Production Records (BPR)
• Packing and labeling operations as per customer requirements
• Hands‑on experience with pharmaceutical equipment like Reactors, Filters, Centrifuges, Dryers, RCVD, Mills, Shifters
• Responsible for product planning as per purchase orders

MSc. - Industrial Chemistry - Vikram University