Sanjay Borade

Highly experienced and results-oriented Quality Assurance (QA) and Quality Control (QC) professional with over 25 years of expertise in pharmaceutical and chemical laboratories. Proven track record in managing laboratory operations, ensuring regulatory compliance with USFDA, TGA, MHRA, NABL, and ISO standards. Expert in Method Validation, Stability Studies, and Analytical Instrumentation.

Adept at leading large teams and implementing 21 CFR Part 11 compliant data integrity practices. Seeking to leverage extensive knowledge to contribute to a dynamic organization.

Head QA/QC at Jubilant Pharma & Chemical Laboratory (2022-12 – 2023-12)

• Managed a 30-person laboratory team, overseeing all activities from sample entry to final report issuance.
• Ensured 100% regulatory compliance during internal and external audits, maintaining rigorous QA/QC records.
• Reviewed and approved Stability Study and Method Validation protocols, aligning with global standards.
• Optimized laboratory workflow, improving report turnaround time and overall productivity.
• Managed calibration schedules and ensured timely renewals for all analytical instrumentation.
• Approved SOPs, STPs, and Certificates of Analysis (COA).

Sr. Scientist at Alkem Laboratories (2008-02 – 2022-12)

• Maintained strict compliance with cGMP guidelines and QMS requirements.
• Led Root Cause Investigations (RCA) for OOS and OOT results, reducing recurrence.
• Reviewed and monitored Data Integrity practices using Empower software (21 CFR Part 11 compliant).
• Developed and implemented CAPA to drive continuous process optimization.
• Delivered training on analytical instruments and GLP documentation.
• Reviewed IQ, OQ, and PQ documents for new laboratory equipment.
• Successfully managed USFDA audits for Amlodipine Hydrochloride Tablet, Gabapentin Capsule, and Tablets.

QC Executive at Marksans Pharma Ltd (2007-01 – 2008-01)

• Performed analytical data reviews and managed stability study data.
• Prepared stability study protocols and conducted internal audits (GMP standards).
• Managed working standards and reference standards.
• Participated in USFDA audits for Metformin Hydrochloride Tablet.

Sr. Chemist at USV Ltd (2005-10 – 2006-12)

• Conducted analytical data reviews and process validation data reviews.
• Managed laboratory operations per cGMP guidelines.
• Supervised calibration data reviews and ensured data compilation accuracy.
• Assisted in USFDA audits for Metformin Hydrochloride Tablet.

Chemist at Glenmark Pharmaceuticals (2003-11 – 2005-09)

• Executed stability studies and finished product analysis (HPLC).
• Performed calibration for HPLC and analytical balances.

Quality Control Chemist at Mayo Pharmaceuticals Ltd (1998-10 – 2003-10)

• Conducted sampling and analysis of raw materials and finished products.
• Managed raw material inventory and quality documentation.

M.Sc. in Organic Chemistry – Dr. BabasahebAmbedkar Marathwada University