Ramdas Mane

Experience Quality Control professional with over 18 years of experience in pharmaceutical quality control both API and Formulation, GMP compliance, analytical testing, laboratory management and regulatory inspections. Skilled in managing QC operations for raw material, in-process samples, finished products and stability samples. Experienced in handling OOS,OOT,OOC,deviations,CAPA,change control ,equipment qualification and audit readiness,

Manager QC - Gopaldas Visram and Company - Mahape

(2026-03 - 2026-06)

Cosmetic Manufacturing USFDA approved unit

• Provided strategic leadership for routine analysis, in-process control, stability studies, and release and testing of raw materials, intermediates, bulk, and finished products.
• Headed end-to-end Quality Control operations for solid oral dosage forms, ensuring compliance with cGMP, GLP, GDP, and Data Integrity (ALCOA+) requirements.
• Led and reviewed OOS, OOT, deviations, incidents, and laboratory investigations, root cause analysis and ensuring timely and effective CAPA implementation.
• Prepared ǪC teams for regulatory inspections and customer audits; supported successful inspections by USFDA, WHO-GMP, MHRA, and other regulatory authorities.
• Ensured effective training, mentoring, and competency development of ǪC personnel to build a strong compliance and quality culture.
• Collaborated cross-functionally with ǪA, Production, R&D, Regulatory Affairs, and Supply Chain to support seamless operations and timely product supply.

Assistant Manager QC - Naprod Life Sciences Ltd - Boisar

(2025-06 - 2026-02)

OSD and Injectable manufacturing EU cGMP and WHO approved unit

• Finished Product section in charge strategic leadership for routine analysis, in-process control, and release and testing of and finished products.
• Timely planning and review of all raw data of bulk and finished product.

Sr.Executive QC - Ciron Drugs and Pharmaceuticals Pvt. Ltd - Boisar

(2024-10 - 2025-06)

Injectable and Liquid oral and ointment manufacturing unit

• Raw material section in charge strategic leadership for routine analysis and release of raw material.
• Support to Vender qualification.

Executive QC - Impulse Pharma - Boisar

(2023-08 - 2025-10)

OSD tablet manufacturing unit

• Raw material section in charge strategic leadership for routine analysis and release of raw material.
• GLP section in charge management of working standard ,reference standard and all daily activities in QC
• Review of calibration data of all instrument in quality control

Assistant Manager R&D - Zuventus healthcare Pvt.Ltd. - Pune

(2020-08 - 2022-05)

Internal transfer sister concern company of Emcure; Formulation R&D department to support US and ROW market

• Stability study section in charge strategic leadership for routine planning and analysis of stability samples.
• Management of stability program for new developed R&D Formulations.
• Review of raw data and preparation of stability protocols and summary sheet.

Assistant Manager QC - Emcure Pharmaceuticals Pvt.Ltd. - Pune

(2014-01 - 2020-08)

Internal Transfer from API to Formulation Unit; OSD Injectable and Liquid oral and ointment outsourcing department

• Stability study section in charge strategic leadership for routine planning and analysis of stability samples.
• Management of stability program for new developed R&D Formulations.
• Review of raw data and preparation of stability protocols and summary sheet.

Executive QC - Emcure Pharmaceuticals Pvt.Ltd. - Pune

(2011-04 - 2013-12)

API Manufacturing WHO approved unit

• Analysis of Stability samples, raw material In-process and finished product by HPLC and by chemical analysis
• Calibration of all laboratory instruments.

Sr.Officer QC - USV Pvt.Ltd. - Lote (Chiplun)

(2006-02 - 2011-03)

API Manufacturing USFDA, TGA, MHRA approved unit

• Analysis of Stability samples, raw material In-process and finished product by HPLC and by chemical analysis
• Calibration of all laboratory instruments.
• Raw material sampling

Master of Science - Organic Chemistry - Shivaji University Kolhapur (2005)

Bachelor of Science - Chemistry - Shivaji University Kolhapur (2002)

HSC - PCM - M.G.Jr.College Dahivadi (1999)