Gunawant Devidas Toke
F-102 Surmya Apartment, NR. Hinavora School Ghodasar, Maninagar Ahmedabad,Gujarat
Summary
Goal-driven and performance-oriented pharmaceutical professional with 16+ years of experience in production operations. Skilled in managing large teams, ensuring compliance with international regulatory standards, and driving efficiency in manufacturing processes. Proven ability to collaborate across departments and deliver production targets in highly regulated environments.
Overview
17
17
years of professional experience
Work History
Assistant Manager – Production
Zydus Healthcare Ltd.
Ahmedabad
08.2016 - Current
- Lead production operations in granulation and coating areas, ensuring compliance with USFDA, MHRA, TGA, and other global regulatory standards.
- Plan and execute production schedules, driving team performance to meet monthly targets.
- Executed production activities to consistently meet established production norms, ensuring compliance with quality standards.
- Conduct training sessions, maintain skill matrices, and oversee qualification/validation documentation.
- Collaborated with cross-functional teams to streamline operations and ensure timely batch record submissions.
- Conducted in-process testing to verify product quality
- Supported investigations for production-related complaints.
- Conducted investigations into product returns and material discrepancies
- Monitored departmental activities to ensure adherence to SOPs
- Configured process parameters in PLC according to BPR/BMR specifications
- Enforced GMP compliance across all relevant departmental areas
- Implemented effective housekeeping practices to maintain a clean and safe environment
- Escalated issues, including cleaning, to the immediate supervisor.
- Maintained thorough and accurate documentation of all records
- Audits & Inspections Faced
- USFDA, MHRA (UK), TGA (Australia), INVIMA (Colombia), IDA (Netherlands EU), ISO
Executive – Production
Unique Pharmaceutical Labs (Division of J.B. Chemicals & Pharmaceuticals Ltd.)
Panoli
01.2011 - 07.2016
- Supervised shop-floor activities, maintained logbooks, ensured calibration compliance to uphold quality standards.
- Executed tasks in accordance with current Good Manufacturing Practices (cGMP).
- Conducted in-process testing to ensure product quality.
- Coordinated with quality teams to ensure timely completion of record reviews, supporting compliance objectives.
- Assisted in regulatory audits and inspections, contributing to successful adherence to industry regulations.
Trainee Production Chemist
Haffkine Ajantha Pharmaceuticals Ltd.
Jalgaon
10.2009 - 12.2010
- Conducted in-process testing to ensure quality control.
- Executed tasks following cGMP guidelines.
- Ensured proper and complete documentation of all related records to maintain compliance with regulatory standards.
- Assisted in investigations of production-related complaints to identify root causes and improve product quality.
Education
M. Pharm - Pharmacognosy
TVES College of Pharmacy, North Maharashtra University
JalgaonB. Pharm -
TVES College of Pharmacy, North Maharashtra University
JalgaonSkills
- GMP compliance
- Regulatory compliance
- BMR review
- PLC configuration
- Machines: Vibrosifter, Rapid Mixture Granulator (RMG), Fluid Bed Dryer, Multimill, Cage Blender, Auto Coater
- Continuous improvement mindset
- Cross-functional collaboration
- Leadership development
Personal Information
- Title: Assistant Manager – Production
- Date of Birth: 1983-06-02
- Marital Status: Married
Languages
English, Hindi, Marathi, Gujarati
Timeline
Assistant Manager – Production
Zydus Healthcare Ltd.
08.2016 - Current
Executive – Production
Unique Pharmaceutical Labs (Division of J.B. Chemicals & Pharmaceuticals Ltd.)
01.2011 - 07.2016
Trainee Production Chemist
Haffkine Ajantha Pharmaceuticals Ltd.
10.2009 - 12.2010
M. Pharm - Pharmacognosy
TVES College of Pharmacy, North Maharashtra University
B. Pharm -
TVES College of Pharmacy, North Maharashtra University