Gunawant Devidas Toke
F 102 Surmya Apartment, Near Nigam Society Bus Stop, Behind Punit Nagar, Ghodasar, Maninagar, Ahmeda
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.
- Conduct training sessions, maintain skill matrices, and oversee qualification/validation documentation.
- Collaborate with cross-functional teams to ensure smooth operations and timely batch record submissions.
- Executed all tasks aligned with cGMP standards to ensure compliance and safety.
- Ensured GMP compliance across all departmental areas to uphold safety and quality standards.
- Met production levels in alignment with established norms to ensure operational efficiency.
- Conducted in-process testing to verify product quality.
- Investigated issues related to returns, material defects, and excess inventory to identify root causes and implement corrective actions, improving operational reliability.
- Execute department tasks in accordance with established SOPs
- Identified issues with machinery and personnel, implementing troubleshooting measures to resolve problems..
- Ensured thorough documentation of all related operational record
- Established PLC setting according to batch production record
- Supported investigations for production -related complaints
- Assisted in investigations of production-related complaints to identify and resolve issues..
- Participated in various audits and inspection
- Participated in various audits and inspections to ensure compliance with regulatory standards.
- 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, and facilitated adherence to operational standards to uphold production integrity.
- Executed in-process testing to validate compliance with production standards, enhancing product quality assurance
- Coordinated with quality teams to ensure timely completion of record reviews, supporting compliance objectives and minimising risks.
- Performed duties following cGMP guidelines to maintain regulatory compliance
- Prepared documentation and coordinated with auditors and inspections to streamline regulatory audit processes and reinforce compliance.
Trainee Production Chemist
Haffkine Ajantha Pharmaceuticals Ltd.
Jalgaon
10.2009 - 12.2010
- Conducted in-process testing to ensure product quality and compliance with standards.
- Ensured strict cGMP compliance across all work processes, reinforcing product quality standards
- Supported investigation of production-related complaints, identifying root causes to improve product reliability
- Documented all relevant information meticulously, enhancing traceability and meeting regulatory requirements
Education
M. Pharm - Pharmacognosy
TVES College of Pharmacy, North Maharashtra University
Jalgaon01-2008
B. Pharm -
TVES College of Pharmacy, North Maharashtra University
Jalgaon01-2006
Skills
- cGMP compliance
- Regulatory Auditing
- Batch Record Review
- Production Scheduling
- Operational Excellence
- Machines: Vibrosifter, Rapid Mixture Granulator (RMG), Fluid Bed Dryer, Multimill, Cage Blender, Auto Coater
- Cross-functional leadership
- Team Leadership
- Languages: English, Hindi, Marathi, Gujarati
Strengths
- Strive for excellence with integrity and hard work
- Strong communication and social adaptability
- Positive, cooperative approach with team-building skills
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