Professional Synopsis
Dr. SUBHASH KUMAR PANDE
Master of Pharmacy
Ph.D. (Pharmaceutics) and J.D.YSc.
+91 9893291573; 7600987504
Email : subhashpande@gxpzone.com
About 29 years of experience in Pharmaceutical Industry.
R&D, Manufacturing Quality Assurance and Quality Control functions of sterile, Oral Solids, dosage forms, Sterile API, Animal health care products Lyophilized Injections, DPIs, MDIs, Nasal sprays, Bio similar, vaccine and Pre-Filled Syringe products.
Execution of green field and expansion Projects with lean concept.
For last 15 years worked in Senior management – strategic and leadership role, ensuring organizational goals objectives, and business opportunities, through problem solving approach, within cGMP compliance framework.
Now associated with GXPZONE Pharma Solutions as a Technical Director and Principal advisor
USFDA Inspections – Oral Solids, Sterile and Non Sterile APIs , Semi Solids (Ointment and Creams )
MHRA / Eu GMP – Dry Powder Injectable, Oral Solids, Semi Solids
ANVISA – Dry Powder Injectable, Oral Solids; Inhaler’s; Biologics Semi Solids
INVIMA – Oral Solids; Biologics
WHO GMP – Oral Solid, semi Solids, Injections , Lyophilization process.
Sanjay Sharma
(Male, 54 yrs, Indian)
M.Sc Chemistry, MSc TQM)
Email: sanjaysharma@gxpzone.com
A dynamic professional with around 31 years of rich experience in Quality Control and Quality assurance Department. I am presently associated with M/S GXPZONE Pharma Solutions Pvt. Ltd. as a founder and Lead GMP Auditor. A project planner with expertise in planning, executing and spearheading Pharmaceutical projects and ensuring on time deliverables with GXP compliances. Excellent communication & interpersonal skills with strong analytical, team building, problem solving and organizational abilities.
I have successfully handled more than 60 inspections by reputed customer and Regulatory agencies like USFDA, MHRA, TGA, MCC, WHO, ANVISA, UKRAINE and regulatory inspections of AFRICAN countries successfully. I have a rich experience in conducting Global GMP, GDP audits and across other GXPs including ‘For Cause Audits’ for various clients.
He has conducted more than 100 API, EXCEPIENTS, Primary Packaging material, Warehousing and Formulations facilities across the Globe.
Dr. Tarun Chugh
(Male, 53Yrs, Indian)
(Ph.D, Microbiology)
Email : tarunchugh@gxpzone.com
Dr. Tarun Chugh is a Pharmaceutical professional with around 30+ years of rich experience in Microbiology Quality Control and Quality assurance Department. Presently associated with M/S GXPZONE Pharma Solutions Pvt. Ltd. as GMP Auditor. Expertise in performing the gap analysis of Formulation, API, Excipients & Packaging Material manufacturing units with respect to the various regulatory standards like USFDA, MHRA, EU, PICs, TGA, ANVISA, WHO etc.
He is expert in various Microbiology techniques, Clean Room Validation, Aseptic Validations, Process validation, Water system Validation, HVAC Validation, QMS Handling, ALCOA+, Data integrity and troubleshooting with Risk Assessment.
Mr. Vivek Saxena
(Male, 49Yrs, Indian)
(M.Sc. Chemistry)
Email: viveksaxena@gxpzone.com
Vivek is a Pharmaceutical professional with around 28 years of rich experience in Quality Control and Quality assurance Department. Presently associated with M/S GXPZONE Pharma Solutions Pvt. Ltd. as GMP Auditor. Expertise in performing the gap analysis of Formulation, API, Excipients & Packaging Material manufacturing units with respect to the various regulatory standards like USFDA, MHRA, EU, PICS, TGA, ANVISA, WHO etc.
He is expert in various analytical techniques, analytical method transfer, analytical method validation, process validation, Water system Validation, HVAC Validation and QMS Handling.
AIain Pulley
(BSc (Hons), MRQA)
Email: iain.pulley@closedloopquality.com
Website: www.closedloopquality.com
A dynamic professional with around 13 years of experience in Quality Assurance and GCP Auditing. I am an independent Good Clinical Practice (GCP) Auditor and Managing Director of Closed Loop Quality Ltd, presently collaborating with M/S GXPZONE Pharma Solutions Pvt. Ltd. With a BSc (Hons) in Product Design, I am passionately process-orientated, and place strong emphasis on ensuring quality management systems add value to achieve right-first-time results. I have excellent communication & interpersonal skills, with strong analytical, team building, problem solving and organizational abilities. I also have an Associate qualification in project management from the Association for Project Management (APM).
I have successfully participated in 6 inspections by regulatory authorities such as the Medicines and Healthcare products Regulatory Agency (MHRA) and UK Prescription Medicines Code of Practice Authority (PMCPA), and have also successfully performed three inspections in the role of a mock inspector.
I have a wide experience in conducting and overseeing Global GCP audits, and have executed more than 140 investigational site, vendor, system/process and for-cause audits across Europe, the United States, as well as parts of Asia, Africa and South America.