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Salil Saksena

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Last update: 05.03.2020

Pharmaceutical GMP Consultant

Company: Independent Pharmaceutical GMP Consultant
Graduation: Master of Pharmacy and MBA
Hourly-/Daily rates: show
Languages: Arabic (Elementary) | English (Full Professional) | Hindi (Full Professional)

Skills

I take this opportunity to introduce myself to your kind self as an independent pharmaceutical GMP consultant associated with the pharmaceutical fraternity for last three decades. I have profound experience of industrial working in the pharmaceutical field in manufacturing and quality assurance. I aspire to be associated with your esteemed organization as a consultant.
My brief credentials are as below:
Academic Details:
  • M.B.A (Consortium) in Human Resource Management (HR) from Institute of Management Studies, Devi Ahilya Vishwavidyalaya, Indore (M.P.), India in 2000.
  • Diploma in Pharmaceutical Production Management from I.P.E.R. Pune in 1994.
  • M. Pharmacy in Pharmaceutics from The Department of Pharmaceutical Sciences, Dr. H.S. Gour Vishwavidyalaya, Sagar (M.P.), India in 1990.
  • B. Pharmacy from College of Pharmacy, Indore (M.P.), India in 1988.
Work Experience:
  1. Industrial Experience
  • 28 years of work experience in Pharmaceutical manufacturing (10 years) and quality assurance (18 years) since 1990.
  • Started carrier with Ipca Laboratories Limited Ratlam in 1990.
  • Companies worked with In India include Ipca Laboratories Limited, Nicholas Piramal India Limited, Ranbaxy Laboratories Limited, Lupin Laboratories Limited, Glenmark Generics Limited.
  • Companies worked with outside India include T3A Industrial Egypt and Ingenus Pharmaceuticals LLC USA.
Achievements:
  • Successful regulatory inspections (more than 500) including USFDA, WHO Geneva, MHRA, EMEA, Health Canada, Germany, Croatia, TGA, Colombia (INVIMA), TFDA, NAFDAC, SAMCC, Kenya, Zimbabwe, Ukraine, Russia, Belarus, Philippines, Uganda, UNICEF, ISO 9001, ISO 14001, EHS, etc.
  • New Product design and development. ANDA filings for various dosage forms in US and Europe.
  • Implementation of QMS, electronic systems, automations, etc. as per the current cGMP and regulatory requirements.
  • Training and development of the employees on cGMP, regulatory requirements, documentation practices, data integrity, validations, etc.
  • New facility design and construction projects. Etc.
  • Vendor development process.
  • Set up of contract manufacturing QA department.
  1. Consultancy Experience:
  • As lead consultant and deviation coach for a US pharmaceutical MNC as a part of their FDA remediation for training, development of the employees and investigations and closure of the QMS.

Project history

Recent Consultancy project:
As lead consultant and deviation coach for a US pharmaceutical MNC (M/s. Pfizer) as a part of their FDA remediation for training, development of the employees and investigations and closure of the QMS for their manufacturing site at Chennai, India.

Local Availability

Only available in these countries: India
Ready to relocate if needed.
Can travel upto 80%.
Can work for 8-10 hours a day as per need.

Other

I take this opportunity to introduce myself to your kind self as an independent pharmaceutical GMP consultant associated with the pharmaceutical fraternity for last three decades. I have profound experience of industrial working in the pharmaceutical field in manufacturing and quality assurance. I aspire to be associated with your esteemed organization as a consultant.
My brief credentials are as below:
Academic Details:
  • M.B.A (Consortium) in Human Resource Management (HR) from Institute of Management Studies, Devi Ahilya Vishwavidyalaya, Indore (M.P.), India in 2000.
  • Diploma in Pharmaceutical Production Management from I.P.E.R. Pune in 1994.
  • M. Pharmacy in Pharmaceutics from The Department of Pharmaceutical Sciences, Dr. H.S. Gour Vishwavidyalaya, Sagar (M.P.), India in 1990.
  • B. Pharmacy from College of Pharmacy, Indore (M.P.), India in 1988.
Work Experience:
  1. Industrial Experience
  • 28 years of work experience in Pharmaceutical manufacturing (10 years) and quality assurance (18 years) since 1990.
  • Started carrier with Ipca Laboratories Limited Ratlam in 1990.
  • Companies worked with In India include Ipca Laboratories Limited, Nicholas Piramal India Limited, Ranbaxy Laboratories Limited, Lupin Laboratories Limited, Glenmark Generics Limited.
  • Companies worked with outside India include T3A Industrial Egypt and Ingenus Pharmaceuticals LLC USA.
Achievements:
  • Successful regulatory inspections (more than 500) including USFDA, WHO Geneva, MHRA, EMEA, Health Canada, Germany, Croatia, TGA, Colombia (INVIMA), TFDA, NAFDAC, SAMCC, Kenya, Zimbabwe, Ukraine, Russia, Belarus, Philippines, Uganda, UNICEF, ISO 9001, ISO 14001, EHS, etc.
  • New Product design and development. ANDA filings for various dosage forms in US and Europe.
  • Implementation of QMS, electronic systems, automations, etc. as per the current cGMP and regulatory requirements.
  • Training and development of the employees on cGMP, regulatory requirements, documentation practices, data integrity, validations, etc.
  • New facility design and construction projects. Etc.
  • Vendor development process.
  • Set up of contract manufacturing QA department.
  1. Consultancy Experience:
As lead consultant and deviation coach for a US pharmaceutical MNC as a part of their FDA remediation for training, development of the employees and investigations and closure of the QMS.
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