プロフィール詳細

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ASHOK P.に依頼

India

Senior Pharma & Biotech professional with expertise in GMP, QMS, Remediation, new facility concept design & Auditing

プロフィール概要

CAREER SUMARY • 33 Years of broad working experience having worked with different Pharmaceutical, Biopharmaceutical and Vaccine manufacturers covering all therapeutic areas and process steps right from R&D to Distribution and Storage complying with the various GxP regulatory requirements. • Expertise in aseptic sterile manufacturing (small volume, large volume and dry powder), but besides this also have worked with other formulation dosage forms such as tablets, capsules, ointments and liquid orals. • Last 20 years have been working in Quality function at Senior to Top Management positions. I had started my career, working in Basic Research & Development for 4 years followed by Production department for 9 years. • Have handled the entire gamut of product life cycle from R&D to Distribution. • Worked for 6 years with Azbil Telstar, a leading Spanish Pharma Consultancy company in charge for overall quality management activities of the Indian operations for the company • As a lead Auditor have performed 180 cGMP audits at various drug substance and drug product manufacturing facilities located in India, China, Japan, S. Korea, Hong Kong, Malaysia, Israel and USA. • Expertise in matters of Quality Assurance including design and validation of green field projects, implementation and management of quality systems and obtaining regulatory approvals such as USFDA, MCA, MCC, MHRA and ANVISA. ACADEMIC QUALIFICATION Masters in Microbiology : - Year 1986 from S.P.University, Gujarat, India Diploma in Materials Management : - Year 1988 form Mumbai University, India LANGUAGE SPOKEN: - Highly fluent in English both in written and oral communication.

専門分野

• ★ Quality Assurance & Quality Control (QA/QC)
• ★ Product Compliance

サービス

• Research
• Consulting

Research Feasibility Study

Consulting Scientific and Technical Consulting

職務経験

PRINCIPAL PHARMA CONSULTANT

Free lance

1月 2020 - 現在

PRINCIPAL PHARMA CONSULTANT

FREELANCER PHARMA CONSULTANT

1月 2020 - 現在

ASSOCIATE VICE PRESIDENT CORPORATE QUALITY

OTSUKA PHARMACEUTICAL INDIA

10月 2014 - 12月 2019

HEAD QUALITY OPERATIONS

AZBIL TELSTAR (formerly Telstar Life Sciences)

5月 2008 - 9月 2014

HEAD QUALITY

INDIAN IMMUNOLOGICALS LIMITED

7月 2005 - 4月 2008

学歴

POST GRADUATE IN SCIENCE - MICROBIOLOGY

S.P. UNIVERSITY, INDIA

8月 1984 - 5月 1986

認定資格

• 認定資格の詳細は未入力です。