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Navin Jain

Quality Consultant: Biotech and Pharma

Can work in or around Ghent

  • 51.057496
  • 3.732703
  • Suggested rate £343 / day
  • Experience 7+ years
Propose a project The project will begin once you accept Navin's quote.

This freelancer has confirmed full-time availability in the past 7 days.

Propose a project The project will begin once you accept Navin's quote.

Location and workplace preferences

Location
Ghent, OV, Belgium
Can work onsite in your office in
  • around Ghent and 50km

Verifications

Freelancer code of conduct signed
Read the Malt code of conduct

Verified email

Languages

  • Hindi

    Native or bilingual

Skills (4)

Navin in a few words

A passionate and quality-oriented professional, with 7 years of experience to lead and manage roles in Quality Assurance function to achieve quality excellence with business acumen.
Believe in Building QUALITY by integrating TECHNICAL knowledge with REGULATORY framework.
Completed Certification in “Quality Management for Business Excellence”, Six Sigma White Belt and IPR Management.

Experience

Consultant

Product Quality Associate

April 2022 - Today (7 months)

Stelis Biopharma

Team Leader

Bengaluru, Karnataka, India

October 2019 - April 2022 (2 years and 6 months)

Zydus Biologics

Deputy Manager - Quality Assurance

Ahmedabad, Gujarat, India

April 2016 - October 2019 (3 years and 6 months)


• Involved in commercial production of therapeutic recombinant proteins of microbial origin (GCSF, PEG-GCSF, IFN, Teriparatide) and mammalian origin (EPO, Trastuzumab, Adalimumab, Bevacizumab, Rituximab, etc)
• To approve Certificate of Analysis (COA) for batch release and stability samples.
• Handling of OOS, OOT, laboratory incidents, change control, deviation.
• Responsible for stability and retention sample management.
• To review and approve the method validation/transfer related documents.
• To review the manufacturing process to reduce sampling.
• LIMS implementation to achieve "Paperless QC".
• To participate in Management review meetings and development activities.

Biocon

Assistant Manager, Quality Assurance

Bengaluru, Karnataka, India

November 2014 - April 2016 (1 year and 5 months)


• Involved in development and scale up of Trastuzumab and Bevacizumab for global markets.
• Review and approval of analytical data of QC (batch release and stability).
• Preparation of CAPA reports, Handling of OOS and Deviations and preparing the investigation reports of the same.
• Responsible for GMP, GLP and technology transfer related documents.
• Review of Audit trails of QC instruments.
• Handling of QMS activities (change control, deviation, CAPA, OOS, etc)

Shree Krishn College

Lecturer  - As a freelancer

Udaipur, Rajasthan, India

July 2008 - December 2008 (5 months)

Involved in designing and conducting theoretical and experimental classes for undergraduate students.

Education