Skill set (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
- ConsultantProduct Quality AssociateApril 2022 - Today (2 years and 10 months)
- Stelis BiopharmaTeam LeaderOctober 2019 - April 2022 (2 years and 6 months)Bengaluru, Karnataka, India
- Zydus BiologicsDeputy Manager - Quality AssuranceApril 2016 - October 2019 (3 years and 6 months)Ahmedabad, Gujarat, India• 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.
Recommendations
Education
- Doctor of Philosophy (PhD), BiotechnologyBirla Institute of Technology and Science2014Doctor of Philosophy (PhD), Biotechnology
- M.Sc., BiotechnologyRajiv Gandhi Biotechnology Centre, Nagpur2008M.Sc., Biotechnology
- Bachelor's degree, Biology/Biological Sciences, GeneralMohanlal Sukhadia University2006Bachelor's degree, Biology/Biological Sciences, General
- MatriculationCentral Public School, Udaipur2003Matriculation