Welcome to Navin's freelance profile!
Location and workplace preferences
- Ghent, OV, Belgium
- Can work onsite in your office in
- around Ghent and 50km
Freelancer code of conduct signed
Read the Malt code of conduct
Native or bilingual
Navin in a few words
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.
Product Quality Associate
Deputy Manager - Quality Assurance
• 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.
Assistant Manager, Quality Assurance
• 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
Are you sure? Your recommendation will be permanently deleted