Vidhya Vincent

Background

About Vidhya Vincent

Quality control Specialist/Manager and trained Molecular biologist with 17 years of experience, technical expertise, lab operations, team management in Biosimilars. Core competencies:* Managing day to day laboratory operations to achieve highly accurate results, meeting GMP and regulatory standards. Leading a team of 32 members.* Designing and execution of Analytical Method Validations and Tech transfers.* Handling Quality Management Systems- CC, CAPA, deviation, lab incident, OOS/OOT, risk management, gap assessment.* Testing and release for Molecular biology - More than 90% TAT for Commercial products (Mabs).* Coordinating with Contract Testing Laboratories for bulk harvest testing- ensuring timely release of batches and product specific qualifications for viral and mycoplasma tests, auditing CTLs.* Expertise in Biosimilars (monoclonal antibodies), GMP compliance and SOP/STP preparations.* Subject matter expert in Molecular biology and Bulk harvest testing (Viral and mycoplasma tests).* Creating short term and long term goals for the team members, training and mentoring them.