Vidhya Vincent Email & Phone Number

Quality control Specialist/Manager and trained Molecular biologist with 15 years of experience, technical expertise, lab operations, team management, improving drug safety and efficacy that transform patients' lives.Certified interviewer from Thomas International.Certified Lean Six sigma green belt. Core competencies:* Managing day to day laboratory operations to achieve highly accurate results, meeting GMP and regulatory standards. Leading a team of 21 members.* Designing and execution of Analytical Method Validations and Transfers (internal and external). * 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.

Listed skills include Molecular Biology, Qms, Good Manufacturing Practice, Polymerase Chain Reaction, and 5 others.