Anilvikas Yamana

Dynamic Manager with a robust background in research leadership at Micro Labs Pvt Ltd, leveraging analytical problem-solving skills to drive successful project execution and maintain regulatory compliance. Specialized in quality control management, implementing process improvements that lower costs and enhance product quality. Effective leader in team training and motivation, consistently achieving superior operational results.

· Administering all quality control activities for a team of 30 members as a Designee.

· Accountable for the planning and execution of raw material, intermediates, and finished products, as well as conduct stability studies through Caliber LIMS.

· Carrying out review and approval of laboratory investigations (LIR, OOC, OOT, OOS, and unknown peaks in residual solvents), deviations, and change controls.

· Diligently approving SOP’s, STP’s, work sheets, and analytical raw data through Caliber LIMS, as well as reviewing OOS, OOT, OOC, and LIR investigation trends.

· Managing responsibilities as an Auditee to maintain compliance of internal, customer, and regulatory audits.

· Regularly interacting with the regulatory affairs department for QC related functions and supporting DMF queries.

· Responsible for CAPA monitoring and CAPA implementation and effectiveness check.

· Working towards stability study management, maintaining standard qualifications, and evaluating pharmacopoeia updates with existing analytical methods.

· Productively liaising with the Technology Transfer and R&D teams for analytical method transfers

· Responsible for Analytical instrument qualifications and computerized system validations as per GAMP-5 guidelines.

· Reviewing the analytical test report for raw material, intermediates and finished products, stability protocols, and stability summary sheets.

· Ensuring the cleaning, calibration, validation, and AMC of stability chambers and laboratory instruments.

· Monitoring analytical instruments, data backup, and audit trails.

· Responsible for audit preparation activities and planning, monitoring, and execution of GLP activities.

• Entire lab instruments are requalified after Ransomware virus within a month
• Attended four international seminars
• Four International journals are published with combination of drugs

Date of Birth:  04 March, 1986

Address:  Flat No. G09, VBM Trendz, 8th Cross, Celebrity Paradise Layout, Doddathoguru, Electronic City, Phase-1, Bengaluru - 560100

Languages Known:  English, Telugu, Kannada, and Hindi