Amit Srivastava

Sr. Manager QC (Head - QC)

Zydus Healthcare Limited

08.2019 - Current

Assess and ensure compliance to QC regulatory requirements and track quality metrics and drive them down
Effectively manage the site Quality Control activities and resources necessary to smoothly run the QC operation including release of incoming materials, drug products and facilitating stability studies of commercial products as per cGMP requirement and regulatory commitments
Ensure analytical methods are validated /transferred at site laboratory as per cGMP requirement and regulatory commitment
Monitor and review investigations and QMS with adequate CAPA to minimize errors
Design, implement and reviews with QC section heads for compliance related to SOPs, policies, standards and quality systems
Design and execute continuous improvement initiatives in the site to enhance compliance, drive efficiencies and cost effectiveness
Facilitate harmonization and consistent implementation of quality systems and procedures at site, in alignment with regional\global quality policies\standards
Assure all time readiness of site for regulatory agency inspections \internal audits and appropriate implementation of corrective actions regarding observations made by the agencies \internal audit teams
Facilitate arrangement of all the resources required to QC laboratory to achieve desired productivity, SLA defined as per KPI by continual improving the process excellence
Provide strong leadership and expertise to ensure achievement of all Quality Control accountabilities at site
Coach and develop both direct and, as appropriate, indirect reports through ongoing, example based performance feedback, annual performance reviews and the provision of training and development opportunities
Ensure that performance issues are managed in a consistent and timely manner
Develop site quality control revenue and capital budgets and headcount projections, track and manage expenditures and headcount to budget over the fiscal year
Responsible for ensuring compliance to regulatory requirements on product, process and release procedures
Finalize & taking approval for QC Budget, QC Capex & other resources on monthly & yearly basis
Routine discussion with CFT for EM & Personal Monitoring to follow Good Aseptic Practices during routine operations
Monitoring of media fill results, Autoclave, tunnel validations etc
At site
Involve in investigations & outcomes of OOS/OOT/Incidents during routine analysis
Achievements as QC Head at Zydus Healthcare Daman: Here two QC lab (Unit-I & II) were running in separate blocks for Beta-lactam Sterile & OSD (Cephalosporins & Penicillin) molecules due to which managing QC was a big challenge
Lab merging taken as a project and both QC labs merged within 6 month without impacting routine release and making it central QC
Resulting big savings in documentation, cost, manpower and ease of working for QC Team
Perform the method verification as per USP general chapter for all Pharmacopeial legacy products at site for 12 products (December 2020 to March 2021)
Implementation of all quality policy, strong compliance structure and QC Organogram at site
Implementation of 10 projects and approx 40 Kaizens at site for smooth running of QC department
Closure of all overdue CAPA, Global CAPA, QI Portal and other audit observations at site
Presented QC department effectively to CQ Lead & HTO (STRM) on a monthly basis
All time audit readiness 24 X 7 with routine QC operations & documentations
Developing second line and SME for each QC instruments operations & activity
Implementation of Server based operations of Chromeleon software with On-line calculations, e-signoff, paperless chromatography and e-log at site
Implement all the policy & procedures related to lean practices at site
Successfully face the CQA/DI/Semi-Regulatory/WHO/CDSCO Audits with zero critical/major observations in QC.