Mohan Kumar

Experienced Quality Assurance Manager in the pharmaceutical industry, specializing in ensuring compliance, regulatory standards, and product integrity. Skilled in risk management, auditing, and continuous improvement processes. Always seeking opportunities to collaborate and drive excellence within the industry.

Associate Manager, Quality Assurance - Biocon Pharma Ltd.

(2018-08)

• Audits & Regulatory Compliance: Handle customer, vendor, and contract manufacturing audits; review audit reports and CAPA responses; manage regulatory queries and ANDA filings.
• Quality Planning & Monitoring: Oversee quality activities in QC, Microbiology, and warehouse; coordinate with team to meet quality standards.
• Digitalization Implementation: Implement LIMS for QC/Microbiology and Novatek LIMS for stability; introduce Track wise software for QMS systems like change control and internal audits.
• Vendor & Laboratory Qualification: Qualify raw material suppliers, packaging vendors, and contract testing laboratories.
• Product Release & Quality Review: Review and approve batch release, OOS reports, change controls, trend analysis, stability data, and method validation reports.
• Training & Technology Transfer: Lead internal training on quality systems and regulatory updates; support technology transfer from R&D to production.
• Handling of Contract manufacturing site: Auditing manufacturing sites, Testing laboratories and Supports for Master documents approvals, supports QMS elements like OOS investigation, deviations, CAPA management and change control management.

Manager, Quality Assurance Dept. - Somerset Therapeutics PVT LTD. - Bangalore

(2014-02 - 2018-07)

• Oversee and coordinate quality activities in QC, Microbiology, and warehouse to ensure compliance with quality standards and regulations.
• Conduct vendor qualification, self-inspection, and regulatory audits, while managing audit reports, CAPA responses, and regulatory queries, including ANDA filings.
• Review and approve batch releases, OOS reports, stability data, change controls, and analytical method validation reports.
• Investigate incidents, OOS/OOT, product failures, and complaints, perform root cause analysis, and implement corrective and preventive actions while supporting technology transfer from R&D to production and providing training on quality systems.
• Handling customer and market complaints.

Executive, Quality Assurance Department - Biocon LTD

(2011-08 - 2014-02)

• Manage immunosuppressant product activities and audits (vendor, customer, and regulatory) in coordination with internal teams, marketing, and regulatory departments.
• Represent the quality team during audits/visits, addressing auditor queries and information requests, and ensuring compliance with audit observations.
• Oversee internal audits, review quality documents (SOPs, protocols, quality manuals), and manage process and cleaning validation protocols and reports.
• Handle quality deviations, change control, out-of-specifications, and out-of-trend issues, while overseeing corrective and preventive actions (CAPA).
• Approve analytical method validation documents, vendor qualifications, stability data (using NOVATEK LIMS), and qualification/requalification records for equipment.
• Prepare Annual Product Reviews, handle batch approvals, dispatches through SAP, and lead internal training on SOP and cGMP topics.

Analytical Executive - Stabicon ltd.

(2010-07 - 2011-07)

• Coordinate method validation, method transfer, and stability study activities with CMO customers, including handling OOS investigations and analysis.
• Manage instrument qualification, SOP preparation, and ensure adherence to GLP for instrument maintenance and calibration.
• Oversee change controls, deviations, customer complaints, and ensure corrective and preventive actions (CAPA) are initiated.
• Prepare and review certificates of analysis, deviations, investigations, and assist in maintaining accurate finished product documentation.
• Train junior chemists on analytical work and assist in the preparation of SOPs and IOPs.

Management staff, Quality Control Department - Cipla

(2007-02 - 2010-07)

• Report to the functional head and analyze raw materials, packing materials, stability samples, and finished products using various instruments (UV, FTIR, HPLC, etc.).
• Prepare stability protocols, summary reports, specifications, test procedures, and Certificates of Analysis (COA) as per market requirements.
• Manage working and reference standards, along with preparing calibration and preventive maintenance schedules for instruments.
• Prepare reagents and volumetric solutions for analysis and ensure proper handling of laboratory equipment.

Post Graduation - Microbiology - Jnana Bharathi campus, Bangalore University

Bachelor of Science - Chemistry, Botany and Microbiology - Government science college, Bangalore University