Giridhar Balasubramanyam
Bangalore
Summary
Dynamic Quality Assurance professional with 24+ years of expertise in pharmaceutical and wellness industries, including 15+ years at Himalaya Wellness Company. Proven leader in managing large-scale projects, ensuring global regulatory compliance, and driving operational excellence. Instrumental in achieving certifications from USFDA, WHO, MOH GMP audits and many more. Adept at leveraging advanced technologies and mentoring teams for superior performance.
Overview
27
27
years of professional experience
Work History
General Manager, Quality Assurance
Himalaya Wellness Company
Bangalore
06.2009 - Current
- Led project execution for Tumkur T40 Formulation Plant and production blocks 1, 2, 3, and 4 at HWC Bangalore, ensuring successful qualification and audit readiness.
- Spearheading the execution of D3 - Tumkur and Project Oasis (beginning phase).
- Served as the key person responsible for driving initiatives and achieving regulatory certifications, including WHO, USFDA, and MOH-GMP certifications for the HWC Bangalore facility.
- Implemented advanced quality systems, including SAP LIMS and Cryptocode module for Russia-specific requirements.
- Coordinated cross-departmental activities to ensure compliance with national and international quality standards.
- Supervised CSV projects, such as artwork implementation, EDGE module, and Tantra software for in-process checks.
- Handled vendor development and qualification for equipment and raw materials.
Senior Manager – Validation Department
Aspen Pharmacare
Port Elizabeth
07.2007 - 05.2009
- Oversaw validation activities for HVAC systems, utilities, and equipment as per cGMP norms.
- Executed risk analysis, gap analysis, and developed Validation Master Plans.
- Ensured compliance with regulatory requirements and successfully met the standards for audits by WHO and USFDA.
- Established the validation team, contributing to the successful WHO certification of the facility.
Deputy Manager - Quality Assurance
Hetero Drugs Limited
Hyderabad
09.2005 - 02.2007
- Ensured compliance with cGMP standards and systems. Reviewed and compiled pre-audit document observations and deficiencies.
- Improved productivity through technology upgrades, cycle time reduction, and process improvements.
- Oversaw the review of process flows, master formulas, and production batch records to ensure adherence to cGMP regulations and SOPs.
- Managed deviation procedures, CAPA, and risk assessments, documenting Risk Assessment Reports (RAR). Implemented In-Process Quality Management Systems and maintained manufacturing documents.
- Conducted training programs, monitored documentation processes, and identified quality improvement opportunities.
Junior Manager – Technical Department
Dr. Reddy’s Laboratories
Hyderabad
07.2003 - 09.2005
- Successfully executed multiple projects across organizations, including Dr. Reddy’s.
- Led the planning, preparation, and execution of qualification protocols for equipment and systems, including Design, Installation, Operational, and Performance Qualifications.
- Managed revalidation, periodic reviews, and compliance with cGMP audit points for the US FDA, MHRA, and MCC. Handled technology transfer, cleaning validation, and training programs.
Manager - Verification Program
United States Pharmacopoeia
Hyderabad
02.2005 - 08.2005
- Managed document inventory and pre-audit reviews, resolving observations and preparing summary reports. Reviewed analytical test reports, OOS investigations, and annual product reviews.
- Led site audits focusing on manufacturing and QC, and contributed to developing monograph standards and GMP guidelines.
- Supported SOP revisions, training, and customer relationships.
Executive - Quality Assurance
Medreich Sterilab Limited
Bangalore
01.2001 - 06.2003
- Prepared and reviewed processes, cleaning validation protocols, reports, and batch records.
- Monitored manufacturing activities, investigated non-compliance, OOS, and incidents. Handled change controls, market complaints, and returned goods.
- Conducted internal audits, and reviewed stability data, analytical test protocols, and COAs.
- Managed product labels, dispatch documents, and ERP system tasks, including batch creation, release, and approval of BOM, and work orders.
Executive - Quality Control
Anglo French Drug Industries Limited
Ban
09.1997 - 06.1999
- Analyzed raw materials, semi-finished products, and finished products (tablets, capsules, liquid orals), and packaging materials. Performed periodic calibrations of lab equipment (pH meter, UV spectrophotometer, balances, dissolution, and friability testers).
- Conducted stability testing for commercial and R&D samples.
- Assisted in preparing and updating Standard Test Procedures, Validation Protocols, and Standard Operating Procedures.
Education
Master of Pharmacy (Industrial Pharmacy) -
Annamalai University
Tamil Nadu01-2000
Bachelor of Pharmacy -
S.C.S College of Pharmacy, Affiliated To Gulbarga
01-1997
Diploma in Pharmacy -
S.C.S College of Pharmacy, Affiliated To Bangalore
01-1992
Skills
- Regulatory compliance
- Quality assurance
- Project planning and execution
- Process Optimization
- ERP System Management
- Total Quality Management
- Project Lifecycle Management
- Team leadership
- Leadership and team building
- Performance improvement
- Cost reductions
- Risk management
- Critical and strategic thinking
Core Competencies
Project Management: End-to-end handling of pharmaceutical projects, from equipment procurement, qualification, and validation to making plants audit-ready.
Regulatory Compliance: Successfully managed audits for regulatory authorities including USFDA, WHO, MOH-GMP, and more.
Quality Systems Implementation: Expertise in developing and maintaining comprehensive Quality Management Systems (QMS).
CSV Implementation: Comprehensive experience in Computer System Validation (CSV) activities including SAP LIMS, AWMS, EDGE, Cryptocode module, and Tantra software.
Technology Transfer & Validation: Extensive experience in technology transfer, process validation, cleaning validation, and equipment qualification.
Leadership & Training: Proficient in team leadership, skill development, and compliance training for cross-functional teams.
Affiliations
Playing Badminton
Driving Cars and Riding Bikes
Languages
English
kannada
Hindi
Tamil
Telugu
Malayalam
Timeline
General Manager, Quality Assurance
Himalaya Wellness Company
06.2009 - Current
Senior Manager – Validation Department
Aspen Pharmacare
07.2007 - 05.2009
Deputy Manager - Quality Assurance
Hetero Drugs Limited
09.2005 - 02.2007
Manager - Verification Program
United States Pharmacopoeia
02.2005 - 08.2005
Junior Manager – Technical Department
Dr. Reddy’s Laboratories
07.2003 - 09.2005
Executive - Quality Assurance
Medreich Sterilab Limited
01.2001 - 06.2003
Executive - Quality Control
Anglo French Drug Industries Limited
09.1997 - 06.1999
Master of Pharmacy (Industrial Pharmacy) -
Annamalai University
Bachelor of Pharmacy -
S.C.S College of Pharmacy, Affiliated To Gulbarga
Diploma in Pharmacy -
S.C.S College of Pharmacy, Affiliated To Bangalore
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