MAHESH GANDHARVA

• Accountable for enterprise-wide quality governance across 8 sites, ensuring regulatory readiness and business continuity.
• Drive regulatory compliance strategy and audit readiness frameworks.
• Conduct corporate audits ensuring zero critical observations and sustained inspection readiness.
• Spearhead quality transformation and process harmonization initiatives.
• Define and monitor quality KPIs, benchmarking and performance frameworks.
• Lead cross-site quality excellence programs and best practice sharing forums.
• Head a 25-member rapid response team for critical quality operations.
• Head Talent Development & Capability Building cell (ATP Lab) of 100+ new hires every year.
• Enhanced communication among team members through regular meetings, promoting an open dialogue about challenges and opportunities for improvement.
• Increased customer satisfaction by addressing and resolving concerns in a timely manner.
• Analyzed customer feedback data to identify areas of improvement and develop solutions.
• Mentored staff members, fostering a supportive work environment that enhanced employee performance and retention.
• Assisted in the recruitment, hiring, and onboarding process for new employees to build a skilled workforce committed to excellence in service delivery.
• Developed and implemented policies and procedures to improve customer service and satisfaction.

• Define quality measures and KPIs to elevate quality maturity and compliance
• Conducted comprehensive reviews of quality policies for adherence to standards. Drove FTR initiatives utilizing HER-based documentation to improve operational efficiency. Achieved 10% reduction in quality deviations through structured HER program implementation.
• Deployed daily management systems (DMS) in accordance with business KPIs
• Spearheaded enterprise-wide operational excellence and analytical excellence initiatives across 21 sites.
• Generated ₹10.0 cr in cumulative savings alongside 12.5% boost in productivity and optimization of 38,000 man-hours through implementation of lean initiatives.
• Created real-time Power BI dashboards for quality performance tracking.
• Unified 100+ SOPs among multiple plants, reinforcing adherence to compliance standards.
• Facilitated teamwork in conjunction with consultants from McKinsey SSA Vector.
• Enhanced manpower and equipment productivity through VSM DILO and workflow assessment.
• Administered ₹25 cr QC budget (₹18 cr OPEX + ₹7 cr CAPEX) and secured 10% cost reduction via strategic resource management and efficiency upgrades.
• Held monthly meetings to create business plans and workshops to drive successful business.
• Provided strong leadership to enhance team productivity and morale.
• Led cross-functional teams to achieve project milestones and deliver high-quality results.
• Consistently met or exceeded annual performance targets set by senior leadership.
• Collaborated closely with peers from other departments to drive organizational success jointly as one cohesive unit.
• Reduced costs, optimized resource allocation, and improved efficiency in managing projects.
• Achieved operational excellence by streamlining processes and implementing best practices.
• Consolidated vendors and renegotiated contracts to optimize costs.
• Championed process improvement initiatives that led to significant cost savings without compromising on quality standards.

• Managed global audit readiness and regulatory compliance execution.
• Handled regulatory and customer audit successfully Zero critical and major observation.
• Led CAPA remediation and data integrity initiatives & Implemented 10+ GxP-compliant digital systems.
• Reduced QC costs by 15% (~₹2.5 Cr savings) and Responsible to prepare and maintain Revenue and CapEx budget of QC.
• Led QMS operations and SOP governance and built and managed data reliability framework.
• Drive KPA/KPI for QC and drive culture transformation program.
• Managed and motivated employees to be productive and engaged in work.
• Accomplished multiple tasks within established timeframes.
• Maximized performance by monitoring daily activities and mentoring team members.
• Enhanced customer satisfaction by resolving disputes promptly, maintaining open lines of communication, and ensuring high-quality service delivery.
• Cross-trained existing employees to maximize team agility and performance.

• Executed 350+ method validations for APIs and intermediates.
• Led a 25+ member QC team across analytical functions
  Established new QC and microbiology laboratories.
• Supported regulatory approvals for USFDA, PMDA, WHO, TGA.
• Responsible for Testing and release of APIs, Salable intermediates, Incoming materials.
• Established cGMP, GDP, and GLP practices in the laboratory.
• Maintain GXP compliance s per GAMP 5 for Laboratory equipment & perform risk assessment wrt to data integrity.
• Led QC team of 25+ members team, conduct meetings regularly to discuss progress updates, identify challenges or roadblocks, and provide guidance towards successful project completion.
• Enhanced team productivity by implementing efficient project management strategies.
• Successfully managed multiple high-priority tasks simultaneously while maintaining strict deadlines ensuring optimal resource allocation.
• Supervised day-to-day operations to meet performance, quality and service expectations.
• Streamlined and monitored quality programs to alleviate compliance activities.

• Assessed quality records for correctness and adherence to standards
• Founded GC lab ensuring GLP compliance
• Executed regular assessments of analytical operations, pinpointing areas for enhancement.
• Stability Studies

• AMV of API, residual solvents, Intermediate, Cleaning samples and cut-off/carry over studies).
• Method development of OVI, residual solvents, Cleaning and Assay and Related compound method.
• Developed methods for Cut off and carry over of APIs
• Handled regulatory queries and prepare responses.

Performed analysis of OSD and non-OSD formulation products including solid and liquid sterile injectables.

Environment Monitoring by Settle plate and Air sampler, Water system qualification, HVAC qualification.

Media preparation , Autoclave operation, Sterility testing, Sterile material sampling and analysis.

Physical and chemical analysis of API in-process finishes and stability of sterile and non-sterile dosage forms.

IPQC testing and line clearance of manufacturing phases for sterile and non-sterile products.

Executed air sampling and plate counts for sterility testing. Collected sterile and non-sterile samples for two injectable mfg. block to assess quality control measures.