Bengaluru, Karnataka, India
Quality Assurance | GMP | Techno-Commercial | Audit & Operations Leadership With over 17 years of specialized experience in pharmaceutical quality assurance, I bring proven expertise in GMP, GCP, and GVP compliance across diverse dosage forms—solid, semi-solid, oral liquid, and parenteral. As a Certified Pharmaceutical GMP Auditor (CPGA – ISQSH), I have successfully led 100+ internal, vendor, supplier, and CMO/CRO audits, ensuring global compliance with MHRA, USFDA, ANVISA, and WHO standards. My background includes technology transfer, batch release, CAPA management, and QMS optimization using Lean Six Sigma methodologies. I specialize in aligning quality initiatives with business goals, enabling operational excellence, regulatory readiness, and cost optimization. Core Value Proposition: I deliver a unique blend of technical depth, leadership, and strategic foresight, empowering organizations to strengthen compliance, elevate quality culture, and achieve sustainable business impact. Key Highlights: ✅ 16+ years in pharma QA across multiple formulations ✅ 100+ successful audits for CMO/CRO compliance ✅ Lean Six Sigma-driven QMS and workflow optimization ✅ Experienced in global regulatory audits (MHRA, USFDA, ANVISA, WHO) 📩 Contact: [email protected]
CQA
Green field project, QMS, Audit and Compliance, Training, Overall QA oversight
In my role as a qualified Trainer and Quality Assurance professional, I have honed my expertise in GMP, GCP, and regulatory compliance while delivering impactful training programs across various domains. My experience spans developing and executing GxP modules, induction programs, human factor analysis, SOP training, and regulatory updates, all tailored to enhance operational excellence and ensure adherence to global standards. I have a strong background in Lean methodologies, where I coach teams through Gemba walks, focus on zero defects, and drive problem-solving behaviors. This has led to significant improvements in workflow optimization, productivity, and overall quality. As a skilled trainer, I excel in analyzing training needs and designing customized programs that foster continuous learning and growth, ensuring measurable impact through detailed evaluations. Key Achievements: • Developed and delivered over 50+ GxP and Lean training modules, leading to a 20% improvement in team performance and reduced operational errors. • Led Rapid Improvement Events that eliminated waste and optimized processes, resulting in 15% efficiency gains across multiple departments. • Conducted comprehensive value stream assessments, identifying inefficiencies and driving future-state visions that reduced waste and enhanced productivity by 30%. • Spearheaded audit readiness programs, preparing cross-functional teams for internal and external audits, with a 100% audit pass rate. • Expertly managed the preparation of monthly quality metrics, driving data-driven decision-making and continuous quality improvements. In my project management role, I oversaw technology transfers and process validations, ensuring projects were completed on time while adhering to the highest quality and regulatory standards. Additionally, my ability to lead vendor and supplier audits has ensured ongoing compliance with GMP, GCP, and GVP standards.
Site Quality Head QMS Compliance/Training/Audit
QA Manager 1. Analyzing training needs, developing training materials, sessions and impact analysis, preparing training packages for team members; ensuring on-time closing of training sessions and follow-ups 2. Imparting training to new employees through cGMP modules; charting training matrix, approving OJT schedules 3. Preparation of self-inspection/internal audit schedules, conducting self-inspection as per schedules, preparation of audit reports and communicate findings to departments, management and review/verification of response/CAPA 4. Preparation of regulatory audit response reports by coordinating with cross functional teams 5. Vendor/Supplier Audit and Qualification, Evaluation of vendor Questionnaire forms and supporting documents and Vendor Audit for Raw and Packaging material 6. Auditing CMO/CRO for GMP/GCP compliance