Pallavi Shetye

A competent professional Microbiologist with over 13 years of experience with Pharmaceutical giant - CIPLA, expertise in working with micro-organisms. Indian FDA approved professional expertise in applying the Microbiological Techniques & best practices (cGMP) in Pharmceutical Organization. Specialist in environmental monitoring, data compilation, audits, compliance, excursion mapping, RIDA (Risk, Issue, Dependency, Assumption) Management. Experienced in daily microbiological tasks for commercial products.

• Managed QC unit oriented for export orders to various European countries and US. Managed Audits: USFDA, ICH, WHO, MHRA, TGA
• Set-up a new unit from scratch and take part in designing the micro unit along with Architects. Review along with Architect the positioning of various equipment and utilities alongside storage and disposals.
• Mentoring the new joiners and demonstrating GLPs and safety precautions
• Capacity Management and batch planning for various products for efficient utilization of resources. Design training needs for the Micro Lab team.
• Streamline existing microbiological measurement techniques, design and implement the future of Micro Laboratory requirements.
• Responsible for creating, governing, harmonizing, and maintaining standards on Microbiology. Assist continuous improvement projects
• Attend seminar and plan for future Micro Lab requirements and enhancement journey to achieve the corporate objectives – Compliance, Conformance, Cost savings, Productivity
• Implemented ISO standards
• Audit other units across India and Loan-Licensees. Audit & Inspect data verification and review

Bachelor of Science [Microbiology]