Pratiksha Patil

Experience in APIs (General, Sterile & non-sterile Oncology, Hormones, Steriods, Narcotics), Formulation (OSD), Supplier qualification & quality audits. A subject matter expert with over 18+ years of experience in Quality Management & Control ranging from Quality Assurance, Audit & Compliance, Quality & Microbiology lab Control, managing contract manufacturing sites including technology transfer, analytical method transfer, planning & execution of validation & commercial batches, dispatch activities from CMO sites, monitoring & approval of QC related activities like analytical method validation, cleaning method validation, instrument calibrations, review of audit trail & approval of analytical data for routine testing, audit of external testing laboratories. Handled CRO related activities i.e. auditing of CRO facility as a part of qualification, monitoring BE studies to meet scheduled timeline, auditing the patient related data etc. 4 years of work experience in Environment management i.e. turnkey design of Effluent Treatment Plant & Incineration system, conducting Environmental Audits & preparing the Environment Audit reports, making application for Environment licenses like CCA, NOC. Executed the project of Cleaner Production lead by GIDC Chairman & MD (IAS Officers) for the optimization of manufacturing processes for zero discharge / effluent reduction & for the conservation of energy & raw materials in ten of the industries of Ankleshwar & was nominated for the Young Best Chemical Engineer Award for the successful completion of Cleaner Production project. 1 year of work experience as Production Head. Leading manufacturing activities of 10 manufacturing blocks which are engaged in the manufacturing of general category APIs, Steriods, Hormones & Narcotics.

Leading a strong Quality Control team and monitoring, implementing Quality system without deviating from cGMP requirements and compliance to SOP, STP and Specification, Maintaining lab productivity while ensuring timely analysis of RM, PM, FG, IP etc, Maintain very good documentation, Validation, Calibration and Qualification of instruments and systems in QC, Implement Cost effective measures like reduce test, and removing unnecessary testing through review of product data profile, Review and approve of Stability Protocols, Validation protocols and Raw data work sheets, Lead QC with timely troubleshooting and analysis with rectification in case of deviation / lab events / unconfirmed OOS

Responsible for 5 months planning, monthly & daily production planning/ scheduling/ organizing/ executing/ monitoring with quality and quantity, Responsible for the production Target/ capacity Utilization/ troubleshooting handling/ implementation of effective techniques to bring efficient quality standards/ Cost effectiveness, Responsible for technology transfer from R&D to production plant, new products handling, selection of equipment as per process and product requirements, Identifying safety needs during process operation and provide training to the personnel and training on awareness of safety precautions, Co-ordinate and follow up with all the inter departments like Production / purchase/ WH/ QC/ ENGG/ EHS for effective and efficient implementation and execution of production schedule, Responsible for encouraging juniors for suggestions and views in developing operational techniques and yields, Responsible for review of documents like MBR, ECR, SOPs, process validation protocol, cleaning validation protocols, facility qualification, APQR etc. and qualification documents (DQ, IQ, OQ and PQ) of the equipment and execution for the same, Ensuring all the deviations are evaluated and investigated as per current Procedures, Reviewing trends of quality and production parameters, Investigating OOT/OOS, Evaluating proposed changes in the product /process/equipment and implementation of CAPA, Responsible for all liaison/statutory compliance, Responsible to prepare departmental OPEX & CAPAX budget, Responsible for non-moving inventory reduction, yield & solvent recovery improvement, Responsible for capacity debottlenecking, implementing cost effective process, reducing batch cycle time & batch cycle frequency, Responsible to achieve D vs C, C vs S, provide justification for supply gaps, Responsible for providing the weekly, monthly & quarterly report to the Top management

• Compilation , review of API DMFs before submission
• Reviewing post filing / approval changes
• Managing audits by agencies USFDA, MHRA, MFDS, WHO-GMP, EDQM & other overseas customers
• Process validations, water validation, HVAC system validation, and equipment qualification (DQ, IQ, OQ, PQ), Isolator qualification, DHS qualification, stability studies management, vendor quality audits

Date of Birth: 10/24/76

• English
• Hindi
• Marathi
• Gujarati

• Current Good Manufacturing Practices (cGMP)
• ISO9001 Lead Auditor’s Training Program (DNV)
• Investigator training
• Soft skills training like The Art of Staying Focused, Maximize your productivity by managing time & tasks, Expert Insights on developing and managing people, Developing personal accountability, Becoming more professional through Business etiquettes, Developing emotional intelligence

• Successfully cleared US-FDA, MHRA, EDQM, WHO-GMP, MFDS, Anvisa and PMDA inspections
• Conducted cGMP audit of Third-Party Vendors
• Successfully released the products and monitored, investigated OOS, OOT, Deviations and customer complaints management
• Handled critical deviations/ Lab investigations, investigation and identified root causes and CAPA
• Played a key role in formulating data preparation for products filing as CTD and DMF
• Nominated for Young Best Chemical Engineer Award

• Preparing the API facilities for USFDA, EDQM, Anvisa, PMDA, Health Canada regulatory standards
• Preparing the OSD facility for MHRA & USFDA regulatory standards
• Handling Regulatory & customer audits
• Timely batch release
• Engaged in designing and approving validated protocols for process, water system, equipment cleaning, facility and equipment qualifications, sterilization protocols, close; safeguarding effective investigation during execution of validation batches to address gaps by conducting validation closure meetings and finally approve validation reports
• Timely submission of data to regulatory department for various applications, responses to regulatory queries
• Administered CAPA monitoring and its implementation at the site
• Synchronizing with the auditee departments to conduct various internal audits (self-inspections) within the unit to assess compliance of quality systems with domestic and international regulatory standards; directing customer & regulatory audits
• Reviewing and approving CMC and non-CMC related documents, including product specification, batch documentation, test method, analytical validation report, method transfer, process validation documents and packaging documentation
• Steering pre-submission review of DMFs for adequacy and correctness
• Liable for initiating External Supplier Quality Risk Assessments & Audits for all External Suppliers
• Harmonizing the procedures
• Delivering support to the Product Development Team in quality & compliance and to support new product launches as required by the intended market
• Contributing towards successful installation of instruments in the analytical laboratory; maintaining the required documents for audit
• Synchronizing with R&D teams to safeguard effective execution of quality systems in the process
• 21 CFR Compliance, Computer System Validation/Qualification to strengthen the quality systems
• To ensure site in 24x7 compliance state
• Verifying the audit trials, responding to audit compliance and monitoring the GMP in lab
• Review of all specifications for quality control activities like Routine activities, Non-Routine activities, Raw material and In- process

• Experience in APIs (General, Sterile & non-sterile Oncology, Hormones, Steriods, Narcotics), Formulation (OSD), Supplier qualification & quality audits