Smita Phatak Email & Phone Number

Pune, Maharashtra, India

• Project Management (Life Science Manufacturing): Involved in all stages for resource management, single point of contact to manage client needs and expectations.• Lead end-to-end CSV activities with complete validation of deliverables for various GxP system activities in compliance with regulations for Pharma Major Clients.• Work on RFPs to contribute towards practice initiatives.• Responsible for tasks assignment to the team, set specific, measurable, achievable results focused and time bound goals for the team in-line with business IT requirements and complete their performance reviews time to time.

Pune, Maharashtra, India

● Lead end-to-end CSV activities with complete validation of deliverables for various GxP system activities in compliance with regulations for Pharma Major Clients.● Project Management (Life Science Manufacturing): Involved in all stages for resource management, single point of contact to manage client needs and expectations.● Leading and managing 50+ CSV resource team.● Responsible for tasks assignment to the team, set specific, measurable, achievable results focused and time bound goals for the team in-line with business IT requirements and complete their performance reviews time to time.● Manage client communication and stakeholder engagement to review of monthly deliverables and KPIs. ● Review existing SOPs, processes, and templates to align and stay relevant to ever changing client requirements.● Plan and conduct trainings as a part of continuous learning objectives.● Work on RFPs to contribute towards practice initiatives.

Pune, Maharashtra, India

● Responsible to ensure all computer systems to follow lifecycle approach and are evaluated, selected, implemented, and maintained in compliance with applicable GxP regulations.● Formulate Risk Management Policy and drive successful implementation globally.● Responsible for QA oversight of applicable CSV documents and SOPs as required.● Support Client Audit activities including post-audit responses.● Responsible to maintain E-documentation like EQMS, DMS, TMS globally.● Lead QA in maintaining Quality Metrics of deviations, CAPA, change control.● Manage stakeholder engagement with internal and external Business Partners, Customers and Vendors.● Active participation in Customer Satisfaction Survey.

Pune

● Design Quality Management System from Greenfield projects to commercial stage and quality compliance by GAP analysis.● Responsible for Technology Transfer of MABs and Microbial Biotechnology products, scale up, Analytical Method Transfer and release.● Development of QMS in pilot plant (GMP) for taking CT batches for domestic and global supply.● Drove QP audit successfully without any major observations.● Site Team Lead for the commissioning of commercial facility for continuous Bio process, vendor identification, validations, qualifications and for development of QMS for US FDA.● Coaching and guiding team for current regulatory requirements.

Hinjwadi, Pune

● Manufacturer of Insulin ph.Eur (rDNA Origin and Insulin analogs).● Developed Quality Management System as per regulatory guidelines (EU/ICH), to establish quality culture throughout the company, heading “QUALITY CIRCLE” drive.

Hinjewadi, Pune

● Implementation of QMS and cGMP standards in the facility as per the regulatory guidelines.● Conduct management reviews, audits and monitor the KPIs of Quality management system.● Drive audits with the drug inspectors of Indian and Foreign authorities.● Conduct trainings for risk analysis, GAP analysis as per the guidelines. ● Wide exposure in almost all areas of Manufacturing Unit, Production, Quality Control, Quality Assurance, Packing, Microbiology for the formulations Tablets, Capsules, Ointments and Creams, Oral liquids, Liquid Injectables, Dry Injectables and Inhalers.● Well versed with all manufacturing and analytical requirements.● Site Team Lead for Operational Excellence.● Lean lab concept initiation and execution.● QMS analytics of Performance Indicators by implementation of Quality Metrics● Technology Transfer.● Execute Stability Studies as per ICH guidelines.● Quality Risk Management and Mitigation for the processes, Equipment and Systems.● Perform all Pharmaceutical Validations (Analytical/Cleaning/Process/Shipping).● Laboratory system reviews, productivity improvements, error reduction through error data trending and analysis, change management and in-depth impact analysis.● Vendor Management.● Training of all QMS, cGMP topics in English and in Vernacular language for regulatory compliance and to reduce human error.

Nashik, Maharashtra.

Glaxo Smithkline- QC dept. (from March 2002 to March2012)• FDA approved in Chemical and InstrumentationWell conversant with analytical methods of formulations like, Tablets, Capsules, Ointments, Cream, Oral liquids, Liquid Injectables, Dry Injectables, Inhalers.Hands on sophisticated instruments, with CalibrationAnalytical Method ValidationsStability Study as per ICH guidelinesDocumentation as per Schedule L1, Self Inspection, Trend analysis Compliance with WHO guidelinesGlaxo Smithkline- Production dept. (Dec. 1994 – Feb. 2002).•FDA Approved in Liquid oralsWorked in liquid manufacturing as well as liquid packaging, areas of Tablet, Ointment, Dry vials, and liquid Injectables.Very well conversant with automatic packaging lines.Active participation in setting target output.Well conversant with cGMP.Glaxo Smithkline- Microbiology dept.All microbiological activities required for SPD and non SPD•Environmental monitoring•Bioassay•Culture maintenance•Bioburdan of water and finished products•BET Test