QUALITY CONTROL MANAGER (FDA Approval in Chemical Testing, Instrumental Testing & Sterility Testing by Maharashtra Government, India)

Address: ARUN SHALIGRAM PATIL, PLOT NO. L-21 NEAR MHASOBA NAGAR, MAYUR PARK, HARSUL, AURANGABAD-431001. MOBILE CONTACT: 750-***-**** / 988*******. Email:

adf64a@r.postjobfree.com,adf64a@r.postjobfree.com

Professional Overview: Appropriate experience in the Pharmaceutical industries, manufacturing of the Sterile- injectable liquid & dry powder, Formulation OSD & liquid manufacturing, Sterile – Non-sterile API & manufacturing, Worked with Oncology division, Aerosol (Pain Relief spray) manufacturing & cosmetic industry, managing QC testing including GMP compliance for a wide variety of pharmaceutical products. I have held positions of increasing responsibility of Stability section, Raw Material section, Packing Material section, Finished Product section, Microbiology testing section and GLP section. And most recently worked with Formulation Unit as the Quality Control Manager with responsibilities for all aspects of quality control for the manufacture of pharma products. Shop floor work experience of parenteral products in production department and quality control department.

Experience

Quality Control Manager

April 2019 to Jan 2020

INDOCO REMEDIES LTD. [FORMULATION UNIT]

Establish the quality management system to describe how the firm complies CGMPs and operates to maintain a state of control, Keep current with good industry practices, and applicable to the mission of QC operations. To audit compliance to the quality system. Audit for compliance to policies and procedures: on paper vs. practice. Report on the performance of the quality system, including trends, that help decision making for targeted actions. To establish procedures and specifications. Ensure that procedures and specifications are appropriate and followed. To establish manufacturing controls. Ensure that appropriate manufacturing in-process controls are implemented. Perform laboratory testing of components, containers, in-process materials, packaging materials and drug product using validated methods against scientifically-derived, fit-for-purpose specifications. To review and approve or reject all things CGMP. To ensure investigation of nonconformance, Deviation, CAPA, OOS, OOT, Change control, Document completion within the time frame. Direction to the microbiology department in all aspects & inform to management

Quality Control Manager: November 2017 to April 2019. [FORMULATION UNIT]

Rubicon Formulations Pvt. Ltd. MIDC Waluj Aurangabad.

Responsible for the Quality Control Department at a contract manufacturing organization, Managed Quality Control lab relocation and expansion to a new facility.

Manage the QC department daily activities including: In process and Batch Release Sample analysis, Stability Studies, and Inspection and testing of Raw Materials. Manage all client correspondence from project initiation to site audits, Support development of QC analytical methods working with the analytical development department. Manage Quality Control operations to validate and support the manufacturing facility's HVAC system, Gas supply, Purified Water systems. Manage Quality Control

equipment validation, calibration and maintenance activities. Member of the site Validation Team. Write, edit, review, approve and implement site Standard Operation Procedures (SOPs) & product specifications, raw material specifications. Review and approve Quality Control Laboratory records including environmental monitoring, deviations, corrections, change controls, OOS and lab investigations Support and site safety audits and responsible for implementing cost savings within the department.

Assistant Manager, Quality Control. November 2014 to November 2017

Aarti Industries Ltd. MIDC Tarapur (Palghar)− Maharashtra. Manufacturing Sterile & Non-sterile API (ONCOLOGY)

Facility approved by US FDA, EDQM, WHO, EUGMP, CGMP, COFEPRIC (MEXICO)

Responsible for the Quality Control program for Phase 3 manufacturing API. Worked closely with the Operations and Quality Teams on site and off site within the companies to improve the internal Quality Control Systems. Initiate all Out of Specification (OOS) investigations, Deviations, CAPAs and Change Controls per GMP procedures. Managed the scheduling for cleaning and environmental monitoring for ISO 7/8 manufacturing sites. Managed the manufacturing QC testing for the API, Bulk Drug Substance, Drug Product in process, release and Stability testing products, sterility. Responsible for review SOP's, Stability protocols, Test Methods, and Stability and trending reports Responsible for sample management and all shipments for high levels of oncology products. Assisted the Quality Assurance group by performing audits for external testing organizations.

Assistant Manager Microbiology Quality Control

Responsible for the Microbiology lab for the method development, method validation, routine release and stability testing and scheduling for sterile Non-sterile products, Implemented the start-up plan for the internal Microbiology Laboratory Implemented, scheduled and performed the following testing: Microbial Limits Testing and Qualification, Bacterial Endotoxin Testing (LAL), Microbial ID, Environmental Monitoring & Sterility testing. Wrote and executed equipment URS and performance qualifications during start-up of the laboratory. Responsible for training and supervising 8 Micro analysts Managed communication with multiple external and internal client projects for Microbiological testing of Pharmaceuticals Member of the site In charge & Night In charge safety committee.

Assistant Manager QC December 2012 to November 2013 [FORMULATION UNIT]

Atra Pharmaceutical Ltd. Aurangabad Facility approved by WHO & CGMP

Responsible for QC/ Microbiology Section routine work allocation & its follow-up testing & COA completion of products, API's, raw materials, method development and validations as per cGMP's and ICH guidelines using approved methods and current USP/EP/JP/BP compendial methods. Responsible for training all new employees for the company to sample management procedures during the initial training orientation

Sr. Executive July 2012 to Dec 2012

Arch Pharma Ltd. Boisar.

Responsible for performing sterility testing & MLT/MET of material, protocol preparation for clean room validation & monitoring of clean rooms as per USP/IP. Investigation of product contamination and identified isolates from FP products contamination.

Sr. Executive

July 2008 to July 2012

Unichem Laboratories Ltd. Roha

Manufacturing Non-sterile API facility approved by WHO, CGMP, US FDA, EDQM

Provides overall direction and management of the microbiology Department. Site technical expert for microbiological testing, environmental monitoring, testing of water, sterility testing, Bioburden testing, investigational testing and any other microbiological testing or projects as needed. To ensure that the data generated by the laboratories (Incoming materials, Release/ Stability) are produced in accordance with all applicable regulations and company policies and procedures. Develops and applies practices, which will enable the laboratory to meet and exceed, desired customer and regulatory standards in a cost-effective fashion. Assist in and/or conduct all laboratory investigations of discrepancies to resolve problems and works with Leadership to ensure corrective action or preventive actions are implemented in a timely manner. Develops and monitors key performance indicators for the laboratory and implements CAPA as needed. Executes or participates in internal and external laboratory quality audits, as directed by management. Plays a key role in the creation of analytical equipment qualification protocols. Experience in various regulatory inspections.

Officer QC. June 2006 to July 2008.

EBPL Limited Mahad.

Manufacturing -Non-sterile API facility approved by WHO, CGMP & USFDA. Responsible for testing & reporting of provided samples for microbiology analysis.

Officer QC Jan 2005 to July 2006 [FORMULATION UNIT & API]

Kopran Limited Mahad Manufacturing -sterile API facility approved by WHO, CGMP & EDQM.

Responsible for sterility testing & documentation. Assist to QA officer for completion of CAPA & Investigation.

Microbiologist.

May 2001 to Dec 2004 [FORMULATION UNIT]

Samrudh Pharmaceuticals Pvt. Ltd. Boisar. Formulation -facility approved by WHO & CGMP. Responsibility: Microbiological testing & its documentation completion. Water analysis as per SOP/Specification & coordinate to QA representative for microbiological concept & audit compliance. chemical. Water validation Phase I, II & III.

Known Equip./ instruments; pH meter, conductivity meter, Analytical weighing balance, GC, HPLC, UV spectrophotometer, Melting point apparatus, water bath, oven, Muffle furnace, Refractometer, Polarimeter, Bursting strength, Reflux condenser, dissolution apparatus, TLC, Viscometer, TOC analyser & KF. Additional certified safety member: First Aid.

Education:

Bachelor of Science: Chemistry (For more detail academic certificate is verified)

Master of Science: M.Sc. Microbiology from Government Institute of Science Aurangabad (For more detail academic certificate is verified).

University: Dr. Babasaheb Ambedkar Marathwada university Aurangabad.

CTC: As per the industrial norms.

Notice Period: As per mutual understanding.

Thanks.

A.S. Patil

Contact this candidate