Experience

Encube Ethicals Private Limited

• India
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Dy. General Manager Quality Control

  • Mar 2012 - Present

  • A result-oriented professional with over 20 years of rich experience in Lab Operations encompassing Inspection, Quality Control, Investigation, Testing, Training and so on. • Excellence in managing testing activities on multiple products and ensuring effective root cause findings of quality problems. • Pivotal in USFDA, ANSM, Ukraine, Kenya, ANVISA Brazil & TGA Audit Approved Plant. • Actively participated in USFDA and ANSM auidts. Sussecfully completed 5 times USFDA and 4 times ANSM audits in Encube. • Played a key role in improving product quality by taking initiatives in resolveing the product analytical method related issues through continual improvement plan. • Played a key role in evaluating gap in the computerized system of QC and implemented necessary CAPA to comply the CSV requirements. • Leading a team of 160 people consisting of Managers, Executive, Officers, Jr. Officers. • Managing the Annual operation budget of QC department, Procurement & installation of Analytical equipment’s along with inventory management of the finished stock. • Capability to use Laboratory Management System (LIMS). • Skilled in communicating in written and oral formats. • Expertise at conducting training sessions on quality concepts and requirements; worked as Trainer for GLP, OOS/OOT investigation and Data Integrity as well as an Auditor for Public Testing Laboratory. • An excellent communicator with strong leadership, decision-making analytical & problem-solving skills. Show less



US FDA, WHO, MHRA,TGA, Brazil. and German audit

• Goa

• Audit Faced

  • Sep 2004 - Present

  I have faced USFDA , ANSM, WHO , MHRA , MCC, Anvisa Brazil TGA ,Uganda ,Kenya audit and Local FDA audit. I have faced USFDA , ANSM, WHO , MHRA , MCC, Anvisa Brazil TGA ,Uganda ,Kenya audit and Local FDA audit.



2 of 2

• Computer literacy

  • Sep 2004 - Present

  Well versed with Microsoft word, excel, PowerPoint and Oasis LIMS Software for QC Documentation. Work as key user for the ERP implementation. Decleration : I here by declared that all above given information is true and correct. Signature /Date.:__________________ Well versed with Microsoft word, excel, PowerPoint and Oasis LIMS Software for QC Documentation. Work as key user for the ERP implementation. Decleration : I here by declared that all above given information is true and correct. Signature /Date.:__________________



Indoco Remedies Ltd.

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr. Executive QC

  • Sep 2004 - Feb 2012

  Role: • Worked as a: o Section Head of raw material, finished product, stability, instrumentation, non-routine section and packing material o Reviewer for the MHRA and USFDA audits of other plants of Indoco o Auditors for Vendor Certification Program of raw material and packing material o Key User during implementation of ERP system and LIMS Software o Trainer for Quality Control Lab • Reviewed and approved all QC documentation • Conducted LIMS validation, new instruments qualification, stability chamber qualifications • Prepared & implemented: o Analyst Validation Program o System, User and Backup/ Archival Guidelines for all instruments • Ensured data review (protocols, instrument calibration and usage records, daily and monthly backup of instrument) Show less



FDC

• United States
• Construction
• 1 - 100 Employee

• QC Officer

  • Jan 2003 - Aug 2004

  Role: • Engaged in method/ cleaning validation, SOP preparation as well as IQ/OQ/PQ documents of instruments preparation • Ensured stability testing and process validation testing • Reviewed analytical reports of raw material finished product Role: • Engaged in method/ cleaning validation, SOP preparation as well as IQ/OQ/PQ documents of instruments preparation • Ensured stability testing and process validation testing • Reviewed analytical reports of raw material finished product



Litaka Pharmaceauticals Limited Pune

• India
• Biotechnology Research

• QC Officer

  • Jan 1998 - Jan 2003

  Role: • Conducted analysis of raw material, finished product, packing material, in process testing and water analysis • Ensured calibration of quality control instruments • Prepared & standardized volumetric solution and working standard • Engaged in in-process quality control & process validation analysis • Worked as In-process QA Chemist in manufacturing and packing of tablets, capsules Role: • Conducted analysis of raw material, finished product, packing material, in process testing and water analysis • Ensured calibration of quality control instruments • Prepared & standardized volumetric solution and working standard • Engaged in in-process quality control & process validation analysis • Worked as In-process QA Chemist in manufacturing and packing of tablets, capsules