Praveen Sharma
Indore
Summary
Audits faced : USFDA MHRA, ANVISA, FIMEA WHO.
1. Team leadership, project management, and Implementation of Quality System as per regulatory requirement.
3. Quality Metrics Data Preparation, Audit and Compliance.
4. Identify the systemic gaps proactively, based on the cGMP requirements, industrial practices and criticality of non-compliances cited by various regulatory agencies.
5. Notification to customer and QPs for OOS/OOT, Deviation and change control. Change Control, Deviation, CAPA, OOS (Phase-I and Phase-II) and OOT.
Well versed in generation, maintenance and revision of SOPs, specifications, procedures, training,
6. Setup the quality control labs and instrument qualification, exposure in Microbiology area i.e. Sterility, MLT, Environment monitoring etc.
7. Trained staff on audit findings and its action plans to prevent the repetitive observation Hardworking and passionate job seeker with strong organizational skills eager to Quality position. Ready to help team achieve company goals.
8. Participate in Internal and Regulatory Audits, as Subject Matter Expert
9. Dedicated Pharmaceutical professional with history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Stability and QC Compliance Manager
PIRAMAL PHARMA SOLUTION INDORE (Regulatory Approvals: USFDA, MHRA, ANVISA, FIMEA),
05.2021 - Current
- Leading team of 20 members for Section Planning to complete activity on time and release on time. Along with this role lead the QC department in the absence of QC head.
- Maintain dashboard for pending cross functional investigations with TCD and way forward and escalate the investigation to Site Quality Leadership if the root cause of the investigation cannot be identified.
- Train the shop floor team about reported deviation, investigation and recommended CAPA to avoid recurrence
- Stability trend review, stability chamber qualification.
- Review of Product specifications, analytical method validation protocols and reports, standard operating procedures, instrument / equipment operating procedures, general analytical methods, in process / finished product/Stability specifications.
- Interact with internal and external auditors for internal / customer / regulatory audit. Ensured that QC are in compliance and data generating in analysis is reliable and accurate. Troubleshoot issues and provide direction to the team to ensure project timelines as well as company goals/objectives are met.
- Investigation of Laboratory event/OOS/OOT in Track Wise.
- Review, approve and Stability Protocol, Monitoring of sample destruction as per procedure and sample management .
- Gap assessment of USFDA 483 and implementation of procedural control to prevent the similar observations.
- Extending necessary QC support to cross functional departments to ensure uninterrupted production.
Deputy Manager Lab QA and QC Compliance
CIPLA LTD, INDORE, (Regulatory Approvals: USFDA, MHRA and Other Regulatory Approvals)
12.2015 - 04.2021
- Manage 13 direct reports for Section Plan to complete activity on time, lead quality control release on time. Ensured that QC are in compliance and data generating in analysis is reliable and accurate.
- SME of QMS (OOS, OOT, Deviation and Compliance) for audits.
- Review change controls, deviations, incidents, OOS / OOT reports, Review of trend analysis reports pertaining to product, water.
- Investigations (Investigation of OOS, OOT and Incidences), preparation of study protocol to perform batch failure investigation and stability failure.
- Audit and compliance writing of observations, Trending of 5. Self inspection / external inspection findings and sharing learning from audits.
- Ensured that Finished product release meets SLA and Stability sample analysis is not overdue, schedule review, sample withdraw, stability release.
- Investigation and tracking of deviation, CAPA, change control to avoid overdue of action plans, involved in handling of product recalls along with QMS Team
Sr. Executive, Quality Control
SIDMAK LABORATORIES, DEHRADUN, (Regulatory Approvals: USFDA)
01.2015 - 12.2015
- Review of analytical data for compliance. Ensure that analytical activities are completed, in compliance with cGMP and GLP standards.
- Sample Planning of FP & Stability section.
- Handling of OOS, OOT and Laboratory Incidents and QMS (Deviation, CAPA, and change control).Coordinate with QA, RA and R&D.
- Verification of log books & other related documents.
- Review of Audit trails related to Empower and other analytical software
- Organize analytical requirements, Working Standards, Lab chemicals/Reagents and Volumetric Solutions required for day to day analysis.
Executive, Quality Control
ELDER PHARMACEUTICAL, DEHRADUN, (Regulatory Approvals: ROW Market)
08.2011 - 01.2015
- Lead Quality Control department with staff of over 25 people. Responsible for Work Planning related to sampling and analyses of Raw Material / Packaging Materials, Intermediates, API (Finished Goods), Stability Samples, Cleaning Samples, Water Samples.
- Documentation responsibilities included SOPs, specifications, and procedures and stability data review of new and existing products.
- Implementation of QC system, As per GLP and regulatory requirement to ensure compliance with regulatory requirements.
- Process validation, Analytical Method Validation, Analytical Method Verification, etc.
- Participate in all departmental training activities and also to impart On-job Training to newly joined employees.
- Maintain general up-keep of Laboratory premises, which includes Testing facilities, Chemicals Store and Retention Samples Room.
Executive, Quality Control
SHREYA LIFE SCIENCE
05.2010 - 07.2011
- Analysis of Stability Sample and Finish Product.
- Calibration of Instruments
- Preparation of Specification, Standard Test Procedure, SOP.
Sr. Chemist, Quality Control
SIDMAK LABORATORIES
08.2008 - 05.2010
- Analytical testing for all, In Process, Finished Products and Stability Testing of Export Product.
- Management of Reference Standard and Working Standard
Chemist , Quality Control
UNICURE INDIA PVT LTD
10.2006 - 07.2008
- Analytical testing for all raw materials, packaging materials, in process, finished products.
- Analysis of Microbiology samples, Water testing and Environment monitoring.
Education
Master of Science - Microbiology
JIWAJI UNIVERSITY
GWALIOR (M.P)09.2005
Bachelor of Science - Chemistry
C. S. J. M. UNIVERSITY
KANPUR05.2003
Intermediate - Science Education
Govt. Inter College
Raebareli07.2000
High School - Science Education
Govt. Inter College
Raebareli07.1998
Skills
- Quickly learned new skills and applied them to daily tasks, improving efficiency and productivity
- Brainstorming, in-order to outline further actions with target completion date (TCD)
- Trouble shooting of Instruments / Methods during routine analyses
- Investigation of Laboratory event/OOS/OOT/ Deviation
- Response of regulatory queries for submission of ANDA
- On time batch release, launches, and submissions by seamless interactions with SCM, RA, R&D, QA and MFG
- GAP assessment of USFDA 483 and implementation of CAPA
- Carried out day-day-day duties accurately and efficiently
- Proved successful working within tight deadlines and fast-paced atmosphere
- Used critical thinking to break down problems, evaluate solutions and make decisions
- Identified issues, analyzed information and provided solutions to problems
- Actively listened to customers, handled concerns quickly and escalated major issues to management
Objective
Versatile quality control manager with 16-year experience of quality control and Laboratory QA in in USFDA, UKMHRA, MCC, Australia TGA, PIC/s Countries & WHO GMP approved Organizations. Use my skills in busy and challenging position that will allow me to continue the work with same integrity, dependability and enthusiasm
Dosage form exposure
A) Tablet and Capsules
B) Aerosol (Metered Dose Inhaler)
C) Injections (DPI and SVP)
D) Oral Liquids (Suspension and Syrup) Lozenges and Transdermal Patches
Software
A) Track Wise, Cipdox and Ensur
B) SAP (System, Application and Products)
C) Laboratory information Management System (LIMS)
D) Chromeleon 6.8 and Empower3.6
E) Software of Thermolab and Newtronics stability chamber software
Certification
1. Approved by Uttarakhand FDA in Chemical and Instrument Section.
2. Approved by M.P FDA in Chemical and Instrument Section
Personnel Details
FATHER’S NAME : Shri K.L. Sharma
MOTHER’S NAME : Smt. Sarala Sharma
DATE OF BIRTH : 15th April 1983
MARITAL STATUS : Married.
LANGUAGE KNOWN : Hindi & English.
NOTICE PERIOD : 02 month
Timeline
Stability and QC Compliance Manager
PIRAMAL PHARMA SOLUTION INDORE (Regulatory Approvals: USFDA, MHRA, ANVISA, FIMEA),
05.2021 - Current
Deputy Manager Lab QA and QC Compliance
CIPLA LTD, INDORE, (Regulatory Approvals: USFDA, MHRA and Other Regulatory Approvals)
12.2015 - 04.2021
Sr. Executive, Quality Control
SIDMAK LABORATORIES, DEHRADUN, (Regulatory Approvals: USFDA)
01.2015 - 12.2015
Executive, Quality Control
ELDER PHARMACEUTICAL, DEHRADUN, (Regulatory Approvals: ROW Market)
08.2011 - 01.2015
Executive, Quality Control
SHREYA LIFE SCIENCE
05.2010 - 07.2011
Sr. Chemist, Quality Control
SIDMAK LABORATORIES
08.2008 - 05.2010
Chemist , Quality Control
UNICURE INDIA PVT LTD
10.2006 - 07.2008
Master of Science - Microbiology
JIWAJI UNIVERSITY
Bachelor of Science - Chemistry
C. S. J. M. UNIVERSITY
Intermediate - Science Education
Govt. Inter College
High School - Science Education
Govt. Inter College
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