Parasharam Pednekar
Mapusa
Summary
Experienced Quality Control professional overseeing compliance, auditing, and electronic data review within manufacturing systems to enhance regulatory readiness. Manages internal audits and QMS investigations, driving CAPA implementation and data integrity. Directs laboratory operations, instrument qualification, and software validation to ensure inspection-ready status while reviewing QMS events and procedure updates to strengthen laboratory governance.
Overview
1
1
Certification
23
23
years of professional experience
Work History
Sr. Manager
Glenmark Pharmaceutical Ltd
Goa
03.2010 - Current
- Outlined primary duties
- Conducted auditing and compliance activities, ensuring integrity of electronic data for manufacturing computerised systems at Goa Unit I and II.
- 2. Served as Group Leader of Raw Material & Packing Material Team from 2010 to 2014.
- 3. Served as Group Leader of Lab Support Team from 2015 to Nov 2023.
- 4. Handling overall activities and functions of Quality control laboratory as a second line to QC HOD.
- 5. Instrument calibration/qualification, Laboratory Standard management, Computer system validations of QC laboratory software (Legacy systems & new software).
- 6. Led QMS investigations in QC laboratory, implemented CAPA, and trained team on compliance protocols.
- 7. Responsible for conducting internal audits in various departments of Unit I & Unit II.
- 8. Writing response to internal and external audits.
- 9. Assessed gaps in existing systems, revised and implemented procedures aligning with current pharmacopoeia updates and guidelines.
- 10. Review of QMS (Incidents/OOS/OOT/CAPA/LER/Change Controls) from QC & stakeholders in SAP/Trackwise.
- 11. Review of Qualification documents (IQ, OQ, PQ) of QC & other stakeholders.
- 12. Preparation of response for internal and external audits and to ensure compliance.
- 13. To ensure overall Lab maintenance, safety and compliance.
- Total Experience : 20.5 Yrs.
- In Glenmark : 14.5 Yrs.
- Department : QA (Goa-Unit I)
Executive-Quality Control
Indoco Remedies Ltd. (Sterile Facility)
Goa
07.2005 - 03.2010
- 4. Led team in raw material section, ensuring adherence to quality standards and regulatory compliance.
- 5. Conducted investigations into out-of-specification results, identifying root causes and implementing corrective actions.
- 6. Revised SOPs, STPs, and GTPs to align with current pharmacopoeia updates, enhancing operational compliance.
- 2. Analytical Method Validation and Technology transfer.
- 3. Calibration & Qualification of Laboratory instruments.
- Reviewed finished product and stability documents.
- Key Responsibilities:
Officer-Quality Control
Cipla Ltd
Verna, Goa
01.2004 - 06.2005
- 1. Sampling & Testing of Raw Materials & Finished products (Tablets & Ointments).
- Developed and implemented standard qualifications for laboratory processes, enhancing consistency and reliability in testing.
- 2. Managed reserve samples to ensure availability for quality testing and compliance.
- 4. Conducted daily performance checks of analytical balances and pH meters to maintain accuracy in laboratory measurements.
- Key Responsibilities:
Education
M.Sc. - Chemistry
Karnataka University
Dharwad, Karnataka05-2003
B.Sc. - Physics, Chemistry, Mathematics
Karnataka University
Dharwad, Karnataka04-2001
P.U.C. -
G S Sc. College
Belgaum04-1998
S.S.L.C. -
Bangalore Board
Karnataka04-1996
Skills
- HPLC Instruments :
- 1) AGILENT 1100 (UV & RI Detectors)
- 2) SHIMADZU (UV Detector, RF)
- 3) WATERS (PDA, FLD & RI Detectors)
- 4] THERMO (UV Detector)
- Gas Chromatography :
- 1) AGILENT with FID & TCD detectors
- 2) PERKIN-ELMER with FID & TCD detectors
- Atomic Absorption Spectroscopy :
- 1] PERKIN-ELMER
- UV Spectrophotometer :
- 1] PERKIN ELMER, 3] SHIMADZU
- FTIR Spectrophotometer :
- 1) PERKIN ELMER
- Dissolution Apparatus :
- 1) ELECTROLAB, 2) LABINDIA
- Other Instruments :
- KF-Autotitrator apparatus, Refractometer, Polarimeter, pH meter, Disintegration Tester, Friability Tester, Hardness Tester, Viscometer, IR Moisture Balance, Analytical Balances, KF Coulometer, Drying Oven, Vacuum Oven, Melting point apparatus, TOC analyser, Tap density apparatus, Sieve analyser, Liquid Particle counter and other analytical instruments involved in testing of Tablets, Ointments and Parenteral preparations
- Sophisticated QC Software:
- Empower 3/361 for Chromatography
- Spectrum ES for IR spectroscopy
- UV WinLab for UV-Visible spectrophotometer
- TOC Control – V
- Rudolph Autopol V Plus for Polarimeter
- Tiamo 24 for Autotitrator
- 1) Actively participating in the audits as a SME for regulatory agencies like USFDA, MHRA, WHO, TGA, MHRA, UGANDA etc and writing compliance to the observations
- 2) Familiar with ICH guideline, USFDA Guidelines, GMP Guidelines and WHO guidelines
- 3) Well versed with Analytical techniques, Regulatory requirements, Pharmacopeia General Chapters, Monographs etc
- 4) Strong hold on Electronic data management of QC laboratory systems, Computer System Validations (CSV), Instrument Calibrations, Qualifications, Software validation & controls, 21 CFR & data integrity requirements etc
- 5) Have good analysing skills on analyzing trends, review of data, statistical evaluation of data, Root Cause Analysis (RCA) using standard tools & deriving appropriate CAPA
- 6) Have hands-on experience in QMS investigations, CAPA implementation & impact assessment
- 7) Six Sigma methodology
- 8) Analytical method validation
- 9) Have strong auditing skills in Quality and operational systems
- 10) Leadership and presentation
- 11) Performance management
- 12) Strong innovative skills in Compliance & Work simplifications in QC activities
- 13) Communication proficiency
- 14) Organisational commitment
- 1) LSSGB training on Process evaluation using statistical tools & Investigation (2021)
- 2) Certification course on Software Compliance & life cycle management by Waters (2015)
- 3) Structured Problem Solving Skills Training at Glenmark (2016)
- 4) Internal Auditors Training programme on (ISO 9001-2008) by TUV India Pvt Ltd (2017)
- 5) 'Failure Investigation and Root Cause Analysis and its CAPA' by M/s PharmaQA Compliance Services, India
- 6) Presentation Skills by GCL (2011)
- 7) Analytical Skills by GCL (2010)
- 8) Executive Development Program by GCL (2012)
- 9) Certification course on USP Residual solvents, Monograph modernization & Harmonization, Qualification of Working standards/Reference standards (2007)
- Quality assurance
- Regulatory compliance
- Audit management
- Computer system validation
- QMS oversight
- Instrument qualification
- CAPA management
- Risk assessment
- ISO standards compliance
Certification
- Chemical and Instrumental Analysis by Local FDA.
Accomplishments
- 1. Gold Medalist in Master of Science at Karnataka University, Dharwad (2003).
- 2. Approved by Local FDA of Goa in Chemical & Instrumental analysis.
- 3. Scored 8 band in International English Language Testing System (IELTS).
Interest and Hobbies :
Reading, Writing Poems & Articles, Playing Cricket & Listening to Music.
Other roles :
- 1) Trained as Senior First Aider by St. John Ambulance Association.
- 2) Trained in Fire Fighting camps.
- 3) Member of EHS (Environment, Heath and Safety) & POSH committe.
Hierarchy :
Reporting to Head-Quality.
Personal Details :
Languages Known: English, Hindi, Marathi, Konkani, Kannada
Timeline
Sr. Manager
Glenmark Pharmaceutical Ltd
03.2010 - Current
Executive-Quality Control
Indoco Remedies Ltd. (Sterile Facility)
07.2005 - 03.2010
Officer-Quality Control
Cipla Ltd
01.2004 - 06.2005
M.Sc. - Chemistry
Karnataka University
B.Sc. - Physics, Chemistry, Mathematics
Karnataka University
P.U.C. -
G S Sc. College
S.S.L.C. -
Bangalore Board