Puneet Bhardwaj
Chandigarh
Summary
Insightful Manager with experience directing and improving quality operations through effective employee motivational strategies and strong policy enforcement. Proficient in best practices, market trends and regulatory requirements of industry operations.
Overview
14
14
years of professional experience
Work History
Manager – Quality Management System
Sun Pharmaceuticals Industries
12.2018 - Current
- Managing Team of Quality Management System encompassing Deviation Management, Complaints Management, Process Validations, Change Controls, CAPA and Master Batch Records management.
- Simplifications and Harmonization - Processes and Procedures simplifications/Harmonization leading to Quality by Design
- Reduction in waste time and enhancement of key capacity constraint resources
- Streamlining and monitoring of quality programs to alleviate overdue compliance activities.
- Launch of quality assurance practices for each phase of development.
- Establishing performance goals for employees and providing feedback on methods for reaching those milestones.
- Establishing team priorities, maintaining schedules and monitoring of performance.
Asst. Manager – Audit & Compliance and site OE lead
Dr. Reddys Laboratories
07.2016 - 12.2018
- Responsible for conducting 6 system audits for both Baddi Sites as a part of USFDA compliance from July 2016 to April 2018
- Compliance verification and procedural incorporation / improvisation of both Baddi sites against recent regulatory observations reported across Pharma industry
- Site OE lead from May 2018 to December 2018 whereby energised the both Baddi sites by increasing overall OEE by initiation of multiple Quality and Productivity projects.
Executive - Quality Management System.
Fresenius Kabi Oncology
03.2014 - 07.2016
- Responsible for investigations related to deviations, management of change control, deviation and CAPA for injectables and Oral Solids Section.
Sr. Executive - Quality Management System
Abbott
08.2012 - 03.2014
- Responsible for management of change control, deviation and CAPA for Oral Solids, Soft Gel Caps and Liquid oral Section.
Officer - Validation and compliance
Fresenius Kabi Oncology
09.2010 - 08.2012
- Responsible for Process Validation, Cleaning Validation, Routine Re-qualification activities, New machine qualification viz
- CVC line, HAPA printing, strip packing and general validations including Cross contamination studies, OEL study etc., IPQA Activities, risk assessments, investigations related to OSD and injectables and SOP Preparations.
Education
Masters in Pharmacetical Sciences - Pharmaceutics
ASBASJS COP
Bela, Ropar08.2010
Bachelors of Pharmacy - Pharmacy
Kurukshetra University
Kurukshetra, India06.2008
Skills
- Total Quality Management
- Internal Audits
- Regulatory Compliance
- Risk Analysis and Mitigation
- Work Planning and Prioritization
- Audit Coordination
- Global CAPA
- Quality Metrics
- Trend Analysis
- Process Analysis
- SOP Development
- Issue Resolution
Profile Snapshot
A competent professional skilled in implementing quality system with a 14 years experience in pharmaceutical industry . Decisive and results oriented with a proven track record to continuously improve the quality management system.
Key Audits Faced
Sun Pharmaceutical Industries Limited:
- United States Food and Drugs Administration (USFDA) - 2022
- European Union (EU) - 2024
- Therapeutic Goods Administration (TGA) - 2024
- Ministry of Health (MOH), Russia - 2024
- Central Drugs Standard Control Organization (CDSCO) - 2024
- Independent GMP Consultant - 2021, 2022
- Corporate Audits - 2022, 2023, 2024
Dr. Reddy's Laboratories
- Ministry of Health (MOH), Russia
- NAMMDR, Romania
Fresenius Kabi Oncology Limited:
- United States Food and Drugs Administration (USFDA)
- Medicines and Healthcare products Regulatory Agency (MHRA), Europe
- National Institute of Drug and Food Surveillance (INVIMA), Columbia
- Brazilian Health Regulatory Agency (ANVISA), Brazil
- Ministry of Health (MOH), Russia
Abbott Healthcare:
- Corporate Quality
- Central Drugs Standard Control Organization (CDSCO)
Software Handling, Training and Publications
Softwares:
- QMS Software - TrackWise
- Batch Records - DCM, Batch Record Management System (BRMS)
- SOPs - EDMS
- Statistical Software - Minitab, Design expert, Sigma stat.
Publications:
- Research paper entitled Formulation, evaluation and optimization of Mouth dissolving tablet of Losartan Potassium: Effect of co-processed superdisintegrants (international journal of pharmaceutical & biological archieves 2010).
- Various abstract presented in national conferences.
Awards and Seminars:
- Bagged Best Research Paper award in Chandigarh Science Congress (CHASCON) 2010, Punjab University.
- Participated in seminar on Change control & Deviations
- Participated in a seminar on intellectual property rights.
- Attended IPC 2007,2008
- Presented abstract in AICTE sponsored seminar at Yamuna nagar.
- Attended AICTE sponsored seminar at Sirsa
- Attended a national seminar at Punjabi university, Patiala.
Alternate Telephone
- +91-8427138134
Hobby
Reading books.
Activities
- Participated in Various Cultural Events &different Competitions at College & School Level.
- Extensive Travelling across India including Exotic places of jaipur, Udaipur, Bombay, goa, nainital.
Disclaimer
The above information and particulars are true and correct to the best of my personal knowledge and belief.
Personal Information
- Father's Name: Sh. Yuvraj Sharma
- Mother's Name: Smt. Asha Sharma
- Date of Birth: 11/10/85
- Gender: Male
- Nationality: INDIAN
- Marital Status: Married
Timeline
Manager – Quality Management System
Sun Pharmaceuticals Industries
12.2018 - Current
Asst. Manager – Audit & Compliance and site OE lead
Dr. Reddys Laboratories
07.2016 - 12.2018
Executive - Quality Management System.
Fresenius Kabi Oncology
03.2014 - 07.2016
Sr. Executive - Quality Management System
Abbott
08.2012 - 03.2014
Officer - Validation and compliance
Fresenius Kabi Oncology
09.2010 - 08.2012
Masters in Pharmacetical Sciences - Pharmaceutics
ASBASJS COP
Bachelors of Pharmacy - Pharmacy
Kurukshetra University
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