Rohit Chaudhary
Professional
Muzaffarnagar
Summary
Seeking position in the area of production/documentation with a challenging and responsible position with opportunity for advancement of potential, where my knowledge and experiences will enhance qualitative productivity and effectiveness of the organization.
Overview
20
20
years of professional experience
2
2
Languages
Work History
Senior Executive in Quality Assurance Department
Swiss Garnier Ganaxia Sikkim
09.2024 - Current
- Assessment of change proposal for logging and departmental.
- Closing of change controls and change effectiveness.
- Preparation of change trends, CAPA and continuous knowledge management.
- Planned, unplanned deviation logging investigation. CAPA and CAPA effectiveness.
- SOP preparation, issuance and retrieval.
- Review MFR, BMR and BPR review with reference to change proposal.
- Identification of digitalization needs and URS preparation for IT (MES), HR (Access) QA (Eqms and LMS)
- Identification of business needs and tentative business plan PPT for year.
- Identification of training digitalization needs for critical aspects like data integrity.
Executive Production & Documentation
Ind-Swift Laboratories
08.2020 - 09.2024
- Handling QMS documents like change control, deviation and CAPA with regulatory Compliance.
- Preparation of BMR, URS, SOPs and qualification protocols etc.
- Investigations of OOS/OOT, deviation and market complaint.
- Well aware about E-QMS system
- Reviewer of APQR
- Improvement: Digital MFR development in ERP, Costing implementation in ERP, RM and PM Specifications development and COA in ERP, Team development of APQR and QMS in QA and cross functional department, Gaps identification in Process validation, SOPs and suggesting CAPA, along with implementation of life cycle management with reference to ICHQ7. Implementation of risk management as per ICH Q9.
- Implementation of ICH Q(QR2) in FR&D department with reference to ICH Q8 (R2)
- Training module development on Machine trouble shooting
Senior Executive Production
Unichem Laboratories Ltd.
07.2018 - 08.2020
- Preparation of training Calendars, Questioners and evaluation of Questioners
- Handling QMS documents like change control, deviation, incident, YNCR, Non Compliance along with Market complaint investigation with suggestion of CAPA.
Executive Production
Panacea Biotech Ltd.
06.2014 - 07.2018
- Planning and execution of monthly packaging plan along with day to day planning.
- Handling packaging trouble shooting.
- Stereo indent and management.
- Batch allocation as per market plan.
- Maintaining following records: Machine log books, Area Cleaning record, Equipment cleaning record, Temperature and relative Humidity records
Assistant Professor
S.D. College of Pharmacy & Vocational Studies
09.2009 - 06.2014
Assistant Officer in Production Tablet Section
Panacea Biotech Ltd.
08.2005 - 08.2006
Assistant Officer in Production Soft Gelatin Capsule Section
Panacea Biotech Ltd.
08.2005 - 08.2006
Education
Senior Secondary - undefined
U.P. Board
AllahabadHigher Secondary - undefined
U.P. Board
AllahabadMaster in Pharmacy - Pharmaceutical Technology
Jeypore College of Pharmacy, BPUT
01.2009
Bachelor in Pharmacy - undefined
S.D. College of Pharmacy & Vocational Studies
U.P.T.U.01.2005
Skills
MS WORD, MS EXCEL, POWER POINT, Internet etc
Interests
Playing cricket, Badminton, Volleyball, Reading research papers
Disclaimer
I hereby declare that the information furnished about me is correct to the best of my knowledge and belief.
PROFESSIONAL EXPERIENCES
About 13 years of extensive experiences in the area of production and documentation in regulatory pharmaceutical industry and five year pharmaceutical academics. Well aware with methods, systems and compliance of quality measure.
AUDIT EXPOSURE
USFDA, ANVISA (Brazil), EU GMP (Austria), EU GMP (Crotia), MCC (South Africa), Ukraine GMP, Russia-MOH, WHO GMP (CDSCO), NDA-Uganda, MOH-Kazakhstan, MOH-Kenya, FDA-Tanzania, Customers Audit like GSK-global, Sandoz, Biocon, Apotex, Cadila Pvt. Ltd, Ranbaxy private limited, Glaxo SmithKline pharmaceuticals limited, Bayer Health care.
REPORTING
Deputy Manager
Timeline
Senior Executive in Quality Assurance Department
Swiss Garnier Ganaxia Sikkim
09.2024 - Current
Executive Production & Documentation
Ind-Swift Laboratories
08.2020 - 09.2024
Senior Executive Production
Unichem Laboratories Ltd.
07.2018 - 08.2020
Executive Production
Panacea Biotech Ltd.
06.2014 - 07.2018
Assistant Professor
S.D. College of Pharmacy & Vocational Studies
09.2009 - 06.2014
Assistant Officer in Production Tablet Section
Panacea Biotech Ltd.
08.2005 - 08.2006
Assistant Officer in Production Soft Gelatin Capsule Section
Panacea Biotech Ltd.
08.2005 - 08.2006
Senior Secondary - undefined
U.P. Board
Higher Secondary - undefined
U.P. Board
Master in Pharmacy - Pharmaceutical Technology
Jeypore College of Pharmacy, BPUT
Bachelor in Pharmacy - undefined
S.D. College of Pharmacy & Vocational Studies