Arvind Nainwal
Dehradun
Summary
Deputy Manager QA at Mankind Pharma Ltd specializing in quality management and regulatory compliance. Led qualification and validation initiatives that enhanced team performance through effective training programs. Strong analytical skills applied in root cause analysis, resulting in improved audit compliance and operational excellence.
Overview
19
19
years of professional experience
Work History
Deputy Manager QA
Mankind Pharma Ltd
Paonta Sahib
12.2015 - Current
- Company Overview: Mankind Pharma Ltd (Unit-I, Injectable), Paonta Sahib (HP)
- Manage & supervision of qualification & validation activities.
- Manage & Supervision IPQA activities.
- Provided technical support and direction to team.
- Trained subordinates through regular training programs and enhancing their understanding for quality requirements.
- Review of qualification and validation documents.
- Handling of change control, deviation, Inter-departmental coordination for root cause analysis & CAPA.
- Audit compliance.
- Exposure of Green field project.
QA- Sr. Officer
Ipca Laboratories Limited
Dehradun
06.2008 - 12.2015
- Company Overview: Ipca Laboratories limited, (Unit-II) Sara Industrial Estate, Village- Rampur, Dehradun (UK)
- Execution of Qualification & Validation Activities.
- Preparation of Qualification Protocols & Reports.
- Preparation of SOP’s & Validation Schedules.
- Preparation of SOP’s.
- Review of qualification and validation documents.
- Handling of Change Control, Deviation, inter-Departmental Coordination for Root Cause Analysis & CAPA.
- Execution of Media Fill activity and Process Validation.
- Audit Compliance.
QA-Officer
Scott-Edil Pharmacia Ltd.
Baddi
10.2007 - 06.2008
- Company Overview: Scott-Edil Pharmacia Ltd. Jharmajari, Baddi (HP)
- IPQA activities in Dry Powder Injection facility.
- In-process and finished goods sampling.
- Execution of Qualification & Validation activities.
- Issuance of BMR, BPR and Formats.
- Review of BMR & BPR.
Chemist QA
Ind-Swift Laboratories Ltd.
Dera Bassi
09.2006 - 10.2007
- Company Overview: Ind-Swift Laboratories Ltd. Dera Bassi, distt. SAS Nagar (PB)
- Issuance and retrieval of SOPs.
- Issuance of batch documents and other daily & monthly formats/logbooks.
- Review of batch records before batch release.
- Documentation control (Retrieval).
- Audit compliance.
Education
M.Sc. - Chemistry
Sri Krishnadevaraya University
Ananthapuramu, Andhra Pradesh01.2015
B.Sc. - CBZ
H.N.B. Garhwal University
Srinagar, Garhwal, U.K.01.2004
Skills
- Quality management and regulatory compliance
- Planning and scheduling
- Risk management
- Root cause analysis and corrective action
- Project management
- Personnel development and training
- Mentoring and collaboration
- Technical writing
- Equipment qualification
- Process validation
- Leadership skills
- Analytical thinking
- Problem solving
Accomplishments
- Winner of the first Kaimex competition at Mankind Pharma Ltd In 2020
- Yellow Belt Certified in Lean Six Sigma
Strengths
Lead a team of 16 quality assurance specialists, Analysed data from various sources to identify root causes of quality issues and develop effective solutions, Develop & implement new processes to resolve quality issues
Handled Qms Software
- Caliber QMS
- DMS
- Nichlon
Technical Key Skills
- Technically sound
- Organized
- Self-motivated
- Result oriented individual with capabilities in handling multiple projects
- Extensive working knowledge of complete validation lifecycle (VLC)
- Handled Projects of Vial filling line and Ampoule filling line
Equipment Qualification
Manufacturing tank
Autoclave
UDAF’s
Vial Filling Machine
Ampoule Filling and Sealing Machine
Vial/Ampoule washing machine
Vial/Ampoule Sterilization and Depyrogenation Tunnel
Garment washer and dryer
Walk in incubators
Stability chambers, incubators, and refrigerators
Utility Qualification
- HVAC system
- Compressed air and nitrogen gas
- Steam Quality Test
Affiliations
- PERU
- PICS Malaysia
- PICS Ukraine
- UGANDA
- KENYA
Languages
- Hindi
- English
Personal Information
- Father's Name: Sh. Dinesh Nainwal
- Date of Birth: 05/07/1983
- Nationality: Indian
Disclaimer
I hereby declare that the information furnished above is true to the best of my knowledge and belief.
Timeline
Deputy Manager QA
Mankind Pharma Ltd
12.2015 - Current
QA- Sr. Officer
Ipca Laboratories Limited
06.2008 - 12.2015
QA-Officer
Scott-Edil Pharmacia Ltd.
10.2007 - 06.2008
Chemist QA
Ind-Swift Laboratories Ltd.
09.2006 - 10.2007
M.Sc. - Chemistry
Sri Krishnadevaraya University
B.Sc. - CBZ
H.N.B. Garhwal University
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