Vikash Tiwari
Stevenage
Summary
Goal-oriented and disciplined Quality Assurance professional with over 17 years of international experience in the Pharmaceutical Industry, specializing in Injectables, Liquid, and OSD dosage forms.
Proven expertise in driving QMS, Validation, Qualification, and Regulatory Compliance (USFDA, MHRA, MCC, TGA, WHO).
Experienced in providing strategic leadership to QA teams, ensuring high-quality outcomes through performance management and skill development.
Adept at implementing digital quality systems (e-BMR, Mastercontrol, TrackWise, SAP) and managing complex regulatory inspections to ensure continuous improvement and operational excellence.
Overview
18
18
years of professional experience
Work History
QA Supervisor (Acting QA Manager)
Crescent Manufacturing Limited
London
12.2023 - Current
- Direct and mentor a high-performing team of 10 QA professionals, fostering growth through structured career development planning, regular one-to-one coaching, and performance reviews.
- Establish departmental KPIs and MIS trend reports to monitor quality performance, providing continuous feedback to ensure alignment with business goals.
- Lead 'Audit Readiness' initiatives and drive continuous improvement strategies to meet and exceed regulatory expectations.
- Maintain and evolve a robust Pharmaceutical Quality System (PQS) in strict compliance with EU GMP and ICH Q10 standards.
- Serve as the primary lead for regulatory inspections, specifically handling MHRA audits and managing the closure of subsequent filings.
- Facilitate Quality Review Meetings (QMR), ensuring minute-taking and tracking of actionable insights.
- Manage Operating Licenses and ensure rigorous compliance for Controlled Drugs, including SOP preparation and security management.
- Oversee the end-to-end Change Management system, including CAPA, Deviations, Risk Management, and Root Cause Analysis (RCA) for Non-Conformance Reports (NCRs).
- Partner with the Qualified Person (QP) to escalate and resolve critical issues, including OOS, complaints, and major deviations.
- Spearhead New Product Introduction (NPI) and site transfer activities, collaborating with cross-functional management to ensure successful product launches.
- Execute batch release activities, including the comprehensive review of batch documentation and management of interim update reports.
- Manage full-cycle validation projects, including Process, Cleaning, Utilities, and Computer System Validation (CSV).
- Oversee temperature monitoring and mapping compliance for warehousing, transport, and QC Equipment.
- Approve critical documentation, including Master BMR/BPR, Artwork (labels/cartons/leaflets), and Preventive Maintenance quality logs.
QA Executive (Validation Lead)
Bristol Laboratories Limited
Luton
07.2019 - 12.2023
- Spearheaded the planning and execution of process validation, risk assessment, and equipment qualification, ensuring organizational control over cleaning validation and utility systems.
- Planned and executed process validation protocols and reports, conducting detailed reviews of QC documents to ensure robust compliance.
- Executed Temperature Mapping across 5 warehouse units and transport validation, delivering £40k in annual savings.
- Maintained organizational control of cleaning validation (VMP, SOP, Risk Analysis) and performed risk assessments for equipment and facilities.
- Managed the re-qualification of critical utilities including HVAC, Water, and Compressed Air systems.
- Prepared apex documents such as SMF, VMP, and Quality Manuals in strict accordance with MHRA requirements.
Asst Manager QA Validation
BDR Pharmaceutical International Pvt. Ltd.
02.2019 - 05.2019
Asst. Manager-Validation
VHB Medi Sciences Limited
06.2015 - 09.2018
Sr. Executive – Validation
Troikaa Pharmaceuticals Limited
03.2013 - 06.2014
Sr. Executive-QMS
Akums Drugs & Pharmaceuticals Limited
05.2011 - 09.2012
Asst. Executive – IPQA
Venus Remedies Limited
08.2008 - 09.2010
Education
MBA - Pharmaceutical Management
Manipal University
India01.2027
B.Sc. - Chemistry
DDU University
Gorakhpur, India01.2007
Skills
- Quality Systems
- PQS Governance
- QMS Management
- CAPA & Deviation Management
- Change Control
- Risk Assessment
- Batch Release
- KPI & Trend Analysis
- Validation & Qualification
- Process Validation
- Media Validation
- Cleaning Validation
- Computer System Validation (CSV)
- Equipment Qualification
- Utility Qualification
- Temperature Mapping
- Regulatory Compliance
- USFDA Guidelines
- MHRA Guidelines
- EU GMP Guidelines
- Audit Preparation
- Hosting
- Data Integrity
- Regulatory Submission Support
- Leadership
- Team Mentorship
- Training
- Visual Site Management
- Vendor Qualification
- Supplier Qualification
- Quality Management Review
- Quality Operations
- Market Complaint Investigation
- GEMBA
- L1 Audits
- L2 Audits
- DI Audits
- Artwork Approval
- Regulatory Submission
- APQR
- MQRM
- CRM
- TA
- Transport Validation
Professional Highlights
- Audit Success: Successfully led QA teams with optimized manpower to achieve zero Data Integrity issues during regulatory audits.
- Implemented quality governance and quality oversight functions for management of quality improvement with current expectation all time.
- Implementation quality organization need in business development and corporate business development including CMO.
- Project Leadership: Successfully implemented greenfield sterile projects within realistic timelines across 5+ sterile dosage forms.
- Cost Reduction: Implemented a temperature mapping program at Bristol Laboratories, resulting in annual cost savings of £40,000.
- Strategic Compliance: Spearheaded the transition to digital quality frameworks, including the implementation of e-BMR, e-Log, and Mastercontrol systems to enhance compliance efficiency.
- Establishing quality organization to meet global regulatory compliance in validation, qualification and calibration.
Area Of Expertise
PQS Governance, QMS Management, CAPA & Deviation Management, Change Control, Risk Assessment, Batch Release, KPI & Trend Analysis, Process, Media & Cleaning Validation, Computer System Validation (CSV), Equipment & Utility Qualification (HVAC, Water), Temperature Mapping, USFDA/MHRA/EU GMP Guidelines, Audit Preparation & Hosting (Internal/External), Data Integrity (DI), Regulatory Submission Support (MIA/MS/WDA), Team Mentorship & Training, Visual Site Management, Vendor/Supplier Qualification, Quality Management Review (QMR)
Websites, Portfolios and Profiles
https://www.linkedin.com/in/vikash-tiwari-649949a7/
Timeline
QA Supervisor (Acting QA Manager)
Crescent Manufacturing Limited
12.2023 - Current
QA Executive (Validation Lead)
Bristol Laboratories Limited
07.2019 - 12.2023
Asst Manager QA Validation
BDR Pharmaceutical International Pvt. Ltd.
02.2019 - 05.2019
Asst. Manager-Validation
VHB Medi Sciences Limited
06.2015 - 09.2018
Sr. Executive – Validation
Troikaa Pharmaceuticals Limited
03.2013 - 06.2014
Sr. Executive-QMS
Akums Drugs & Pharmaceuticals Limited
05.2011 - 09.2012
Asst. Executive – IPQA
Venus Remedies Limited
08.2008 - 09.2010
MBA - Pharmaceutical Management
Manipal University
B.Sc. - Chemistry
DDU University