Supriya Tiwari
Indore
Summary
Seeking Sr. Managerial Corporate Quality assignment with an organization of high repute, who takes up challenges and constantly innovates and set new benchmarks in pursuit according to Global Regulatory Standards.
Overview
21
21
years of professional experience
Work History
Manager- Quality
Endo India Par Formulation, Indore (M.P.)
04.2024 - Current
- Responsible for ensuring all time readiness for regulatory inspections by continuously monitoring cGMP system via self-inspection and tracking the action created for internal and external/ regulatory audit.
- Review and approve master documents like SOPs, PQR, stability protocol, QTA, validation/verification/Transfer/ feasibility/ optimization documents
- Reviewing and approving analytical documents and approving the Certificate of Analysis (CoA) for Raw materials, packaging materials, In-process, finished products, stability studies for submission, validation, and commercial batches.
- Performing/reviewing investigations for Quality issues such as Out of Specification (OOS), Deviations, Incidents, Corrective and Preventive Actions (CAPAs) related to laboratory.
- Ensuring implementation of CAPAs recommended in OOS, Out of Alert Limits (OOAL), Incidents, and deviations in the laboratory.
- Reviewing and approval of Change controls
- Reviewing chromatographic and non-chromatographic data, Audit trials in Empower/LIMS for ensuring data integrity
- Participating in the development and implementation of Standard Operating Procedures (SOPs), Specification, methods for laboratory compliance and relevant QC functions
- Reviewing and approving Quality control documents like qualification documents/Calibration reports of instruments
- Imparting training to subordinates and other personnel for development
- Reviewing and approving Raw material sample quantity evaluation form cum list and raw material storage conditions
- Reviewing and approving stability protocols in LIMS, Miscellaneous study protocols, and related reports in the laboratory
- Involve in finalization of Quality review boards
- Preparation and management of Quality budget and training expenses
- Well verse with Trackwise, Compliance wire, SAP and EDS software
Manager- Corporate Quality
Jubilant Generics Ltd. (Corporate), Delhi NCR
08.2017 - 03.2024
- Organizing and tracking monthly/ Quarterly Quality review meetings and tracking action items till closure along with cross functional department.
- Review of Quality business projects ex. like Training Automation, Document automation etc.
- Trending QMS elements for management review and tracking action item weekly/ monthly.
- Preparation and tracking Quality budget
- Centre point for collaboration of Jubilant and training vendors, training implementation at manufacturing sites, TNI and mapping training effectiveness for technical training
- Quality culture campaign executer for Jubilant with behavioral and technical identified modules implementer
- Planning and executing corporate quality audits at site and involved in its compliance.
- Involve in Vendor/ Supplier Qualification management for Generics sites and testing laboratories which include Raw material, packaging materials, excipients, intermediate, KSM etc.
- Responsible for implementation, maintenance and upgrading of the local Quality system and standard operating procedures for compliance of cGXP and their implementation.
- Involve in all critical Quality issues (deviations, complaints, recalls, counterfeits and product tempering, stability failures, etc.)
- Responsible for stability studies and trending
- Responsible for the change management for corporate change controls.
- Well verse with Trackwise, Compliance wire, SAP and EDMS software and working as corporate administrator.
- Reporting to: Corporate Quality Head -India
Assistant Manager - Site Quality
Glenmark Pharmaceuticals, Indore
08.2016 - 11.2016
- Training and compliance manager for Site
- Review of Critical OOS / OOT
- Involved in managing site Training budget
- Managing External Training vendors
- Representing site during critical audits
- Involved in CAPA preparation for regulatory audits observation
Management staff-Site QA
Cipla Ltd. Pithampur, Indore (M.P.)
02.2015 - 08.2016
- Site Lead for Training and internal audit
- Tracking audit compliance for Regulatory and customer audits
- Management and Tracking of Change control, CAPA
- Investigation of Deviation, Market complaint, LIR, OOS, OOT and OOC
Executive – Stability QA
Ranbaxy Laboratories Ltd. Dewas (M.P.)
11.2013 - 01.2015
- Preparation and management of SOP,
- Preparation and Review of Stability Protocol, Preparation and updating Grid using Novatek Software, Sharing Stability Data with Stake holders,
- Departmental Training Coordinator, Preparation of data as required with other market, ensuring lab compliance
- OOS and OOT handling in Track wise software.
Sr. Officer – (QC)
IPCA LABORATORIES LTD. Indore, Ratlam/ Pithampur Indore (MP)
08.2008 - 10.2013
Research Associate
Dishman Pharmaceutical and Chemicals Limited, Ahmedabad (Gujrat)
06.2007 - 08.2008
Executive – (QC)
Sandoz Private Limited, Mahad (Maharashtra)
12.2006 - 05.2007
Jr. Officer – (QC)
IPCA LABORATORIES LTD. Ratlam (MP)
10.2004 - 12.2006
- Oversaw daily operational workflows for Quality control (Packaging material, raw material, stability, In-process, water, Finish product) to ensure adherence to cGMP
- Experience of various operation critical instruments like HPLC, LCMS, GC, KF, IR, UV etc.
Education
Master of Science - Organic Chemistry
Vikram University
Ujjain02-2004
MBA - Marketing
CV Raman University
Bilaspur06-2010
Bachelor of Science - Science
Govt. Arts And Science College
Ratlam04-2001
Higher Secondary - PCM
GTB School
RatlamPROFESSIONAL SYNOPSIS
- An Expert with over 20+ years of rich experience in field of Corporate Quality Assurance (7 years) and Quality Assurance/ QC (13 years) with good exposure to functions-production, stores and engineering & Regulatory affairs departments
- Wide experience covering different sections of Pharma Viz. API, OSD and sterile.
- Presently working as Manager QA with Endo India Par Pharmaceutical, Indore Madhya Pradesh
- Faced various audits as team leader for USFDA, MHRA, WHO, GENEVA, EDQM, NDA Uganda, CDSCO and EUGMP.
- Expertise in QMS implementation, CAPA handling, Facing & conducting GMP Audits, GMP training, Equipment Qualification and Review of Chromatographic systems & data integrity compliance.
- Have Good exposure to costing and project handling.
- Good knowledge of 21 CFR Part 210, 211, 11 requirements
- Efficient Trainer and expertise in development of training material for trainer and end users on the job and off the job trainings.
- Ability to inspire and motivate people to embrace changes. Energetic character, strong commitment, uses a practical approach towards customer expectations, Quality and compliance requirements.
Accomplishments
- Achieved Chairmen award at Jubilant for successful implementation of Quality culture campaign
- Achieved prestigious above and beyond award at Endo India Par formulation for tracking and involve in closing of change controls
Skills
- Monitoring of Effective implementation of Good manufacturing practice
- Quality agreements, Technical agreements
- Audit and compliance for site (self inspection)
- Audit of Various contract-manufacturing sites (LL), CTL and vendors in India
- Vendor Qualification
- Change controls, Deviations (Incidences), Non-conformities, OOS, OOT.
- Investigation and handling of Market complaints.
- Preparation and review of SOPs, SMF, VMP, Quality manual
- Conducting GMP, GLP, GDP, Data integrity related training
- CAPA & CAPA effectiveness
- Conducting and tracking internal audits.
- Review and approval of Annual product Review report
- Compliance to different regulatory, external audits.
- SOPs, STP, Methods
- Compendial updates
TRAINING & PARTICIPATION
- Participated in GMP Auditor's qualification course titled “Need and Necessities of WHO, MHRA, TGA, MCC, ICH & USFDA”, ISO Auditor's qualification course, Trainer’s qualification course.
- Attended training on GMP, GLP practices, QRM, BRC, HACCP, FMECA, Cleaning validation, Process Validation, HVAC, Water system validation. Also participated in training on Communication skill & presentation skills, 5S, 7 Habits of Highly effective people, Mindset triggers, Self-awareness & Team Building etc.
- GMP Auditor’s Qualification course by Insight Systems Inc. in Sept-2019
- Six Sigma Green belt by Jubilant Generics-Business excellence team in Oct-2018
- Advanced excel by KPMG-Delhi NCR in Jan-2018
- Certificate Course in Computer Operation with M.S. Office in Oct-2004
Declaration
I hereby declare that the above particulars are true to the best of my knowledge and belief
Place: Indore (M.P.)
(Supriya Tiwari)
Date:
LANGUAGE
Language Known : Hindi & English
Bilingual or Proficient (C2)
Timeline
Manager- Quality
Endo India Par Formulation, Indore (M.P.)
04.2024 - Current
Manager- Corporate Quality
Jubilant Generics Ltd. (Corporate), Delhi NCR
08.2017 - 03.2024
Assistant Manager - Site Quality
Glenmark Pharmaceuticals, Indore
08.2016 - 11.2016
Management staff-Site QA
Cipla Ltd. Pithampur, Indore (M.P.)
02.2015 - 08.2016
Executive – Stability QA
Ranbaxy Laboratories Ltd. Dewas (M.P.)
11.2013 - 01.2015
Sr. Officer – (QC)
IPCA LABORATORIES LTD. Indore, Ratlam/ Pithampur Indore (MP)
08.2008 - 10.2013
Research Associate
Dishman Pharmaceutical and Chemicals Limited, Ahmedabad (Gujrat)
06.2007 - 08.2008
Executive – (QC)
Sandoz Private Limited, Mahad (Maharashtra)
12.2006 - 05.2007
Jr. Officer – (QC)
IPCA LABORATORIES LTD. Ratlam (MP)
10.2004 - 12.2006
Master of Science - Organic Chemistry
Vikram University
MBA - Marketing
CV Raman University
Bachelor of Science - Science
Govt. Arts And Science College
Higher Secondary - PCM
GTB School