Documentum
Nirali Shah
Quality Assurance Manager
Gurgaon,HR
Summary
Versatile Senior Manager specializing in Quality Management System and skilled at planning, implementing and overseeing key improvements to drive high-performing teams. History of cultivating an open culture with free exchange of information. Skilled at handling regulatory inspections. Pursuing new professional challenges with a growth-oriented company.
Overview
4
4
years of professional experience
7
7
years of post-secondary education
Work History
Assistant Manager, NPD/EPD - Quality
Reckitt
02.2024 - Current
- Embarked on a transformative journey from pharmaceuticals to FMCG sector in pursuit of new horizons
- Overseeing a diverse portfolio encompassing iconic power brands like Dettol, Moov, Durex, Veet, Harpic, Lizol, Vanish, Colin, Strepsils, Mortein and many more
- Quality insights into a diverse portfolio of formulations like liquids, oral solid dosage forms, oral liquid dosage forms, bar soaps, gels, powders, aerosols, liquid vaporisers and many others
- Risk Assessment at every stage of Tech Transfer
- End to end project leadership; orchestrating the entire product development lifecycle from concept to post- launch analysis, ensuring seamless collaboration and alignment throughout the process
- Strategic conceptualisation; key role in new product concept brainstorming sessions fostering innovation and contributing valuable insights to drive product excellence
- Ensured compliance with all safety regulations by conducting regular inspections of retail stores.
- Timely project execution
- Instilling quality requirements at the initial stages of product development aligning closely with Global policies to establish a foundation of excellence
- Overseeing Tech Transfer ensuring seamless transition from laboratory to manufacturing line
- Ensuring approval of new RM/PM suppliers and CMOs/EMOs prior to their involvement in any projects
- Performing Due Diligence of ready-to-go formulations/products
Senior Manager, Quality Assurance
Injectables Division, Alembic Pharmaceuticals Ltd.
6 2023 - 02.2024
- Handling of all functions of QMS - OOS, OOT, Complaints, Deviations, Change Management, CAPA and Risk Assessment along with Training and Document Cell Management
- Handling of regulatory inspections
- Monitored remediation plan for 483s at injectable division with 3rd party consultants, QxP and helped introduced new systems and processes to achieve challenging objectives.
- Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.
- Conducted investigations into OOS, OOT, Laboratory Incidents.
- Collaborating with quality team and cross-functional team to implement corrective and preventive actions against OOS/Deviations/Complaints
- Developed and implemented procedures to meet product quality standards.
- Evaluated hiring and promotions requests
Manager, Quality Assurance
Injectables & OSD Division, Alembic Pharmaceuticals Ltd.
05.2021 - 05.2023
- Maximized performance by monitoring daily activities and mentoring team members.
- Accomplished multiple tasks related to QMS within established timeframes.
- In-charge of handling Deviations, Market Complaints, Change Management, Risk Assessment and CAPA
- Managing over 100 change controls and approx. 20 complaints per month
- Performed root cause analysis to identify and resolve quality issues and defects.
- Conducted risk assessments to identify and mitigate potential quality issues.
- Developed and implemented comprehensive quality assurance plans to monitor product quality and adherence to regulatory standards.
Deputy Manager, Quality Assurance
OSD Division, Alembic Pharmaceuticals Ltd.
02.2020 - 05.2021
- Functioned as point of contact for Market Complaints and Deviations
- Analyzed and reported data pertaining to complaints, translating findings into practical improvement actions.
Senior Executive, Quality Assurance
OSD Division, Alembic Pharmaceuticals Limited
7 2014 - 6 2018
- Functioned as SME for Lab QMS - OOS, OOT and Laboratory Incidents
- Handled regulatory inspections from USFDA to EU-GMP and customer audits
- Instrumental in remediation to achieve over 50% reduction in OOS results over a period of 2 years
Education
Master of Science - Pharmacology
University of Oxford
Oxford, United Kingdom 09.2018 - 09.2019
Masters of Pharmacy - Pharmaceutical Sciences
Gujarat Technological University
India 06.2012 - 05.2014
Bachelors of Pharmacy - Pharmacy
Gujarat Technological University
India 06.2008 - 05.2012
Skills
Self-Motivated, Proactive
undefinedAdditional Information
- Certifed as Lead Investigator and Change Control Lead by QxP, qualified third party consultants
- Volunteered for over a year at Branch Up Active run by Oxford Hub -a youth organization that provides extra-curricular opportunities to kids who may otherwise not have access to them
- Volunteered for over 3 months at Hellevad Vandmoelle, Denmark to learn organic farming
Software
LMS
SAP
Microsoft Office
Quality One
Interests
Avid explorer having travelled to over 15 countries
Reading
Art
Timeline
Assistant Manager, NPD/EPD - Quality
Reckitt
02.2024 - Current
Manager, Quality Assurance
Injectables & OSD Division, Alembic Pharmaceuticals Ltd.
05.2021 - 05.2023
Deputy Manager, Quality Assurance
OSD Division, Alembic Pharmaceuticals Ltd.
02.2020 - 05.2021
Master of Science - Pharmacology
University of Oxford
09.2018 - 09.2019
Masters of Pharmacy - Pharmaceutical Sciences
Gujarat Technological University
06.2012 - 05.2014
Bachelors of Pharmacy - Pharmacy
Gujarat Technological University
06.2008 - 05.2012
Senior Manager, Quality Assurance
Injectables Division, Alembic Pharmaceuticals Ltd.
6 2023 - 02.2024
Senior Executive, Quality Assurance
OSD Division, Alembic Pharmaceuticals Limited
7 2014 - 6 2018
Similar Profiles
Eduardo Ivan Ruiz AnayaEduardo Ivan Ruiz Anaya
Técnico De Mantenimiento A at ReckittTécnico De Mantenimiento A at Reckitt
James NewloveJames Newlove
QC Lab Area Lead at ReckittQC Lab Area Lead at Reckitt
Rineet RatnakarRineet Ratnakar
Vice President IT&D for Supply Chain at ReckittVice President IT&D for Supply Chain at Reckitt
Fife FakoyaFife Fakoya
Territory Sales Representative at ReckittTerritory Sales Representative at Reckitt
ANJALI SINGHANJALI SINGH
Senior Talent Acquisition Specialist at Accor PlusSenior Talent Acquisition Specialist at Accor Plus