ABHIMANYU KUMAR
Associate Manager, Quality Operation
Hyderabad,India
Summary
Passionate, Driven and Agile Pharma candidate with a strong background in Pharmaceutical Quality Management with 10 + Years of experience. Presently I am working as an Associate Manager at Quality Operation at Novartis Healthcare Private Limited from Sep 2020. Presently I working as a SPOC for QRA (Quality Risk Assessment) for QSC India site. Transitioned 12 projects successfully in the year 2021. Received Global Quality Stewardship award for major service transitioned in the year 2021. Completed my Masters and Bachelors with distinction. My Research Article Published Titled “Pharmacological Screening of Herbal Extract of Piper nigrum (Mari- cha) and Cinnamomum zeylanicum (Dalchini) for Anticonvulsant Activity” in Inventi Rapid: Ethnophar- macology Vol.2013, Issue 2. Received Sir Ratan Tata Scholarship for Academic Excellence at all India level.
Overview
10
10
years of professional experience
10
10
years of post-secondary education
7
7
Certifications
Work History
Associate Manager
Novartis Healthcare Private Limited
Hyderabad, India
09.2020 - Current
- Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows.
- Hold accounts in workflow applications (such as SAP, Dragon, SUBWAY, etc.) to ensure appropriate execution of service deliverables.
- Ensure compliance to the Novartis internal quality standards, relevant regulatory requirements, filed product quality standards and service level agreements.
- Support implementing service quality and process improvement projects, CAPA management within Quality Service Centers.
- Comply with all internal functional operating procedures like time tracking, KPI reporting, ticket management tools and other internal systems and processes.
- Learn & develop understanding to generate insights through data and digital.
- Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations.
- Lead / transition new service or expansion projects, monitor and report progress and deviations, as appropriate.
- Train, develop or mentor personnel for successful and timely onboarding in Quality Operations.
- Provide active support during internal and external audits by collecting and presenting the requested process data/reports.
- Adhere to the current GxP and compliance policies of Novartis.
- Drafting of Annual Monitoring and Certification report for incoming materials.
- Evaluation and Management of Supplier Change Notifications.
- Drafting and Evaluation of Supplier’s incoming materials Specification.
- Performing Quality Risk Assessment (QRA) for existing and new Suppliers / Service providers.
- Management of Supplier/ Material qualification and supplier related documentations.
- Preparation of regulatory statement for materials and finished products.
- Management Quality records, Support the Service Delivery team (SDT) with quality topics and 3rdPAP Management in TPRM (Third Party Risk Management) tool.
- Evaluation of Agile PCC change control tasks related to supplier quality management.
- Coordination in handling Discrepant Materials.
- Preparation of UQAP (Unified Quality Audit Program), Audit preparation support and QARP (Quality assurance responsible Person) Role for audit CAPA Management
Assistant Manager
Biocon Pharma Limited
Bengaluru, India
01.2018 - 09.2020
- Handling of QMS Management encompasses (Handling Change Management, Deviations, Root Cause Analysis, OOS and CAPA) and its effectiveness verification as per regulatory requirement.
- Routine manufacturing compliances in Facility.
- Preparation and review of Process Validation Protocols and Reports.
- Preparation of APQR.
- Vendor Management and Vendor Evaluation.
- Preparation of Internal Audit Planner.
- Preparation of Training Matrix and Schedule.
- Preparation and Review of Process Optimization Protocol and Reports.
- Preparation of Quality Risk Assessment.
- Preparation of Trend for all QMS Events.
- Preparation and review of Qualification Protocols.
- Preparation and checking of standard operating procedure.
- Responsible for the review of master, executed BPR and other relevant documents for regulatory sub- mission.
- Review and compliances of online BMRs, BPR’s, manufacturing process and SOPs.
- Implementation of GMP, quality systems and procedures during the manufacturing process.
Senior Executive
Strides Shasun Limited
Bangalore
12.2014 - 01.2018
- Implementation of GMP, quality systems and procedures during the manufacturing process.
- Sampling of In - process, finished product and validation samples.
- In - process tests, swab sampling, testing and documentation of IPQA activities.
- Line clearances of ongoing products for dispensing manufacturing & packing operations.
- Calibration and operation of IPQA instruments.
- Initiation and Investigation of deviation/incident.
- Raising, Logging, Evaluation and Closing of change control.
- Preparation and review of Validation Protocols and Reports.
- Preparation and review of Qualification Protocols.
- Preparation and checking of standard operating procedure.
- Responsible for the review of master, executed BPR and other relevant documents for regulatory sub- mission.
- Investigation of OOS.
- Review and compliances of online BMRs, BPR’s, manufacturing process and SOPs.
- Involvement in process validation activities and data compilation of finished product, stability and hold time study samples.
- Implementation of GMP, quality systems and procedures during the manufacturing process.
Quality Assurance Officer
Glenmark Pharmaceuticals Limited
Mapusa, India
06.2012 - 12.2014
- Implementation of GMP, quality systems and procedures during the manufacturing process.
- Sampling of In - process, finished product and validation samples.
- In - process tests, swab sampling, testing and documentation of IPQA activities.
- Line clearances of ongoing products for dispensing manufacturing & packing operations.
- Calibration and operation of IPQA instruments.
- Initiation and Investigation of deviation/incident.
- Preparation and review of Validation Protocols and Reports.
- Preparation and review of Qualification Protocols.
- Preparation and checking of standard operating procedure.
- Responsible for the review of master, executed BPR and other relevant documents for regulatory sub- mission.
- Raising, Logging, Evaluation and Closing of change control
- Implementation of GMP, quality systems and procedures during the manufacturing process.
Education
M.Pharm - Pharmaceutical Science
Narsee Monjee Institute of Management Studies(NMIMS
Mumbai 07.2010 - 05.2012
Post Graduate Executive Diploma - Food Quality Assurance and Quality Control
Institute of Good Manufacturing Practices (IGMPI)
New Delhi 07.2016 - 01.2017
B.Pharm - Pharmaceutical Sciences
Sree Siddaganga College of Pharmacy
Tumkur 09.2005 - 11.2009
A.I.S.S.C.E -
CBSE Board
Bokaro Steel City 04.2001 - 05.2003
A.I.S.S.E -
CBSE Board
Bokaro Steel City 04.2000 - 03.2001
Skills
Collaboration
Problem Solving
Productivity & organization
Effective communication
Time management
Adaptability
Leadership
Accomplishments
- Received GQS (Global Quality Stewardship) Award for Major Service transitions in 2021.
- Completed 12 Transitions in the year 2021.
- Implementation of Sintella Project at QSC.
- Implementation of CRM tool for various Supplier Quality Management activities.
- Qualified Trainer for Supplier Quality Management Team.
- Received Galaxy Team Award.
- Quality Service Centre India QRA Service SPOC.
- Best Employee Award at Glenmark Pharmaceutical Limited.
- 06 Appreciation Award at Strides Shasun Limited.
- Excellence Award for the Product Development at Biocon Pharma Limited.
Certification
Six Sigma Green Belt
Additional Information
- Presented Poster Presentation on India Pharma Convention, on “Compulsory Licensing: An Inevitable Chasm for Pharmaceutical Industry” at DIPSAR, New Delhi.
- Presented Poster Presentation on National Seminar on “Emerging Trends in Education and Research in Ayurveda” at Banaras Hindu University (BHU).
- Served as a secretary for student’s fortnightly wall magazine “Pharma Voice” for four years.
- Served as a secretary of the cultural committee for four years.
Declaration
I hereby certify that the information given in my Curriculum Vitae are correct and complete to the best of my knowledge.
Date: - 23 March 2022
Place: - Hyderabad
Timeline
Patent Law
03-2022
Evaluating Problems
02-2022
The Growth Mindset
02-2022
Supplier Management
02-2022
Six Sigma Green Belt
01-2022
Associate Manager
Novartis Healthcare Private Limited
09.2020 - Current
Six Sigma Green Belt
08-2020
Six Sigma Black belt
08-2020
Assistant Manager
Biocon Pharma Limited
01.2018 - 09.2020
Post Graduate Executive Diploma - Food Quality Assurance and Quality Control
Institute of Good Manufacturing Practices (IGMPI)
07.2016 - 01.2017
Senior Executive
Strides Shasun Limited
12.2014 - 01.2018
Quality Assurance Officer
Glenmark Pharmaceuticals Limited
06.2012 - 12.2014
M.Pharm - Pharmaceutical Science
Narsee Monjee Institute of Management Studies(NMIMS
07.2010 - 05.2012
B.Pharm - Pharmaceutical Sciences
Sree Siddaganga College of Pharmacy
09.2005 - 11.2009
A.I.S.S.C.E -
CBSE Board
04.2001 - 05.2003
A.I.S.S.E -
CBSE Board
04.2000 - 03.2001