YATENDRA PAL SINGH
HYDERABAD
Summary
Accomplished Senior Manager in Quality Control with 18 years of diverse experience across dosage forms, including injectable, complex injectable, OSD, oral liquids, and oncology products. Demonstrated expertise in regulatory compliance and leadership, successfully managing complex stability studies, while enhancing laboratory management systems. Proficient in cross-functional communication, and committed to driving quality improvements to ensure operational excellence and adherence to industry standards.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Senior Manager (Quality Control)
Natco Pharma Limited
Hyderabad (Telangana)
06.2024 - Current
- Managed compliance and GLP functions across multiple QC laboratories.
- Oversaw periodic calibration plans to maintain accuracy of laboratory tools.
- Ensured completion of preventive maintenance plan for laboratory instruments and equipment.
- Oversaw AMC, CMC, and TAP for laboratory instruments and equipment.
- Coordinated with cross-functional teams for installation and qualification of QC laboratory instruments.
- Conducted GXP assessments ensuring regulatory compliance for laboratory instruments computerized systems.
- Conducted monthly audit trail reviews for chromatographic systems, non-chromatographic systems, and laboratory standalone instruments.
- Oversaw execution of data backup audits for laboratory instruments on a quarterly basis.
- Managed laboratory standards across multiple QC laboratories.
- Ensured timely completion of periodic revisions for Laboratory standard operating procedures.
- Harmonized and implemented Laboratory standard operating procedures.
- Oversaw training management for QC personnel in various laboratories.
- Investigated, reviewed, and managed Laboratory QMS within the GLP team.
- Conducted and managed internal, external, and regulatory inspections.
- Managed inspection findings across internal, external, and regulatory audits.
Senior Manager (Quality Control)
Alembic Pharmaceutical Limited
Vadodara (Gujarat)
12.2019 - 06.2024
- Directed the Quality Control team across multiple sections, consisting of 70 members, under Head-QC guidance.
- Managed multiple stability studies, including exhibit, commercial and additional projects, using LIMS.
- Coordinated the charging and withdrawal of samples according to protocols with precision using LIMS.
- Directed completion of stability sample evaluations within designated timeframes.
- Oversaw the review process of analytical data compilation sheets in Stability studies.
- Collaborated with various departments to ensure effective execution of stability studies.
- Reviewed protocols for routine and additional stability studies.
- Prepared regulatory query responses for QC Lab, including DRL and CRL.
- Oversaw stability chambers maintenance.
- Investigated, reviewed, and managed the Laboratory QMS (Incident, OOS, OOT, LIR, etc.).
- Conducted and managed internal, external, and regulatory inspections.
- Managed inspection findings across internal, external, and regulatory audits.
Team Leader (Quality Control)
Mylan Laboratories Limited
Bangalore (Karnataka)
09.2015 - 11.2019
- Managed multiple stability studies, including exhibit, commercial and additional projects, using LIMS.
- Coordinated charging and withdrawal of stability samples in accordance with protocols within specified timelines using LIMS.
- Directed completion of stability sample evaluations within designated timeframes.
- Directed examination of analytical data and stability compilation sheets in Stability studies.
- Collaborated with various departments to ensure effective execution of stability studies.
- Reviewed protocols for routine and additional stability studies.
- Drafted comprehensive responses to regulatory queries regarding stability studies.
- Oversaw stability chambers maintenance.
- Investigated, reviewed, and managed the stability studies QMS (incident, OOS, OOT, etc.) In Trackwise, by applying various investigation tools.
- Conducted and managed internal, external, and regulatory inspections.
- Managed inspection findings across internal, external, and regulatory audits.
Assistant Manager (Quality Control)
Natco Pharma Limited
Dehradun (Uttarakhand)
01.2010 - 08.2015
- Coordinated daily work schedules and managed in-process, finished, and stability samples according to production and stability plans.
- Conducted analytical review of In-process, Finished product, Stability samples, Raw material and Packaging material within defined timelines.
- Prepared and reviewed SOP, Specification, Standard testing procedure, General testing procedure and Raw data sheet.
- Preparation and review of various laboratory protocols.
- Investigated, reviewed, and managed the Laboratory QMS.
- Conducted various validation studies, including process and cleaning validation.
- Conducted calibration of laboratory instruments.
- Conducted an analysis of in-process, finished product, stability samples, raw material, and packaging material samples.
- Conducted and managed internal, external, and regulatory inspections.
Executive (Quality Control)
Zeiss Pharmaceutical Pvt. Ltd.
Baddi (Himachal Pradesh)
05.2009 - 01.2010
- Conducted an analysis of in-process, finished product, stability samples, raw material, and packaging material samples.
- Conducted calibration of laboratory instruments.
- Performed various validation studies (process validation, cleaning validation, hold time study, etc.).
- Prepared SOPs, specifications, standard testing procedures, general testing procedures, and raw data sheets.
Executive (Quality Control)
Ind-Swift Limited
Baddi (Himachal Pradesh)
02.2008 - 02.2009
- Analysis of in-process, finished product, stability samples, raw material, and packaging material samples.
- Calibration of laboratory instruments.
- Analysis of various validation studies (process validation, cleaning validation, hold time study, etc.).
- Conducted sampling of raw materials and packaging components.
Chemist (Quality Control)
Acme Formulation Pvt. Ltd.
Baddi (Himachal Pradesh)
04.2007 - 02.2008
- Analysis of raw material and packaging material samples.
- Conducted sampling of raw materials and packaging components.
- Calibration of laboratory instruments.
Education
MBA - Project Leadership Management
Suresh Gyan Vihar University
Jaipur (Rajasthan), India09-2023
Master of Science - Chemistry
Beekay Institute of Management And Technology
Chandigarh,(Punjab),India06-2011
Bachelor of Science - Chemistry,Zoology,Botany
R S M College
Dhampur,(Bijnor),Uttar Pradesh06-2003
Skills
- Laboratory management
- Quality management system
- Team leadership
- Audit management
- Cross-functional communication
- Data-driven decision making
- Troubleshooting and problem resolution
- Documentation and reporting
- Quality control
- Team development
- Problem-solving abilities
- Good judgment
- Reliability
- Strategic planning
- Employee training
- Analytical techniques
- Regulatory compliance
Certification
- Certification for "Empower 3 Advanced Concepts" by Waters.
- Certification for "Experimental Testing to Established Root Cause Program" and recognized for demonstrating the knowledge, skills, and attitude of an effective leader by the "Mylan Laboratories Limited Global Quality Team".
Languages
Hindi
First Language
English
Upper Intermediate (B2)
B2
SOFTWARE
- LIMS (Labware)
- Track wise
- SAP
- Documentum & DCS
- HPLC Software's (Empower 3, Chromaleon & LC Solution)
- MS Office
AUDIT FACED
- US-FDA
- UK-MHRA
- AUSTRALIA-TGA
- BRAZIL- ANVISA
- GERMANY & Greece -EU
- WHO-Geneva
- SFDA
- WHO-GMP
- Many more clients audit
TRAINING
- Experimental testing to Establish Root cause
- Empower 3 Advanced Concepts
- Corrective and Preventive Actions
- Quality Management System
- Good Documentation Practice
- Good Laboratory Practice
- Safety Trainings
Timeline
Senior Manager (Quality Control)
Natco Pharma Limited
06.2024 - Current
Senior Manager (Quality Control)
Alembic Pharmaceutical Limited
12.2019 - 06.2024
Team Leader (Quality Control)
Mylan Laboratories Limited
09.2015 - 11.2019
Assistant Manager (Quality Control)
Natco Pharma Limited
01.2010 - 08.2015
Executive (Quality Control)
Zeiss Pharmaceutical Pvt. Ltd.
05.2009 - 01.2010
Executive (Quality Control)
Ind-Swift Limited
02.2008 - 02.2009
Chemist (Quality Control)
Acme Formulation Pvt. Ltd.
04.2007 - 02.2008
MBA - Project Leadership Management
Suresh Gyan Vihar University
Master of Science - Chemistry
Beekay Institute of Management And Technology
Bachelor of Science - Chemistry,Zoology,Botany
R S M College
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