Abhishek Gupta
Joya
Summary
Accomplished Assistant Manager (AQA-Lead) at Unichem Laboratories Limited with 12+ years in pharmaceutical manufacturing. Internal auditor certified, adept at handling regulatory inspections like USFDA,ANVISA,ROW,MHRA and accreditation bodies.
Excelled in implementing QMS activities and training development, significantly enhancing data integrity and compliance. Proven leadership in demonstrating exceptional decision-making and people management skills.
Overview
13
13
years of professional experience
Work History
Assistant Manager (AQA-Lead)
Unichem Laboratories Limited
Ghaziabad
11.2019 - Current
- Company Overview: (US FDA Approved Organization)
- To monitor and ensure the compliance of quality control and GLP norms, and to train/retrain the personnel on the same, so that the quality control department is always ready for regulatory inspections.
- Responsible for reviewing the analytical method validation, analytical method transfer, and quality control laboratory.
- Responsible for the review and approval of stability study data/protocols, and ensure that stability studies are performed as per SOP and regulatory requirements.
- To review and approve the Standard Operating Procedure, Analytical Protocols, Stability Protocols, Qualification, and Validation Protocols and reports.
- Responsible for the approval and release of raw materials, packing materials, intermediates, bulk, and finished products is carried out as per the approved sampling/testing plan and by validated procedures.
- Handling of 11 team members.
- To continuously improve the existing systems and procedures in line with current requirements.
- Responsible for ensuring that adequate investigations are conducted for QMS activities, laboratory events, OOT results, OOS results, out-of-calibration issues, and stability failures, and ensuring that appropriate corrective and preventive actions are taken as per the prescribed procedures.
- Planned and delivered training sessions to reduce the laboratory events, OOT, and OOS.
- Coordinated with other departments to ensure smooth flow of operations.
- Implemented quality control measures to uphold company standards.
- Hands-on experience in electronic systems, like SAP and LIMS.
- Performing gap assessments, coordinating internal audits, and self-inspections, ensuring GLP compliance.
- Stability testing, including accelerated and long-term studies, is conducted to evaluate the quality and shelf life of pharmaceutical products.
- Ensure data integrity and reliability of the various analytical reports during the review.
Sr. Executive
Zydus Cadila
Baddi
08.2017 - 10.2019
- Company Overview: (USFDA Approved Organization)
- To review all analytical method validation/verification analytical raw data and cross verify with respective logs to ensure data reliability
- Review audit trails and electronic data of system wherever applicable
- To investigate Laboratory incident (Non Quality Impacting and Quality Impacting Incident), Out of Trends as per defined procedures
- To review AMV Protocol and AMV Report related to quality control testing
- Responsible for Tech Transfer activity through R&D to Quality Laboratory of new formulation
- To review finished product, Stability reports and cross verify with respective logs to ensure data reliability
- To maintain cGLP in the quality control department
- To co-ordinate with regulatory affairs personnel for filling of New ANDA Product
- To plan routine activities under consultations with respective section head.
Executive Quality Control Dept.
Amneal Pharmaceuticals Limited
Ahmedabad
09.2016 - 07.2017
- Company Overview: (USFDA Approved Organization)
- To perform Analytical Method Validation and Analytical Method Verification as per current guidelines and requirements
- Enrollment in analysis of products of Tech Transfer activity through R&D to Quality Laboratory of new formulation in OSD (oral solid dosage form)
- Effective implementation of SOPs across the Quality Control Department
- Analysis of Oral Solid Dosage products of various dosage forms like Tablets, Capsules containing various test parameters like Assay, Related Substances, and Content Uniformity.
Officer- Quality Control Dept.
LUPIN LIMITED
Indore
06.2015 - 07.2016
- Company Overview: (USFDA Approved Organization)
- Analysis of Finished goods, Stability, process validation sample of various Dosage form like MDI (metered dose inhaler) of various Test parameter like APSD (Aerodynamic Particle size
- Distribution), Spray Pattern View, DCTUTCL (Dose Content Uniformity through canister Life), Assay, DP (Degradation Product) and Related Substance Test
- Analysis of Derma and oral solid dosage products of various dosage forms like liquid, semi-solids, ointment of various test parameter like Tube content uniformity, Assay, Degradation Product
- Stability sample management Through Software
Officer- Quality Control
AKRON INDIA PRIVATE LIMITED
Poanta Sahib
09.2014 - 06.2015
- Company Overview: (US Based MNC)
- Analysis of Finished Products and Stability Samples
- Preparation & Maintenance of Working standards and Volumetric Solutions
- Preparation of Calibration schedule & to do calibration accordingly
- Analyst Qualification, its document and Training Records of individual analyst
- Review of log books and the Usage records of Standards
- Preparation and implementing Preventive maintenance schedules for instruments so as to increase equipment reliability
- (US Based MNC)
QC Officer
Maxcure (Subsidiary of Akums Drugs and Pharmaceuticals)
Haridwar
06.2012 - 09.2014
- Analysis of Finished Products and Stability Samples
- Preparation & Maintenance of Working standards and Volumetric Solutions
- Preparation of Calibration schedule & to do calibration accordingly
- Analyst Qualification, its document and Training Records of individual analyst
Education
Bachelor in Pharmacy -
I.F.T.M
Moradabad, UP01.2012
Intermediate -
KV
Ghaziabad01.2008
High School -
St. Mary convent
Gajraula01.2006
Skills
- GXP Internal
- Data Integrity and 21 CFR Part 11 Audits
- Review and Approval of SOPs
- Documentation Management
- QMS Activities
- Events/OOT/OOS/Deviation\OOC
- People management
- Laboratory management
- Decision making
- Handling and Approval of change control related to QC
- Stability data and stability protocol Approval
- Analytical Method Validation / AMT
- Regulatory
- Training and development
Soft Skills
- Fast Learner Lab
- Effective time managment
- Decision Maker
- Adaptability
- Anaytical Expert
Technical Software Handled
- Empower 3.0
- Lab solution
- SAP
- LIMS
- DMS
- QMS
Instrument Handled
HPLC - Shimadzu (Software: Labsolution)
Waters (Software: Empower 3.0)
UV/FTIR- Shimadzu (Software: Labsolution)
Dissolution Appratus (Make: Distek, Ecletro lab)
Karl Fisher Instrument (Make: Methrom)
GC : Perkin (Software: Empower 3.0)
PH Meter , Balance, Spray Pattern View
Languages
Hindi
First Language
English
Proficient (C2)
C2
Personal Information
- Father's Name: Pradeep Kumar Gupta
- Mother's Name: Savita Gupta
- Date of Birth: 09/14/89
- Marital Status: Married
- Spouse Name : Jyoti Agarwal
Timeline
Assistant Manager (AQA-Lead)
Unichem Laboratories Limited
11.2019 - Current
Sr. Executive
Zydus Cadila
08.2017 - 10.2019
Executive Quality Control Dept.
Amneal Pharmaceuticals Limited
09.2016 - 07.2017
Officer- Quality Control Dept.
LUPIN LIMITED
06.2015 - 07.2016
Officer- Quality Control
AKRON INDIA PRIVATE LIMITED
09.2014 - 06.2015
QC Officer
Maxcure (Subsidiary of Akums Drugs and Pharmaceuticals)
06.2012 - 09.2014
Bachelor in Pharmacy -
I.F.T.M
Intermediate -
KV
High School -
St. Mary convent
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