Sikandar Jagirdar
Quality Assurance
Mumbai
Summary
A Quality Manager, R and D professional, having an extensive experience of 14 years in the field of Quality management system, 21 CFR part 11 and Clinical/Bioanalytical Application with an excellent knowledge of Global Regulatory Requirements and Guidelines to conduct BA/BE studies for NDA and ANDA submissions. Review of computer system validation data in compliance with 21 CFR part 11 and GxP regulations. Handling regulatory inspections. Authoring and review of SOPs, Protocols, Reports. Working knowledge of GCP, GLP, GAMP5 guidelines. Experience and knowledge of Good Documentation Practices. Review of study and validation reports as per eCTD format and Global Regulatory requirements. Review of laboratory data, IQ OQ PQ documents and electronic data including audit trails. Review of USR user specific requirement. Training employees. Strong communication and interpersonal skills to manage all cross-functional organization through inspiration and influence. Ensure laboratory work in compliance with Standard Operating Procedures, GCP/GLP/GDP/GxP, ALCOA+ and Regulatory guidelines. Ability to work independently as well as a team with a mindset of continues improvement and first time right approach, proactive and self-starter attitude.
Overview
13
13
years of professional experience
3
3
years of post-secondary education
1
1
Language
Work History
Assistant Manager-Quality Assurance
Raptim Research PVT LTD
6 2023
- Ensuring compliance of laboratory for GCP/GLP/GDP/GxP to achieve first time right approach
- Project planning for various projects to meet on time delivery of results
- Review raw data and electronic data of Method Validation and Subject sample analysis
- Facing regulatory Inspections US-FDA, UK-MHRA, ANVISA, DCGI etc as a Quality Manager
- Review of computer system validation (CSV) data in compliance with 21 CFR part 11 and regulatory requirements
- Review of user requirement specifications (URS)
- Providing responses to various national and global regulatory queries for effective compliance
- Retrospective review of raw data, reports and electronic records/data generated in lab
- Review of study protocols
- Handling/closure of deviation and CAPA and gap analysis
- Prepare and revise SOPs as per need and ensure implementation
- Review of final report for submission as per regulatory requirements
- To ensure timely calibration and maintenance of instruments/equipments
- Work with management to develop programs for ensuring continuous improvement of Quality Management Systems
- Handle/Coordinate with project management team for submission of projects
- To archive raw data, reports and other necessary documents.
Quality Reviewer- Research Scientist
Wockhardt Research Center
01.2010 - 05.2023
- Ensuring compliance of laboratory for GCP/GLP/GDP/GxP to achieve first time right approach
- Project planning for various projects to meet on time delivery of results
- Review raw data and electronic data of Method Validation and Subject sample analysis
- Facing regulatory Inspections US-FDA, UK-MHRA, ANVISA, DCGI etc as a Quality Manager
- Providing responses to various national and global regulatory queries for effective compliance
- Retrospective review of raw data, reports and electronic records/data generated in lab
- Review of study protocols
- Handling/closure of deviation and CAPA and gap analysis
- Prepare and revise SOPs as per need and ensure implementation
- Review of final report for submission as per regulatory requirements
- To ensure timely calibration and maintenance of instruments/equipments
- To impart technical training and to laboratory staff on current trends, white papers and updated guidance
- Work with management to develop programs for ensuring continuous improvement of Quality Management Systems
- Handle/Coordinate with project management team for submission of projects
- Maintain inventory management and documentation of API/analytical standards
- To archive raw data, reports and other necessary documents.
Education
Master of Pharmacy - Pharmaceutical Analysis
Rajiv Gandhi University of Health Sciences
Bengaluru, KarnatakaBachelor of Pharmacy -
Pune University (Savitribai Phule Pune University)
Pune, Maharashtra 04.2001 - 04.2004
Diploma of Pharmacy - undefined
Channabasveshwar College of Pharmacy
Latur, MaharashtraSkills
Good advanced knowledge of MS-Office with excellent processing skills of MS-WORD, MS-Excel and MS-Power point
Accomplishments
- Presented USFDA and MHRA inspections without any 483s/observation from regulatory agency.
- Merit Award: Ranked 1st and received merit award for outstanding performance in M.Pharm Pharmaceutical Analysis, in 2008 awarded by National College of Pharmacy, Shimoga.
Majorinspectionsfaced
- USFDA, 2013, Inspection
- USFDA, 2016, Unannounced Inspection
- USFDA, 2019, Inspection
- USFDA, 2019, Unannounced Inspection
- UK-MHRA (Europe), 2011, Inspection
- UK-MHRA (Europe), 2013, Inspection
- ANVISA (Brazil), 2021, Virtual Inspection
- WHO, 2024, Inspection
- GCC, 2024, Inspection
- DCGI, 2011, Inspection
- DCGI, 2013, Inspection
- DCGI, 2014, Inspection
- DCGI, 2016, Inspection
- DCGI, 2018, Inspection
- DCGI, 2019, Inspection
- DCGI, 2023, Inspection
Personal Information
- Father's Name: Farooq Jagirdar
- Date of Birth: 03/02/81
- Marital Status: Married
Affirmation
I hereby declare that the above-mentioned information is correct up to my knowledge and I bear the responsibility for the correctness of the above-mentioned particulars.
Yours Sincerely,
Sikandar Jagirdar
Timeline
Quality Reviewer- Research Scientist
Wockhardt Research Center
01.2010 - 05.2023
Bachelor of Pharmacy -
Pune University (Savitribai Phule Pune University)
04.2001 - 04.2004
Assistant Manager-Quality Assurance
Raptim Research PVT LTD
6 2023
Master of Pharmacy - Pharmaceutical Analysis
Rajiv Gandhi University of Health Sciences
Diploma of Pharmacy - undefined
Channabasveshwar College of Pharmacy
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