Sambhaji Shelar
Aurangabad
Summary
Senior Manager Corporate Quality with a proven track record at Ajanta Pharma Limited, specializing in corporate quality assurance and regulatory compliance. Excelled in leading team efforts to enhance sterile, nonsterile, and API product quality, mastering multitasking and problem-solving.
Overview
16
16
years of professional experience
Work History
Senior Manager Corporate Quality Assurance
Ajanta Pharma Limited
Aurangabad
12.2017 - Current
- Led investigations of media fill failures, sterility failures, and sterile operation deviations.
- Managed the resolution of non-conformances within sterile operations.
- Conducted thorough reviews of smoke studies, HVAC qualifications, and autoclave tunnel and dry heat sterilizer qualifications.
- Led the investigation of microbial failures in the environment and performed personnel monitoring and bacterial endotoxin failures.
- Reviewed change controls to ensure compliance and effectiveness.
- Evaluated corrective and preventive actions for efficacy and implementation.
- Conducted effectiveness checks on corrective and preventive measures.
- Handling regulatory audits, maintaining adherence to corporate quality guidelines.
- Conducted comprehensive internal audits to ensure compliance with corporate quality standards.
- Executed vendor audits to assess and enhance supplier quality performance.
- Performed thorough audits on contract manufacturing and testing laboratories to maintain high standards of quality assurance.
- Managed the skip and reduced testing project, aiding regulatory affairs with necessary documentation.
- Prepared detailed risk assessment reports and developed effective risk mitigation strategies.
- Oversaw the handling of market complaints for sterile products and microbiology.
- Conducted gap identification, developed detailed analysis reports, and recommended suitable solutions.
- Conducted evaluations of 483s and warning letters to maintain adherence to compliance requirements.
- Developed and implemented Standard Operating Procedures (SOPs), specifications, study protocols, and reports.
- Led the qualification of HVACs, WFI, and purified water systems for new sterile facilities.
- Reviewed sterility method validations, microbial method validations, and disinfectant validations to ensure compliance with industry standards.
- Reviewed Media Fill Batch Manufacturing Records (BMR) to ensure compliance with quality standards.
- Evaluated smoke studies to identify potential contamination risks and improve environmental controls.
- Assessed environmental monitoring locations for optimal placement and effectiveness in maintaining cleanroom standards.
- Perform the unit operations to identify root causes and enhance operational parameters.
Executive
Emcure Pharmaceuticals
Kurkumbh, Pune
08.2016 - 12.2017
- Managed the investigation process for out-of-specifications, deviations, and non-conformance cases.
- Directed the execution of change controls and CAPAs, ensuring regulatory compliance.
- Performed qualification of water systems, HVACs, and Water for Injection systems to maintain regulatory compliance.
- Ensured microbiological compliance by rigorously monitoring and maintaining standards.
Management Staff
Cipla
Kurkumbh, Pune
11.2008 - 07.2016
- Conducted microbiological investigations to identify and resolve issues.
- Developed comprehensive risk assessments and formulated effective mitigation plans.
- Developed and prepared SOPs, method validation protocols, qualification protocols, study protocols, and reports.
- Executed autoclave and dry heat sterilizer validations to ensure compliance with industry standards.
- Conducted environment monitoring and water analysis to maintain optimal production conditions.
- Performed microbial analysis of raw materials, finished products, and APIs, including sterility assessments.
Education
Master of Science - Microbiology
Pune University
08-2008
Bachelor of Science - Microbiology
Pune University
07-2005
Skills
Lead the team
Multitasking
Problem-solving
Teamwork
Good communication skills, training skills, managerial skills, convincing skills, and presentation skills
Strong work ethic
Languages
Marathi
First Language
Hindi
Proficient (C2)
C2
English
Proficient (C2)
C2
Digital Literacy
- SAP
- Trackwise
- LIMS
- Microsoft Office
Timeline
Senior Manager Corporate Quality Assurance
Ajanta Pharma Limited
12.2017 - Current
Executive
Emcure Pharmaceuticals
08.2016 - 12.2017
Management Staff
Cipla
11.2008 - 07.2016
Master of Science - Microbiology
Pune University
Bachelor of Science - Microbiology
Pune University
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