Senior Manager Quality Assurance

SANJAY KUMAR GHOSH

Senior Manager – Sterility Assurance / GMP Audit/

Aseptic Processing

Phone : 635-***-****

EmailID : ************@*****.***

Address :Allahabad, Uttar Pradesh

Date of Birth: 16-04-1984

Highly accomplished Quality Assurance and Microbiology professional with over 18 years of experience in the Pharmaceutical industry specializing in Microbiology, Sterility Assurance and Market Complaint seeks Senior Management role. Expertise in leading teams, ensuring GMP Audit and Compliance, cGMP/GDP compliance, and driving continuous improvement initiatives to contribute to a dynamic and challenging organization. Proven ability to manage complex investigations, implement corrective actions, and maintain the highest quality standards within a fast-paced manufacturing environment. Good experience in Bio-similar.

Professional Summary

Proven Quality Senior Manager with over 18 years of experience in the pharmaceutical industry, specializing in Microbiology /Sterility Assurance/Aseptic Process Validation/QMS/ Audit and Compliance

Successfully led teams of up to 15 direct reports and ensuring compliance with cGMP/GDP regulations, GMP Audit-Compliance and driving continuous improvement initiatives. Expertise in managing complex investigations, implementing corrective actions (CAPA), and ensuring adherence to stringent quality standards.

Strong understanding of Aseptic Process Validation, Cleaning Validation, Process Validation techniques, Contamination Recovery Rate and Market Complaint.

Proficient in conducting microbiological testing (BET, MLT, Sterility, DET), environmental monitoring, and data analysis.

Experienced in reviewing and approving validation protocols and reports, ensuring comprehensive documentation and compliance.

Adept at collaborating with cross-functional teams to investigate audit observations, identify root causes, and implement effective solutions.

Proven ability to manage multiple projects simultaneously while maintaining a strong focus on quality and efficiency

Excellent communication, interpersonal, and problem-solving skills, with a strong commitment to teamwork and collaboration.

Strong understanding of QMS systems, Change Control procedures, and Training Compliance requirements.

Career Timeline

Oct 2023 - Present

Senior Manager - Quality Control

Medivant Healthcare Chandler AZ

Jan 2018 - Sep 2023

Manager - Quality Assurance

Alembic Pharmaceutical Limited

Apr 2016 - Jan 2018

Asst. Manager- Quality Control Microbiology

Dr. Reddy's Laboratories Limited

Feb 2013 - Mar 2016

Senior Executive - Quality Control Microbiology

Aurobindo Pharmaceutical Limited

Aug 2009 - Jan 2013

Management Staff-Quality Control Microbiology

Cipla Ltd.

Oct 2007 - Jul 2009

QC Officer

ResSancta (Pharma Unit)

Aug 2006 - Sep 2007

Trainee Chemist

Bakson Drugs & Pharmaceuticals Pvt. Limited.

Technical Skills

Microbiology

Sterility Assurance

GMP Audit

IPQA

Aseptic Processing

Validation

Market Complaint

C R R

Investigation

Training and

Compliance

Soft Skills

Communication

Teamwork

Leadership

Problem-solving

Analytical Skills

Management

Organization

Adaptability

Continuous Improvement

Core Competencies

Quality Assurance & Compliance

Microbiological Testing & Analysis

Team Leadership & Management

Process Validation & Incident

Investigation & Corrective Action

& Sterility Assurance & Aseptic

Process Validation, Market

Complaint, Contamination

Recovery Rate (C R R), QMS

Education

M.Sc. (Microbiology)

Agricultural Institute- Deemed

University, Allahabad, Uttar Pradesh

2004 - 2006

B.Sc. (Botany, Chemistry and

Microbiology)

Govt. College of Arts & Science,

Aurangabad, Maharashtra

2000 - 2003

Languages

English

Bengali

Hindi

Hobbies

Traveling

Photography

Culinary Arts

Volunteer Work

2

4

Work Experience

Oct 2023 - Present

Senior Manager M i c r o b i o l o g y S M E

Medivant Healthcare Chandler AZ (Chandler Az (Remote)) Responsible for leading a team ensuring sterility assurance, and maintaining cGMP and GDP compliance. Played a key role in Deviation Investigations, Change Control, CAPA, and document review for Cleaning, Process Validation, and Aseptic Process Simulation. Led a team ensuring the sterility assurance of pharmaceutical products, strictly adhering to cGMP and GDP regulations. Oversaw the Microbiology Sample review and release process, guaranteeing adherence to established standards and procedures. Played a critical role as a core member of the Cross-Functional Team (CFT) for Deviation Investigations, conducting root cause analysis, and successfully implementing corrective and preventive actions (CAPA). Initiated and reviewed essential documentation for Change Control, CAPA, and Deviation Investigations, ensuring meticulous compliance and adherence to regulatory requirements.

Effectively managed the Cleaning and Process Validation Document Review processes, fostering seamless collaboration among team members and ensuring comprehensive execution of activities. Achievements:

Successfully led investigations for internal and external audit observations, Market Compaint, EM or water excursion as part of the Cross-Functional Team (CFT), developing and implementing robust corrective action plans to address identified gaps and enhance overall compliance. Jan 2018 - Sep 2023

Manager - Quality Assurance

Alembic Pharmaceutical Limited (Vadodara)

Responsible for the overall Manufacturing Assurance and Sterility Assurance of all manufacturing lines, leading a team of 8 direct reports. Ensured cGMP & GDP compliance, manufacturing & sterility assurance compliance, reviewed batch release activities and market Complaint. Acted as part of the cross- functional team for internal and external audits, initiating Change Control/CAPA and ensuring training compliance. Managed all aspects of Manufacturing Assurance and Sterility Assurance for all manufacturing lines, leading and mentoring a team of 8 direct reports.

Served as a key member of the Manufacturing Assurance and Sterility Assurance team for Formulation III, ensuring strict adherence to all applicable regulations and guidelines.

Maintained rigorous adherence to cGMP and GDP principles, guaranteeing the highest standards of product quality and safety throughout the manufacturing process.

Oversaw Batch Review and Release activities, meticulously verifying that all products met or exceeded stringent quality specifications. Reviewed and approved validation-related activities, including Aseptic Process Simulation (Media Fill) and Process Validation, ensuring adherence to established protocols and regulatory requirements. Collaborated effectively within cross-functional teams to thoroughly investigate observations from internal and external audits, proactively implementing corrective actions to address identified areas for improvement. Achievements:

Successfully initiated and managed Change Control and CAPA processes, driving continuous improvement initiatives within Manufacturing and Sterility Assurance processes to enhance overall operational efficiency and product quality. Apr 2016 - Jan 2018

Asst. Manager- Quality Control Microbiology

Dr. Reddy's Laboratories Limited (Visakhapatnam)

Responsible for leading the Microbiology Compliance Team, conducting incident investigations, and managing QMS activities including CAPA and Change Control. Conducted independent reviews of BET documents and laboratory compliance, ensuring adherence to established standards and training requirements.

Led the Microbiology Compliance team, ensuring adherence to all applicable regulations and guidelines within the pharmaceutical manufacturing environment.

Participated in incident investigations as part of the Site Investigation Team, effectively identifying root causes and implementing corrective actions to prevent recurrence.

Managed and executed key Quality Management System (QMS) activities, including CAPA and Change Control processes, driving continuous improvement initiatives within the Microbiology department. Conducted independent reviews of Bioburden Testing, BET documents and overall laboratory compliance, ensuring strict adherence to established standards and regulatory requirements. Achievements:

Successfully ensured compliance with training requirements for all Microbiology Laboratory personnel, enhancing their knowledge and skills in line with industry best practices.

Feb 2013 - Mar 2016

Senior Executive - Quality Control Microbiology

Aurobindo Pharmaceutical Limited (Hyderabad)

As part of the Microbiology team, responsible for analysis of raw materials, in-process and finished products, and stability samples for various microbiological tests, including MLT and PET. Conducted BET on products and water samples and performed environmental monitoring of the manufacturing lines.

Performed comprehensive analysis of raw materials, in-process and finished products, and stability samples for a variety of microbiological limit tests (MLT) and Preservative Efficacy Testing (PET) to ensure product quality and safety. Conducted Bioburden Testing and BET of products and water, adhering to established standards and procedures within the Quality Control laboratory.

Performed meticulous environmental monitoring of the manufacturing lines, ensuring sterility and compliance with regulatory requirements for aseptic processing.

Aug 2009 - Jan 2013

Management Staff-Quality Control Microbiology

Cipla Ltd. (Baddi)

Responsible for analyzing raw materials, in-process and finished products, and stability samples for various Microbiological Limit Tests. Performed a wide range of microbiological tests, maintained and validated microbial cultures, and conducted media validation. Demonstrated a proactive approach to process improvement by performing and completing Time Studies. As part of the Microbiology team, performed analysis of raw materials, in-process and finished products, and stability samples for various Microbiological Limit Tests, ensuring compliance with regulatory standards. Executed and performed a wide range of microbiological tests, including Water Analysis, Bioburden Testing, BET, Culture Dilution, Preservative Efficacy Testing (PET), Disinfectant Efficacy Testing (DET), Environmental Monitoring, Growth Promotion Testing (GPT), Culture Enrichment, Media Preparation, Ampoule Spore Count of Geobacillus stearothermophilus, Bioindicator (BI) Testing, and Surface Challenge Tests with disinfectants.

Maintained and validated microbial cultures, conducted validation of media, and implemented newly introduced methods within the laboratory setting, ensuring accuracy and reliability of testing procedures. Achievements:

Successfully optimized sampling procedures by performing Time Studies for swab samples, increasing accuracy of environmental monitoring processes.

Proactively identified and addressed potential areas for improvement by completing Time Studies evaluating media suitability for environmental monitoring and determining the optimal time interval between sanitization and environmental monitoring. Oct 2007 - Jul 2009

QC Officer

ResSancta (Pharma Unit) (Baddi)

Responsible for performing analysis of raw materials, in-process and finished products, and stability samples for various microbiological tests, including MLT and PET. Conducted BET on products and water samples and performed environmental monitoring of the manufacturing lines. Performed analysis of raw materials, in-process and finished products, and stability samples for various microbiological limit tests (MLT) and Preservative Efficacy Testing (PET), ensuring compliance with established quality standards. Conducted Bioburden Testing, BET on water and product samples, contributing to the overall quality control processes within the pharmaceutical manufacturing environment.

Performed environmental monitoring of the manufacturing lines to ensuresterility and adherence to regulatory requirements, guaranteeing a controlled and aseptic processing environment.

Aug 2006 - Sep 2007

Trainee Chemist

Bakson Drugs & Pharmaceuticals Pvt. Limited. (Parwanoo) As a Trainee Chemist, gained practical experience in pharmaceutical analysis by performing Microbiological Limit Tests, PET analysis, and BET on various samples. Performed Bioburden Testing (BET) on water and product samples and gained exposure to environmental monitoring procedures.

Gained practical experience in a pharmaceutical manufacturing setting, performing Microbiological Limit Tests, Preservative EficacyTesting (PET) analysis, and BET on raw materials, in-process and finished products, and stability samples. Conducted Bio-burden Testing,BET on water and product samples, contributing to the quality control processes and ensuring product integrity.

Gained exposure to environmental monitoring procedures within a pharmaceutical manufacturing setting, understanding the importance of maintaining a sterile and controlled processing environment. References:

1. Christine Anderson

Email ID: ******************@*****.***

Ph No.: +1-702-***-****

2. Rohit Sompura

Ph No.: +91-823*******

3. Rajesh Patel

Email ID:

*******************@*****.**.**

Ph No.: +1-602-***-****

Contact this candidate