Sandeep Srivastava
Ahmedabad
Summary
Accomplished assistant QA manager with extensive experience in quality assurance and compliance auditing in the pharmaceutical sector. Expertise in risk assessment, document management, and trend analysis using advanced tools like SAP LIMS and TrackWise. Proven ability to enhance product quality through method validation and environmental monitoring while promoting continuous improvement. Skilled in leading teams with effective communication and leadership, dedicated to maintaining industry standards and driving operational excellence. Reliable Assistant QA Manager with strong background in quality assurance and team leadership. Consistently improves processes, enhances product quality, and ensures compliance with industry standards. Demonstrates solid problem-solving skills and proactive approach to identifying and rectifying issues. Brings collaborative spirit to motivate teams and drive continuous improvement. Quality assurance professional with experience in leading quality control processes and ensuring compliance with industry standards. Skilled in identifying defects, implementing corrective actions, and collaborating with cross-functional teams to enhance product quality. Committed to maintaining high safety and regulatory standards.
Overview
18
18
years of professional experience
Work History
Assistant QA Manager
Zydus Pfizer pvt. ltd.
Ahmedabad
12.2023 - Current
- Assisted in reviewing and updating quality assurance protocols to comply with industry standards.
- Supported product testing by measuring dimensions and evaluating functionality.
- Helped assess batch records to identify successes and areas for improvement in quality.
- Aided in managing documentation for audits, certifications, and inspections to ensure compliance.
- Participated in the preparation and review of the annual product quality report.
- Contributed to final batch release processes.
- Assisted with risk assessment reviews.
- Helped conduct trend reviews of microbiology and manufacturing.
- Supported study protocol and VSR reviews of microbiology.
- Reviewed BDIS and CWO documentation.
- Collaborated with cross-functional teams.
- Review of SOPs for microbiology and QA.
- Review of the contamination control strategy.
- Aseptic behaviour review in the manufacturing line.
Asst. Manager (Reviewer)
Zydus Cadila Healthcare Ltd
Ahmedabad, GUJ
01.2015 - 11.2023
- Supported review of environment monitoring reports.
- Assisted in the review of sterility and MLT reports.
- Aided in the preparation and review of method validation protocols.
- Conducted document reviews in compliance with regulatory requirements.
- Participated in SOP preparation using Documentum software.
- Managed QMS handling including deviations, OOS incidents, and change controls in TrackWise.
- Operated SAP LIMS software and CAPEX processes.
- Contributed to the preparation of compliance reports.
- Helped prepare for audits.
- Collaborated in trend preparation and review.
- Monitored staff performance and developed improvement plans.
- Trained new employees on company policies, customer service excellence, and sales techniques.
- Cultivated work environment focused on personal responsibility, continuous improvement and delivering high-quality results.
Executive
Claris Lifesciences
Ahmedabad, GUJ
01.2011 - 01.2015
- Assisted in monitoring environmental metrics to ensure compliance with standards.
- Supported micro validation processes involving HEPA filters and tunnel systems.
- Participated in media fill activities to maintain production quality.
Technical Supervisor
Zydus Cadila Healthcare
Ahmedabad, GUJ
01.2009 - 01.2011
- Assisted with observation of raw materials during dispensing.
- Supported batch release processes through sterility checks.
- Monitored eggs through pre-candling and post-candling observations.
- Conducted environment monitoring in designated areas.
Research Trainee
Dabur India Pvt. Ltd
Ghaziabad
04.2008 - 05.2008
- Project Title: Bioburden Recovery Validation Using Anti-Cancer Drug Leterozole.
Education
M.Sc. - Microbiology
Jiwaji Univ.
Gwalior01-2008
B.Sc. - Biotechnology
Jiwaji Univ.
Gwalior01-2006
HDCA -
Bhopal University
01-2002
Skills
- Quality assurance
- Risk assessment
- Document management
- Compliance auditing
- Trend analysis
- SAP LIMS
- TrackWise management
- Method validation
- Environmental monitoring
- Positive attitude
- Leadership skills
- Decision making
- Active listening
- Team Leadership
- Effective communication
- Quality standards awareness
- Risk Management
- Root cause analysis techniques
- Risk analysis
- Self-motivation
- Decision-Making proficiency
- Critical-thinking
- QA tools usage
Languages
Hindi
Proficient
C2
English
Advanced
C1
gujrati
Beginner
A1
Carrier Summary
- M.Sc. (Microbiology), 2008-01-01, Jiwaji University, Gwalior, Madhya Pradesh, India, First Division with 71%
- B.Sc. (Biotechnology), 2006-01-01, Jiwaji University, Gwalior, Madhya Pradesh, India, First Division with 62%
Hobbies and interests
- Watching Cricket
- Listening Music
- Travelling
- Making Food
proffessional Experience
-17th All India General Knowledge Competition Readers Research, Modern Institute (RRMI), Jaipur, Rajasthan, India, 1998-01-01, Second Division
-18th All India General Knowledge Competition Readers Research, Modern Institute (RRMI), Jaipur, Rajasthan, India, 1999-01-01, Second Division
-Attended National Level Seminar on 'Recent Trends in Biotechnology'
Timeline
Assistant QA Manager
Zydus Pfizer pvt. ltd.
12.2023 - Current
Asst. Manager (Reviewer)
Zydus Cadila Healthcare Ltd
01.2015 - 11.2023
Executive
Claris Lifesciences
01.2011 - 01.2015
Technical Supervisor
Zydus Cadila Healthcare
01.2009 - 01.2011
Research Trainee
Dabur India Pvt. Ltd
04.2008 - 05.2008
M.Sc. - Microbiology
Jiwaji Univ.
B.Sc. - Biotechnology
Jiwaji Univ.
HDCA -
Bhopal University