Rahul Prakash Saini
Assistant Manager Corporate Quality Assurance
Gurgaon
Summary
Dynamic Assistant Manager in Quality Assurance with extensive experience in Quality Management Systems (QMS) and Vendor Audit Management, cultivated through a successful tenure at Sentiss. Proven track record of leading over 200 quality system audits, demonstrating exceptional interpersonal and leadership capabilities. Expertise in complaint management and execution of internal audit processes ensures strict compliance while driving continuous improvement in quality standards across the pharmaceutical and medical device industries. Committed to fostering a culture of quality and operational excellence aligned with organizational goals.
Overview
16
16
years of professional experience
Work History
Assistant Manager CQA
Sentiss Pharma
02.2021 - Current
- QMS Implementation and Monitoring.
- Enhanced compliance standards and quality metrics.
- Oversaw handling of deviation, investigation, CAPA, and change control.
- Performed comprehensive vendor audits for Raw material manufacturer and Suppliers including warehouse, Packaging materials and GMP Consumables.
- Managed approval process for artwork, print proofs, and shade cards.
- Handled complaints from customers and distribution channels effectively.
- Oversaw the development and assessment of standard operating protocols.
- Audits exposure, like Russian FDA, Ukraine FDA, Kazak FDA, Kirghizia FDA, Indian FDA, W.H.O., ISO 9001:2015, ISO 13485:2016, CE Audits, etc.
- Conducted internal audits to ensure compliance.
Sr. Executive Quality Assurance
Sentiss Pharma
11.2018 - 02.2021
- Oversaw shift operations as IPQA Shift In-charge.
- Team handling of 8 persons for I.P.Q.A and Batch Release activity.
- Directed aseptic operations.
- Executed thorough review of batch documentation.
- Maintained accurate records with comprehensive audit trails.
- Executed media fill operations to confirm contamination-free conditions.
Quality Assurance Executive
Avantor , Medical Devices
10.2017 - 11.2018
- Created and enforced quality assurance policies, procedures, and processes.
- Executed systematic reviews of manufacturing operations to uncover improvement areas.
- Engaged in CE certification audits serving as auditee.
- Participated in WHO audit for IVD in role of Auditee.
Lead Auditor
URS Certification Limited
09.2014 - 10.2017
- Performed over 200 quality system audits across pharmaceuticals, medical devices, government, and private sectors.
- Recognized NABCB Auditor specializing in pharmaceutical industry
- Managed teams to carry out audit programs and recognized opportunities for improvement.
- Carried out audits to ensure conformity with applicable regulations, laws, and standards.
- Lead Auditor for QMS Standards like ISO 9001:2015.
Executive - Solution Preparation Area
Hospira Pharmaceuticals Ltd.
05.2014 - 09.2014
- Drafted comprehensive SOPs for Solution Preparation tasks.
- Qualified manufacturing area, equipment, and holding vessels.
- Organized and managed training programs.
- Allocated tasks across shifts to optimize workflow.
Production Officer
Albert David ltd.
12.2010 - 05.2014
- Established and sustained production schedules to assure prompt distribution of items.
- Collaborated with various departments to address production challenges promptly.
- Supervised functions in Small Volume Parenteral department.
- Managed batch production and packaging processes.
- Executed batch processing in real-time environments and as well as in ERP.
Production Chemist
Eurolife Healthcare Pvt. Ltd
06.2009 - 12.2010
- Manufacturing of Parenteral (SVP & LVP): Sterile Area controlling by proper managing of cleaning, Area Monitoring, Fumigation, etc.
- Implemented checks to maintain quality throughout production.
- Executed detailed procedures for autoclave validation.
- Ensured adherence to quality standards during manufacturing processes.
Education
Bachelor Of Pharmacy - Pharmacy
Shree Gopichand College of Pharmacy
Baghpat05.2009
Diploma For GMP Auditors -
Insight Professional Management Academy
H.S.S.C.(12th) -
S.S.N. INTER COLLEGE, SHAMLI
01.2005
H.S.C.E.(10th) - undefined
S.D. NIC INTER COLLEGE
01.2003
Skills
Vendor Audits for RM,PM and GMP Consumables
Awards
Rajyapal Award in Scout & Guide
Personal Information
- Date of Birth: 01/09/88
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Timeline
Assistant Manager CQA
Sentiss Pharma
02.2021 - Current
Sr. Executive Quality Assurance
Sentiss Pharma
11.2018 - 02.2021
Quality Assurance Executive
Avantor , Medical Devices
10.2017 - 11.2018
Lead Auditor
URS Certification Limited
09.2014 - 10.2017
Executive - Solution Preparation Area
Hospira Pharmaceuticals Ltd.
05.2014 - 09.2014
Production Officer
Albert David ltd.
12.2010 - 05.2014
Production Chemist
Eurolife Healthcare Pvt. Ltd
06.2009 - 12.2010
H.S.C.E.(10th) - undefined
S.D. NIC INTER COLLEGE
Bachelor Of Pharmacy - Pharmacy
Shree Gopichand College of Pharmacy
Diploma For GMP Auditors -
Insight Professional Management Academy
H.S.S.C.(12th) -
S.S.N. INTER COLLEGE, SHAMLI
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