Trackwise
Pratik Savaliya
M.Pharm. | QA Professional | Injectables | QMS | Investigations | Certified Lead Auditor QMS (ISO 9001:2015) | Regulatory Market | Audit and Compliance
Ahmedabad
Summary
Experienced Quality Assurance professional with nearly 12 years of expertise in the regulated pharmaceutical industry.
Demonstrated proficiency in Investigations, change control, and CAPA management.
Adept at managing Quality Management Systems (QMS), overseeing batch release, and ensuring regulatory compliance.
Proven track record in leading teams and supporting successful audits.
Skilled in regulatory requirements for sterile manufacturing processes (injectables), in-process quality assurance, and batch release management.
Proficient in designing and executing process validation protocols.
Overview
12
12
years of professional experience
6
6
years of post-secondary education
1
1
Certification
Work History
Sr. Executive
Amneal Pharmaceuticals Private Limited
8 2021 - Current
Associate
Baxter Pharmaceuticals India Private Limited
2017.03 - 2021.08
Executive
Intas Pharmaceuticals Limited
2016.04 - 2017.03
Executive
Pfizer (Hospira Healthcare)
2015.04 - 2016.04
Sr. Officer
Unimark Remedies Limited
2014.01 - 2015.03
Jr. Executive
Lyka Labs Limited
2012.12 - 2013.12
Education
M.Pharm. (Pharmaceutics) -
Rajiv Gandhi University of Health Science
Belgaum, Karnataka 2010.04 - 2012.04
B. Pharm. -
Sant Gadge Baba Amravati University, Maharashtra
Yavatmal, Maharashtra 2006.04 - 2010.04
Skills
Investigations (Deviations, Market Complaints, EM excursions, OOS and OOT)
CAPA Management
Change Management
Process Validation-Design, Execution and compilation
In-process QA and Batch Release Management
MS Office, SAP and QMS Software (Trackwise 8, Caliber QAMS)
Regulatory Compliance and Requirements
Investigation Tools and Techniques
Strong Problem Solving, Communication and Critical thinking Skills
Audits
- USFDA: Led as 2nd line SME for batch release system at Pfizer (Hospira) and 1st line SME for investigations at Baxter. Played key roles in supporting and ensuring successful audits at Amneal.
- UK-MHRA, TGA, INVIMA: Played key roles in supporting and ensuring successful audits.
- Qualified Person-Europe : Supported audits and ensured compliance as 2nd line SME (Investigations) at Amneal.
Software
SAP
Caliber QAMS
MS Office
Certification
IRCA Certified Lead Auditor QMS (ISO 9001:2015)
References
- Mr. Vaibhav Taware, QA, Eugia Pharma (Aurobindo Pharma), Hyderabad, 9962297484
- Mr. Samar Doshi, QA, Amneal Pharmaceuticals, Ahmedabad, 9427675876
Timeline
Associate
Baxter Pharmaceuticals India Private Limited
2017.03 - 2021.08
Executive
Intas Pharmaceuticals Limited
2016.04 - 2017.03
Executive
Pfizer (Hospira Healthcare)
2015.04 - 2016.04
Sr. Officer
Unimark Remedies Limited
2014.01 - 2015.03
Jr. Executive
Lyka Labs Limited
2012.12 - 2013.12
M.Pharm. (Pharmaceutics) -
Rajiv Gandhi University of Health Science
2010.04 - 2012.04
B. Pharm. -
Sant Gadge Baba Amravati University, Maharashtra
2006.04 - 2010.04
Sr. Executive
Amneal Pharmaceuticals Private Limited
8 2021 - Current
IRCA Certified Lead Auditor QMS (ISO 9001:2015)
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