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Girish Kumar Vagvala

Sydney, New South Wales, Australia

Specialties: – Pharma IT, Regulatory & Quality
– Validation and Verification of Pharma Processes and applications.
– GAMP 5.0, 21CFR Part 11, GxP, ITIL V3, ISO 9001:2000.
– Process implementation, Process Consulting.
– Quality/Regulatory Auditing, Application Development & Support.

6 Sessions POC
12 Sessions POC

Industry:
Biotechnology
Cosmetics (also see Pharmaceuticals)
Information Technology (IT) & Services (incl Gaming, Programming & Development)
Pharmaceuticals (also see Cosmetics)
Technology (incl Biotechnology & Nanotechnology

Education: Masters in Science - Microbiology Bachelors in Science - Microbiology, Botany, Chemistry

Languages: English, Hindi

LinkedIN Profile: https://www.linkedin.com/in/girishvagvala/

Current Company: ANSTO

Current Position: CSV Specialist

Experience:
Experience Description: Please refer my Linkedin Profile. Experience includes: • CSV Specialist - ANSTO (Nov 2016 - Present) (Australia) • Manager / Senior Consultant CSV - Cognizant Technology Solutions (Nov 2014 - Jul 2016) (India) • Compliance & Validation Lead (ASPAC) - Johnson & Johnson (Feb 2012 - May 2014) (Singapore) • Computer System Validation Lead - Mahindra Satyam (Nov 2008 - Jan 2012) (India) • Functional Consultant - Pharma - Q-Cent Technologies (May 2007 - Nov 2008) (India) • Production cum Q.C Incharge - Ganga Enviro Systems (Jan 2006 - May 2007) (India) • Microbiologist - Kakatiya Enviro Engineers (May 2004 - Dec 2005) (India)

Contact Preferences:
Contact Telephone


Other Information:


Seasoned and competent Computer System Validation consultant with around 14 yrs of experience with balanced combination of technology, domain and leadership skills with proven track record of accomplishing objectives in-time.

He has almost 11 yrs of experience in IT as a CSV Consultant with core competencies in Quality Module applications for pharmaceutical industry. He has done Process analysis, design, functional testing, implementation, Validation and training of software solutions for Pharmaceutical industry. He was responsible to assist in legacy data organization to successfully Validate & Implement the Software solutions like LIMS, EBPR, CDM,SAP,Document Management, Learning management and Clinical Data Management Systems.

He has extensive 4+ years of experience with in Pharma/Life sciences/Biotech manufacturing units with diverse roles such as a Production cum QC In-charge, Microbiologist and Analyst in various departments of the industry.

He was internally trained on Quality standards, QMS, Validation life cycle, Reviews, Audits, Six Sigma and GXP etc., and under went certifications in Satyam certified ITIL V3, DEEP certification in Argus & Pharmacovigilance.

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