
Pallavi Vijayakumar
Experience Quality and Compliance Specialist with a demonstrated history of working in the pharmaceutical and Biopharmaceutical industries. Strong... | Cork, County Cork, Ireland
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Pallavi Vijayakumar’s Emails pa****@gs****.com
Pallavi Vijayakumar’s Phone Numbers No phone number available.
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Pallavi Vijayakumar’s Location Cork, County Cork, Ireland
Pallavi Vijayakumar’s Expertise Experience Quality and Compliance Specialist with a demonstrated history of working in the pharmaceutical and Biopharmaceutical industries. Strong Biotechnology, Operational, Leadership and Management academics has helped in performing diverse roles across pharmaceutical and biopharmaceutical industries: • Worked as Quality Assurance and Compliance specialist in Solid dose, BDS and Sterile Injectables projects. • Worked as Data Integrity Lead, responsible for implementing the Site Data Integrity Strategy and leading projects in the areas of data management and data governance. • Worked as QA IT for IT systems (SAP), Manufacturing Control Systems (PLC, SCADA) and Analytical Systems. • Worked in compliance to EudraLex Vol 4, ICH Q10, ICH Q 9, ICH Q8, ISPE-GAMP, FDA, MHRA guidelines. • Skilled in Change Management, Deviation Management and CAPA Management • Involved conducting Self inspections, CAPA plans and support regulatory audits. • Review/approval of Validation documents-DQ/ IQ / OQ / PQ protocols for all major Pharma / Biopharma equipment systems. • Involved in preparation of SOPs, conduct trainings on quality documentations and DI • Experienced in Trackwise, Veeva Vault , CDMS tools .
Pallavi Vijayakumar’s Current Industry Leo Pharma
Pallavi
Vijayakumar’s Prior Industry
Sartorius Stedim Biotech
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Ivy Works
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Astrazeneca
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Gsk
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Process Engineering Specialists
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Ge Healthcare
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Leo Pharma
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Work Experience

Leo Pharma
Senior CSV Engineer
Wed Mar 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Ge Healthcare
QA Validation Lead
Tue Sep 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Mar 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Process Engineering Specialists
QA Validation Engineer and CQV Compliance Lead
Fri Jun 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Sep 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Gsk
Assistant Manager - Validation (CSV&Site Data Integrity Lead)
Tue Sep 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue May 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Astrazeneca
Quality Compliance and Security Consultant
Fri Aug 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Aug 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Ivy Works
Validation Engineer (CSV)
Tue Jan 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Aug 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
Sartorius Stedim Biotech
Project Engineer (Qualification and Validation)
Thu Apr 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Nov 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)