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T

CSV lead

tjjdnw3gpkwlpmq7qttmi8vox1rmzd09da8sjkc0z5wc5kgw7eewbu75l4yg3o0d · 30+ days ago

Hyderabad, TS, IN

Negotiable

Full-time

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Job Description:

location:- Hyderabad

13 – 14 years of work experience in the life science and IT service industry in various positions
CSV Lead responsible for Quality oversight and overall management of Computerized System Validations.
Experience in CSV, CSA, QA, QMS, Regulatory/Internal/Supplier Audits.
People Manager, A strategist with recognized proficiency in spearheading business to accomplish corporate plans and goals successfully and motivates high performance amongst team members
Business Software, Hardware, Firmware: ERP (ORACLE, SAP ECC, LIMS), Agile, Val Genesis, JIRA, Track Wise, eDMS, Lonza MODA-EM, cloud computing, Client, MES, BI Tool, Ample logic (QMS), RIM
SDLC Models: Waterfall Model, V-Model, Agile Methodology
Regulatory Exposure: USFDA (2011, 2014, 2015, 2016, 2017, 2018, 2019, 2020), WHO (2011, 2018, 2019), ANVISA (2012), TGA (2012) MHRA (2012) etc.
Regulations: 21 CFR Part 211, Annex/Part 11, ICH, FDA, WHO, EMA, predicate GLP, GCP, GMP rules.
CSV Deliverables: Validation Test Plan, URS, FS, DS, CS, Supplier assessment, Testing Review, Validation Test Summary Report, Traceability Matrix
QMS: Change Control, Impact assessment, Deviations, CAPA, Risk Management, Periodic Reviews
Auditing: Lead Auditor, Internal and External Auditor, Certified ISO 9001 and 27001 Lead Auditor
CSV, QMS, Audit and Compliance Subject Matter Expert (SME) in support of audits and regulatory inspections.
Project management experience for regulatory projects. (Greenfield, Brown field, Blue field Projects and Multi National Projects)
Executing high level quality and ISMS strategies, and overcoming complex business challenges using experience-backed judgment, strong work ethics, irreproachable integrity and guidance.

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Last updated on Aug 28, 2023

About the company

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