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Lab Validation Analyst

3 - 8 years

0 Lacs

Greater Kolkata Area

Posted:3 weeks ago| Platform: Linkedin logo

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Skills Required

testing lims communication writing documentation gcp test automation network model migration leadership compliance management traceability audits service agile development jira certifications software

Work Mode

On-site

Job Type

Full Time

Job Description

Job Summary We are seeking a skilled Analyst with 3 to 8 years of experience in Validation and Testing in Labware LIMS Labvantage LIMS GLIMS CDS and any Lab Systems. Responsibilities Experience/ exposure to Computerized System Validation (CSV) US FDA 21 CFR Part 11 EU Annex 11 and GAMP 5. Experience of CSV Validation in any one of the Lab systems (LIMS CDS SDMS etc) is must. Should worked in pharmaceutical domain and its related knowledge is must Good communication and technical writing skills are a must Developing validation documentation for pharmaceutical equipment facilities and computerized systems used in GLP GMP and GCP environments. Project Deliverables will encompass validation plans specifications test protocols and standard operation procedures and systems may include Process Automation Laboratory Automation Enterprise IT Applications and Network Infrastructure. CSV GAMP 5 CPFR Part 11 Validation Worked in V model SOP & SDLC Lifecycle To provide a planned approach for the implementation of the CSV deliverables migration due diligence GXP and Non GXP areas Provide guidance and leadership regarding Regulatory Compliance and Quality Management requirement. Prepare and execute SCA URS MVP VP RTM TP IQ OQ PQ VSR Traceability Matrix FRA / FEMA Exposure to Regulatory Audits The service will benefit if knowledgeable about and capable of advising on product & ingredient regulation within the industry (not mandatory). Using previous use cases and best practice counsel on highly regulated environments Ensure the CSV artefacts are in line and meets regulatory requirements Preferred Experience in Agile Development Knowledge on working in Jira / Service Now Certifications Required ISTQB Certified Tester Certified Software Quality Analyst (CSQA) Show more Show less

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Teaneck New Jersey

10001 Employees

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