Posted:2 weeks ago|
Platform:
On-site
Full Time
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 US FDA 21 CFR Part 11 EU Annex 11 and GAMP 5. Experience in testing and knowledge 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 specifications test protocols and standard operation procedures and systems may include Process Automation Laboratory Automation Enterprise IT Applications and Network Infrastructure. Prepare and execute TP IQ OQ PQ TSR Traceability Matrix FRA Exposure to Regulatory Audits Using previous use cases and best practice counsel on highly regulated environments Knowledge on working in Jira HP ALM or any automation testing tools Certifications Required Certified LIMS Administrator Labware LIMS Certification Labvantage LIMS Certification Show more Show less
Cognizant
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