Analysts

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

Industries: Consumer Services, Information Services, Outsourcing/Offshoring