Job Summary (ISG)
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