Lab Validation Analyst-ASAM Level
Lab Validation Analyst-ASAM Level
Posted on :
19-03-2025
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1 Vacancy
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Job Description
Lab Validation Analyst (Experience 6 Years)
- 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
Employment Type
Full Time
Key Skills
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