Requirements :
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)