Computer System Validation - Hyderabad, India - Pharmatek Solutions

Description

• 9 years of relevant experience.
• Experience in drafting the OQ and PQ protocols/test cases against the FRS and URS.
• Experience in executing the OQ and PQ/UAT test cases.
• Experience in authoring the endtoend validation deliverables including but not limited to Validation Plan, User Requirements Specifications, Functional Requirements Specifications, Functional Risk Assessment, Part 11 Assessment, Traceability Matrix, and Validation Summary Report.
• Experience in Good Documentation Practices
• Good understanding of Computer System Validation(CSV) lifecycle.
• Knowledge of GAMP5 guidelines and categories.
• Knowledge of GxP best practices, and international standards for quality management throughout the CSV life cycle.
• Knowledge and 21 CFR Part 1
• Effective communication skills
• Effective and independent problemsolving skills

• We started our journey in mid2017 and are now spread across San Ramon, CA and Hyderabad, India.
• Currently we are partnered with 20+ emerging biotech, pharma, and cloudbased solution providers in US providing both Onsite and Managed Service capabilities in CSV, IT QA, GxP System Support, SQA Testing, Analytics domains.
• Pharmatek solutions also performs both internal and external audits, mock inspections, GAP assessments and Remediations.
• Pharmatek solutions provide Project Management support in GxP System Implementations, Core IT CSV, QA and Business SOPs.
• We cater Strong Infrastructure Qualification Expertise (both cloud and datacentres) and SQA testing capabilities supporting both manual, automation testing.

• Monday to Friday