Job Description

• 3 - 7 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 end-to-end 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 11.

• Effective communication skills

• Effective and independent problem-solving skills

Education: Bachelor's degree in a science, engineering, or business discipline is requiredAbout Pharmatek Solutions:

• We started our journey in mid-2017 and are now spread across San Ramon, CA and Hyderabad, India.

• Currently we are partnered with 20+ emerging biotech, pharma, and cloud-based solution providers in US providing both On-site 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.

Job Type: Full-timePay: ?300,000.00 - ?1,000,000.00 per yearSchedule:

• Flexible shift
• Morning shift
• Rotational shift

Ability to commute/relocate:

• Hyderabad - 500084, Telangana: Reliably commute or planning to relocate before starting work (Required)

Experience:

• total work: 3 years (Preferred)