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Job Description
- Act as Functional SME for QA testing of regulatory submission and document management systems.
- Analyze business requirements and convert them into detailed functional test cases and test scenarios.
- Perform test case execution, defect identification, and validation of fixes.
- Support User Acceptance Testing (UAT) and ensure system functionality aligns with regulatory processes.
- Ensure testing activities comply with GxP and validation standards.
- Collaborate with Regulatory Affairs, IT, and QA teams during system implementations, upgrades, and releases.
- Maintain testing documentation including test plans, test scripts, traceability matrices, and defect logs.
- Support audit readiness and documentation reviews related to system validation.Required Qualifications:
- Bachelors or Masters degree in Pharmacy, Life Sciences, or related field.
- 5+ years of experience in QA, Regulatory Affairs, or regulatory submission support in the pharmaceutical industry.
- Experience with regulatory systems such as Veeva RIM, Documentum, or similar platforms.
- Strong knowledge of global regulatory submissions (eCTD lifecycle management).
- Understanding of GxP, validation, and data integrity principles.3 must havesFunctional Testing 4/5Pharma domain 4/5GxP 3/5
Skills
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About Company
Defective software can result in lost clients and users, fallen business processes, revenue impacts, security breaches or regulation violation. These risks grow as organizations increase their dependency on software. To mitigate these risks, testing and QA have become an essential part of the success of every software project. Unfortunately most testing and QA miss the critical business context, and instead just focus on the obvious technical risks. This approach does not take into account the bigger picture and does not look at the interrelationship between software testing and business risks.
Important dates & deadlines?
Application Deadline
29 May 26, 04:43 PM IST
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