Functional QA (Pharma exp - Regulatory domain)Key Responsibilities:
- 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:
- Bachelor's or Master's 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
