Job Title: Manager, IT QA & CSV

Introduction/Overview:
- The Manager, IT QA & CSV will be responsible for ensuring the validation and compliance of IT systems used in the pharmaceutical and life science industries.
- They will oversee application validation, GxP products, and drug safety, following CSV practices and best practices.

Roles & Responsibilities:
- Conduct application validation for GxP products and drug safety applications.
- Implement and maintain CSV practices and best practices.
- Work with the RxLogix team to ensure compliance with customer forums and deliverables.
- Review and support the creation of Requirement Specifications, Validation Plan, Test Plan, Traceability Matrix, Test Summary Report, Qualification Scripts, and Validation Summary Report.
- Familiarity with SaaS Models and validation of cloud-based systems.
- Collaborate with internal stakeholders, product owners, and client users to gather business requirements, functional requirements, and non-functional requirements.
- Identify and suggest software product improvements based on validation test plan, strategy, and requirement traceability matrix.
- Prepare and review validation test summary reports.
- Conduct system testing, functional testing, manual testing, and automation testing.
- Perform OQ (Operational Qualification), PQ (Performance Qualification), and IQ (Installation Qualification) activities.
- Review work performed by the team and provide feedback to ensure quality.
- Coordinate UAT (User Acceptance Testing) activities.
- Manage the QA team and conduct audits to ensure compliance.
- Ensure Infrastructure, Operation, and Performance qualification of IT systems.
- Apply Software Engineering Practices to ensure quality and compliance.
- Conduct requirements analysis and risk assessment.
- Manage defect management, change control procedures, deviation handling, and document management.
- Oversee CAPA (Corrective and Preventive Actions) management.
- Implement a risk-based system validation approach following the V-Model.

Years of Experience: 14 years

Education Qualification:
- Bachelor's degree in Engineering (BE/B.Tech.) or Master's degree in Computer Applications (MCA) or Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma).

Skills/Knowledge:
- Strong knowledge of GAMP 5, CFR (Code of Federal Regulations), EU Annex 11, ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), GDP (Good Distribution Practice), and GTP (Good Testing Practice).
- Familiarity with the pharmacovigilance domain and drug safety applications.
- Experience with electronic QMS (Quality Management Systems) and DMS (Document Management Systems).
- Proficient in manual execution and ALM (Application Lifecycle Management) Tool-based executions.
- Experience in training coordination.
- Familiarity with Agile/Scrum methodologies.
- Proficient in SQL and PLSQL.

Domain/Industry: Pharmaceutical IT Compliance, Life Science industries

Employment Type: Full Time

Company Overview: N/A

Benefits & Opportunities: N/A

Location & Travel: Noida, India