Amneal Pharmaceuticals
Deputy Manager, Application Development
- Compensation
- Not disclosed
- Location
- Ahmedabad City, Gujarat, India
- Work setup
- Onsite
- Seniority
- Not specified
- Employment
- Not specified
- Experience
- 8+ years
- Category
- Not specified
- Posted
Skills
Must have
- Minimum 8+ years of overall IT/CSV/SAP experience, preferably within pharmaceutical, biotechnology, medical device, healthcare, or other regulated industries.
- Strong hands-on experience in Computerized System Validation for SAP systems.
- Practical understanding of SAP implementation and application lifecycle activities.
- Experience supporting at least one full SAP implementation, upgrade, rollout, or major transformation program preferred.
- Good understanding of pharmaceutical GxP business processes and associated computerized-system controls.
- Working knowledge of applicable regulations and guidance, including: US FDA 21 CFR Part 11. EU GMP Annex 11. GAMP 5 principles and risk-based validation. Data Integrity / ALCOA+ principles. Applicable
- Experience preparing and reviewing validation lifecycle documentation.
- Hands-on experience with risk assessment, requirements management, traceability, testing, deviation management, and validation reporting.
- Good understanding of SAP configuration versus custom development and associated validation risks.
- Understanding of SAP interfaces, data migration, security, authorization, audit trails, and master-data controls.
- Experience with validation/document management tools such as ValGenesis, Kneat, OpenText, HP ALM, Jira, SAP Cloud ALM, Solution Manager, or equivalent is desirable.
- Ability to interpret technical and functional SAP documentation from a regulatory and quality perspective.
- Strong analytical and documentation skills with attention to accuracy, traceability, and compliance.
- Ability to work effectively with business, Quality Assurance, IT, SAP functional/technical teams, System Integrators, and external vendors.
- Good communication, stakeholder-management, and problem-solving skills.
- Ability to manage multiple validation deliverables and priorities within project timelines.
Full description
- Execute CSV activities for SAP implementation, enhancement, upgrade, integration, and support projects.
- Participate in validation planning and determine validation requirements based on system criticality, intended use, GxP impact, and risk.
- Support preparation, review, and approval of validation deliverables such as:
- Validation Plan / Master Validation Plan inputs.
- GxP and system impact assessments.
- Computerized System Risk Assessments.
- User Requirements Specifications (URS).
- Functional and Design Specifications, where applicable.
- Requirements Traceability Matrix (RTM).
- Test plans, test scripts, test protocols, and test evidence.
- Installation, Operational, and Performance Qualification documentation, where applicable.
- Validation Summary Reports.
- Standard Operating Procedures and Work Instructions.
- Review SAP business and functional requirements to ensure applicable GxP, quality, regulatory, and data integrity requirements are adequately addressed.
- Ensure requirements are clear, testable, traceable, and appropriately linked to business and regulatory risks.
- Support risk-based validation and testing strategies to avoid unnecessary testing while ensuring adequate control of GxP-critical functionality.
- Review SAP configuration, custom developments, workflows, reports, forms, interfaces, conversions, enhancements, and integrations from a CSV/GxP perspective.
- Participate in SAP testing activities including:
- Functional testing.
- System Integration Testing (SIT).
- User Acceptance Testing (UAT).
- Regression testing.
- GxP/validation testing.
- Review executed test evidence for completeness, accuracy, traceability, objective evidence, and compliance with validation procedures.
- Ensure test deviations, incidents, and defects are documented, investigated, resolved, and appropriately assessed for GxP impact.
- Support validation of SAP interfaces with external or third-party applications and ensure appropriate controls for data transfer, reconciliation, error handling, and audit trail.
- Assess and document data integrity controls including ALCOA+ principles, audit trails, electronic records, electronic signatures, access controls, and record retention.
- Support evaluation of SAP roles, authorization controls, segregation of duties, and privileged access where relevant to GxP processes.
- Participate in SAP data migration validation including source-to-target mapping, data verification, reconciliation, completeness, and accuracy checks.
- Support assessment and validation of SAP master data and transactional data impacting regulated business processes.