Job Title: Manager – IT QA & CSV

Keywords: Manager, IT QA, CSV

Roles & Responsibilities:

1. Application Validation Expertise: Possess in-depth knowledge and expertise in validating GxP products in the drug safety space.
2. Subject Matter Expert (SME): Act as a subject matter expert in CSV practices and best practices.
3. RxLogix: Familiarity with the RxLogix platform and its functionalities.
4. Customer Forums: Participate in customer forums to understand their requirements and provide necessary support.
5. Deliverables: Review and support the creation of various CSV deliverables such as Requirement Specifications, Validation Plan, Test Plan, Traceability Matrix, Test Summary Report, Qualification Scripts, and Validation Summary Report.
6. SaaS Models: Understand and validate software products based on SaaS models.
7. Communication: Effectively communicate with internal stakeholders, including product owners, client users, and business teams, to gather and understand requirements.
8. Requirements Review: Conduct thorough reviews of business requirements, functional requirements, and non-functional requirements to ensure software product improvements.
9. Validation Test Plan and Strategy: Develop and execute a comprehensive validation test plan and strategy.
10. System Testing: Perform system testing, functional testing, manual testing, and automation testing.
11. Qualification: Execute OQ (Operational Qualification), PQ (Performance Qualification), and IQ (Installation Qualification) activities.
12. Work Review: Review the work of the QA team to ensure adherence to quality assurance, validation, and documentation practices.
13. Quality Testing: Conduct quality testing to ensure the release of high-quality product features.
14. Product Testing Documents: Create and maintain validation and UAT (User Acceptance Testing) documents.
15. Client Product Implementation Projects: Support client product implementation projects by providing QA expertise.
16. Audits: Participate in audits, including Infrastructure, Operation, and Performance qualification audits.
17. Software Engineering Practices: Apply best software engineering practices to ensure quality and compliance.
18. Requirements Analysis: Analyze requirements and perform risk assessments to identify potential issues.
19. Defect Management: Implement effective defect management processes.
20. Change Control Procedure: Follow the Change Control Procedure to manage changes in the system.
21. Deviation Handling: Handle deviations from standard procedures and ensure appropriate documentation.
22. Document Management: Manage documentation related to validation activities.
23. CAPA Management: Implement and manage Corrective and Preventive Action (CAPA) plans.
24. Risk-Based System Validation Approach: Implement a risk-based approach to system validation.
25. V-Model: Apply the V-Model methodology for validation activities.
26. GxP, GDP, GTP: Ensure compliance with GxP, GDP, and GTP regulations.
27. QA Best Practices: Implement and adhere to QA best practices.
28. Regulatory Guidelines: Stay updated with regulatory guidelines, including FDA, EMA, MHRA, and PMDA regulations.
29. 21 CFR Part 11, EU Annex 11 Compliance: Ensure compliance with 21 CFR Part 11 and EU Annex 11 requirements.
30. Client Audits: Support client audits and ensure compliance with their requirements.
31. QMS: Implement and maintain a Quality Management System (QMS).
32. Continual Improvement Programs: Drive continual improvement programs within the QA team.
33. IT SOPs: Develop and maintain IT Standard Operating Procedures (SOPs).
34. Training: Coordinate and manage training programs for the QA team.
35. Client Engagement: Engage with clients to understand their needs and provide necessary support.
36. Stakeholder Management: Effectively manage stakeholders and ensure their satisfaction.
37. Multi-Tasking: Handle multiple tasks and projects simultaneously.
38. Team Management: Manage and lead the QA team.
39. Performance Evaluation: Conduct performance evaluations for team members.
40. Employee Development: Identify and provide opportunities for employee development.
41. Capacity Planning and Forecasting: Plan and forecast resource capacity for QA activities.
42. Client Support: Provide support to clients during product releases and implementations.
43. Organization Skills: Demonstrate strong organizational skills to manage multiple tasks and deadlines.
44. Communication Skills: Possess excellent communication skills to effectively interact with stakeholders.
45. Self-Motivation: Be self-motivated and proactive in driving quality initiatives.
46. Prioritization: Prioritize tasks and activities based on business needs.
47. Quality vs. Productivity: Maintain a balance between quality and productivity.

Years of Experience: 14 Years

Education Qualification: BE/ B.Tech./ MCA/ B.Pharma/ M.Pharma

Skills/Knowledge:

1. CSV: Strong knowledge and experience in Computer System Validation (CSV).
2. GxP: Familiarity with GxP regulations and compliance requirements.
3. SaaS Models: Understanding of software products based on SaaS models.
4. Requirements Analysis: Proficient in requirements analysis and gathering.
5. Risk Assessment: Ability to perform risk assessments and identify potential issues.
6. Defect Management: Experience in managing defects and implementing effective defect management processes.
7. Change Control Procedure: Knowledge of Change Control Procedure and its implementation.
8. Deviation Handling: Familiarity with handling deviations from standard procedures and ensuring appropriate documentation.
9. Document Management: Experience in managing documentation related to validation activities.
10. CAPA Management: Knowledge of Corrective and Preventive Action (CAPA) management.
11. Risk-Based System Validation Approach: Understanding and application of risk-based system validation approach.
12. V-Model: Proficiency in using the V-Model methodology for validation activities.
13. GxP, GDP, GTP: Understanding and compliance with GxP, GDP, and GTP regulations.
14. QA Best Practices: Knowledge and implementation of QA best practices.
15. Regulatory Guidelines: Familiarity with regulatory guidelines, including FDA, EMA, MHRA, and PMDA regulations.
16. 21 CFR Part 11, EU Annex 11 Compliance: Understanding and compliance with 21 CFR Part 11 and EU Annex 11 requirements.
17. Client Audits: Experience in supporting client audits and ensuring compliance with their requirements.
18. QMS: Knowledge and implementation of Quality Management System (QMS).
19. Continual Improvement Programs: Experience in driving continual improvement programs within the QA team.
20. IT SOPs: Proficiency in developing and maintaining IT Standard Operating Procedures (SOPs).
21. Pharmacovigilance Domain: Familiarity with the pharmacovigilance domain and drug safety applications.
22. Drug Safety Applications: Experience in validating drug safety applications such as Argus and ArisG/J.
23. Electronic QMS/DMS: Knowledge of electronic Quality Management System (QMS) and Document Management System (DMS).
24. Manual Execution: Proficiency in manual execution of test cases.
25. ALM Tool Based Executions: Experience in executing test cases using Application Lifecycle Management (ALM) tools.
26. Training Coordination and Management: Ability to coordinate and manage training programs.
27. Agile, Scrum Team Structure: Familiarity with Agile methodologies and Scrum team structure.
28. SQL, PLSQL Writing: Proficiency in writing SQL and PLSQL queries.

Domain/Industry: Pharmaceutical IT Compliance, Life Science industries

Employment Type: Full Time

Location & Travel: Noida, India