Computer System Validation QA Manager
Computer System Validation QA Manager
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Job Description
Senior Manager CSV QA
Experience: 12 to 20 Years
Minimum Requirements
- Exposure to pharmacovigilance domain and drug safety applications Argus or ArisG/J Mandatory
- Experience with electronic QMS/DMS is a plus.
- Experience in Manual execution and ALM Tool based executions
- Experience with training coordination and management
- Worked in Agile / Scrum team structure
- Experience in SQL and PLSQL writing
- BE/ B.Tech./ MCA/ B.Pharma/ M.Pharma from recognized institute with good academic scores
- IT Quality Assurance professional with 10 years of experience with computerized system validation in Life Sciences industry
Essential Duties & Responsibilities
- Provide Software development Software implementation and Cloud validation expertise on GxP products for drug safety space.
- Be an SME in CSV practice and ensure best practices are followed consistently within the organization
- Facilitate adoption of CSV best practices into the organizations application services and Cloud management.
- Represent the organization to customer meetings/discussions and ensure confidence in our deliverables
- Hands on experience and be accountable in reviewing and supporting key CSV deliverables Requirement Specifications Validation Plan Test Plan Traceability Matrix Test Summary Report Risk Assessment Qualification Scripts Disaster Management BCP Internal Tool Validations Periodic Reviews and Validation Summary Report
- Lead in maintaining the organizations QMS towards best practices of GxP practices.
- Understanding of implementing projects on SaaS Models
- Coordinate with stakeholders and communicate effectively
- Interact with internal product owners and client users to understand business regulatory functional & nonfunctional requirements or improvements for software product. Review understand and ensure that the requirements are detailed unambiguous complete and testable.
- Lead mentor & guide the team members for all type of testing activities and artefacts including (but not limited to) system testing functional testing manual testing automation testing OQ PQ IQ etc.
- Review the work performed by the team members provide feedback to ensure adherence to the validation and documentation practices and be accountable for the quality of work products created by the team.
- Sound Defect management skills
- Well experienced in doing Root cause aligning to practices of 5 Why Analysis FishBone FMEA and other statistical techniques
- Provide adequate understanding and expertise on Change Control Procedure Deviation Handling Document Management and CAPA management
- Understanding of riskbased system validation approach and VModel
- Knowledge of GxP GDP GTP QA best practices
- In depth understanding of the regulatory guidelines for IT systems primarily FDA EMA MHRA and PMDA
- In depth understanding of 21 CFR Part 11 EU Annex 11 compliance
- Minimum 10 years experience of client internal and regulatory audits
- Anchor updates to QMS
- Engage in Continual Improvement programs
- Coordinates the revision review and approval of IT SOPs and other GxP documents
- Train resources
- Client engagement and ability to convince based on companys Best Practices
- Ability to manage Stakeholder needs and do multi tasking
- Oversee work of direct reports and crosstrain staff on different quality areas
- Interview hire train develop and manage employees
- Capacity planning and forecasting resource requirements
- Performance evaluation and appraisals
- Motivating agent for the team and fosters the spirit of teamwork
- Coach mentor and develop staff including overseeing new employee onboarding and providing career development planning and opportunities
- Closely work with clients project team and product owners to support product releases and implementations
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Employment Type
Full Time
