Manager It Qa & Csv Job in Rxlogix Corporation

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Essential Duties & Responsibilities:
Note: This opportunity is not a fit for the software testing professionals. The candidate must possess experience in the Pharmaceutical IT Compliance areas and CSV and a good understanding of regulations for LifeScience industries such as GAMP 5, CFR , EU Annex 11, ICH etc.
1. CSV:

• Provide application validation expertise on GxP products for drug safety space.
• Be accountable for reviewing and supporting key CSV deliverables Requirement Specifications, Validation Plan, Test Plan, Traceability Matrix, Test Summary Report, Qualification Scripts and Validation Summary Report
• Understanding of implementing projects on SaaS Models
• Understanding needs of Infrastructure , Operation and Performance qualification in alignment with Software Engineering Practices.
• Requirements Analysis and Risk Assessment, Profiling and Mitigation in collaboration with the SME
• Sound Defect management skills
• Provide adequate understanding and expertise on Change Control Procedure, Deviation Handling, Document Management and CAPA management
• Understanding of risk-based system validation approach and V-Model

• Knowledge of GxP, 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

• Client engagement and ability to convince based on RxLogix Best Practices
• Ability to manage Stakeholder needs and do multi tasking
• Oversee work of direct reports and cross-train 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

• Well-organized and detailed oriented professional, with strong verbal and written communication skills
• Self- motivated with ability to manage, organize and prioritize multiple tasks
• Should be able to achieve the optimum balance for Quality vs. Productivity

Minimum Requirements:
1. Exposure to pharmacovigilance domain and drug safety applications Argus or ArisG/J strong preference
2. Experience with electronic QMS/DMS is a plus.
3. Experience in Manual execution and ALM Tool based executions
4. Experience with training coordination and management
5. Worked in Agile / Scrum team structure
6. Experience in SQL and PLSQL writing