Senior Manager CSV QA 2024HP120028yM1oQ12
Senior Manager CSV QA 2024HP120028yM1oQ12
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Job Description
Job Summary
Our Customer is looking for Senior Managers having 10 years IT experience.
Job Responsibilities
The candidate must possess experience in the GxP IT Compliance areas and CSV a good understanding of regulations for LifeScience industries such as GAMP 5 CFR EU Annex 11 ICH GDP GTP GDPPICs etc. Knowledge on Validation and Testing of Software Products is desired.
1. CSV:
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
2. Quality Assurance Operations:
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
3. Team and Stakeholder Management Skills:
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
4. Other Musthave skills:
Wellorganized 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
Essential Skills
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
Nice to Haves
Background Check required
No criminal record
Others
05% Travel expectations
Open to candidates who are originally from Noida and looking to relocate back.
Candidates from IT companies not form Pharma manufacturing companies will be highly preferred.
Employment Type
Full Time
