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Validation Tester
1 week ago
Time Zone:
- US Eastern Time Zone
Role Overview:
As a Validation Tester within our Managed Services model, you'll play a pivotal role in ensuring compliance and quality within our IT processes, particularly in the context of GxP and SDLC standards.
Key Responsibilities:
1)
Service Portfolio Definition:
Define and maintain the service portfolio to align with client needs and regulatory standards.2)
Capacity Planning:
Assess resource requirements and plan capacity to meet project demands effectively.3)
Financial Management:
Monitor actuals, manage invoices, and follow up on purchase orders to ensure financialtransparency and adherence to budget.4)
Service Delivery:
Ensure timely and quality delivery of services, both locally and globally, meeting-predefined-standards-and-requirements.5)
OperationaL Meetings:
Organize and facilitate operational meetings and tactical service performance boards to reviewand improve service delivery.6)
Project Management Support:
Assist in project intake, create work orders, and oversee resource allocation to support projectneeds.7)
Resource Management:
Onboard new resources and manage allocation to projects, ensuring optimal resourceutilization.8)
Knowledge Management:
Foster a culture of continuous learning and upskilling within the team to meet evolving needsand maintain industry standards.9)
Client Satisfaction:
Act as the first point of contact for project managers, addressing concerns, and ensuring clientsatisfaction through regular feedback mechanisms.10)
Operational Planning:
Contribute to operational planning activities to ensure alignment with strategic objectives andefficient service delivery.
Required Skills and Experience:
In-depth knowledge of GxP and SDLC standards, including cGxP, CFR21 Part 1 1, and ISO regulations.
Background in scientific (Pharma R&D) combined with IT understanding is highly desirable.
Proven experience in quality assurance, validation, or relevant domains withinthe life sciences industry.
Strong analytical and critical thinking skills, with attention to detail and investigative abilities.
Familiarity with Agile/Waterfall frameworks and project management methodologies.
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