Senior Validation Specialist

20 hours ago

Pune, Maharashtra, India Quantum Integrators Full time

Join Quantum Integrators, a Certified Minority Women owned Small Business Enterprise (MWBE, SBE), as a Senior Validation Specialist. We are seeking an experienced professional to lead our Managed Services model and ensure compliance and quality within our IT processes.

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 financial transparency 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 review and improve service delivery.
  6. Project Management Support: Assist in project intake, create work orders, and oversee resource allocation to support project needs.
  7. Resource Management: Onboard new resources and manage allocation to projects, ensuring optimal resource utilization.
  8. Knowledge Management: Foster a culture of continuous learning and upskilling within the team to meet evolving needs and maintain industry standards.
  9. Client Satisfaction: Act as the first point of contact for project managers, addressing concerns, and ensuring client satisfaction through regular feedback mechanisms.
  10. Operational Planning: Contribute to operational planning activities to ensure alignment with strategic objectives and efficient service delivery.
Required Skills and Experience:

We are looking for a candidate with in-depth knowledge of GxP and SDLC standards, including cGxP, CFR21 Part 11, and ISO regulations. A background in scientific (Pharma R&D) combined with IT understanding is highly desirable. The ideal candidate will have proven experience in quality assurance, validation, or relevant domains within the life sciences industry.

A strong analytical and critical thinking skills, with attention to detail and investigative abilities, are essential for this role. Familiarity with Agile/Waterfall frameworks and project management methodologies is also required. Excellent verbal and written communication skills, especially in compliance writing, are necessary to succeed in this position.

Certification in ITIL, GAMP5, Prince2, or relevant qualifications is preferred. Experience in audit support and a proactive approach towards validation processes is also desirable. Ability to manage people and teams, resolve conflicts, and prioritize tasks based on identified risks is crucial for this role.

The estimated salary for this position is $120,000 - $150,000 per annum, depending on location and experience.

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