CSV Consultant

3 weeks ago

Pune, India Quantum Integrators Full time

Company Profile: Quantum Integrators is an international strategy and business consulting group whose mission is to help clients create and sustain competitive advantage. As a truly client-focused firm, our highly trained and experienced consultants consider it their mandate to help client organizations achieve a 'quantum state.


Role: CSV Consultant (Computer Systems Validation)

Location: Pune, Maharashtra (Onsite from Quantum Integrators Pune Office)

Duration: Fulltime with Quantum Integrators/Quanta Systems

***Shift Timing: USA EST (06.30 PM to 03.30 AM IST)


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. Your responsibilities will span from managing resources and teams to ensuring service delivery and adherence to regulatory requirements.


Required Skills and Experience:

  • In-depth knowledge of GXP and SDLC standards, including CGxP, CFR21 Part 11, 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 within the 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.
  • Excellent verbal and written communication skills, especially in compliance writing.
  • Certification in ITIL, GAMP5, Prince2, or relevant qualifications is preferred.
  • Experience in audit support and a proactive approach towards validation processes.
  • Ability to manage people and teams, resolve conflicts, and prioritize tasks based on identified risks.
  • Capability to identify process deviations, propose solutions, and implement corrective actions effectively.
  • Proficiency in coaching and mentoring team members to enhance performance and capabilities.


Key Responsibilities:

Service Portfolio Definition:

  • Define and maintain the service portfolio to align with client needs and regulatory standards.

Capacity Planning:

  • Assess resource requirements and plan capacity to meet project demands effectively.

Financial Management:

  • Monitor actuals, manage invoices, and follow up on purchase orders to ensure financial transparency and adherence to budget.

Service Delivery:

  • Ensure timely and quality delivery of services, both locally and globally, meeting predefined standards and requirements.

Operational Meetings:

  • Organize and facilitate operational meetings and tactical service performance boards to review and improve service delivery.

Project Management Support:

  • Assist in project intake, create work orders, and oversee resource allocation to support project needs.

Resource Management:

  • Onboard new resources and manage allocation to projects, ensuring optimal resource utilization.

Knowledge Management:

  • Foster a culture of continuous learning and upskilling within the team to meet evolving needs and maintain industry standards.

Client Satisfaction:

  • Act as the first point of contact for project managers, addressing concerns, and ensuring client satisfaction through regular feedback mechanisms.

Operational Planning:

  • Contribute to operational planning activities to ensure alignment with strategic objectives and efficient service delivery.

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