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Lead Commissioning and Qualification Specialist

2 weeks ago


Pune, Maharashtra, India DD Enterprises Full time

Job Summary:

We are seeking an experienced Lead Commissioning and Qualification Specialist to join our team at DD Enterprises. In this role, you will be responsible for leading the commissioning and qualification process for systems and equipment at our clients' sites.

About the Role:

  • Regulatory Compliance Expertise: As a seasoned expert in regulatory compliance, you will ensure that all systems and equipment meet the required standards and protocols.
  • Commissioning and Qualification: You will lead the commissioning and qualification process, including site cost management and drive continuous improvement processes.
  • Team Management: With your excellent leadership skills, you will manage a team of resources, plan appraisals, provide training, and handle grievances.
  • Validation and Testing: You will oversee system and equipment validation, process validation, risk management, compliance testing, functional and performance testing, documentation, and change control.

Key Responsibilities:

  • Installation and Qualification: Carry out installation and qualification activities for systems and equipment.
  • Equipment Qualification: Ensure that all equipment meets the required standards and protocols.
  • Process Validation: Validate processes to ensure they meet the required standards and protocols.
  • OQ and CSV: Oversee overall qualification and computer system validation.

Requirements:

  • Education and Experience: A graduate degree in engineering, biotechnology, or a related field with 6-10 years of experience in commissioning and qualification.
  • Travel Requirements: Travel requirements are PAN India, with the need to visit client sites regularly.

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