Quality Assurance Engineer

1 day ago

Gulbarga, Karnataka, India beBeeCqv Full time ₹ 45,00,000 - ₹ 75,00,000

Job Title: Senior CQV Trainer

Location: Remote

Employment type: Part-time

Overview of the Position

We seek an accomplished CQV engineer trainer with extensive experience in Commissioning, Qualification, and Validation activities across the pharmaceutical and medical device sectors.

This role involves preparation, execution, and lifecycle management of CQV documentation for new and existing facilities, utilities, systems, and equipment.

Key Responsibilities:

  • Lead and execute CQV activities for manufacturing equipment, utilities, and computerized systems in compliance with regulatory and industry standards.
  • Develop and review CQV documentation including URS, DQ, FAT, SAT, IQ, OQ, PQ, and risk assessments.
  • Manage and implement validation master plans and system impact assessments.
  • Collaborate with cross-functional teams to ensure seamless CQV integration into capital and remediation projects.
  • Conduct remote FAT/SAT support, data review, and validation strategy planning.
  • Support Data Integrity assessments and 21 CFR Part 11 compliance for computerized systems.
  • Ensure documentation complies with GAMP 5, FDA, EMA, and ISO 13485 requirements.
  • Oversee remote execution of validation test protocols, ensuring deviations are captured and resolved.
  • Drive continuous improvement and risk-based validation strategies in line with current industry best practices.

Requirements

Required Skills and Qualifications:

  • Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
  • 10+ years of hands-on CQV experience in the pharma and/or medical device industries.
  • Deep understanding of regulatory requirements (FDA, EU Annex 15, ICH Q8-10).
  • Expertise in GAMP 5, 21 CFR Part 11, and risk-based validation.
  • Experience working in remote project environments.
  • Proficient in using validation lifecycle software and document management systems.

Preferred Qualifications

Desirable Skills and Experience:

  • Experience with sterile manufacturing, biologics, cell/gene therapy, or combination products.
  • CQV experience in greenfield or brownfield capital projects.
  • Knowledge of Agile, Lean Six Sigma, or project management certifications.
  • Prior experience working with global, cross-cultural teams remotely.

Tools & Platforms

Software and Technologies:

  • Veeva Vault, ValGenesis, TrackWise, Kneat Gx
  • Microsoft Office Suite, MS Project, SharePoint
  • Remote collaboration tools (MS Teams, Zoom, Slack)

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