Senior Pharmaceutical Operations Specialist

2 weeks ago

Palakkad, Kerala, India beBeeValidation Full time ₹ 50,00,000 - ₹ 65,00,000

Job Title: Senior CQV Trainer

We are seeking a highly experienced engineer with over 10 years of proven expertise in Commissioning, Qualification, and Validation activities across the pharmaceutical and medical device sectors.

The ideal candidate will support global projects remotely, ensuring compliance with regulatory requirements including GxP standards. This role involves the preparation, execution, and lifecycle management of documentation for new and existing facilities, utilities, systems, and equipment.

Key Responsibilities:

  • Lead and execute validation activities for manufacturing equipment, utilities (e.g., HVAC, WFI, clean steam), and computerized systems in compliance with regulatory and industry standards.
  • Develop and review validation documentation including URS, DQ, FAT, SAT, IQ, OQ, PQ, and risk assessments (e.g., FMEA).
  • Manage and implement validation master plans (VMP) and system impact assessments.
  • Collaborate with cross-functional teams to ensure seamless integration into capital and remediation projects.
  • Conduct remote data review, validation strategy planning, and support Data Integrity assessments.
  • Ensure documentation complies with GAMP 5, FDA, EMA, and ISO 13485 requirements.
  • Oversee remote execution of test protocols, ensuring deviations are captured and resolved.
  • Drive continuous improvement and risk-based strategies in line with current industry best practices.
  • Mentor junior engineers and act as a subject matter expert (SME) in audits and inspections.

Required Skills and Qualifications:

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

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