Senior Validation Expert

1 week ago

Delhi, Delhi, India beBeeValidation Full time ₹ 15,00,000 - ₹ 20,00,000

Job Overview:

We are seeking a highly skilled Validation Specialist to join our team. The ideal candidate will have extensive experience in validation methodologies and regulatory guidelines, as well as expertise in sterile injectable manufacturing processes and aseptic techniques.

The selected individual will be responsible for preparing, reviewing, and approving validation protocols and reports for media fill studies, ensuring aseptic process integrity.

  • Analyze remote media fill results, identify deficiencies, and recommend corrective or preventive actions.
  • Prepare and review area qualification protocols and reports for classified manufacturing areas (Grade A–D) based on environmental monitoring and qualification data from the site.
  • Prepare and review periodic requalification protocols, data, and environmental monitoring summaries for compliance with cGMP and regulatory requirements.
  • Prepare, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for manufacturing equipment.
  • Support and participate in Factory Acceptance Test (FAT) execution for equipment at vendor locations (onsite when required, otherwise through live remote connection), ensuring test protocols are followed and results are documented.
  • Prepare and review utility qualification documentation, including HVAC, Water for Injection (WFI), and compressed air system validation.
  • Prepare, review, and approve cleaning validation protocols and reports to ensure adequacy, compliance, and suitability for product changeover.
  • Prepare, review, and approve process validation protocols, data, and reports to confirm process robustness and consistency in product quality.
  • Maintain and update the Validation Master Plan (VMP), ensuring alignment with regulatory expectations and site needs

Key Requirements:

  • Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.

Skills and Competencies:

  • In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.
  • Expertise in validation methodologies and regulatory guidelines (US FDA, cGMP etc.).
  • Strong analytical and problem-solving skills.
  • Effective communication and documentation skills.
  • Ability to manage cross-functional teams and prioritize tasks.
  • Proficiency in QMS tools and software.

What We Offer:

  • Competitive salary and benefits package.

About Us:

We are a leading organization dedicated to delivering high-quality products and services. Our team is passionate about innovation, customer satisfaction, and continuous improvement.

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