Pharmaceutical Validation Expert

1 week ago

Solapur, Maharashtra, India beBeeValidation Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Job Summary

As a Validation Specialist, you will play a key role in ensuring the integrity of our sterile injectable manufacturing processes. You will be responsible for preparing, reviewing, and approving validation protocols and reports to ensure compliance with regulatory requirements.

The ideal candidate will have a strong background in pharmaceutical sciences, specifically in sterile injectable manufacturing and aseptic techniques. They will also possess excellent analytical and problem-solving skills, as well as effective communication and documentation skills.

Additionally, this position requires the ability to manage cross-functional teams and prioritize tasks. Proficiency in QMS tools and software is also essential.

Key Responsibilities
  • Prepare, review, and approve 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.
Requirements
  • Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.
  • In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.
  • Expertise in validation methodologies and regulatory guidelines.
  • 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.

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