Senior Validation Specialist

1 day ago

Tiruppur, Tamil Nadu, India beBeeValidation Full time ₹ 30,00,000 - ₹ 40,00,000
Job Description

We are seeking a highly skilled Quality Assurance Specialist for our Sterile Injectables team. The ideal candidate will have at least 10 years of experience in the field and be proficient in quality management systems and software.

Key Responsibilities:

  • Develop, review, and approve validation protocols and reports for media fill studies to ensure aseptic process integrity.
  • Analyze remote media fill results, identify areas for improvement, and recommend corrective or preventive actions.
  • Create 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.
  • Collaborate with cross-functional teams and participate in Factory Acceptance Test (FAT) execution for equipment at vendor locations, ensuring test protocols are followed and results are documented.
  • Develop and review utility qualification documentation, including HVAC, Water for Injection (WFI), and compressed air system validation.
  • Develop, review, and approve cleaning validation protocols and reports to ensure adequacy, compliance, and suitability for product changeover.
  • Develop, review, and approve process validation protocols, data, and reports to confirm process robustness and consistency in product quality.

Key Skills and Qualifications:

  • 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.

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