Senior Validation Specialist

5 days ago

Gandhinagar, Gujarat, India beBeeValidation Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Job Summary:

Ensure the quality of sterile injectable manufacturing processes through effective validation and compliance strategies.

Develop, implement, and maintain comprehensive validation programs to guarantee product integrity and regulatory adherence.

  • Design and execute validation protocols for equipment, systems, and processes to ensure aseptic process integrity.
  • Prepare and review area qualification reports for classified manufacturing areas (Grade A–D) based on environmental monitoring and qualification data from the site.
  • Analyze remote media fill results, identify deficiencies, and recommend corrective or preventive actions.
  • Prepare and review periodic requalification protocols, data, and environmental monitoring summaries for compliance with cGMP and regulatory requirements.
  • Develop and review 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.

Required Skills and Qualifications:

Key Responsibilities:

We are seeking an experienced Validation Specialist to join our team. The ideal candidate will have a strong background in validation methodologies, regulatory guidelines, and sterile injectable manufacturing processes.

  • 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.

Education and Qualifications:

The successful candidate will possess a Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or a related field.

About Us:

Our company is committed to providing a work environment that supports collaboration, innovation, and growth.

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