Senior Validation Specialist

1 day ago

Alleppey, Kerala, India beBeeValidation Full time ₹ 30,00,000 - ₹ 40,00,000
Job Title: Senior Validation Specialist

Job Summary:

We are seeking a highly skilled Senior Validation Specialist to join our team. The ideal candidate will have in-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.

About the Role:

This is a challenging opportunity for a seasoned professional to take on a key responsibility in ensuring the quality and integrity of our products. As a Senior Validation Specialist, you will be responsible for preparing, reviewing, and approving validation protocols and reports for media fill studies, area qualification, and equipment qualifications.

You will work closely with cross-functional teams to ensure that all validation activities are completed efficiently and effectively. This includes analyzing remote media fill results, identifying deficiencies, and recommending corrective or preventive actions.

Responsibilities:

  • Develop and implement validation strategies to ensure compliance with cGMP and regulatory requirements.
  • Analyze data from media fill studies and environmental monitoring to identify trends and areas for improvement.
  • Prepare and review area qualification protocols and reports for classified manufacturing areas (Grade A–D).
  • Support and participate in Factory Acceptance Test (FAT) execution for equipment at vendor locations.
  • Maintain and update the Validation Master Plan (VMP) to ensure alignment with regulatory expectations and site needs.

Requirements:

  • Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.
  • At least 10-15 years of experience in sterile injectable manufacturing and validation.
  • 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.

What We Offer:

  • A competitive salary and benefits package.
  • The opportunity to work with a talented team of professionals in a dynamic and fast-paced environment.
  • A chance to develop your skills and expertise in a growing industry.

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