Aseptic Process Integrity Specialist

6 days ago

Agra, Uttar Pradesh, India beBeeValidation Full time ₹ 15,00,000 - ₹ 20,00,000

Job Title: Validation Specialist

The Validation Specialist is responsible for preparing, reviewing, and approving validation protocols and reports for media fill studies, ensuring aseptic process integrity. This includes analyzing remote media fill results, identifying deficiencies, and recommending corrective or preventive actions.

Additional responsibilities include preparing and reviewing area qualification protocols and reports for classified manufacturing areas based on environmental monitoring and qualification data from the site.

The specialist will also prepare and review periodic requalification protocols, data, and environmental monitoring summaries for compliance with regulatory requirements.

Other key responsibilities include supporting and participating in equipment testing at vendor locations, ensuring test protocols are followed and results are documented.

Key Requirements:

  • 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 quality management systems tools and software.

Qualifications:

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

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