Sterile Injectables Validator

5 days ago

Kota, Rajasthan, India beBeeValidation Full time ₹ 15,36,000 - ₹ 20,32,000
Senior Validation Specialist

This role is ideal for individuals with a strong background in sterile injectable manufacturing processes and aseptic techniques. The successful candidate will be responsible for developing, implementing, and maintaining validation protocols and reports to ensure compliance with regulatory requirements.

  • The Senior Validation Specialist will work closely with cross-functional teams to prepare, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for manufacturing equipment.
  • The individual will also be responsible for supporting and participating in Factory Acceptance Test (FAT) execution for equipment at vendor locations, ensuring test protocols are followed and results are documented.
  • Maintaining and updating the Validation Master Plan (VMP) will be an essential aspect of this role, ensuring alignment with regulatory expectations and site needs.

Key Responsibilities:

  • Preparation, review, and approval of validation protocols and reports for media fill studies.
  • Analysis of remote media fill results, identification of deficiencies, and recommendation of corrective or preventive actions.
  • Preparation and review of area qualification protocols and reports for classified manufacturing areas based on environmental monitoring and qualification data from the site.
  • Preparation and review of periodic requalification protocols, data, and environmental monitoring summaries for compliance with cGMP and regulatory requirements.

Required 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.
  • Proficiency in QMS tools and software.

Benefits:

  • Opportunity to work with a dynamic team.
  • Chance to develop expertise in validation methodologies and regulatory guidelines.
  • Professional growth and development opportunities.

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