Validator Position

2 days ago


Anantapur, Andhra Pradesh, India beBeeQuality Full time ₹ 15,00,000 - ₹ 20,00,000
Job Title: Quality Assurance Specialist

We are seeking a highly experienced Quality Assurance Specialist with expertise in sterile injectable manufacturing processes and aseptic techniques. The ideal candidate will have a strong background in validation methodologies and regulatory guidelines.

The successful candidate will be responsible for preparing, reviewing, and approving validation protocols and reports for media fill studies, analyzing remote media fill results, and identifying deficiencies. Additionally, they will prepare and review area qualification protocols and reports for classified manufacturing areas based on environmental monitoring and qualification data from the site.

The selected individual will also prepare and review periodic requalification protocols, data, and environmental monitoring summaries for compliance with cGMP and regulatory requirements. They will support and participate in Factory Acceptance Test (FAT) execution for equipment at vendor locations, ensuring test protocols are followed and results are documented.

The Quality Assurance Specialist will maintain and update the Validation Master Plan (VMP), ensuring alignment with regulatory expectations and site needs. They will work closely with cross-functional teams to prioritize tasks and manage projects effectively.

  • Expertise in sterile injectable manufacturing processes and aseptic techniques.
  • Strong analytical and problem-solving skills.
  • Effective communication and documentation skills.
  • Ability to manage cross-functional teams and prioritize tasks.


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