Sterile Products Validation Manager

3 days ago


Alwar, Rajasthan, India beBeeAsepticProcess Full time ₹ 30,00,000 - ₹ 40,00,000
Job Title:

Aseptic Process Specialist

">Job Description:

We are seeking a highly skilled Aseptic Process Specialist to join our team. In this role, you will be responsible for ensuring the integrity of aseptic process controls throughout our manufacturing operations.

  • Develop and execute validation protocols to ensure aseptic process control equipment is functioning correctly.
  • Review and approve media fill study results to validate aseptic processing capabilities.
  • Collaborate with cross-functional teams to implement corrective actions based on environmental monitoring data.
  • Conduct Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for equipment and utilities.
  • Prepare and review cleaning validation protocols and reports to ensure adequacy and suitability for product changeover.
">Required Skills and Competencies:

To succeed in this role, you should possess:

  • Expert knowledge of 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.
  • Proficiency in QMS tools and software.
">Education and Qualifications:

You should hold a Bachelor's or Master's degree in Pharmacy, Biotechnology, Microbiology, or a related field.

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