Sterile Manufacturing Process Specialist

3 days ago


Delhi, Delhi, India Medivant Healthcare Full time

We are seeking a highly skilled Sterile Manufacturing Process Specialist to join our team at Medivant Healthcare. Our company is a pioneer in the pharmaceutical industry, providing high-quality products reliably, efficiently, and affordably for hospitals, healthcare providers, and their patients.

Maintaining regulatory compliance with cGMP and US FDA guidelines is crucial for our success. As a Sterile Manufacturing Process Specialist, you will be responsible for ensuring that our manufacturing processes meet these standards. This includes planning, executing, and reviewing media fill trials, area qualification, equipment qualification, utility qualification, and cleaning validation.

You will also be involved in quality management system activities such as change control, deviation management, CAPA implementation, and regulatory compliance. Additionally, you will participate in internal and external audits and inspections.

To succeed in this role, you must have in-depth knowledge of sterile injectable manufacturing processes and aseptic techniques. Strong analytical and problem-solving skills, effective communication and documentation skills, and proficiency in QMS tools and software are essential.



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