Sterile Injectables Regulatory Compliance Professional

6 days ago


Kollam, Kerala, India beBeeQualityCompliance Full time ₹ 15,00,000 - ₹ 25,00,000
Job Description:

We are seeking a highly skilled Quality Assurance Compliance Specialist to join our team. This is a senior role that requires significant experience in sterile injectable manufacturing processes, including aseptic techniques and validation methodologies.

The successful candidate will be responsible for preparing and reviewing QMS-related documents, reviewing and approving Change Control records, handling deviations, reviewing market complaint investigations, conducting remote compliance checks of controlled documents, managing vendor quality activities remotely, supporting internal and external audits, and monitoring QMS performance metrics.

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:

This role offers the opportunity to work with a highly experienced team and to contribute to the development of our company's quality management system. The ideal candidate will have a strong track record of delivering high-quality results in a fast-paced environment and will be passionate about continuous improvement.

Others:

A Bachelor's or Master's degree in Pharmacy, Biotechnology, Microbiology, or a related field is required for this position. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.



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