Sterile Injectables Compliance Expert

1 week ago

Guntur, Andhra Pradesh, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 30,00,000
Job Description

We are seeking a skilled Sterile Injectables Compliance Expert to join our team. The ideal candidate will have in-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.

The role involves reviewing QMS-related documents, including SOPs, work instructions, and templates for validation, qualification, and compliance processes. You will also be responsible for reviewing and approving Change Control records, assessing potential impact on validation, process performance, and regulatory compliance.

In this position, you will handle deviations by reviewing deviation reports, assessing adequacy of root cause analysis, recommending corrective/preventive actions, and ensuring timely closure in compliance with procedural requirements.

You will review and approve market complaint investigations, ensuring thorough root cause identification, adequacy of corrective/preventive actions, and compliance with regulatory timelines.

Additionally, you will conduct remote compliance checks of controlled documents to ensure adherence to cGMP, US FDA, and other applicable 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

This is an excellent opportunity to join a dynamic team and contribute to the success of our organization. If you have the necessary skills and experience, we encourage you to apply for this challenging and rewarding role.

Please note that only candidates who meet the required qualifications and skills will be considered for this position.

Others

We are an equal opportunities employer and welcome applications from diverse candidates. If you require any assistance or accommodations during the recruitment process, please do not hesitate to contact us.

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