Quality Assurance Expert

6 days ago

Agra, Uttar Pradesh, India beBeeCompliance Full time ₹ 20,00,000 - ₹ 25,00,000

Job Title: Regulatory Compliance Specialist

 

We are seeking a highly skilled and experienced Regulatory Compliance Specialist to join our team. The ideal candidate will have a strong background in sterile injectable manufacturing processes, aseptic techniques, and regulatory guidelines.

 

The successful candidate will be responsible for:

  • Preparing and reviewing QMS-related documents, including SOPs, work instructions, and templates for validation, qualification, and compliance processes.

  • Reviewing, approving, and trending Change Control (CC) records, assessing potential impact on validation, process performance, and regulatory compliance.

  • Handling deviations by reviewing deviation reports, assessing adequacy of root cause analysis, recommending corrective/preventive actions, and ensuring timely closure in compliance with procedural requirements.

  • Reviewing, approving, and trending deviations for recurrence patterns and systemic issues; preparing periodic deviation trend analysis reports for management.

  • Reviewing and approving market complaint investigations, ensuring thorough root cause identification, adequacy of corrective/preventive actions, and compliance with regulatory timelines.

  • Reviewing and approving investigation reports for OOS (Out-of-Specification), OOT (Out-of-Trend), and any critical quality incidents, ensuring accuracy, completeness, and regulatory compliance.

  • Conducting remote compliance checks of controlled documents to ensure adherence to cGMP, US FDA, and other applicable regulatory requirements.

  • Managing vendor quality activities remotely, including review of vendor qualification/approval documentation, participation in vendor audits (virtual or on-site as required), and review of vendor audit reports.

  • Handling vendor quality notifications and change notifications by reviewing the impact on processes, products, and regulatory compliance, and coordinating required actions with relevant departments.

  • Supporting and participating in virtual internal and external audits, providing requested documentation, clarifications, and evidence.

  • Monitoring and trending QMS performance metrics (e.g., CC closure rates, deviation frequency, CAPA on-time completion, vendor performance metrics) and preparing quarterly quality performance reports for management.

 

Key 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.

 

Education and Qualifications:

  • Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.

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