Senior Quality Assurance Compliance Specialist

5 days ago

Nellore, Andhra Pradesh, India beBeeRegulatory Full time ₹ 10,00,000 - ₹ 15,00,000
Key Responsibilities:

The Quality Assurance Compliance Specialist plays a pivotal role in ensuring regulatory compliance, quality system management and process improvements in sterile injectable manufacturing environments.

  • Document Management: Prepare and review QMS-related documents, including SOPs, work instructions and templates for validation, qualification and compliance processes.
  • Change Control: Review, approve and trend Change Control (CC) records, assessing potential impact on validation, process performance and regulatory compliance.
  • Deviations and Corrective Actions: 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.
  • Market Complaint Investigations: Review and approve market complaint investigations, ensuring thorough root cause identification, adequacy of corrective/preventive actions and compliance with regulatory timelines.
  • Investigation Reports: Review and approve investigation reports for OOS (Out-of-Specification), OOT (Out-of-Trend) and any critical quality incidents, ensuring accuracy, completeness and regulatory compliance.
  • Compliance Checks: Conduct remote compliance checks of controlled documents to ensure adherence to cGMP, US FDA and other applicable regulatory requirements.
  • Vendor Quality Management: Manage 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.
  • Audits and Performance Metrics: Support and participate in virtual internal and external audits, providing requested documentation, clarifications and evidence. Monitor and trend QMS performance metrics (e.g., CC closure rates, deviation frequency, CAPA on-time completion, vendor performance metrics).
Required Skills and Qualifications:
  • Domain Knowledge: In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.
  • Regulatory Expertise: Expertise in validation methodologies and regulatory guidelines.
  • Analytical and Problem-Solving Skills: Strong analytical and problem-solving skills.
  • Communication and Documentation Skills: Effective communication and documentation skills.
  • Leadership and Team Management: Ability to manage cross-functional teams and prioritize tasks.

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