Compliance Quality Assurance Specialist

2 days ago

Salem, Tamil Nadu, India beBeeQuality Full time ₹ 90,00,000 - ₹ 1,20,00,000

We are seeking a Quality Assurance Compliance Specialist to ensure the quality and compliance of our sterile injectable products.

Key Responsibilities:
  • Prepare and Review Documents: Develop and review quality management system (QMS) related documents, including standard operating procedures (SOPs), work instructions, and templates for validation, qualification, and compliance processes.
  • Review Change Control Records: Assess the potential impact of changes on validation, process performance, and regulatory compliance by reviewing, approving, and trending change control records.
  • Manage Deviations: Handle deviations by reviewing deviation reports, assessing root cause analysis, recommending corrective/preventive actions, and ensuring timely closure in compliance with procedural requirements.
  • Review Deviation Trends: Identify recurrence patterns and systemic issues in deviations and prepare periodic deviation trend analysis reports for management.
  • Market Complaint Investigations: Review and approve market complaint investigations, ensuring thorough root cause identification, adequacy of corrective/preventive actions, and compliance with regulatory timelines.
  • Critical Quality Incidents: Review and approve investigation reports for out-of-specification (OOS), out-of-trend (OOT), and any critical quality incidents, ensuring accuracy, completeness, and regulatory compliance.
  • Remote Compliance Checks: Conduct remote compliance checks of controlled documents to ensure adherence to current Good Manufacturing Practice (cGMP), US FDA, and other applicable regulatory requirements.
  • Vendor Quality Activities: Manage vendor quality activities remotely, including review of vendor qualification/approval documentation, participation in vendor audits, and review of vendor audit reports.
  • Vendor Notifications: Handle vendor quality notifications and change notifications by reviewing the impact on processes, products, and regulatory compliance, and coordinating required actions with relevant departments.
  • Internal and External Audits: Support and participate in virtual internal and external audits, providing requested documentation, clarifications, and evidence.
  • Performance Metrics: Monitor and trend quality management system (QMS) performance metrics, such as change control closure rates, deviation frequency, CAPA on-time completion, and vendor performance metrics, and prepare quarterly quality performance reports for management.

Requirements:

  • Bachelor's or Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.
  • 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 quality management system (QMS) tools and software.

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