Quality Assurance Expert

3 days ago

Meerut, Uttar Pradesh, India beBeeCompliance Full time ₹ 90,00,000 - ₹ 1,20,00,000

Job Overview:

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We are seeking a Quality Assurance Compliance Specialist to ensure compliance with regulatory requirements and maintain high standards of quality in our operations.

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  • ">
  • Prepare and review QMS-related documents, including SOPs, work instructions, and templates for validation, qualification, and compliance processes.">
  • Review, approve, and trend Change Control (CC) records, assessing potential impact on validation, process performance, and regulatory compliance.">
  • 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.">
  • Review, approve, and trend deviations for recurrence patterns and systemic issues; prepare periodic deviation trend analysis reports for management.">
  • Review and approve market complaint investigations, ensuring thorough root cause identification, adequacy of corrective/preventive actions, and compliance with regulatory timelines.">
  • 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.">
  • Conduct remote compliance checks of controlled documents to ensure adherence to cGMP, US FDA, and other applicable regulatory requirements.">
  • 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.">
  • Handle vendor quality notifications and change notifications by reviewing the impact on processes, products, and regulatory compliance, and coordinating required actions with relevant departments.">
  • 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) and prepare quarterly quality performance reports for management.">
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Key Responsibilities:

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  • ">
  • 1. Prepare and Review QMS Documents:">
  • 2. Manage Change Control Records:">
  • 3. Handle Deviations and Corrective Actions:">
  • 4. Investigate Market Complaints:">
  • 5. Conduct Remote Compliance Checks:">
  • 6. Manage Vendor Quality Activities:">
  • 7. Participate in Audits and Investigations:">
  • 8. Monitor QMS Performance Metrics:">
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Requirements:

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  • ">
  • A minimum of 10-15 years of experience in Quality Assurance">
  • Expertise in validation methodologies and regulatory guidelines (US FDA, cGMP etc.)">
  • In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques">
  • 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">
  • Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field">
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