Quality Assurance Compliance Professional

5 days ago

Cochin, Kerala, India beBeeCompliance Full time ₹ 20,14,784 - ₹ 25,59,849

Job Summary:

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  • We seek a Quality Assurance Compliance Specialist with extensive experience in sterile injectable manufacturing processes and aseptic techniques. The ideal candidate will possess strong analytical skills, effective communication abilities, and proficiency in QMS tools.
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Main Responsibilities:

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  1. ">
  2. Prepare, review, and trend documents related to QMS, including SOPs, work instructions, and templates for validation, qualification, and compliance processes.">
  3. Review, approve, and assess Change Control (CC) records for potential impact on validation, process performance, and regulatory compliance.">
  4. Investigate deviations by reviewing deviation reports, assessing root cause analysis, recommending corrective/preventive actions, and ensuring timely closure in compliance with procedural requirements.">
  5. Review and approve market complaint investigations, ensuring thorough root cause identification, adequacy of corrective/preventive actions, and compliance with regulatory timelines.">
  6. Conduct remote compliance checks of controlled documents to ensure adherence to cGMP, US FDA, and other applicable regulatory requirements.">
  7. Manage vendor quality activities remotely, including review of vendor qualification/approval documentation, participation in vendor audits, and review of vendor audit reports.">
  8. Support and participate in virtual internal and external audits, providing requested documentation, clarifications, and evidence.">
  9. Trend QMS performance metrics (e.g., CC closure rates, deviation frequency, CAPA on-time completion, vendor performance metrics) and prepare quarterly quality performance reports.">
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Required Skills and Competencies:

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  • ">
  • 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.">
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Education and Qualifications:

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