Sterile Injectables Compliance Manager

4 days ago

India beBeeRegulatory Full time ₹ 90,00,000 - ₹ 1,20,00,000
Job Overview

The Quality Assurance Compliance Specialist plays a crucial role in maintaining the quality and regulatory compliance of sterile injectable manufacturing processes.

  • Key Responsibilities:
  • Prepare, review, and update QMS-related documents, including SOPs, work instructions, and templates for validation, qualification, and compliance processes.
  • Review, approve, and analyze Change Control (CC) records to assess their potential impact on validation, process performance, and regulatory compliance.
  • Address deviations by reviewing deviation reports, assessing root cause analysis adequacy, recommending corrective/preventive actions, and ensuring timely closure in accordance with procedural requirements.
  • Review, approve, and analyze deviations for recurrence patterns and systemic issues; prepare periodic deviation trend analysis reports for management.
  • Examine and approve market complaint investigations to ensure 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 to ensure accuracy, completeness, and regulatory compliance.
  • Conduct remote compliance checks of controlled documents to verify 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 their 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 analyze 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.

Requirements:

  • 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.

What We Offer:

  • Competitive salary package.
  • Opportunities for professional growth and development.
  • Collaborative and dynamic work environment.

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