Sterile Injectables Quality Compliance Manager

4 days ago

Anantapur, Andhra Pradesh, India beBeeQuality Full time ₹ 20,00,000 - ₹ 25,00,000
Quality Assurance Compliance Specialist

The Quality Assurance Compliance Specialist will be responsible for ensuring compliance with regulatory requirements and maintaining the highest standards of quality in the production of sterile injectables.

Responsibilities:
  • Document Control: Prepare and review QMS-related documents, including SOPs, work instructions, and templates for validation, qualification, and compliance processes.
  • Change Control Management: Review, approve, and trend Change Control (CC) records, assessing potential impact on validation, process performance, and regulatory compliance.
  • Deviation Management: 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, approve, and trend 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 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.
  • 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.
  • Audit Support: Support and participate in virtual internal and external audits, providing requested documentation, clarifications, and evidence.
  • QMS Performance Metrics: 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.
Requirements:
  • Bachelor's/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 QMS tools and software.

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