Sterile Injectable Manufacturing Compliance Specialist

6 days ago

Vellore, Tamil Nadu, India beBeeCompliance Full time ₹ 12,50,000 - ₹ 17,50,000
Quality Assurance Compliance ExpertAbout the Role:

We are seeking a highly skilled Quality Assurance Compliance Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements and maintaining a high level of quality in our sterile injectable manufacturing processes.

Key Responsibilities:
  • 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.
Requirements:
  • 10-15 years of experience in quality assurance and compliance.
  • 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.
  • Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.

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