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Quality Assurance Specialist
3 weeks ago
Job Title: Quality Assurance Compliance Specialist
This is a highly specialized role that requires 10-15 years of experience in quality assurance and compliance. The ideal candidate will have in-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.
- Main 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.
Key Skills and Competencies:
- 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.
Education and Qualifications:
- Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.