Quality Assurance Compliance Specialist

QA-Compliance – Sterile Injectables

Experience Required:

Location:

Department:

No. of vacancy:

Key Responsibility:

• 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.