Role & responsibilities

QC Documentation Management

1. Lead the development, review, and approval of all Quality Control (QC) documentation, including SOPs, specifications, test methods, and protocols.

2. Ensure all QC documentation adheres to regulatory guidelines (US FDA, EU GMP, ICH) and internal quality standards.

3. Oversee the lifecycle management of QC documents, including version control, archiving, and retrieval processes.

4. Implement and maintain robust documentation practices to ensure data integrity across all QC activities.

5. Prepare and present QC documentation during internal and external audits, demonstrating compliance and control.

Quality Management System (QMS) Implementation & Oversight

1. Contribute to the overall QMS framework, aligning QC processes with company-wide quality objectives.

2. Facilitate incident management processes within QC, ensuring proper documentation, investigation, and reporting.

3. Lead Corrective And Preventive Actions (CAPA) initiatives, including root cause analysis, action plan development, and effectiveness verification.





4. Manage and track all deviations, out-of-specification (OOS) results, and out-of-trend (OOT) events, ensuring timely investigation and resolution.

5. Drive the implementation and continuous improvement of Quality Management System (QMS) activities within the Quality Control department.

Compliance and Regulatory Affairs

1. Collaborate with regulatory affairs and quality assurance teams to ensure seamless integration of QC processes into global regulatory submissions.

2. Stay updated on evolving pharmaceutical regulations and industry best practices related to QC and QMS.

3. Address audit observations and implement effective corrective actions to maintain regulatory compliance.

4. Actively participate in audit preparation (Pharma) activities, including gathering documentation, preparing responses, and supporting audit walkthroughs.

5. Ensure all Quality Control operations comply wi

📌 Assistant Quality Control Manager (Visakhapatnam)
🏢 LYWO RECRUITMENT CONSULTING
📍 Visakhapatnam