Location: Visakhapatnam (Vizag)

We seek a highly experienced Senior Executive/Assistant Manager - Quality Control Documentation & QMS to lead our critical QC Documentation Management and Quality Management System (QMS) initiatives at Synnat Pharma. If you have 10 to 12 years in Pharmaceutical Quality Control, a strong grasp of US FDA Regulations, EU GMP, and ICH Guidelines, and a passion for ensuring Data Integrity, this role is for you.

Roles & 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 with US FDA Regulations, EU GMP, and ICH Guidelines.

Laboratory Investigations and Data Integrity

1. Promote a culture of quality and data integrity within the QC laboratory.

2. Review and approve investigation reports, ensuring scientific soundness and regulatory compliance.

3. Implement measures to enhance data integrity in all QC analytical processes and reporting.

4. Apply systematic root cause analysis techniques to identify underlying causes of quality issues.

5. Lead and conduct thorough laboratory investigations for any non-conformances, deviations, or OOS/OOT results.

Leadership and Training

1. Contribute to the continuous improvement of QC processes and operational efficiency.

2. Act as a subject matter expert for QC documentation and QMS-related queries.

3. Foster a collaborative and high-performance workplace within the Quality Control department.

4. Conduct training sessions on new SOPs, QMS updates, and data integrity principles for the QC team.

5. Provide guidance and mentorship to junior QC staff on documentation practices, QMS procedures, and regulatory compliance.

📌 Senior Executive / Assistant Manager - QC Documentation & QMS (Visakhapatnam)
🏢 Synnat Pharma
📍 Visakhapatnam