Synergen Bio Immediate Joining for Clinical QC- Manager Position

Synergen Bio invites dynamic and qualified professionals for the role of Clinical QC- Manager at its Pune location. This is a full-time position suited for professionals with a strong academic background in M.Sc., B. Pharm, or M. Pharm and 6 to 10+ years of relevant experience in the field.

With just one vacancy available, Synergen Bio is looking for an immediate joiner who can contribute effectively to its high standards of clinical research and quality management.

About Synergen Bio

Synergen Bio, a reputed name in the clinical research and biopharmaceutical services sector, is known for delivering high-quality and ethically sound clinical trials. The organization upholds international regulatory standards and promotes a collaborative work environment driven by innovation and compliance.

Job Overview

Position: Clinical QC- Manager

Experience: 6 to 10+ years in Clinical Research Quality Control

Qualification: M.Sc., B. Pharm, or M. Pharm

Vacancy: 01

Location: Shivajinagar, Wakadewadi, Pune

Joining: Immediate joiner preferred

Key Responsibilities

As a Clinical QC- Manager, your role will encompass comprehensive quality oversight in clinical trials, including:

• SOP Development & Review: Ensure SOPs are up to date, complete, and compliant with clinical research regulations.
• Audit Planning & Execution: Design quality control checklists and execute internal audits across all clinical research phases, including screening, dosing, sample collection, and more.
• Training & Compliance Monitoring: Conduct SOP training for the clinical team, identify areas for improvement, and support process optimization.
• Documentation Review: Retrospective QC of clinical study records such as CRFs, informed consent documents, medical reports, and more.
• Departmental Audits: Audit various clinical units like ICU, Screening, Housing, and Sample Processing units to ensure compliance with protocols and regulatory guidelines.
• Report Generation: Draft audit reports, summarize findings, and communicate with department heads or PIs.
• Regulatory Preparedness: Support audit readiness for sponsor and regulatory inspections.
• Instrument Monitoring: Maintain schedules for
• equipment calibration and preventive maintenance.

How to Apply

Qualified and interested candidates can share their CV at careers@synergenbio.com.