07 Sep
|
Zydus Group
|
India
Job Description (JD) - Sr. Manager/Manager, Drug Product (Vaccines):
Position Title:
Manager - Drug Product (Vaccines)
Department:
Manufacturing / Production / Vaccine Operations
Location:
VTC, Zydus Biotech Park, Ahmedabad
Reporting To:
Head - Manufacturing / Senior Manager - Vaccine Operations
Job Summary:
The Manager, Drug Product (Vaccines) is responsible for overseeing vaccine drug product manufacturing operations, including formulation, filling, freeze-drying (lyophilization), packaging coordination, process optimization, compliance, and team management. The role ensures product quality, regulatory compliance, operational excellence, and adherence to GMP requirements while meeting production targets.
Key Responsibilities:
Manufacturing Operations:
Lead end-to-end drug product manufacturing activities for vaccines, including:
Formulation
Aseptic processing
Filling and finishing
Lyophilization (where applicable)
Visual inspection and product handling
Ensure production schedules are achieved safely and efficiently.
Monitor batch execution and ensure compliance with approved Batch Manufacturing Records (BMRs).
Drive process improvements to enhance productivity and reduce manufacturing deviations.
Quality & Compliance:
Ensure compliance with cGMP, GLP, GDP, and applicable regulatory requirements.
Support regulatory inspections, customer audits, and internal audits.
Review and approve manufacturing documentation, SOPs, change controls, deviations, CAPAs, and risk assessments.
Ensure data integrity and documentation practices meet regulatory standards.
Technical & Process Management:
Provide technical oversight for vaccine drug product processes.
Lead technology transfer, scale-up, process validation, and process performance qualification activities.
Collaborate with QA, QC, Engineering, Validation, and Supply Chain teams.
Troubleshoot manufacturing issues and implement sustainable solutions.
Team Leadership:
Manage and dev
📌 Section Head Ahmedabad (India)
🏢 Zydus Group
📍 India