Date: Sep 23, 2021
Location: Gurgaon, IN
Company: Pharmaceutical
Job summary
Understanding the Protocol released by Clinical Research Team. Design the Pack style & Packaging process in accordance with the study parameters / regulatory guidelines. Document preparation, Training & coordination with all stakeholders to ensure availability of intended pack samples to clinical research team within agreed timelines.
Adequate knowledge of preparation of packaging documents, risk assessment strategy reports.
Knowledge of the development of packaging as an overall skill is desirable.
Area Of Responsibility
- Prepare Clinical Presentation for new study and impart training to all concerned stake holders.
- Ensure availability of required packaging materials, equipment, change parts, documentation for Clinical batches.
- Timely completion of Clinical batches manufactured at site.
- Change control approvals and timely closure.
- Timely revision of SOPs, calibration & maintenance of lab machines and equipment. Proper storage and handling of packaging materials in store.
- Handling of AMS system, Master Data Management (MDM Tool), SAP.
- Quality assurance of Packaging Process.
- Development and Design of Packaging materials.
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Education and Job Qualification: PG Diploma in Packaging with Graduation in Science / Technology.
Experience: 10 to 15 Years of experience in Clinical Trial Packaging coordination & Packaging Development.
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