Ct Packaging
7 months ago
**Job summary**
- Understanding of pharmaceutical packaging materials, components, machines and packaging processes.
- Understanding of test procedures and critical attributes of packaging items.
- Understanding of container-closure system, pack configuration and shop floor activities.
- Adequate knowledge of preparation of packaging documents, packaging development & risk assessment reports.
- Adequate knowledge on development of new packaging change parts, designing of pack style and packaging process in accordance to the study parameters / regulatory guidelines.
- Understanding of IPR kit pack and design for clinical studies along with related documentation and co-ordination with CFTs across sites
- Development of new packaging change parts, design of pack style & packaging process in accordance to the study parameters / regulatory guidelines. Knowledge on development of packaging as an overall skill is desirable.
**Area Of Responsibility**
- Execution of stability batch packaging for development batches at R&D and co-ordination and monitoring of exhibit batches at DF sites.
- Execution of packaging activities for BE samples in DFL area.
- Ensure availability of required packaging materials, artworks, equipment, change parts, documentation with related compliances for development and exhibit batches.
- Coordination with CFTs and plant functions for smooth execution of clinical trial batches and IPR kit packs.
- Preparation of packaging material specification and testing procedures (STPs)
- 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. Development and Design of Packaging materials.
Geographic Scope/ Market
Regulated and Non-Regulated markets
**Education and Job Qualification**
PG Diploma in Packaging / Graduation in Science / Technology.
**Experience**
8 to 10 Years of experience in Packaging Development / Operation
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