13 Aug
|
Opes Healthcare
|
Ahmedabad
13 Aug
Opes Healthcare
Ahmedabad
Role & responsibilities
1. Lead and guide the PDC and Artwork teams for all packaging material and finished product development activities.
2. Develop and qualify current packaging materials for all dosage forms.
3. Conduct development trials for new packaging materials and evaluate their performance.
4. Select appropriate packaging materials based on their compatibility, efficacy, and ability to preserve product quality, potency, and safety.
5. Finalize packaging material specifications and testing methodologies.
6. Conduct pre-development compatibility studies between packaging materials and products throughout shelf life.
7. Evaluate and optimize existing packaging materials for commercialized products.
8. Perform MVTR (Moisture Vapour Transmission Rate) studies for unit-dose and multi-dose containers.
9. Plan and execute transportation validation studies (vibration test, drop test, etc.).
10. Design packaging strategies as per market and regulatory requirements.
11. Ensure availability of approved packaging materials prior to exhibit batch packaging.
12.
Design and review MPR, BPR, and packaging validation protocols.
13. Verify PM BOM (Packaging Material Bill of Materials).
14. Develop, review, and finalize artwork as per inputs from RA, BD, and regulatory guidelines.
15. Coordinate with BD, RA, and QA teams for timely artwork execution.
16. Support RA team in dossier preparation, submissions, and regulatory queries.
17. Provide packaging-related document support for regulatory submissions.
18. Assist RA in packaging sample submissions and related activities.
19. Investigate packaging-related market complaints and implement CAPA.
20. Develop, review, and maintain packaging-related documentation (SOPs, risk assessments, stability protocols, qualification/validation documents, change controls, deviations, and CAPAs).
21. Identify, evaluate, and develop new packaging material vendors.
22. Assess packaging facility suitability for products and prep
📌 Packaging Development Manager (Ahmedabad)
🏢 Opes Healthcare
📍 Ahmedabad