Role & responsibilities

1. Lead and guide the PDC and Artwork teams for all packaging material and finished product development activities.

2. Develop and qualify new 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 prepare equivalency reports for site transfer.

23. Procure innovator packaging samples and perform comparative analysis.

24. Prepare and maintain MRM/MIS reports as per company procedures.

25. Design and equip the PDC lab with required instruments and equipment.

26. Establish and review procedures related to PDC operations and equipment.

27. Train team members on PDC and artwork-related activities.

28. Provide cross-functional packaging support for commercial and new product development batches

Preferred Candidate Profile

- Education: B.Pharm / M.Pharm / B.Tech / M.Tech (Packaging Technology, Pharmacy, or related field).
- Experience: 10- 17 years in Pharmaceutical Packaging Development, with team handling experience.
- Solid knowledge of packaging development, artwork management, packaging validation, compatibility studies, commercial packaging activities for international markets, and global regulatory requirements
- Experience in primary & secondary packaging, vendor qualification, technology transfer, and dossier support.
- Well-versed in cGMP, GDP, ICH guidelines, CAPA, Change Control, Risk Assessment, and SOPs.
- Excellent leadership, communication, and cross-functional coordination skills.

Employee Benefits

- Employee Health Insurance
- Employee Accidental Insurance
- 2nd & 4th Saturday Off
- AC Transportation Facility
- Attractive HR Policies

📌 Packaging Development Manager / Sr. Manager (Ahmedabad)
🏢 Opes Healthcare
📍 Ahmedabad