Senior Executive Packaging Development

Documentation cell and Coordination with CFT:

a) Preparation of Submission/ Process optimization, Scale -up/Scale down, Validation, Commercial batch packing documents. (Batch records, Protocols).

b) Design of change parts for appropriate packaging machine for validation batches

c) Review and Approval of Packing documents (if required) (Batch records, Protocols etc.)

d) Due diligence of product and evaluation of pack suitability for the launches and proposal of any changes if required from initial development or during the site transfer

e) Responsible for meeting the timelines for packaging related activities/PPIC requirement.

f) Co-ordination with CFT teams for the flow of documentation activities.

g) Review and approval of artworks and packaging materials specifications

h) Monitoring and execution of Validation batches of NPL and BCDR.

Packing development support:

a) Batch packing records, Protocols and Reports for new line equipment for all site transfer, validation, and commercial products.

b) Planning of packing documentation as per the production feasibility for the usage of equipment.

c) Packing strategy finalization and developing alternate strategies with strong scientific rationale for submission/ validation batches packaging

d)Technical evaluation of alternative packaging materials for flexibility in supply or for cost reduction.

e) On requirement, Lab Trial/ Machine feasibility protocols.

f) Counter check and ensure the Machine capacity and qualification status during planning of documents.

g) Review of ANDA packaging details filed for launch products and review of packing equipment and packing materials availability for new launch products or site transfer products.

h) Training of resources regarding packaging activities.

Able to work in shifts based on the project requirement.

This is a plant based position

USFDA or similar regulatory audits.