Abbott - Manager - MS&T

Description:

- Work Experience (Total number of years/ experience/ background or equivalent):

- Total experience (in years): 15.

- Experience in current role (in years): 6.

- 5 Years.

- Work Background: Formulation Development, Technology Transfer, Root Cause Investigations, Project Management.

Primary Job Function :

- To drive technology transfer for Third party manufacturing, Loan license projects, Abbotts own manufacturing plants.

- To support Abbott site MS&T team as per requirements.

- To support Alternate supplier qualification of raw materials & API.

- To comply with the regulatory, quality, statutory, EHS and Pharmacovigilance requirements.

- Core Job Responsibilities -

- To perform effective gap analysis between sender & receiving site in process & equipment and to provide solution for smooth technology transfer.

- To prepare Master formula record & Technology transfer protocol for products identified for transfer.

- To Review receiving sites draft documents pertaining to manufacturing, process validations & analysis of product under transfer & executed documents post validation.

- To execute validation batches and to ensure validation batch reproducibility is demonstrated in commercial batches.

- To review executed process validation batch documents & support FLQR approvals.

- To service, trouble shoot and solve production process problems at manufacturing site.

- To acquire sufficient process understanding at current manufacturing site to enable effective investigations of commercial batch failure or market complaints and to contribute towards appropriate CAPA.

- To carry out due diligence of new sites with focus on formulation and required infrastructure and support new product acquisitions & product certifications.

- To work towards improving knowledge base for handling of Parenteral products in addition to the other dosage forms such as Oral solids, Oral liquids, Topicals, etc.

- To extend technical support and batch execution (as applicable) to activities like Alternate Supplier Qualification and Material Harmonization.

- To initiate, review & approve change controls in Soltraq.

- To author, review & approve technical documents in Darius.

- To extend support to NPI activities like Dossier review, Product certification & FLQR approval.

- To extend support to I&D for new product launches, review & approval of technical documents, batch monitoring & FLQR approval.

- To keep track of ongoing projects and update senior management beforehand.