Job 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, Abbott's 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 site's 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.