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.