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 current 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 The base pay for this position is N A In specific locations the pay range may vary from the range posted JOB FAMILY Manufacturing DIVISION EPD Established Pharma LOCATION India Chandigarh Remote ADDITIONAL LOCATIONS WORK SHIFT Standard TRAVEL Not specified MEDICAL SURVEILLANCE Not Applicable SIGNIFICANT WORK ACTIVITIES Continuous sitting for prolonged periods more than 2 consecutive hours in an 8 hour day

📌 Ms&t (Chandigarh)
🏢 Abbott
📍 Chandigarh