Website Syngene International Ltd
Post Name: Pharmacist
Location: Bangalore, KA, IN, 560100
Division: Discovery Services
JOB DESCRIPTION:
Department: Biometrics
About Syngene:
Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.
Job Purpose : The Pharmacist plays a significant role in IP management for all Clinical Trials
Key Responsibilities:
Preparation of protocol specific pharmacy plan & secondary labeling plan
Receipt, verification & storage of Investigational Medicinal Product (IMP) / Non-Clinical Supplies (NCS) as per the protocol requirement and pharmacy plan at Syngene Clinical Supply Unit (SCSU)
Preparation of documents related to and performing labeling/relabeling (expiry extension & secondary labeling) of Investigational Medicinal Product (IMP) / Non-Clinical Supplies (NCS) as per approved plan at Syngene Clinical Supply Unit
Supply & resupply of Investigational Medicinal Product (IMP) / Non-Clinical Supplies (NCS) to investigational sites from Syngene Clinical Supply Unit as per the required temperature
Preparation of shipment documents, planning, distributing & maintaining sufficient quantity of Investigational Medicinal Product (IMP) / Non-Clinical Supplies (NCS) at investigational sites
Perform the inventory management of Investigational Medicinal Product and Non-clinical supplies during the study and maintain related documentation
Arrange return/recall and perform reconciliation of Investigational Medicinal Product and Non-clinical supplies from site to Syngene Clinical Supply Unit
Witness destruction of Investigational Medicinal Product / Non-Clinical Supplies as per approved pharmacy plan
Maintain and ensure all clinical supply management activities are in compliance with applicable ICH-GCP, local regulatory requirements and SOPs
Ensure periodic maintenance and calibration of Syngene Clinical Supply Unit instrumentation as per applicable SOPs
Any other responsibilities assigned by the organization from time to time
Educational Qualification: Masters Degree in Life Science / Masters in Pharmacology
Technical/functional Skills:
Sound knowledge on ICH-GCP and Indian Regulatory guidelines
Well versed with Microsoft Office documents (MS word, Excel, Powerpoint)
Knowledge about developing SOPs
Well versed with facing internal and external audits
Looking for an experienced Pharmacist with expertise in IP management for clinical trials.
Behavioral Skills: Proficient in English (reading and writing), Integrity
