Pharmacist
Bangalore, KA, IN, 560100
JOB DESCRIPTION
Job Location: Bangalore
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
- 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
Equal Opportunity Employer:
It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities