Title:  HPU QC Executive

JOB DESCRIPTION

 
Job Location:  Bangalore
Department:   Human Pharmacology Unit

About Syngene
Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene’s 4500+ scientists offer both skills and the capacity to deliver great science, robust data management and IP security and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation. With a combination of dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, as well as 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.

Key responsibilities:

• Perform QC checks of draft CRF and other study related documents.
• Monitor the pre-check-in, check-in, pre-dose, dosing, post-dose study activities as per protocol, SOP/IOPs and regulatory guidelines.
• Perform Periodic checks for essential documents filed in TMF or study related files at different stages such as before study activity starts, during the study and after the completion of the study.
• QC check for source documents transcribed data with CRF entries and other study related documentation.
• Provide Line clearance, Line Opening and Line Cleaning to the Lab technician for the generation of Labels pertaining to Vacutainers and RIA vials.
• Provide Line clearance, Line Opening and Line Clearance for dispensing labels in pharmacy.
• Generate Quality Control Report for study activities and/or supporting documents.
• Verify the response to sponsor/QA observation noted during their data review or visit to facility in coordination with HPU staff and Investigators.
• Review of CSR and appendices.
• Archival of all study files.
• Verification of oceasoft and archival as per the sop SOP-GCP-HPU-0065
• Review of qualification documents as and when required.
• Prepare and present trend analysis report of observations to Head HPU and reporting managers once in a month or as and when needed as per Head HPU instructions.
• Issue True copy of verified calibration / validation reports for display in their respective areas.
• Review SOP/IOPs as and when required.
• Perform Quality Control checks of HPU facility systems and issue QC report and coordinate with concerned departmental person/Head of HPU in resolution of observation/clarification pertaining to systems.
• To carry out any other responsibility as and when assigned by the Head-Human Pharmacology Unit / Head-Syngene Clinical Development.

Experience:

1-4 years

Qualification: 

B.Pharma

Equal Opportunity Employer:
It is the policy of Syngeane 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 accommodation for qualified individuals with disabilities.