Syngene International looking for Associate Manager - M.Pharm apply

Syngene International Ltd 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.

Post : Associate Manager

Department : Quality Assurance - GLP

Job Description :
• Assure compliance to the OECD Principles of GLP
• Assure compliance and meeting the requirements of ISO/IEC 17025:2017
• Assure compliance and meeting the requirements of ISO 9001:2015
• Assure preparation and /or review of SOPs and other documents
• Assure receipt and dispatch of documents/SOPs, Study Plans and Study Reports
• Assure Planning and scheduling of audits/ inspections for Studies and report, facilities, processes and contract facilities (as and when required)
• Assure the findings are resolved in compliance with GLP
• Involve in the inspection by regulatory agencies and sponsors/ clients
• Assure preparation and review of application for surveillance and re-certification inspections
• Compilation of Action taken report/response and corrective and preventive actions
• Assure training of personnel within GLP Quality department on QA process
• Assure submission of records relevant to GLP-QAU for archival in a timely manner
• Assure that observations/findings of inspections are reported to the respective auditee and management in a timely manner
• Assure preparation and issue of signed QA statement for Study Reports
• Assure compliance of data finding indices

Candidate Profile :
M.Pharma
Minimum 12 to 15 years.

Additional Information
Experience : 12 to 15 years
Qualification : M.Pharm
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th December, 2022