Work as Head Investigations at Syngene International | B.Pharm, M.Sc
Syngene International is one of India’s premier contract research and manufacturing organizations in providing customized service. Our services encompasses all across discovery chain: early stage discovery, process development, cGMP manufacturing and formulation development both in the small molecule and novel biologics area. Based in Bangalore, Karnataka, the Company is situated in a 90 acre Special Economic Zone with over 100000 sq. mt of built up facilities.
Post : Head Investigations
The Head Investigation Team needs to establish a Robust procedure for conducting, documenting and approving investigations associated with any Out of specification (OOS), Out of Trend (OOT), Incident, Deviation results across all Quality and manufacturing systems of Syngene verticals. The Head Investigation Team shall be responsible for ensuring overall compliance of Investigation procedure, deriving and approving recommended actions for investigations and ensure implementation of CAPA.
• Head Investigation Team shall be responsible to prepare an effective and robust Investigation Procedure in consultation with BU Heads.
• Ensure review of all OOS, OOT, Deviation and Incidents. Evaluate the findings and results. He should be responsible to ensure timely logging the details in appropriate GMP systems by the relevant department.
• Ensure closure of investigations associated with but not limited to Raw materials, Excipients, API, Finished Product, Semi Finished products, In Process samples, Stability samples, environmental monitoring samples, Microbiological tests, water samples, packaging materials, cleaning samples, process validation samples, qualification samples, external Laboratory testing etc.
• Implement necessary investigation tools like 5 Whys, Fishbone, Cause and effect or any other statistical tools as deemed necessary.
• Shall be responsible for establishing scientifically sound and appropriate investigation to identifying assignable root cause, conducting risk/impact assessments, regulatory impact wherever applicable, Hypothesis analysis, resampling and retesting approvals, investigation conclusion.
• Shall be responsible for timely, unbiased, well documented and scientifically sound report preparation.
• Ensure identifying and finalizing CAPA as wells as disposition recommendation wherever applicable.
• Ensure intimation to the client as per approved procedure within the timeline as agreed in Quality Agreement wherever applicable. Any further query to be addressed as per the agreed timeline.
• Should implement an alert system for developing trend if any and present to management for timely resolution.
• Graduate in Pharmacy / Master in Science with minimum 10 years of Experience in Quality Assurance.
• Technical knowledge in API, Biologics and Finished dosage form
• Investigation and report writing skill
• Should have good Communication and Presentation skills
• Can establish good Interpersonal skills with cross-functional teams
Experience : 5+ years
Qualification : B.Pharm, M.Sc
Location : India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : CQA
End Date : 20th June, 2019
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