Incorporated in 1993 Syngene International Ltd. is an innovationfocused 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 BristolMyers 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 Description
Role: Section Head Central Laboratory
Key Responsibilities
Serve as authorized signatory as per national and local regulations.
Establish and validate/verify testing capabilities for new assays/tests as per ISO15189 NABL and CAP standards.
Understand and comply with the requirements of the quality management system
Assist in development of costing estimates logistics and testing strategies for new projects in line with GXP requirements..
Provide consultations about the medical significance of clinical laboratory data. Interpret correlate and communicate laboratory data to clients clinical staff patients and other appropriate requestors.
Provide consultations to clients sponsors investigators clinical staff data management team patients or others with regard to the medical significance of laboratory findings for purposes of further diagnosis and possible treatment as appropriate.
Define implement and monitor standards of quality control and cost effectiveness within respective sections.
Monitor work within the section of the laboratory to ensure medically reliable data is being generated; correlate laboratory data for diagnosis with patient management.
Assume responsibility for implementation of the quality management plan within respective sections.
Authorize quality improvement processes within the respective sections.
Ensure that there are sufficiently qualified personnel with adequately documented training and experience to meet the requirements of the work performed within the section.
Assist the laboratory director in planning for setting goals and developing and allocating resources appropriate to the service requirements
Provide educational programs for medical and laboratory staff.
Implement a safe laboratory environment in compliance with good practices and local regulations.
Provide input into the selection of equipment methods and reagents appropriate to the needs of clients the scope of testing and the financial constraints on the laboratory or institution..
Establish and implement an adequate system of recordkeeping within the respective sections of the laboratory and monitor adherence to that system.
Educational Qualification
M.B.B.S M.D. (Biochemistry)
Experience
1 4 Years
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.
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