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 Purpose
To support characterization analytical method development validation and dose formulation analysis.
The role will involve conducting all work in compliance with applicable regulatory requirements and Good Laboratory Practice.
Key Responsibilities
Assist in the conduct of the study in compliance with the Principles of Good Laboratory Practice.
Operating analytical equipment and ancillary equipment
Compliance with the study plan and Standard Operating Procedures applicable to their involvement in the study.
Recording of data with compliance to ALCOA principles
Documenting and communicating and deviation to supervisor/team lead/study director
Ensuring health and safety practices at the workplace
Communicate with Management QAU Document Controller TICO and Archivist as per the Study Director's instructions.
Verify the calibration and maintenance of the instrument/equipment before the start of the experiment.
Educational Qualification
M.Sc./ M. Pharm in Chemistry
Technical/Functional Skills
Experience/awareness of analytical and bioanalytical studies.
Knowledge of different extraction techniques.
Ability to handle analytical and ancillary instruments viz GC UPLC/HPLC LCMS Solo VPE pH meter.
Review of calibration and maintenance records
Calibration and use of micropipettes
Using MS office especially Microsoft Excel
Documentation logbooks and raw data for activities performed without any errors.
Knowledge of regulatory requirements practices and guidelines like OECD USFDA EMEA ICH etc.
Experience
36 years in the relevant regulated environment
Behavioral Skills
Good communication skill both verbal and written
High level of dedication enthusiasm motivation and persuasive ability in a team and crossfunctional environment.
Ability to work successfully in a dynamic ambiguous environment.
Ability to meet tight deadlines and prioritize workloads.
Ability to develop new ideas and creative solutions.
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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