Opportunity for Principal Scientist – Analytical Development (API) in Eisai Pharma - alp consulting
Post: Principal Scientist – Analytical Development (API)
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Job Description:
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Plan and organize for timely installation of analytical equipments in R&D (API)
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Preparation of Standard Operating Procedures (SOPs) for all the equipments
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Control and provide the documentation requirements such as Note books, log books
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Conducting the training and qualifying the each scientist in the department
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Plan and conduct the timely calibrations of each instruments as per written procedures
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Analytical Method Development, validation of those methods for Active Pharmaceutical Ingredients (API) and Intermediates
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Perform planned day to day activities
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Providing the analytical support to the synthetic R&D department in terms of timely analysis of samples and sharing the results with synthetic R&D
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Preparation and execution of validation protocols
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Train and plan the work in day to day activities for trainees
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Ensure the compliance with the regulatory requirements
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Transferring the validated methods for the commercial production
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Preparation of Standard test procedures and specifications
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Investigation into Out Of Specifications results and try to find out the probable reasons
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Follow the Good Laboratory Practices and maintain the Good Manufacturing conditions in the laboratory
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Maintain the cordial relationship within the department and with the customer departments
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Ensure the 100% utilization of the instruments
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Plan and perform the preventive maintenance of all the instruments to minimize the down time for each instrument
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Order and procure the reference standards
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Plan and prepare the working standards
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Procure and maintain the spare parts for the analytical equipments
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Plan and procure the consumable items like columns, solvents, reagents, and stationary
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Perform the wet chemical analysis with a good analytical hand to produce the good results
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Knowledge to understand the audits to help in preparing for the audits by different agencies like USFDA, MHRA, TGA and ANVISA
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Understand the different pharmacopoeias requirements and develop and validate the analytical methods as per the pharmacopoeias
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Candidate Profile:
M.Sc. in organic/analytical chemistry with good academic track record with 6-9 years of experience in reputed pharma companies Hands in experience to handle the analytical equipments such as HPLC, GC, NMR, UV-Vis spectrophotometer and IR
Knowledge to understand the regulatory requirements with sound scientific knowledge and with good documentation skills
Enthusiastic and dynamic, capable of working individually and also in a team Ability to manage the situations to work hard Good communication skills.
Additional Information:
Exp: 6-9 years
Location: Visakhapatnam
Education: M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: R&D
Forward your resume at, malathi.a@alpconsulting.in
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