For more than 40 years, ALS has provided comprehensive testing solutions to clients in a wide range of industries all over the world. Our adoption of state-of-the-art technology and innovative methodologies – coupled with the strength of our international teams – ensure that we deliver the highest quality services using local expertise and personalized solutions.
Post: Analytical Method Development Executive / Sr. Executive - 4 posts
ROLES & RESPONSIBILITIES:
• To identify, develop a methodology suitable for the phase appropriate characterisation, release and stability testing of customers products.
• Execute Analytical Method Development activities based on QbD principles and regulatory requirements.
• Trouble shooting related to Testing methods, Stability studies, test results and designing of additional experimentations as necessary
• Design of analytical studies and the writing of protocols to support method development activity.
• Writing and review of analytical method development and characterisation reports, and validation protocols and reports.
• Support technology transfer activities at internally and externally, including transfer strategy. Support transfer protocol and reports, and risk assessments.
SKILLS REQUIRED:
• Minimum of 5 years experience in the pharmaceutical industries conducting Method Development and method transfers and coordinating the activities cross functionally
• Adequate Job knowledge and exposure to different Analytical methods and instrumentations like HPLC, UPLC, GC, LCMSMS, GCMSMS, and IC, ICPMS.
• Adequate Job knowledge and exposure to QbD. DoE and statistical interpretation etc.
• Experience in the use of GxP practices relevant to analytical activity.
• Understanding of Quality Management Systems and GMP requirements
• The ability to work on your own and manage projects to tight deadlines
• Strong conceptual, analytical development and validation skills.
• Good communication (verbal, writing) and presentation skills.
• Ability to work overtime as needed.
• Excellent communication and interpersonal skills Regular and reliable attendance.
• Ability to work on-call and shift changes may be required.
Additional Information
Experience : 8+ years experience in the QC Laboratory
Qualification : Masters in science / Pharmacy
Location : Bangalore
Industry Type : Pharma/ Healthcare
Functional Area : Research & Development
End Date : 30th July, 2022
Apply at: alsin.career@alsglobal.com
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