Website www.twitter.com/drgjpmc DRG Job Placement Manpower Consultant Hyderabad
Position: Analyst (E&L)
Experience:6 years
Location: Pragathi Nagar, Hyderabad, Telangana 500090
Salary:4- 8LPA
Qualification: Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, or a related field.
Roles and Responsibilities:
Planning and execution of method development, Perform routine, stability analysis, and Validation activities on GC-MS E&L, nitrosamines, and other applicable tests by GC-MS.
Development of stability indicating test methods and other methods as per the dosage form in line with regulatory requirements.
Provide inputs, observations during analysis to identify root cause of failure and OOT data.
Literature search of relevant projects and testing methods
Preparation and review of protocols for verifications, validations, and related activities
Evaluation of analytical results and correspondence with formulation departments
Preparation and review of AMDRs
Adherence to GLP and compliance
Preparation and review of risk assessment reports for Extractables
Active participation in meetings/discussion related to projects as and when required
Qualifications & Pre-Requisites–
M.Sc in chemistry, M.Pharm Analysis, with experience of operating GC-MS of any make.
Possesss basic knowledge of chromatography, and mass spectrometry
Sound knowledge of method development by chromatography
Developing and interpretation of mass spectra
Aware ICH guidelines Q1 stability,Q2 Validations, Q3 Impurities, M7, PQRI, USP general chapters on Extractables and Leachables, Nitrosamines guidelines of USFDA, EMA.