The candidate must have strong technical knowledge of analytical techniques and strong knowledge of related laboratory equipment in one or more of the following areas: Chemistry, Biochemistry, Bioassay or Microbiology.
The individual will be responsible for:
Qualification of analytical equipment and related testing functions, for example HPLC, Spectrophotometry, Nephelometry, Endotoxin, Cell Culture and Total Organic Carbon etc.
Sampling and testing coordination during plant and laboratory utility qualification.
Co-ordinates & plans activities related to the successful transfer of Analytical Methods for relevant NMEs.
Co-ordination of Raw material, Utilities, In Process, Final Bulk and Final product analytical testing and sampling.
Support and Implementation of Analyst Training programs.
Partners with other Departments and Team Leaders to ensure that activities related to QC are completed in an efficient manner.
Qualifications and Experience
Bachelor’s Degree in Chemistry, Biochemistry, Microbiology or related science field.
4-6 years related experience in biopharmaceutical or pharmaceutical industry and/or an equivalent combination of education and experience.
Working knowledge of regulatory requirements, policies and guidelines.
Experience with Quality Control document reviews and regulatory inspection processes.
Working knowledge of Quality systems.
Strong technical knowledge in and experience with QC analytical testing methods and equipment is required.
Knowledge of cGMP regulations and FDA/EU guidance is required.
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