Required! Analytical Development Anal...
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May
28
ragupathyrenganathan
Required! Analytical Development Analyst – courtesy (Pharma job.ca)
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Laboratoires Confab inc.

Confab Laboratories is growing and offers unique and exciting challenges. Future projects in the coming years leads the organization to add new talent  in his team of Research & Development. Reporting to the Chief, Analytical development and validation, the Analyst will be responsible to develop and validate analytical methods related to various projects and perform laboratory analyzes by selected analytical methods.

Responsabilities:

  • Conduct laboratory analyses using analytical methods, in accordance with Good Manufacturing Practices (GMPs);
  • Conduct analyses required by R&D during process validation;
  • Develop and validate analytical methods for cleaning residues (cleaning validation);
  • Validate analytical methods according to protocols;
  • Transfer analytical methods according to protocols;
  • Prepare protocols and validation reports;
  • Train other analysts on various analytical techniques or methods, fill out training forms and send them for approval;
  • Assist the Chief, Analytical Development, in planning and monitoring analyses, and attend meetings with external laboratories, clients and internal partners for assigned projects;
  • Complete analysis-related documents as tasks are performed (lab workbooks, logs, etc.);
  • Check and maintain certain analytical instruments, according to Standard Operating Procedures (SOPs);
  • Keep the premises clean and orderly at all times;
  • Apply the OHS policy in the performance of tasks;
  • Make purchase requisitions based on analysis requirements: standard, reagents, other consumables;
  • Attend project meetings;
  • Perform all other tasks as requested by the Chief, Analytical Development.

Qualifications:

  • Bachelor’s degree in chemistry or biochemistry, preferably an MSc or a PhD.
  • At least five (5) years of experience in developing analytical methods using HPLC, UPLC and GC.
  • At least five (5) years of experience validating and transferring analytical methods: drafting protocols and reports, establishing acceptance criteria, and compiling and interpreting results.
  • Demonstrated ability to develop a dissolution method for solid and semi‒solid forms.
  • Very good knowledge of ICH, FDA, USP and Health Canada guidelines regarding method validations or transfers, and of regulatory submission requirements in order to prepare documents accordingly (ANDA, CBE‒30).
  • Experience in qualifying an API supplier, source change.
  • Experience in creating or modifying raw material specifications and finished products (choice of methods, limitations, rationale provided to authorities).
  • Proficiency in using Microsoft Office (Word, Excel, PowerPoint) and Empower 3.
  • Membership or eligibility for membership in the Ordre des Chimistes.
  • Ability to work autonomously, with a sense of responsibility and organization.
  • Keen sense of observation.
  • Meticulousness and professionalism.
  • Logic and analytical thinking.
  • Excellent interpersonal skills.
  • Reading and writing skills in French and English, and a good grasp of technical vocabulary;
  • Ability to communicate in French.


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