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Required – Analyst, analytical validation! – courtesy(Pharma
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Job ID 166451BR
Position Title Analyst, analytical validation
Division SANDOZ
Business Unit Product Dev SZ
Country Canada
Work Location Montreal South Shore – Boucherville
Company/Legal Entity Sandoz Canada
Functional Area Research & Development
Job Type Full Time
Employment Type Regular
Job Description Located in Boucherville, the Canadian division of Sandoz houses one of the most important sterile pharmaceutical manufacturing sites in the country. Our vision: to become the main provider of high quality, affordable medicines and help secure long-term access to healthcare for people around the world. If you are results oriented and recognized for your leadership, expertise, commitment to quality and customers, come join our team!

We are currently looking for an Analyst, Analytical validation:

Reporting to the Supervisor, Analytical Development and validation, the Analyst, Analytical validation performs all the steps for the testing and transfer of analytical methods used by the Analytical Departments. These steps include the preparation of testing protocols, the management of analytical data and, as applicable, the drafting of testing and transfer reports. They also include the development and/or optimization of new analytical methods (HPLC, GC, etc.) for raw materials and finished products in the context of new or existing projects (maintenance). He or she participates in the integration of new employees in the laboratory and provides analytical technical support to other members of the analytical team and external laboratories, in terms of testing analysis, release and stability. He or she actively participates in training and coaching employees.

Summary of tasks:

Test new analytical methods according to the regulatory requirements for all components related to the manufacturing of Sandoz products (analyses by GC, HPLC, UV-VIS, dissolution, forced degradation, cleaning validation, etc.), develop and/or optimize existing methods (e.g. pharmacopoeia methods, in house), dosage, impurities, excipients, etc.;
Draft protocols and testing reports;
Analyze results and write up the analytical methods related to the testing;
Audit file reports as well as internal and external testing;
Participate actively in all steps relating to analytical transfers to or from external laboratories – These steps include the preparation and implementation of transfer protocols, the analysis of results and the drafting of transfer reports;
Analyze the raw materials for manufacturing regulatory batches and prepare certificates of analysis;
Carry out analyses required by regulatory authorities (deficiency letters);
Support pharmaceutical development (analyses for internal requisitions, QbD batches);
Support the stability team (release and stability testing);
Assess the impact of specification and other changes;
Provide technical and analytical support in the analysis of specific cases.
Diagnose and apply solutions to correct analytical problems encountered in the laboratory and analyze complex samples;
Follow up on external testing and provide technical and analytical support;
Prepare the materials needed for external validation studies and analytical transfer;
Actively participate in the training and coaching of new employees;
Participate in various routine maintenance activities and other tasks essential to laboratory operations;
Draft or revise procedures.

Minimum requirements Bachelor’s degree in Science (Chemistry or Biochemistry).
Excellent level of spoken and written French and English.
Five (5) to eight (8) years of experience in the pharmaceutical industry.
Experience in development and validatino of analytical methods (HPLC, GC, UV, titration, dissolution).

At Sandoz Canada, we are committed to equitable access to employment opportunities and workplace diversity.

Only candidates selected for an interview will be contacted.

Copy & Paste the link below to apply

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