- Perform the method development and validation of analytical testing procedures for drug substances and drug products
- Write protocols, drafts methods and technical reports for the Research and Development department and clients
- Executes experiments, following the company's Standard Operating Procedures, Deviations and Change Control programs and cGMP guidelines.
- Write and Review technical data, documents, SOPs and proposals as required.
- In case of a testing failure, immediately report to the Department Head or the designee before proceeding further with the test, lead/assist failure investigations to identify the cause of failure and prepare a deviation report and/or Corrective Preventative Actions (CAPA) if it is appropriate.
- Ensure that work order documentation is complete in every respect and all results are entered into the Electronic Laboratory Information System or client's Certificate of Analysis before submission to the QA reviewer.
- Ensure that equipment is maintained properly. Also perform calibrations and qualifications as required
- Oversee, train, mentor and guide Analysts/Scientists in their work
- Education: MSc/PhD
- Experience: 5+ years in a pharmaceutical chemistry environment, demonstrated ability to complete more complex role/duties as mentioned above.
- Must be proficient in using various types of computer software (Word, Excel. PowerPoint & Outlook).
- Proven ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.
- Demonstrates excellent verbal and written communication skills.
- Ability to work well with others & independently.
- Proven time management skills and a strong attention to detail.
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R&D Scientist - Mississauga, Canada - SGS
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Job Description
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