Development and Validation Specialist

• Develop, improve and validate analytical methods within deadlines

• Perform required analyses on R&D batches, physical tests, assays, degradation products, etc. (in-process, initial and stability)

• Ensure good communication between customer, PDS Group and AS Group for assigned projects

Responsibilities:

• Write and execute method validation protocols, issue reports

• Maintain accurate experimental records, instrument logs and perform analytical data entry

• Verify laboratory notebooks

• Actively participate in laboratory investigations

• Follow up on modifications, maintenance, calibration and qualification of laboratory instruments

• Purchase, drafting SOPs and training on new equipment as required

• Participate in training QC and R&D technicians on new methods and assist as required

• Prepare solutions required for analyses

• Maintain equipment logs

• Meet deadlines

• Any other tasks required for the smooth running of the laboratory

Skills and experience required:

• College diploma (DEC) or undergraduate degree in Science (Chemistry, Biochemistry), or related discipline.

• Minimum of three (3) years’ experience in analytical method development and validation in the pharmaceutical industry.

• Knowledge of Canadian (Health Canada) Good Manufacturing Practices (GMP)

• Knowledge of pharmacopoeias (USP, Ph. Eur. and BP) and their applications within a laboratory

• Practical experience performing HPLC (UPLC) and GC

• Great troubleshooting skills

• Works well in a team

• Good organizational, interpersonal and presentation skills

• Has a sense of initiative; excellent concentration; aptitude for technical writing and analytical mind, good stress management

• Good communication skills

• Good computer skills (Microsoft Office, Outlook)

• Bilingual (French and English)