Development and Validation Specialist

3 weeks ago


Montreal, Canada Groupe PARIMA Inc Full time

Groupe PARIMAis aContract Development and Manufacturing Organization (CDMO), established in 1994. For over 30 years, we have developed an expertise in the development and manufacturing of non-sterile liquids, suspensions and semi-solid drug products. 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 the 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 investigationsFollow 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 - 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 - Bilingual (French and English) What we offer: - Recognition program & social activities - Personal days - Employee assistance program & online medical service - Accessible by public transit or free parking - Referral program " * " indicates required fields #J-18808-Ljbffr



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    Groupe PARIMAis aContract Development and Manufacturing Organization (CDMO), established in 1994. For over 30 years, we have developed an expertise in the development and manufacturing of non-sterile liquids, suspensions and semi-solid drug products. Development and Validation Specialist Develop, improve, and validate analytical methods within deadlines...

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