Groupe PARIMA is a Contract Development and Manufacturing Organization (CDMO), established in 1994. For over 25 years, we have developed an expertise in the development and manufacturing of non-sterile liquids, suspensions and semi-solid drug products. https : / / www.groupeparima.com / fr /
Investigation and Compliance Quality Control Specialist
The Investigation and Compliance Specialist will manage investigations related to quality control. He will also track and report compliance documents in the company’s quality management system.
Responsibilities :
- Initiation, drafting and conduct of laboratory investigations and trend monitoring
- Initiation and monitoring of change control (CC)
- Initiation and monitoring of corrective and preventive actions (CAPA)
- Initiation and Investigation of Quality Deviation (DEV)
- Initiation and follow-up of periodic verifications of laboratory quality documents (Analytical methods, procedures, Log books)
- Preparation of documents relating to quality management meetings
- Drafting and revision of Standard Operating Procedures (SOP)
Skills and experience required :
Bachelor of Science (Chemistry, Biochemistry), or related discipline, from a universityCanadian or a diploma recognized by a Canadian university or a Canadian accrediting organization as being of equivalent level in a scientific field.Minimum of five (5) years of laboratory experience in the pharmaceutical industryGood knowledge of various analytical techniques (Viscosity, PSD, HPLC, GC, UV, Karl Fisher, dissolution, specific gravity)Proficiency with EMPOWER software is an assetGood knowledge of Good Manufacturing Practices (GMP) Canadian (Health Canada) and American (FDA).Good technical writingWorks well in a team and good communication skillsBilingual (French and English)What we offer :
Flexible work schedule and telework (if applicable)Medical – dental & travel benefitsGroup retirement planRecognition program & social activitiesPersonal daysEmployee assistance program & online medical serviceHot Beverages (Hot chocolate, Coffee, Mokaccino)Accessible by public transit or free parkingReferral programThe use of the masculine gender is intended to lighten the text and make it easier to read.Location : 4450 Cousens St., Montreal, QC, Canada, H4S 1X6
Additional information :
Employment type : Full-time