Groupe PARIMA is a Contract 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. https://www.groupeparima.com/fr/
Process and Cleaning Validation Specialist
The Process and Cleaning Validation Specialist is responsible for activities related to validating the cleaning of the company’s manufacturing and packaging equipment processes.
Responsibilities:
• Perform all tasks (non-analytic) pertaining to cleaning validation activities such as:
o Preliminary activities of cleaning verification
o Writing protocols and reports
o Preliminary cleaning verification activities
o Drafting of protocols and reports
o Operator training on cleaning procedures
o Surface sampling
o Supervision and execution of protocols in collaboration with the production team
• Perform all tasks related to process validation according to the schedule defined in collaboration with the Project Managers:
o Drafting of manufacturing and packaging process validation protocols and reports
o Supervision and execution of protocols in collaboration with the production team
• Ensure updates to procedures and methods following validations
• Ensure GMP compliance during validation activities and initiate change notices or CAPAs as required.
• Initiate and write investigations related to cleaning and process validation activities.
• Provide technical support to the operations group
• Any other tasks deemed relevant
Required skills and experience:
• Bachelor’s degree in Science (Chemistry, Biochemistry), or a related discipline, from a Canadian university or a degree recognized by a Canadian university or accreditation body as being of equivalent level in a scientific field.
• Minimum of five (5) years’ experience in validation and/or processes in the pharmaceutical industry
• Knowledge of Canadian Good Manufacturing Practices (GMP) (Health Canada)
• In-depth knowledge of validation strategies
• Problem-solving skills
• Team player
• Good organizational, interpersonal and presentation skills
• Initiative; excellent concentration; technical writing and analytical skills; good stress management skills
• Good communication skills
• Good computer skills (Microsoft Office, Outlook)
• Bilingual (French and English)
• Able to provide training and assist in the training of individuals,
• Flexible and able to adapt to production schedules.
What we offer:
• Flexible work schedule
• Medical – dental & travel benefits
• Group retirement plan
• Recognition program & social activities
• Personal days
• Employee assistance program & online medical service
• Hot Beverages (Hot chocolate, Coffee, Mokaccino)
• Accessible by public transit or free parking
• Referral program
• Subsidized meal program