Groupe PARIMA is a Contract Development and Manufacturing Organization (CDMO), established in 1994. For over 25 years, we have developed expertise in the development and manufacturing of non-sterile liquids, suspensions and semi-solid drug products. https://www.groupeparima.com
- Ensure registration of products undergoing stability according to approved protocols
- Ensure that stability samples and finished products are sent to the various laboratories (internal and external).
- Ensure that stability products are tested according to the specifications indicated in the stability protocol.
- Print out the specifications for stability products undergoing analysis and place them in the associated binders.
- Write stability reports at the end of each stability study
- Ensure trend analysis of products during stabilities and at the end of each stability study
- Participate in the revision of the stability protocol
- Follow up on stability product analyses with the team leader of each department
- Ensure that certificates of analysis for each stability station and stability reports are communicated to the company’s various customers
- Ensure that the stability chambers are running smoothly on a daily basis, and complete the associated records
- Ensure that temperature data are extracted from the temperature and humidity recorders (dataloggers) at the frequency specified in the SOP and recorded in the network.
Compétences et expériences recherchées:
- Bachelor’s degree in Science (Chemistry, Biochemistry), or related discipline,
- Minimum of three (03) years’ experience in Quality Control in the pharmaceutical industry.
- Knowledge of Canadian (Health Canada), American (FDA) and MHRA Good Manufacturing Practices (GMP).
- Knowledge of ICH Harmonized tripartite Guideline for Stability Testing, Q1A (R2) and Q1E
- Knowledge of FDA regulations 21 CFR part 210, 211
- Good organizational, interpersonal and presentation skills
- Basic knowledge of various analytical techniques (viscosity, PSD, HPLC, GC, UV, Karl Fisher, dissolution, specific gravity)
- Knowledge of pharmacopoeias (USP, Ph. Eur. and BP) and their application in a laboratory setting
- Good communication skills
- Initiative and participation in change
- Excellent concentration, technical writing and analytical skills, good stress management
- Good computer skills (Microsoft Office, Outlook, Excel)
- Bilingual (French and English)
Ce que nous offrons :
- Medical, dental and travel insurance
- Group pension plan
- Recognition program and social activities
- Personal leave
- Employee support program and telemedicine
- Free beverages (hot chocolate, coffee, mochaccino)
- Accessibility by public transit or free parking
- Referral program
- Subsidized meal service
* The masculine gender is used to lighten the text and make it easier to read.