Stability Coordinator

Job Responsibility:

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.

Stability Coordinator

Responsabilities:

· 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.

#GP1

Job Type: Full-time

Benefits:

• Dental care
• Disability insurance
• Discounted or free food
• Employee assistance program
• Extended health care
• Life insurance
• On-site parking
• Paid time off
• RRSP match

Schedule:

• Monday to Friday

Work Location: In person