Job Title: Regulatory and Quality Specialist
Duration: 12 Months
Location: Saint-Laurent, Quebec, CAN
 
 
Primary Role Purpose

• Ensuring adherence to GMP regulations, corporate policies, and compliance standards during operations.

 Key Responsibilities

• Draft stability protocols for routine lots and for pre-market studies.
• Draft stability reports following periodic evaluations of stability data for routine lots and for pre-market studies.
• Perform annual statistical evaluations of routine stability data on marketed products to evaluateprocess compliance with established release limits.
• Conduct linear regression analyses to establish optimal release limits, ensuring product expirationconfidence.
• Evaluate lots released on the market using linear regression and calculate stability risks.
• Provide recommendations based on statistical analyses involving release limits, contributions,expiration, etc.
• Identify off-trend results and recommend appropriate actions.
• Document deviations from stability protocols, evaluate their impact on studies and provide recommendations.
• Monitor subsequent corrective and preventive actions.
• Initiate and/or monitor change controls if required based on recommendations.
• Perform impact assessment on product stability and stability program as part of change controls.
• Carry out various stability-related tasks and support the QA Supervisor in charge of the stability department.

 Regulatory compliance:

• Organizes the preparation and review of CTD sections of drug submissions for compliance with corporate practices and client requirements.
• Prepares and reviews specifications, methods, stability data, and other pertinent CTD sections for completeness and accuracy before submitting to Affiliate.
• Ensures site documentation aligns with approved registrations.
• Maintains documentation for Export Registrations to ensure compliance and supports registration updates.
• Liaises with Regulatory Affairs via the Global group to provide QA documentation in support of export registrations.
• Provides QA responses to Regulatory Authority queries from export markets.
• Prepares and provides MBR scan, API CoA, stability data, chromatogram, etc., for product renewals or submissions.
• Supports impact evaluation as SME for Change Control.
• Ensures documentation supports change and coordinates site-to-site interaction.
• Reviews information from each market and conveys it to the site change control process.
• Acts as Functional approver within the Change Control process.
• Reviews and approves manufacturing master files and packaging master files.
• Performs additional related duties as assigned by the QA Supervisor.

 Job Requirements and Qualifications

• Minimum Education: DEC or B.Sc.
• Area of Specialization: Chemistry, Science or Chemical Engineering

 Preferred Education:

• B. Sc.
• Area of Specialization: Strong knowledge of relevant regulations, excellent analytical and organizational skills, technical writing abilities, demonstrated leadership abilities, communication skills, computer literacy, and bilingualism in French and English.

 Minimum Experience:

• Minimum of five years of experience in Quality, Compliance, and/or Regulatory Affairs within the pharmaceutical or healthcare industry.
• Experience in stability testing and data analysis in a GMP-regulated environment and extensive experience in regulatory submissions and interactions with Health Canada or other regulatory bodies.

 Other Job-Related Skills/Background (include licenses/certifications):

• Knowledge of the Mexican market regulations is an asset

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 41.00/hr.