Job Description

Job Summary

We are seeking a highly skilled

Regulatory Affairs and QA Manager

to join our dynamic team. This role will require developing and implementing SOP's and associated regulations to comply with FDA and Health Canada requirements, as well as lead the quality assurance operations. Formulating HBC Products a plus.

Job Responsibilities:

Develop implement and update Regulatory and quality programs, verifications, and SOPs to ensure the plant is meeting regulatory compliance requirements Conduct risk assessments Manage non-conformances and ensure corrective actions are taken Lead and coordinate internal and external audits Update current SOPs and develop and implement new SOPs as required Ensure compliance with SOPs, GMP, and quality practices and validation Implement, track, and report on KPIs Conduct stability studies for expiration date determination Manage water system qualification and water testing Ensure all documentation, procedures, and records related to product quality and safety Stay up to date on regulatory compliance and implement necessary adjustments. Implement/Update and manage programs for Pest Control, Line Clearance, Sanitization, Validation, Risk Management, and recalls (mock recalls). Ensure Supplier/Vendor qualification (including third-party lab qualification) Establish procedures and controls for the handling of materials and non-conformities Ensure completion of Out of Specifications (OOS) Investigations Develop and implement specifications and procedures related to release of raw materials and components (quarantine, sample testing, releasing and reject area) Building Design Compliance Environmental Monitoring, GMP Mapping and Sanitization program Complete Annual Product Quality Reviews (APQRs)

Training and Leadership:

Develop and implement the training to all staff on quality, GMP, and SOPs Be a leader and create an understanding of quality expectations across all departments Develop the quality team

Qualifications:

Comprehensive knowledge of FDA and Health Canada regulations related to Cosmetic and Drug products Previous experience with external audits 3 to 5 years experience in a quality department 2 years experience as a Supervisor or Manager Degree in related field (chemistry, biochemistry, biochemistry, engineering) Previous work experience with Quality compliance in the pharmaceutical/cosmetic industry, GMP, SOPs, and interacting with Health Canada & FCA with regards to GMP/cGMP compliance.
Job Types: Full-time, Permanent

Pay: From $70,000.00 per year

Benefits:

Dental care Extended health care Life insurance On-site parking Vision care
Ability to commute/relocate:

Aylmer, ON: reliably commute or plan to relocate before starting work (preferred)
Application question(s):

What Industry is your Quality Assurance experience in? (Pharmaceutical, Cosmetic, Food, etc)
Experience:

Quality assurance: 3 years (preferred)
Work Location: In person