QUALIFICATIONS:

• A bachelor’s degree in Biological, Chemistry, Pharmaceutical, Health Sciences, or a related field from a recognized institution.
• Minimum 1 year of experience in a regulated environment.
• Good scientific writing skills, strong problem-solving abilities, high integrity.
• Familiarity with regulatory frameworks such as the Cannabis Act, ICH, Food & Drug Regulations, CFR, Eudralex, or experience in food manufacturing considered an asset.

SKILLS, KNOWLEDGE, AND ABILITIES:

• Ability to understand and follow complex written procedures.
• Excellent written and verbal communication skills.
• Excellent organizational and analytical skills with a high attention to detail.
• Proficient in utilizing Microsoft Office applications.
  Must have the ability to maintain integrity and honesty at all times

ROLE OVERVIEW:

The primary purpose of the QA Analyst is to oversee and execute quality assurance activities, including tasks like documentation, addressing deviations, managing changes, and enhancing site processes within a cGMP (current Good Manufacturing Practices) environment. Furthermore, the role encompasses executing quality assurance duties related to the Quality Management System for manufacturing cGMP pharmaceutical products. The emphasis lies on ensuring compliance with regulations and maintaining high-quality standards throughout the manufacturing process.

The following is a general description of duties that are done regularly in this role. Please note that employees will be asked to perform duties outside of the following to assist in other Company-related activities as required.

• Lead documentation of non-conformances: Documenting instances that do not meet specified standards.
• Perform records review and site audits: Ensuring compliance through inspection and scrutiny of records and site conditions.
• Lead equipment and facility qualifications: Oversee and execute the qualification processes for equipment and facilities.
• Perform activities related to inventory control: Managing and maintaining inventory levels.
• Participate in Change Control activities: Contributing to managing changes in processes or procedures.
• Participate in deviation/customer complaints investigations: Investigating and participating in the resolution of deviations and complaints from customers.
• Participate in routine Quality System maintenance: Regularly maintaining and ensuring the integrity of the quality management system.
• Create and revise Standard Operating Procedures (SOPs) and other controlled documents: Creating, updating and improving standard procedures and documents.
• Participate in the Annual Product Quality review: Contributing to the annual product quality review process