Job Description

Description :

Do you want responsibilities worthy of your know-how? Are you looking to excel at work and have a positive impact on your community? If the entrepreneur in you wants to open doors, act boldly and make a difference all while focusing on our patients and customers we\xe2\x80\x99re a match made in heaven. Change your life and the lives of others! Join us at Pharmascience, an agile and inclusive company where you\xe2\x80\x99ll be free to reach your full potential and achieve great things. Here, your ambition is part of the equation!

Benefits of working at Pharmascience

• Competitive salaries on experience
• In-house referral program up to $3000
• Yearly bonus program based on team and individual performance
• Holidays and floater days
• Collective insurance & access to free telemedecine
• Pension plan

Biopharmaceutics (GLP/GCP) Activities:

• Responsible for performing Quality Assurance (QA) functions that assure the GLP compliance of the Biopharmaceutics facilities, including regulated studies and projects performed at Pharmascience, and reporting the results of these functions, including all findings and recommendations, to management.
• Must assist management in the following three areas covering quality assurance and compliance: study/ project activities, facility/ compliance activities, and client/ regulatory agencies / subcontractor audits. The Senior QA Auditor will be a fully trained individual who can adequately execute within the three areas.
• The QA functions include, but are not limited to, independent assessment of study protocols and study plans, drug shipment, Trial Mater Files, TK/PK data review, system validation records, system use, laboratory procedures, equipment records, training records, study data, and reports to determine the level of compliance with applicable Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) regulations, company policies (POL), SOPs, and study protocols.
• Performs in-process audits according to protocols/study plans, GLPs, and departmental SOPs.
• Maintains the QA Master Schedule.
• Audits system validation records and procedures for compliance with the GLPs, Validation Master Plan, POLs, and departmental SOPs.
• Performs process audits according to departmental SOPs
• Performs inspections of designated facility areas and applicable 3rd party vendors.
• Host regulatory agencies/ client inspections
• Performs audits of equipment, departmental, and training records.

Royalmount Laboratories GMP Activities:

• Performs the review/approval of protocols, SOPs, raw data and results (reports) generated during QC testing of raw material, and finished products for the testing of nitrosamine impurities for internal/external/third party clients and ensure that all produced data and results are in accordance with methods, specifications, SOP\xe2\x80\x99s, GMP.
• Performs regular audits of the laboratory
• Performs audits SOPs for compliance with GMPs
• Performs the review / approval of LIR
• Responsible for investigating non-conformances and approve deviations and ensure CAPAs are implemented to improve quality

Analytical Testing Laboratory (Cannabis Laboratory):

• Performs facility audits
• Manage and maintain SOP procedure
• Audits SOPs for compliance with GMPs
• Continuously improve procedures
• Establish and maintain strategies towards compliance (i.e GLP, GMP, ISO).

Other Responsibilities:

• Communicates effectively with operational managers, colleagues, Departmental Management, and Study Directors/Bioanalytical Investigators/Principal Investigators.
• Demonstrates commitment to quality.
• Effectively works in a team and demonstrates a commitment to achieving company goals.
• Efficiently prioritizes assigned daily workload and uses time productively. \xc2\xb7
• Maintains accurate Quality Assurance (QA) reports of inspections.
• Assists with the training and development of QA Auditors.
• Serves as a professional and positive role model for the QA department.
• Attends all applicable study, project, and department meetings.
• Serves as QA Representative for special groups or projects.
• Adheres to safety procedures at all times.
• Punctual and reliable attendance according to company policy.
• Ability to work extended hours beyond normal work schedule to include, but not limited to,
• evenings, weekends, extended shifts, sometimes on short notice.
• Ability to work under specific time constraints.

This position includes, but is not limited to the above responsibilities. The incumbent may perform other duties as assigned.

#LI-Onsite

Education : Bachelor
Bachelor

Experience : 5 years: of experience in quality assurance, biopharmaceutical within the pharmaceutical industry

Pharmascience