Quality Systems Specialist

仕事内容

Quality Systems Specialist (8233)

Career Opportunities: Quality Systems Specialist (8233)

Requisition ID 8233 - Posted - US - Quality - CA - Laval - City (1)

Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians.

Our team manufactures and markets a wide variety of pharmaceutical and health products that are distributed in pharmacies, healthcare practices and hospitals across the country.

At Bausch Health, we invest in our employees and we believe in the importance of cultivating performance and outdoing ourselves in finding new and better solutions with the aim of responding innovatively and effectively to current needs.

Summary Of The Position

Reporting to the Supervisor, Commercial QA, your will be responsible for:

Managing the complaint and change control systems;

Managing documentation and 3PS product management;

Updating procedures related to quality systems.

Key Responsibilities

• Maintain the quality system related to change control, investigation of non-conformance issues, CAPAs and customer complaints. Follow-up with CMOs to receive missing documents and reports.
• Maintain the complaints system by coordinating investigation requests, requests for medical information, review of CMO investigation reports and closing in the complaints database.
• Review and authorize change requests submitted by contract manufacturing companies, perform QA impact assessments and effectiveness checks;
• Managing the notifications of changes applicable to Bausch Health products sent by the suppliers (Finished products, raw materials, packaging materials, etc.);
• Participate in the review and approval of internal SOPs;
• Track the progress of quality KPIs regarding change controls and complaints. Report KPIs monthly to management;
• Provide regular status and trend studies of quality related indicators to management;
• Review, file 3PS documentation and follow up with CMOs to receive missing documentation required by regulations;
• Assist and conduct internal inspections and issue inspection reports;
• Other responsibilities, deemed necessary by the management of the quality system, may be assigned additionally.
  

Qualifications

• Education: B.Sc. in an appropriate scientific discipline
• Specialized Training: Comprehensive knowledge of cGMP, Canadian and American regulations (Health Canada and FDA). Experience in auditing procedures, processes and mechanisms in a GMP environment is highly considered an asset. Good understanding of USP and Regulatory expectation regarding Analytical Method Validation criteria (HPLC, GC, etc.). Very strong skills in investigations and problem solving;
• Excellent oral and written communication skills in French and English;
• , and high level of autonomy;
• Ability to occasionally work under pressure and meet tight deadlines;
• At least 5year experience within a pharmaceutical Quality Unit, including experience in management of Third-Party suppliers, quality agreements, audits and updates of establishment licenses for pharmaceutical products.
  

The masculine is used in this publication without prejudice for the sake of conciseness.

Bausch Health is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.

Bausch Health is an EEO/AA employer M/F/D/V.