Career Opportunities: Stability Operations Specialist (7769)
Requisition ID 7769 – Posted – Canada – Steinbach – Operations – CA – Steinbach – 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.
ROLE TITLE: STABILITY OPERATIONS SPECIALIST
DEPARTMENT: QUALITY – STABILITY
REPORTS TO: SUPERVISOR, STABILITY OPERATIONS
HOURS: MONDAY-FRIDAY, 8:00 -16:30
Reporting to the Supervisor, Stability Operations for the Steinbach site this position is responsible to complete analysis and trending as well as review and approval of stability data. This position will support various documentation requirements across the site as it relates to both existing and emerging products through the preparation of clear and concise written documentation.
Responsibilities:
Generate and revise documents related to Stability, ERs, CAPAs, audit observations, continuous improvements, and validation reports.
Assist in Stability protocol study design for new and ongoing stability programs in accordance with ICH guidelines. Summarize and communicate requirements to facility departments to maintain compliance for existing product lines and support new project applications.
Complete review, analysis, and trending of stability data. Notify management of out of specifications and out of trends for marketed products and assist in internal investigations.
Compile and prepare Annual Product Quality Reviews. Review applicable trending and linear regression analysis for marketed products.
Maintain documentation and support systems in compliance with all applicable procedures and regulations including SOPs.
Prepare final written reports assessing and describing the behavior of product.
Ensure compliance with good manufacturing practices (cGMP) and regulatory requirements in manufacturing of pharmaceutical products.
Participate in the area of occupational health, safety, and wellness.
Education and Experience:
Bachelor of Science degree or diploma in Chemistry or related studies and/or equivalent combination of education and experience is required.
Minimum of three years’ experience in a pharmaceutical manufacturing environment
Working knowledge in Microsoft Office with a proficiency in Word and Excel.
Working knowledge and understanding of ERP (SAP) and GLIMS.
Ability to use software to analyze and interpret data.
Working knowledge of the associated regulations that govern the pharmaceutical industry.
Required competencies/Abilities:
Additionally, successful candidates will demonstrate:
A strong solution focus and high attention to details to identify problems and drive for results.
Excellent time management skills with a proven ability to meet deadlines and commitments.
Sense of urgency and flexibility.
Good verbal and written communication skills.
Why Bausch Health?
Bausch Health is a dynamic, growing company with a dedicated team committed to excellence and to helping Canadians by providing them with important, high-quality healthcare solutions. It is a progressive, exciting place to work where opportunities abound for current and new employees to help make a difference for Canadians.
We strongly believe the success of Bausch Health coincides with the achievement of personal and professional goals. We are a progressive, exciting place to work – where opportunities abound for new and current employees.
Our team members work in a dynamic environment where professional and personal growth is encouraged. You have the satisfaction of knowing that you are working with dedicated individuals who share a common vision of innovation and an unrelenting focus on improving people’s lives with our health care products.
Bausch Health accomplishes its commitment to diversity and inclusiveness by simultaneously nurturing the diversity of thinking, ideas and outlook that already exists among our employees. Through consistent and aggressive efforts, we attract, develop and retain talented people with a variety of perspectives from all backgrounds and cultures. Working in an environment that enables them to apply their collective talents to our shared principles and commitments will enable us to deliver the greatest value to our customers and the patients we serve.
By cultivating a winning attitude, we empower employees to seize opportunities that support the company’s mission to improve people’s lives.
What we have to offer our employees in our state-of-the-art Steinbach manufacturing site:
Annual Bonus Plan
Insurance coverage (Medical – Dental – Vision – Short & Long-Term Disability – Life – AD&D)
Employee Assistance Program (EAP)
Employee Stock Purchase Plan (ESPP)
Registered Retirement Savings Plan (RRSP)
Gym on site
Tuition Reimbursement
INSPIRE: Employee Recognition Program
Service Awards
Employee Referral Program
Top Up Maternity Leave
Full-service Cafeteria – Free coffee & tea
Free parking
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.
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