Cleaning Validation Specialist

3 weeks ago

Steinbach, Canada Bausch Health Companies Full time

Cleaning Validation Specialist (9127)

**Career Opportunities: Cleaning Validation Specialist (9127)**

Requisition ID **9127** - Posted - **Canada - Laval** - **Manufacturing / Operations** - **CA - Laval** - City (4)

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.

**TITLE: CLEANING VALIDATION SPECIALIST - LAVAL SITE**

**GENERAL RESPONSIBILITIES**

Verify the effectiveness of cGMP cleaning procedures for removal of product residues, degradation products, excipients, and/or cleaning agents as well as the control of potential microbial contaminants. In addition ensure there is no risk associated with cross-contamination from active ingredients.

**KEY RESPONSIBILITIES**
- Prepare or review cleaning validation documentation including Cleaning Validation Master Plan, Cleaning Validation procedures, protocols and reports.
- Review and approve cleaning procedures.
- Coordinate analytical studies with QC labs and cleaning procedure development and/or method development to ensure all key elements are incorporated and scientifically justified.
- Coordinate with production operators and managers cleaning validation activities.
- Coordinate with QC labs sampling and testing related to cleaning validation studies.
- Perform study for the on-going maintenance of the cleaning validation program including the annual monitoring, new product assessments, revalidation activities, clean/dirty equipment hold times.
- Review change related to cleaning process to address all impacts related to cleaning validation.
- Analyze data and prepare final reports and where required implement corrective actions.
- Ensure compliance with good manufacturing practices (cGMP) and regulatory (Canada, USA) requirements in a manufacturing environment.
- Participate in the area of occupational health, safety, and wellness.

**COMPETENCIES**
- Drive for results
- Can be counted on to deliver results successfully
- Sets challenging goals and strives to be a top performer
- Steadfastly pushes self for results in support of division
- Customer Focus
- Acts with the customer in mind
- Establishes & maintains effective relationships with customers, gains trust & respect
- Teamwork/working with others
- Relates well to all kinds of people, up, down, sideways, inside & outside the organization
- Builds constructive and effective relationships with the team / work group
- Uses diplomacy and tact and can diffuse even high tension situations comfortably
- Time Management
- Values time, uses it effectively and efficiently
- Concentrates efforts on the more important priorities
- Gets more done in less time than others
- Can attend to a broad range of activities
- Planning
- Accurately scopes out length & difficulty of tasks & projects
- Sets objectives & goals - More appropriate for Manager
- Anticipates & adjusts for problems/roadblocks
- Evaluates results
- Problem Solving
- Uses logic & methods to solve difficult problems with effective solutions
- Probes all fruitful sources for answers
- Can see hidden problems
- Looks beyond the obvious & doesn’t stop at the first answer
- Attendance
- Attends work regularly
- Punctual
- Quality & Compliance
- Adheres to standard operating procedures, defined practices & regulations
- Attentive to detail & accuracy with optimal speed & volume
- Produces work that is right the first time
- Workplace Safety, Health & Environment
- Accepts responsibility for the safety of self & others
- Identifies & eliminates safety hazards & risks of injury / incidents
- Ensures use of fitted personal protective equipment as appropriate

**POSITION SPECIFICATIONS**

Knowledge/Qualifications:

- Bachelor’s degree in Science or Engineering or related studies and/or equivalent combination of education and experience is required. Considerations will be made for Cleaning Validation Specialists who do not currently hold a degree, but are committed to continuous learning and ongoing development. Working knowledge in Microsoft Office.
- Previous Experience:

- Working knowledge of associated regulations that govern the pharmaceutical industry. Minimum 3 years experience in a pharmaceutical manufacturing environment.

**WORKING CONDITIONS**
- Manufacturing, offices
- 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 opp

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