Production Compliance Associate

6 months ago

Strathroy, Canada Catalent Full time

**Production Compliance Associate**

**Position Summary**

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

Reporting to the Operations Manager, Production, this salaried position is responsible for implementing, applying, and maintaining quality standards inside a manufacturing and packaging production environment. Leading and supporting quality initiatives within the production department including processes, products, and personnel.

This position is located in Strathroy, Ontario, one of two sites located in Canada offering softgel development and manufacturing capabilities for the Pharmaceutical and Consumer Health industries. We have a broad range of integrated formulation, manufacturing, analytical and packaging services to offer full-service turnkey solutions.

Regular working hours: 8:00 AM - 4:30 PM or 8:30 AM - 5:00 PM with a 30-minute unpaid lunch.

**The Role**
- Leading and coordinating investigations within production including CAPA implementation
- Conducting self-inspections in production ensuring compliance to standard
- Assessing quality issues in production areas in collaboration with QA
- Supporting the process of creating, reviewing, and revising master production documents ensuring and maintaining consistency
- Follows all SOP’s, GMP’s and Safety procedures
- Participates and leads in regulatory inspections and customer audits and completes all documentation as required
- Reports and implements corrective actions for trends and quality issues
- Perform other duties as required.
- High School Diploma, GED or equivalent is required.
- Post secondary Degree or Diploma is preferred.
- Certificate or other formal qualification awarded based on completion of a course in a Life Sciences related field would be considered an asset.
- Two (2) years of relevant and practical experience in a manufacturing, pharmaceutical and/or GMP facility is preferred.
- Excellent interpersonal, organizational, and communication skills (both verbal and written).
- Demonstrated strong technical writing skills
- Works cooperatively in teams, communicates clearly, and has effective listening skills.
- Ability to work independently, as required, and complete daily activities according to schedule.
- Strong problem solving and analytical skills.
- Demonstrates trustworthiness by being honest, dependable, and reliable
- Ability to operate in a respectful and professional manner at all times
- Knowledge of workplace safety and safe lifting and handling procedures
- Strong working knowledge of computers and skilled in the use of Microsoft Office
- The employee is often required to sit and use their hands and fingers, to handle or feel and to manipulate keys on a keyboard.
- The employee is occasionally required to stand, walk, reach with arms and hands, bend, or twist, and to stoop, kneel, crouch or crawl.
- Vision abilities required by this job include close vision.

**Why you should join Catalent**:

- Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance);
- Group Retirement Savings -Registered Pension Plan (RPP) with employer contributions;
- Paid Time Off Programs incl. vacation, banked time & personal time;
- Employee Reward & Recognition programs;
- Opportunities for professional and personal development & growth incl. tuition reimbursement

**Catalent offers rewarding opportunities to further your career** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.

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