Quality Assurance Supervisor

by Catalent Pharma Solutions

Position Type: Full-time
Location: Strathroy, ON
Date Posted: Jul 09, 2024
Catalent Pharma Solutions

Job Description


Quality Assurance Supervisor

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. This is an exciting opportunity to play a pivotal role in developing the strategy for our new pharmaceutical site and shape the future of our operations in North America.

 

Reporting to the Director of Quality, the Quality Assurance Supervisor is responsible for overseeing the day-to-day activities of the Quality Assurance team, ensuring effective resolution of quality-related compliance issues. The Quality Assurance Supervisor will oversee the management of various quality systems to maintain GMP compliance.

 

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

 

The Role

  • Provide support in various quality system areas, including supplier and material assurance, internal audits, customer regulatory inquiries, change control, document control, and metrics provision.

  • Leads, coordinates, and participates in investigations and corrective action identification/ implementation for Deviations and Right First-Time documentation.  Ensures on-time closure of deviations and corrective action/preventative action items.

  • Provide daily supervision of the Quality Assurance teams, including performance management and support for staff in achieving their personal development goals.

  • Conduct and document training for all team members, ensuring they are adequately trained for their respective duties.

  • Responsible for resource planning for the team based on information from the Master Production Schedule (MPS) and monthly commitment meetings.

  • Provide support during regulatory and customer audits, ensuring readiness and compliance.

  • Provide support ensuring that the batches released for commercial/ clinical needs fully meet regulatory requirements and existing policies and procedures.

  • Perform other duties as required.

 

The Candidate

  • A bachelor's degree in a relevant field such as Life Sciences, Engineering, or a related discipline is required. An equivalent combination of education and experience may also be considered.

  • Bachelor’s degree in Chemistry, Microbiology, or Pharmacy is preferred

  • Minimum 3+ years experience in leading and supervising a team in a Quality Assurance environment, ensuring safety, quality, and productivity.

  • Experience working in a manufacturing, pharmaceutical and/or GMP facilities preferred.

  • Strong commitment to workplace safety and a thorough understanding of occupational health and safety regulations in Ontario

  • In-depth knowledge of GMP compliance and regulatory requirements with a strong understanding of quality systems.

  • Experience in reviewing and approving controlled documents.

  • Proven track record in supporting regulatory and customer audits, and proficiency in overseeing internal audit processes and conducting compliance reviews.

  • Effective attention to detail and a high degree of accuracy.

  • Strong organizational and time management skills to prioritize tasks, allocate resources effectively, and meet operational schedules.

  • Demonstrate applicable ethics and due diligence.

  • Excellent communication (written and verbal), and interpersonal skills.

  • Strong computer skills including Microsoft Office Suite (Outlook, Excel, PowerPoint, Word) and familiarity with quality management systems and related software is advantageous.

  • While performing the responsibilities of the job, the employee is required to talk and hear.

  • The employee is often required to sit and use their hands and fingers, to handle or feel and to manipulate keys on a keyboard. Use of manual dexterity is required.

  • The employee is 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 including vacation, banked time & personal time.

  • Employee Reward & Recognition programs

  • Opportunities for professional and personal development & growth including 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.

 

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

    

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.



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