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Manager, Quality Assurance
Manager, Quality Assurance
Windsor, Ontario is 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.
Position Summary
Reporting to the Director of Quality, Consumer Health Canada, the Manager, QA is accountable for the Quality Assurance and cGMP compliance activities related to commercial operations for the Catalent Ontario, Windsor manufacturing site.
The Role
Plan, organize, schedule, and maintain the activities of the Quality Assurance department to ensure that the department supports the needs of manufacturing.
Ensure comprehensive technical and administrative review of the batch manufacturing and analytical data generated by Operations and GMP test laboratories relating to in-process testing and product release.
Lead, coordinate and participate in investigations and corrective action identification and implementation of Deviation Management excellence and Right First-Time documentation and monitor and facilitate on-time closure of corrective action/preventative action items within all areas of the organization.
Perform quality review of qualification protocols and reports for facility, equipment, process, and cleaning
Monitor and participate in Quality Trend programs and analysis for quality metrics including but not limited to Deviations, CAPA/Corrections, BRRFT, Customer Complaints, Reprocessing, etc.
Actively participate in and monitor existing metrics to ensure required results are met or exceeded.
Must be able to work extended hours, weekends as needed, especially when problems occur or when deadlines must be met.
The Candidate
Bachelor's Degree in Science (Chemistry, Biology, Microbiology) or related field.
3 - 5 years of experience in QA/QC or related field, direct people management experience required.
Experience working in a manufacturing, pharmaceutical and/or GMP facility an asset.
Strong computer skills in Microsoft Office Suite (Word, PowerPoint, Excel, Access, Outlook).
Solution oriented to solving issues and an effective team player.
Must possess confidence and be able to communicate with all levels of personnel and regulatory authorities.
Must have the ability to manage complex projects and resolve complex issues.
Must have excellent working knowledge of the current Regulatory landscape, FDA 21CFR Parts 210&211. HPFBI GMP guidelines, and EU GMP guidelines.
Strong analytical skills with the ability to assess scientific data.
Ability to work independently and under pressure.
Natural talent in building and maintaining strong working relationships with internal and external contacts.
Regular working hours: 8:00 AM – 4:30 PM or 8:30 AM – 5:00 PM with a 30-minute unpaid lunch.
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.
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.
Windsor, Ontario is 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.
Position Summary
Reporting to the Director of Quality, Consumer Health Canada, the Manager, QA is accountable for the Quality Assurance and cGMP compliance activities related to commercial operations for the Catalent Ontario, Windsor manufacturing site.
The Role
Plan, organize, schedule, and maintain the activities of the Quality Assurance department to ensure that the department supports the needs of manufacturing.
Ensure comprehensive technical and administrative review of the batch manufacturing and analytical data generated by Operations and GMP test laboratories relating to in-process testing and product release.
Lead, coordinate and participate in investigations and corrective action identification and implementation of Deviation Management excellence and Right First-Time documentation and monitor and facilitate on-time closure of corrective action/preventative action items within all areas of the organization.
Perform quality review of qualification protocols and reports for facility, equipment, process, and cleaning
Monitor and participate in Quality Trend programs and analysis for quality metrics including but not limited to Deviations, CAPA/Corrections, BRRFT, Customer Complaints, Reprocessing, etc.
Actively participate in and monitor existing metrics to ensure required results are met or exceeded.
Must be able to work extended hours, weekends as needed, especially when problems occur or when deadlines must be met.
The Candidate
Bachelor's Degree in Science (Chemistry, Biology, Microbiology) or related field.
3 - 5 years of experience in QA/QC or related field, direct people management experience required.
Experience working in a manufacturing, pharmaceutical and/or GMP facility an asset.
Strong computer skills in Microsoft Office Suite (Word, PowerPoint, Excel, Access, Outlook).
Solution oriented to solving issues and an effective team player.
Must possess confidence and be able to communicate with all levels of personnel and regulatory authorities.
Must have the ability to manage complex projects and resolve complex issues.
Must have excellent working knowledge of the current Regulatory landscape, FDA 21CFR Parts 210&211. HPFBI GMP guidelines, and EU GMP guidelines.
Strong analytical skills with the ability to assess scientific data.
Ability to work independently and under pressure.
Natural talent in building and maintaining strong working relationships with internal and external contacts.
Regular working hours: 8:00 AM – 4:30 PM or 8:30 AM – 5:00 PM with a 30-minute unpaid lunch.
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.
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.