Manager Packaging Process-13-12116
MANAGER PACKAGING PROCESS
Reference #13-12116 (DS)
Sanofi Pasteur Limited is looking for a knowledgeable and results driven individual to join our Formulation, Filling and Packaging team as Manager Packaging Process. Reporting to the Deputy Director Label and Pack, this individual will ensure that the packaging process is compliant with safety, quality and regulatory requirements. Key responsibilities will include the following:
1. Packaging Process Management:
- Ensure SOPs related to the labeling and packaging processes are written, revised and approved in a timely manner.
- Ensure all Labeling and Packaging equipment are compliant to safety requirements.
- Ensure all Labeling and Packaging equipment are compliant to Quality internal requirements and cGMP (validation, qualification CFR 11 when required and proper documentation).
- Ensure all labeling of packaging equipment is properly maintained (PM program) and have all critical spare parts in inventory.
- Develop, review and/or revise Batch Production Records (BPRs) for labeling and packaging.
- Develop and revise specifications related to labeling and packaging components.
- Establish and define packaging processes and technology for new presentations.
- Support supervisors with active supervision and operational troubleshooting.
2. Quality and Regulatory Compliance:
- Ensure corrective and preventive actions (CAPAs) are completely in a timely manner.
- Ensure internal, corporate and agency audits are completed in a timely manner and actions are closed and documented.
- Support EBLA submission teams by providing file information and reviewing files.
- Perform investigations involving customer complaints, PDs, IRs and Non-conformances.
3. Project Management:
- Work with the department and initiate capital projects relevant to the labeling and packaging processes.
- Define project objective and scope.
- Develop, define and write Labeling and Packaging equipment specifications and URS.
- Determine cross functional team that works on projects and define roles and responsibilities.
- Manage budgets, project quality and time lines.
- Manage a project team of up to ten (10) individuals to achieve project objectives.
- Manage the equipment installation, commissioning and validation activities.
4. Process Improvement:
- Initiate and carry out process and equipment improvement projects.
- Submit Change Control Requests (CCRs) and take actions to document changes and close them in a timely manner.
- Perform and/or support validation and qualification activities.
5. Administrative and Budgetary:
- Assist the department with the development and review of budgets related to the Labeling and Packaging operations.
- Filing, emails, memos and office correspondence.
- Participate in meetings and assist/collaborate with other departments.
6. Productivity Management:
- Establish production performance expectations and line standards.
- Lead the production team and run daily production meetings.
- Manage and maintain the department's productivity monitoring and reporting database.
- Issue production and performance reports and review with staff.
- Perform root cause analysis and troubleshooting.
• Minimum Bachelor’s degree in Engineering or Business; a degree in Industrial and Systems Engineering or Operation and Production Planning is preferred.
• Minimum of seven (7) years of previous relevant experience in a biological, pharmaceutical or food manufacturing environment is required.
• Industry related knowledge of labeling and packaging processes, technology and machinery.
• Knowledge of packaging components (labels, cartons, etc.) design and application.
• Excellent knowledge of cGMP with the context of pharmaceutical/biological manufacturing.
• Strong systematic problem solving skills.
• Ability to organize, motivate, focus and lead a cross-functional team to achieve a common goal.
• Strong computer skills - Word, Excel, PowerPoint, Visio AutoCAD and MS Project.
• Experience in validation technology (test development) and writing and execution of protocols.
• Ability to manage multiple projects with focus and consistency.
• A P. Eng. designation is beneficial
• A certificate or diploma from a Packaging Institute or packaging related courses is preferred
Qualified candidates may submit their on-line resume with cover letter to www.sanofipasteur.ca quoting reference Manager Packaging Process, Ref. #13-12116(DS).
Sanofi Pasteur, the vaccine division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Sanofi Pasteur Limited, located in Toronto, is one of the company’s four major R&D and manufacturing sites. We are home to Sanofi Pasteur’s North American centre for Analytical and Bioprocess R&D. As well, we are the largest Canadian vaccine producer: each year, we manufacture 50 million doses of vaccine and distribute them to more than 90 countries around the world. This variety of activities offers employees diverse opportunities for personal and professional growth. Our company attracts some of the best minds in the business from across the globe. Our 1,200 employees give us their best and we offer the best in return.
Sanofi inCanadaembraces diversity in the workplace and is committed to achieving employment equity. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome applications from women, members of visible minorities, Aboriginal peoples and persons with disabilities.
Thank you in advance for your interest. Only those candidates selected for interviews will be contacted.
Job : Production
Primary Location : Canada-Ontario-Toronto
Job Posting : Jan 21, 2014, 9:08:49 AM
Shift : Day Job
Job Type : Regular
Employee Status : Regular