Project Leader, Prod Invest

• Responsible to ensure all manufacturing investigations are investigated and documented in a manner which ensures compliance with site procedures and all applicable GMP's.

• Recognize critical path for investigations leading to timely identification of root cause, corrective & preventative actions.
• Facilitate meetings with multiple Subject Matter Experts (SME's) as required.
• Perform throrough impact analysis in collaboration with all SMEs including Vendors.
• Ensure identification of most probable root cause, corrective action & preventative action for all completed investigations.
• Regularly review on-going progress on all open investigations with Production Investigations team, QA approver team and Production Management team to ensure all timelines are attainable.
• Escalate any roadblock/issues which may pose the risk for meeting the investigation timelines.
• Prepare clear, accurate and concise investigation reports and review the reports for completeness and accuracy prior to approval by Department Manager.
• Lead, oversee, or participate in cross functional projects associated with manufacturing deviation reduction initiatives.
• Assist Production Supervisors/Team Leaders in ensuring investigations are initiated and relevant information pertaining to the deviations are gathered in a timely manner. Act as technical resource and provide support & guidance to groups within Operations.
• Work as members of a team to achieve all outcomes;
• Operate in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements;
• Perform all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

• Education

• Post Secondary degree in Engineering, Sciences or a related technical field preferred or equivalent combination of College diploma and experience in a manufacturing environment

• Knowledge, Skills and Abilities

• Fluency in project management & Root Cause Corrective Action (RCCA) tools
• Superior organizational, interpersonal communication skills
• Ability to manage time effectively
• Ability to work independently and manage multiple priorities in a fast-paced and changing environment
• Strong command of the English language, both written and verbal
• Knowledge of Good Manufacturing Practices (GMP)
• Proficiency with Microsoft Word, Excel, and SAP.

• Experience

• 5-7 years' experience in a pharmaceutical or manufacturing industry, preferably in a Manufacturing, Engineering or QA/QC role.

Apotex