QUALIFICATIONS

• Bachelor’s Degree in Science or related field
• Minimum 5 years’ experience in a pharmaceutical manufacturing environment
• strong supervisory experience is an asset
• Knowledgeable and experienced application of Health Canada and FDA regulations
• Ability to establish and maintain trusted and respected relationships with all internal and external stakeholders
• High energy level, ability to promote positive change and influence others
• Promote and maintain a lean culture
• Strong knowledge of analytical instrumentation
• Excellent written and oral communication skills with ability to articulate messages and interact with a variety of audiences (internal and external)
• Strong organizational, analytical, multi-tasking, detail oriented, trouble shooting, problem solving and root cause identification skills
• Proficiency with applicable software (LIMs and Empower)
• Ability to identify any deviations to procedures or systems and make recommendations for corrective measures
• Ability to implement short range strategies and objectives towards enhancing the quality standards of the department
• Any deviations to procedures or systems are brought to the Director’s attention with logic, data and corrective measures
• Implement short range strategies and objectives towards enhancing the quality standards of the department and facility.

PHYSICAL REQUIREMENTS

• Continuous walking and standing

JOB PURPOSE

The main responsibility of this position is to lead and mentor staff, establish and maintain the quality control systems and processes for assessing and qualifying alternate vendors for materials (API, Raw Materials and Packaging Components) to meet Health Canada and FDA regulations. This position will provide full quality control reports (Vendor Assessment in regards to analytical specifications, analytical validations and product assessment in reference to Residual Solvent Requirements, Elemental Analysis Requirements and Nitrosamines) to assist in the qualification of new vendors, in a GMP manner and according to all approved procedures. This position promotes right first time quality achievement in their lab and support lab investigations, ensuring their completeness/robustness, while ensuring their timely closure.

DUTIES AND RESPONSIBILITIES

• Supervise, lead and mentor staff including ongoing coaching, performance feedback and reviews, routine meetings, standard hours, collaboratively identifying objectives and career development
• Ensure staff are working in a safe environment and are complying with safety procedures at all times
• Responsible for overall day-to-day operation of the lab
• Plan, schedule, organize and monitor workload optimally to ensure all operations and tasks are performed within required turnaround time metrics and adherence to set schedules, accommodating testing requirements and meeting departmental goals
• Author risk assessments and reports for Nitrosamines, Elemental Analysis and Residual Solvents evaluations
• Act as the Lab Manager back up if needed
• Investigate and documents discrepancies where required.
• Provide troubleshooting of test method and equipment issues.
• Responsible for full-cycle internal lab investigations, including trending and preventative actions.
• Work closely with and perform follow-ups with Purchasing, Vendor(s), Materials Management, Warehouse, R & D and the QA Department
• Establish and maintain a tracking mechanism to monitor daily requirements
• Identify and implement key process improvements to areas to enhance systems, gain site efficiencies and elevate GMP requirements
• Create, review and write procedures
• Review current systems and procedures and implement changes where appropriate to improve productivity
• Provide analytical instrumentation support to the lab staff
• Participate in Internal, Customer and Regulatory Audits
• Partner with Warehouse and Purchasing to proactively build quality into the processes and systems
• Automates job functions to achieve efficiency improvements
• Perform monthly Health and Safety Audits and safety awareness training
• Respond to Health and Safety audit reports
• Other responsibilities and special projects as required

ADDITIONAL RESPONSIBILITY (ONLY APPLICABLE TO CUSTOMER FACING ROLES)

• Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day