Discover Impactful Work:

Supervise the activities of a team of QA Technicians within Laboratory Operations, ensuring that all Standard Operating Procedures (SOP), current Good Manufacturing Practices (GMP), current Good Laboratory Practices (GLP) and corporate quality standards and client objectives/timelines are achieved. 

Day in the Life:  

• Supervise a Team of QA Technicians responsible for completing the sampling of packaging components and raw materials; completing testing and release of Packaging Components and inspecting/testing In-Process materials (i.e. tablets/capsules). 

• Review/Approve packaging component specifications 

• Develop and prepare schedule for quality support; assigns workload and sets objectives on a priority-based system.   

• Review analytical data for accuracy and compliance.  Perform failure investigations and apply agreed upon strategies.  Update SAP systems.  Produce monthly labour reports as required, update and create SOP’s. 

• Ensure cGMP and Environmental Health & Safety (EHS) compliance, as well as good laboratory housekeeping practices of direct reports is maintained. Conduct EHS incident investigations for the group. 

• Provide technical leadership for sampling challenges. 

• Conduct daily team huddles in order to facilitate problem solving and communication.  Maintain accountability of the team with regards to standard work, compliance, scientific integrity and project execution. 

• Ensure that all documentation within the Group are completed to the highest quality standards, in compliance with Attributable Legible Contemporaneous Original and Accurate (ALCOA) and that any formal investigations. 

• Design, monitor and communicate progress against the schedules for each QA Technician to ensure that samples are received in accordance with project timelines, On Time Delivery (OTD) dates and client expectations. 

• Supervise the training of all associates within Group to ensure that they are fully competent to conduct the projects assigned to them and that they are provided with a career development plan. 

• Ensure professional development of self and staff by keeping up to date with advances in analytical, pharmaceutical and regulatory developments. 

• Perform annual performance reviews for associates in the group. 

• Support, develop and implement departmental continuous improvement initiatives. 

• Makes recommendations to Manager for additional personnel and equipment resources that might be needed to meet our project commitments. 

• Promote a safe working environment, reports potential hazards and ensure all direct reports follow Environmental Health and Safety procedures. (include for all People Leaders) 

• Select, develop and evaluate staff to ensure the efficient operation of the function. Works with and advises staff on administrative policies and procedures. (include for all People Leaders) 

Keys to Success:

Education:  

Bachelor of Science (B.Sc.) in organic chemistry, analytical chemistry or a science related to pharmaceutical analysis. 

Experience:  

Minimum 5 years’ experience in quality control/analytical development within the pharmaceutical industry  

Previous Supervision and/or leadership and training experience 

Equivalency:  

Equivalent combinations of education, training, and relevant work experience may be considered.  

Knowledge, Skills and Abilities: 

Excellent knowledge of Good Manufacturing Practices, Good Laboratory Practices (GLP), International Conference on Harmonization (ICH) and United States Food and Drug Administration (FDA) compliance knowledge. Strong knowledge of Pharmaceutical Quality Assurance and Packaging process. Proven problem solving skills. Ability to deal with some confidential information which is restricted. Previous method and analytical instrumentation validation experience in the pharmaceutical industry. Well organized and detail oriented. Strong interpersonal and communication skills (both oral and written). Demonstrated leadership skills. Experience with Microsoft Office Applications. Proficiency in the English Language.