Supervisor, Quality Control

Job purpose

The main responsibility of this position is to lead and mentor staff, establish and maintain the quality control systems and processes for, bulks and finished goods including stability studies to meet Health Canada and FDA regulations.This position will also provide release requirements for the full QC lab cycle and functions and will be accountable to ensure all activities are performed in a GMP manner and according to all approved procedures.This position will implement improvements to efficiency, and work with all departments to maintain the company’s regulatory compliance status and ensure right first time quality is achieved within 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

·Act as the Lab Manager back up if needed

·Ensure stability program meets the current requirements of the regions where product is marketed

·Schedule stability testing according to program schedule

·Ensure all stability requirements for Operational Products are met on an annual basis

·Review APR/SSR in order to determine OOT results

·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

·Ensure calibration programs are maintained and compliant to program

·Performs routine warehouse audits and follows up on action items

·Participate in Vendor audits, quality meetings and programs

·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

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

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

·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

Working conditions

·Continuous walking and standing

·Ability to work under stressful conditions and prioritize workload

·Numerous and varied responsibilities demanding attention and detail

Physical requirements

Office based

Direct reports

Analyst & Senior Analyst Quality Control