Lab manager Jobs in Brampton, ON

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

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

Working conditions

Physical Requirements

Office based

Direct reports

Analyst & Senior Analyst Quality Control

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Quality Assurance

Industries

Pharmaceutical Manufacturing

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