Production Shift Manager - Afternoon/Evening

Piramal Pharma Solutions; Aurora; On-site; CAD 90,000 - 130,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Shift Manager, Production to lead the active pharmaceutical ingredient production in Canada, ensuring safety, quality and adherence to cGMP and GDP standards.

You will plan shifts, manage batch processing, drive continuous improvement, lead audits and mentor staff, focusing on OTIF and client delivery while reporting KPIs to senior leadership.

Responsibilities

• Plans shift activities and assigns shift targets to all shift members to ensure production safety, quality, efficiency, output and adherence to production schedule.
• Manages and monitors batch processing operations according to SOPs across units (charging liquids/solids, distillation, filtration, sampling, cleaning, etc.).
• Promotes a strong Safety First culture by ensuring EHS procedures are followed and regulatory requirements are met by the production team.
• Ensures safety incidents or near misses are reported, root cause analyzed, and corrective actions implemented within timelines.
• Leads Daily Site meetings with cross-functional teams; works toward weekly/monthly production targets and proper scheduling and execution.
• Ensures batches are produced safely and efficiently in accordance with master batch records, focusing on weekly/monthly targets, OTIF and client delivery schedules.
• Provides leadership to the production team through performance management, mentoring, coaching, training, and corrective actions.
• Ensures GMP documentation (batch records, cleaning sheets, logbooks, etc.) is completed per ALCOA principles and supports Right First Time.
• Represents production during audits and customer visits; drives audit readiness and regulatory compliance ratings.
• Initiates change controls, deviations and investigations related to non-conformances; CAPAs are executed and improvement opportunities are realized.
• Maintains production equipment records; ensures equipment is maintained and inspected prior to use; initiates maintenance work orders.
• Manages shift time and attendance for payroll processing; reviews onboarding and training documentation; identifies and closes training gaps.
• Plans and monitors training objectives and future competencies; drives learning plans and feedback.
• Monitors process performance, reviews master batch records, and oversees training of personnel involved.
• Owns and reports departmental KPIs (safety, quality, productivity, efficiency, labor utilization, downtime, schedule adherence) to Senior Leadership.
• Participates in cross-functional meetings and drives continuous improvement initiatives (LEAN, Six Sigma) and client-driven projects.
• Contributes to cost-saving initiatives in production by applying industry best practices.
• Performs other duties as assigned

Job description

As Shift Manager, Production you will manage and lead the production of active pharmaceutical ingredients and intermediates in a safe and efficient manner that is compliant with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), safety and environmental standards, company regulations and client requirements.

• Plans shift activities and assigns shift targets to all shift members to ensure the highest level of production safety, quality, efficiency, output, labour efficiencies, housekeeping, and adherence to production schedule.
• Manages and monitors the batch processing operations according to Standard Operating Procedures (SOP’s) through various units of operations (i.e., charging liquids/solids, distillation, filtrations, sampling, cleaning, etc.)
• Facilitates and maintains emphasis on “Safety First” culture by promoting adherence to Environment, Health, and Safety (EHS) procedures and legislative requirements to production team.
• Ensures that all safety incidents or near misses are reported in a timely manner, root cause analysis performed, corrective and preventive measures assigned and executed as per agreed timelines.
• Leads Daily Site meetings by working with cross-functional teams, strives for weekly/monthly production targets and ensures proper scheduling and execution.
• Ensures batches are produced safely and efficiently, in compliance with instructions in master batch records, with focus on weekly / monthly production targets, OTIF and customer delivery schedule.
• Provides leadership to production team through activities such as performance management, mentoring, recruitment, coaching, training, and corrective actions.
• Ensures that Good Manufacturing Practices (GMPs) are followed by staff through the effective use of Standard Operating Procedures (SOPs). Ensures all personnel receive and complete GMP and skills training as required.
• Ensures that all executed GMP documentation, including but not limited to batch records, cleaning sheets, logbooks, etc. are completed by following ALCOA principle, thoroughly reviewed and supports “Right First Time” performance objective.
• Endorses a culture of “24/7 Audit Readiness” and drives positive compliance ratings for regulatory (Health Canada, FDA), customer, corporate and internal audits. Represents the production team during audits and customer visits.
• Initiates change controls, deviations, planned deviations and conducts investigations related to non-conformances. Ensures CAPA’s are executed as intended and stimulates an environment where problems are proactively identified and addressed, and deviations become improvement opportunities.
• Maintains all records relevant to production equipment, cleaning, and processes. Ensures production equipment is well maintained and inspected prior to use, and initiates maintenance repairs by issuing Maintenance Workorder and follows up on the timely completion of the maintenance work orders.
• Manages the shifts time and attendance management system ensuring accuracy of hours, vacation requests and timely approvals for payroll processing.
• Reviews training documents (onboarding and skill development) for completeness and identifies any gaps in training assessments and closes the identified gaps.
• Envisions team’s learning objectives, future competencies, training needs and facilitates the execution of training plans by motivating and sharing feedback.
• Monitors process performance, identifies gaps and takes lead on reviewing the master batch records and training of the involved personnel.
• Owns and reports the departmental KPI’s (safety, quality, productivity, efficiency, labour utilization, downtime, schedule adherence) with Senior Leadership team.
• Participates in inter-departmental / cross- functional meetings with various key stakeholders and contributes to the implementation and success of continuous improvement initiatives and/or client driven projects.
• Leads Continuous Improvement / OE projects to support employee development, process improvements, increase equipment uptime, optimization of cleaning practices, production efficiencies and yield improvements using methodologies such as LEAN manufacturing and Six Sigma.
• Actively contributes to all cost saving initiatives in production department, by focusing on industry best practices and adherence to departmental objectives.
• Perform other duties as assigned

Canada Salary Range :CAD90,000.00 - CAD130,000.00/Per Year