QC Maintenance Team Leader at Aspen Pharma Group

Overview

• Manage and coordinate of all laboratory equipment maintenance, calibration, and compliance activities and adherence to specified timelines
• Facilitate the repair of lab equipment
• Manage resources to execute maintenance plan and monitor maintenance schedule compliance
• Ensure safe and efficient execution of routine maintenance work
• Ensures legal compliance of all maintenance activities
• Ensure continual compliance of lab standards and SOPs
• Performance management of direct reports
• Manage costs relating to maintenance repairs and calibrations

Responsibilities

Planning and Section management

• Provide input into operational planning and prioritization of section objectives
• Provide input into, interpret and execute policies and procedures
• Provide input into and manage budgets & resource requirements for section
• Plan daily and weekly activities of technicians
• Provide daily coaching and supervision for technicians

Equipment maintenance and calibration

• Ensures that the Laboratory Maintenance/calibration schedule is maintained
• Manage and execute priority work orders/ jobs when necessary
• Ensures that calibration and preventative maintenance of lab equipment is performed according to SOPs
• Ensures that faulty lab equipment is repaired within set timelines and according to policies and procedures.
• Ensures OOS, OOT and OOE results are investigated according to set procedures
• Ensures all data generated are LQRed and released according to cGMP and data integrity policies.
• Ensures that technicians are adequately trained and deemed competent to perform their jobs.
• Escalate calibration, maintenance deviations/instrument failures to Laboratory management
• Participate in development of quality job plans with Maintenance Planners
• Test effectiveness of maintenance plan
• Liaise with Laboratory management teams to ensure that the maintenance plan is accommodated
• Co-ordinate problem solving and prioritise execution of tasks
• Participate in development of work schedules
• Ensure weekly routine maintenance schedule is executed as planned/scheduled
• Monitor and track progress of all open requisitions
• Review work order for completeness and sign off work requisition feedback
• Ensure that jobs are properly completed and closed on time
• Oversee contractors in the execution of maintenance activities
• Monitor contractor adherence to SLAs and KPIs
• Ensure tools and assets are maintained within standards
• Ensure all new equipment are qualified according to the set procedures
• Ensure that all maintenance related records are maintained and are easily retrievable
• SME with regards to laboratory maintenance in regulatory audits

Reporting and record –keeping

• Consolidate information for reports on a weekly and monthly basis
• Analyse consolidated data and provide recommendation
• Compile details reports and consolidate documents

Governance, Risk & Compliance

• Provide input for improvement of risk-based compliance systems
• Monitor implementation and correct own and/or team compliance with legislation, policies and procedures

Background/experience

• National Diploma in Analytical/Mechanical/ Electrical Engineering with 5 years’ laboratory experience.
• GxP experience within a pharmaceutical laboratory
• Supervisory experience

Specific Job Skills

• Advanced knowledge of methods, practices, techniques and equipment used in laboratory, maintenance and repair
• Working Knowledge of laboratory processes, procedures and maintenance activities
• Knowledge of pharmaceutical manufacturing, standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives

Competencies

• Interrogate information
• Managing Performance
• Planning and organizing
• Creating Clarity
• Customer awareness
• Attention to detail
• Compliance and process driven
• Quick and informed decision making skills

Accountability & Decision Rights

• Set overall direction for direct reports in alignment with departmental policies, procedures and objectives
• Consistent execution of objectives, holding staff accountable to established policies
• Provide guidance over scope of management to ensure accurate and timely completion of work
• Independent resolution of highly complex services/support problems
• Escalate out of policy matters

Independent decisions relating to:

• Resources, approach and tactical operations
• Staff productivity and operational processes, tools and services
• Non-routine issues and daily priorities for a work group
• Correction and /or containment of errors of significant impact
• Recommendations to management on new processes/tools/techniques