QC Supervisor

Description Overview

Reporting to the QC laboratory Manager, responsible for supervising the Routine Stability Testing and Stability Coordination teams. 

Ensure that long term, on-going stability programme for products marketed by Perrigo and contract customers is managed efficiently, and in compliance with cGMP/ICH requirements.

Chemical testing, paperwork and conclusions are right first time, tested and passed within lead times. 
 

Scope of the Role

Planning and Schedule Adherence:

• Manage people and equipment resources appropriately to ensure current and future demand can be accommodated
• Manage day to day workload and scheduling ensuring that batches are consistently set down on stability, tested at each time point, passed, and concluded inside lead times
• Measure defined KPI to manage the throughput and quality output of the function
• Actively manage technical, relational, and organisational issues which may cause delay, identifying both root cause and appropriate short term and long-term corrective actions to prevent reoccurrence
• Proactively manage team holiday, absence, and wellbeing to ensure adequate staffing levels 

People and Team Management:

• Provide clear direction to the team in alignment with business and departmental objectives
• Personally demonstrate and foster the Perrigo Core Values in all aspects of individual and team working
• Ensure all staff have a development and training plan and clear personal objectives to develop a strong, motivated team
• Manage day to day performance of the team, ensuring all team members can contribute effectively – provide recognition and reward for good performance and ensure that improvement measures are in place for under-performance
• Flex resource deployment to provide Right First Time, On Time testing
• Actively focus on continual improvement of employee engagement

Cross Functional Working and Interaction:

• Maintain positive and effective relationships with all other functions, specifically, packing, project management and regulatory
• Work collaboratively in cross functional teams to deliver business objectives and resolve problems
• Use principles of voice of the customer to identify requirements and expectations of internal customers
• Communicate function performance clearly
• Ensure mechanisms are in place for early communication of problems that may impact other departments and steps taken to resolve

Compliance to cGMP:

• Ensure that stability studies are set down, tested, and concluded in line with current procedures and these procedures are aligned with cGMP, ICH, and relevant quality standards 
• Ensure all methods are suitable and validated
• Actively manage data integrity  
• Ensure that stability chambers are maintained
• Investigate all non-conformance and out of specifications to identify root cause and implement corrective actions
• Investigate all adverse genuine stability trends and make recommendations i.e., reporting failures to DMRC, reducing shelf life, changing packaging materials

Innovation and Operational Excellence:

• Use the principles of operational excellence and lean management in operation of the function: - visual management, managing for daily improvement, etc 
• Measure the performance of the function for quality timeliness and efficiency to identify improvement opportunities 
• Stay abreast of industry innovation in testing, analytical methods, and cGMP

Budgetary Control:

• Manage overtime effectively ensuing any overtime is agreed in advance
• Manage and control spending for consumables associated with all testing activities
• Identify capital expenditure items required to continue the effective functioning of the department prior to breakdown
• To undertake such other reasonable duties as may be required from time to time to support the Perrigo business.

Experience Required

• Minimum of a Scientific degree of equivalent, although relevant experience and demonstrated competence may be considered in place of formal qualification
• 5 years’ experience of working in a cGMP or other regulated laboratory environment
• 3 years’ supervisory experience
• Familiarity and experience with both instrumental and wet chemistry techniques
• Understanding of data integrity principles and control methods
• Familiarity with statistical techniques