Job Introduction

Assist with the company’s Remediation Consent Decree and CMC programme(s) to ensure the improvement initiatives are delivered on time. 

This Role supports Operations/Quality and reports to the Operations SME / Workstream Lead. 

Provide leadership & support to the Manufacturing value stream team to ensure problems are rapidly resolved by delivering root cause(s) analysis (RCA) and implementing effective corrective and preventive actions (CaPa). 

Participate in, and when required, lead multifunctional teams to deliver identified remediation project RCA, CaPas and resolution of technical issues, with the aim of preventing re-occurrence of the issue. 

Support the development of an improvement culture, being an advocate for constructive change and challenges. 

Ensure Manufacturing and the wider Site team always delivers business KPIs to target or better. 

Role Responsibility

• Deliver, by self or through team/others rapid problem solving which includes root cause(s) analysis (RCA) and implementing effective corrective and preventive actions (CaPa). 

• Support an improvement culture within operations, where all team members are engaged in and participate in continuous improvement activities where constructive challenge is encouraged. 

• Lead and support use of Operational Excellence (ODPS) tools and techniques to improve Right First Time (RFT) manufacture of products at high levels of efficiency and constructively challenge existing processes and behaviours, raising new ideas to improve current standards and performance. 

• To identify any issues and proactively resolve these using prescribed techniques and escalating when support is required for issue resolution. 

• Lead investigations for deviations /Manufacturing LIRs; identifying root causes & implementing effective CAPAs in a timely manner.  

• Lead & actively participate in meetings to progress the on-time closure of deviations, CAPAs and change controls. 

• Ensure effective Ongoing Process Monitoring (OPM) is in place, in use, effective and sustained; including e.g. reviews of IPC trends, yield loss, waste, etc with actions being implemented as required. 

• Take ownership for implementation, update and closeout of CAPAs, Change Controls and updating SOPs in a timely manner. 

• Identify current gaps and ensure appropriate “technical standards” are in place, in use, effective and sustained in Manufacturing, including development of standards where required. 

• Support a compliance culture within operations, ensuring all team members adhere to SOPs and other documents, and comply with their individual responsibilities to GMP. 

• Attend and comply with any planned in-house training or on the job training, ensuring that all learnings are put into routine practice as part of the “day job”. 

• Challenges existing processes and behaviours and raises ideas to improve the current norm. 

• Support MS&T with data gathering for ongoing process monitoring (OPM). 

• Support the implementation of new product introductions, tech transfers and equipment change into the Manufacturing department. 

• Any other reasonable request made by another member of staff. 

Key Performance Indicators  

• Drive the departmental goal of zero overdue CAPAs, deviations and change controls. 

• Ensure all manufacturing processes are completed to standard “Right First Time”. 

• Ensure all paperwork is completed to standard “Right First Time”. 

• Support operational excellence incentives to drive and improve efficiency. 

• Maintaining GMP and Health & Safety at all times ensuring the close out of hazards and risk assessments in a timely manner. 

• Challenges existing processes and behaviours and raises ideas to improve the current norm. 

• Acceptable absence levels and timekeeping. 

The Ideal Candidate

• 6 years plus of experience.

• Experience of low to medium volume manufacturing/packaging, manual/semi-automated manufacturing processes and managing a team. 

• Good Knowledge of Quality Management Systems (QMS and processes). 

• Proven industry experience from a highly regulated GMP manufacturing/packing facility, either from the Pharmaceutical or similarly regulated industry/environment. 

• A working knowledge and practical experience of pharmaceutical manufacture and ability to manage time and workload effectively. 

• Good knowledge and understanding of Health & Safety compliance. 

• Ability to communicate effectively, both with the team and with other areas of the business. 

• Ability to use problems solving techniques for root cause analysis. 

• A working knowledge and practical experience of 5’s, continuous improvement activities. 

• Proven ability to lead a team and drive change and improvement in that team. 

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Dechra Pharmaceuticals PLC