Compliance Lead

**Your Duties & responsibilities**
- Complete prospective in the moment observations within the production units,
- Giving feedback and coaching on GMP good practice and improvement areas to production team members, especially, but not limited to the areas of comportment, clean activities, and contamination reduction,
- Focus observations on trends in improvement areas,
- Coaching and assisting team members in understanding SOPs and the importance of compliance,
- Giving direct support to newly qualified and members of staff with performance gaps,
- Leading by example and challenge all unacceptable behaviour,
- Identify any comportment deficiencies and promote comportment best practice,
- Supporting and coach staff in processes concerned with any Aseptic Pharmaceutical activity within the unit,
- Facilitating and in bedding a GMP culture, to maintain and improve the GMP standards,
- To escalate any team member issue providing relevant data to substantiate and enable progression of issue,
- Complete QER process reviews in a timely manner to maintain department KPIs,
- Feedback QER observations to the individuals involved, recommending, and completing where necessary required CAPA,
- Complete compliance daily checks in a timely manner to maintain department KPIs,
- Feedback daily check observations to the individuals involved, recommending, and completing where necessary required CAPA,
- To carry out peer reviews / observations to ensure on-going compliance with Standard Operating Procedures,
- To assist in the investigation and resolution of production deviations including the introduction and monitoring of CAPA,
- Evaluate the effectiveness of implemented corrective and preventive actions,
- Support the smooth introduction of changes implemented as a result of approved change controls to ensure that new / improved best practice is understood, implemented and maintained,
- Initiate and revise Production documentation (SOPs) to ensure that Best Practice is employed, and that documentation is an accurate reflection of the process,
- To assist with the generation and delivery of Production training materials.Specifically, when new ways of working are introduced,
- To assist with quality improvement activities within the Quality Management System,
- To attend such study days and up-dating courses as are deemed necessary for the development of the unit and yourself,
- To ensure that the relevant principles of (GMP) are always applied,
- To ensure compliance with the Health and Safety at Work Act and all other relevant legislation e.g. Medicines Act, Control of Substances Hazardous to Health (COSHH),
- Commitment to participate in any overtime, extended hours and Bank Holidays rotas when required,
- Completion of the NCFE Level 2 Intermediate Award in Aseptic Services as part of your induction.
- To undertake any other duties as required by the Production Management Team.

**The skills & attributes you will bring**
- You will have the confidence to be able to challenge others when GMP is not being followed
- You will have good communication, interpersonal skills and influencing skills
- You will be resilient, self-motivated and able to work well under pressure.
- You will understand the requirements of GMP
- You will be passionate about delivering excellent customer service
- You will be organised and able to prioritise

**Review**

This job description is not intended to be exhaustive. The post holder will be required to be flexible and take on projects and responsibilities as the company grows.

**P**ERSON SPECIFICATION*

**Job Title**: **Compliance Lead (Production)**

**SUMMARY**

Have the ability to identify and use relevant understanding, methods and skills to address problems that are well defined but complex and non-routine. It includes taking responsibility for overall courses of action as well as exercising autonomy and judgement within fairly broad
parameters. It also reflects understanding of different perspectives or approaches within an area of work.

**Knowledge and understanding**

Use practical, theoretical or technical understanding to address problems that are well defined but complex and non-routine.
Analyse, interpret and evaluate relevant information and ideas.
Be aware of the nature and approximate scope of the area of work.
Have an informed awareness of different perspectives or approaches within the area of work.

**Application and action**

Address problems that are complex and non -routine while normally fairly well defined. Identify, adapt and use appropriate methods and skills. Initiate and use appropriate investigation to inform actions.
Review the effectiveness and appropriateness of methods, actions and results.

**Autonomy and accountability**

Take responsibility for courses of action, including, where relevant, responsibility for the work of others. Exercise autonomy and judgement within broad but generally well-defined parameters.

**FACTOR**

**ESSENTIAL**

**DESIRABLE**

**Qua