Compliance Lead

Job Description

Compliance LeadYour 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.

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