Quality Lead (Healthcare)

The Quality Team are a vital function within our business ensuring that our QMS is maintained and developed. Our internal quality system covers all the divisions of our business. This role is a new role and will be focussed on our healthcare manufacturing operations. This is a hands-on role which requires an individual who is willing and able to flex and adapt to operational challenges and the evolving needs of our business.

You will have proven experience of managing a manufacturing QMS, handling operational systems and processes, developing new quality procedures and working with colleagues to deliver quality on the ground. You will be able to multi-task, be incredibly organised and have the ability to manage and organise others. You should also have impeccable written and communication skills, including experience of generating quality documentation such as standard operating procedures, quality forms, training materials and KPIs. You will be proficient at leading and managing a team, as well as reporting to senior management. On a day to day basis you will manage operational issues, assess risks, ensure that actions are completed and oversee operational plans to ensure that we deliver high quality products that meet all required regulatory requirements.

The Quality Lead (Healthcare) reports directly into the Director of Quality. Frequent day to day liaison will be with the Healthcare Production Manager, Warehouse Manager, QA Officers and other Quality Leads across the business.

Role and Responsibilities:

  • Ensuring that the quality objectives of the healthcare division are clearly disseminated, understood and achieved.
  • Working closely the production colleagues to ensure quality activities and actions within the healthcare production environment are established, managed and fulfilled.
  • Proactively identifying risks and potential issues, determining systems improvements and implementing changes.
  • Ensuring that all Healthcare QMS maintenance activities are accurately planned, resourced and executed.
  • Ensuring all records generated in the healthcare production area of the highest quality – ensuring that operational systems are in place for the checking of batch records for accuracy and compliance.
  • Review of manufacturing deviations and investigations conduct of risk assessments and impact evaluations Planning and overseeing process qualification activities.
  • Approving CofAs and batch release certificates for healthcare products.
  • Planning and management of facilities and equipment qualification, calibration and maintenance.
  • Production, implementation and management of SOPs and associated forms and appendices.
  • Management of CAPA, change controls, deviations. Ensuring that all quality actions are delivered on time and in full to the highest of standards.
  • Preparing materials and KPIs for Quality Management review meetings.
  • Management of complaints.
  • Managing a programme of self-inspections. Conducting and documenting the self-inspections.
  • Management of supplier approvals.
  • Top level management of third-party service providers e.g. third-party laboratories and technical agreements with such suppliers.
  • Managing a programme of external audits, prepare and host on a regular basis. Manage the completion of CAPAs resulting from these audits.
  • Overseeing the planning and delivery of all GMP induction and refresher training.
  • General monitoring of data quality and performance.
  • Line management, coaching and mentoring of the QA Officers.

Key Skills and Experiences Required: 

  • Experience of working in healthcare production environment, including the manufacture of sterile products. 
  • Proven experience in Quality Management. 
  • Strong communication skills, specifically with internal colleagues to establish sound and positive relationships. 
  • Methodical with the ability to follow procedures accurately and to understand when processes and procedures require updating to either support compliance or to save time or money. 
  • Organisational skills with the ability to prioritise, multi-task and manage adhoc tasks which may fall outside your role. 
  • Problem solving and negotiating skills. 
  • Excellent attention to detail. 
  • Ability to work under pressure and meet deadlines whilst showing attention to detail. 
  • Passionate about quality and compliance. 
  • Experience hosting third party audits and inspections. 
  • Line management experience. 

Preferable Skills and Experiences:

  • Experience in validation.  
  • Cleanroom qualification and monitoring. 
  • Microbiological experience or qualification.  
  • Lead auditor certified. 

If this sounds interesting, the role suits your skills and experience and your values are aligned with ours, this could be your potential next step. Please get in touch.

Please send your CV and a covering email including why you think you are suitable for this role, both in terms of the skills and experience and the values that we have identified. Please also note your salary expectations and write to careers@originltd.com

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