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Quality Systems Lead

3 months ago

Beeston, Nottinghamshire, United Kingdom BCM Fareva Full time

Quality Systems Lead

Grade:
I

Location:
Nottingham, NG90 2PR

Salary:
£Competitive plus benefits, DOE

BCM is part of Fareva, FAREVA is one of the world's leading subcontractors in the Industrial and Household, Cosmetics and Pharmaceuticals fields

We have a range of solutions to suit our customers' needs and requirements - we manufacture iconic brands right from the client brief through to the completed product. We believe that whatever field you're in and at whatever level, you will be able to take ownership of your own development and progression and we will support you in this.
We have an opportunity for an experienced
Quality Systems Lead to join our team.

If you have an interest in working in a fast paced, commercial Quality environment, and have relevant experience in a similar role, we would like to hear from you.


The Quality Systems Lead will be responsible for the development, maintenance, audit and effective implementation of the Quality Management System (QMS) in BCM Fareva.

They will need to be a self-starter and able to drive improvement.

The Quality Systems Lead will report directly into the Quality Manager - Pharma.

The key priorities will be to ensure site compliance with cGMP, CFR Part 211 and ISO Support will also be required to a lesser extent in the Beauty business with regards to ISO 22716.


Your working day may involve:

  • Manage and maintain the company's Business/Quality Management Systems (QMS) in Q-Pulse.
  • Continually scrutinise, update and drive continuous improvement of the QMS to ensure compliance with relevant standards (cGMP, CFR Part 211, ISO 13485, ISO whilst being commercially sustainable.
  • Report on and drive improvement of site adherence to QMS KPIs. (Deviation, CAPA, Change Control Closure).
  • Preparing and supporting management reviews in line with the requirements of applicable standards.
  • Act as Subject Matter Expert (SME) for the QMS to support customer audits and regulatory inspections.
  • Plan and manage the delivery of the selfinspection schedule.
  • Following up and ensuring completion of nonconformances raised from internal and external audits, assisting and ensuring that corrective actions are implemented in a timely and effective manner to resolve any issues.
  • Manage and maintain the site risk register.
  • Assist the Head of Quality and Quality Manager in any other required actions to support the smooth running of the Quality Department.

Knowledge, Skills and Experience

  • Knowledge of and practical experience of cGMP, CFR Part 211, ISO 13485 and ISO 2271
  • Knowledge of and practical experience of Q-Pulse
  • Lead Auditor Qualified
  • Welldeveloped communication skills, enabling proactive interaction with other departments/internal stakeholders to ensure adherence to both internal and external standards
  • Ability to influence, motivate others and improve performance

Benefits
We have a comprehensive benefits package, dependant on the role you are performing. In addition to a competitive salary, you may be entitled to the following;

  • 25 Days Holiday plus Bank Holidays
  • Option to purchase additional Holiday
  • Onsite parking with site security
  • Opportunity to be part of an international company (Fareva)
  • Onsite subsidised Café
  • Cycle to Work Scheme
  • Employee reward portal with huge range of discounts available
  • Professional Subscriptions paid
  • Defined contribution Pension scheme
  • Life Assurance
  • Employee Assistance Program