Quality Manager

Chapel, GB
Sandwich, GB
About this position:

Do you want to be part of a business that genuinely values entrepreneurialism, innovation and individual accountability? We focus on our customers and are proud of the difference our technology makes. We partner with some of the biggest manufacturing companies in the world and our technical innovations are used to enhance well-known brands across multiple industries.

The Role

Reporting to the Head of Quality, this role is an exciting opportunity for the successful candidate to further their career. The role will include working with the existing GMP team at the Sandwich and Chapel-en-le-Frith sites to maintain compliance with GMP requirements for the manufacture and testing of starting materials and APIs. In addition, the role will be responsible for the Quality Assurance aspects of GLP testing carried out at the Sandwich site. The role will involve working with other sites and therefore some travel between sites will be required.

Main Duties to:

  • Work with the teams at the Sandwich and Chapel-en-le-Frith sites to ensure compliance to applicable regulations:

  • Develop and improve the QMS.

  • Train appropriate staff in the requirements of GMP, GLP and associated QMS requirements.

  • Assist with/host audits by customers and regulators/accreditation bodies (GMP & GLP).

  • Support the completion of agreed action plans arising from regulatory audits of the facility

  • producing reports and following-up action points as agreed with the management team responsible for ensuring the programmes are completed.

  • Develop, maintain and execute the site internal audit schedule, reporting any deficiencies to CLS Management and Head of Quality, including audits of:

  • Facilities, equipment, systems, procedures, records, data and information.

  • Review and approve production and analytical documentation necessary for the manufacture, analysis and subsequent the release of API and drug product.

  • Perform investigations and review information and draw conclusions in support of CAPA, customer complaints etc.

  • Identify and participate in Quality Improvement activities.

  • Manage the Quality team that supports the Sandwich and Chapel-en-le-Frith sites.

  • Support the Business Development function with Client calls and proposal development regarding services.

  • Work collaboratively and proactively with the Operations team to ensure ongoing regulatory compliance and to develop a program of continuous improvement.

  • Support all Concept Life Science personnel, to ensure a quality culture is encouraged and maintained as part of ‘one Concept’ values.

Qualifications/Role Requirements:

The role of the Quality Manager would be suitable for self-motivated candidates working within Quality Assurance within a similar environment, currently looking to progress into this high-level role.

  • A science graduate (preferably chemistry).

  • Proven experience in GMP requirements associated with API manufacturing.

  • Experience in GLP Quality assurance activities.

  • Proven experience in hosting/supporting regulatory inspections and customer audits.

  • Experience in the continuous improvement of Quality Management Systems within a pharmaceutical manufacturing organisation.

  • Proven knowledge and experience of scheduling and performing risk-based audits.

  • Excellent organisational and interpersonal skills.

  • Excellent oral and written communication skills to produce clear and concise factual findings and ability to present effectively to all levels of the organisation.

  • Competent at preparing and delivering presentations to employees, customers and regulatory bodies.

  • Ability to challenge and drive quality and a compliant culture forward.

  • Ability to investigate and review information and draw conclusions in support of CAPA, customer complaints etc.

  • Ability to develop audit schedules and training initiatives.

  • Looking to develop a career within a large organisation.

  • Team player.

  • IT literate (e.g. Microsoft Office).

  • Ability to work unsupervised.

  • Some travel between other sites within the group.

  • A full clean UK driving licence.

Working Hours

  • Monday to Friday between 9:00am and 5:30pm. Flexibility is required, some weekend work may be needed and earlier or later start and finish times may also be required.

Company Benefits

In addition to a competitive salary, we offer as a minimum: Pension scheme, Healthcare Plan, Retail Discount scheme, Cycle to Work scheme, Childcare Vouchers, Discounted Gym membership rates and local Reward & Recognition schemes. We offer a range of learning and development opportunities depending on the role, with all employees having access to a range of internally delivered training modules as standard.

Posted 7 Days Ago
Job ID: 2743