Quality Officer

The Company

Concept Life Sciences is a knowledge based, science led business focused on delivering the services, expertise and capabilities our clients require. Our business is focussed on a number of core sectors including pharmaceutical, biotechnology, food, environmental, agrochemical, petrochemical, chemical and consumer products industries. We support drug research, discovery and development to our pharmaceutical and biotechnology clients; provide testing and specialist analytical services and consultancy to the pharmaceutical, food and environmental sectors, toxicology services to the pharmaceutical, chemical, agrochemical and consumer products industries and materials chemistry services to the petrochemical industry.

In order to enhance our client services, we are developing existing manufacturing facilities and associated analytical laboratories within our Sandwich site to deliver Active Pharmaceutical Products (API) that are compliant with Good Manufacturing Practices (GMP).

The Role

The role involves working with the team of Scientists at the Sandwich and Chapel-en-le-Frith sites to implement, maintain and improve procedures and processes that support GxP compliance. In addition, assisting the development of Good Scientific Practice as part of the Quality Team, at Concept Life Sciences to create and improve ‘one Concept’ systems. Some travel between UK sites may be required to fulfil this role.

Main Duties to:

- Assisting the Quality Manager in:

- Commission and validation activities.
- Implementing, maintaining & improving the QMS.
- Train personnel in GMP and associated QMS requirements as required.
- Supporting the completion of agreed action plans arising from regulatory/customer audits of the facility.
- Developing, maintaining and executing the site internal audit schedule.
- Maintaining the Vendor Oversight programme.
- Main duties to include:

- Perform audits and inspections as assigned, reporting any deficiencies to the Quality Manager and Site Director to include:

- Facilities, equipment, systems (including Computerised systems), procedures, records, data and information.
- Review and approve production and analytical documentation necessary for the manufacture, analysis and subsequent release of API.
- Ensure that document control system is maintained.
- Perform investigations and review information and draw conclusions in support of CAPAs, customer complaints etc.
- Assist with/host audits by customers and regulators/accreditation bodies.
- Identify and participate in Quality Improvement activities.

Qualifications/Role Requirements:

- A science graduate (preferably chemistry).
- Proven experience in GMP requirements associated with API manufacturing.
- Experience of regulatory inspections and customer audits.
- Experience in the development and maintenance of Quality Management Systems within a pharmaceutical manufacturing organisation.
- Experience of 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.
- Experience of preparing and delivering presentations.
- 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.
- Looking to develop a career within a large organisation.
- Team player.
- IT literate (e.g. Microsoft Office).
- Ability to work unsupervised.
- In addition, awareness of GLP processes would be advantageous.
- Some travel will be required.
- 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
- 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.
- In addition to a competitive salary, we offer as a minimum: Pension scheme, Healthcare Cash Plan, Retail Discount scheme, Cycle to Work scheme, Childcare Vouchers, and local Reward & Recognition schemes.