Quality Officer
7 months ago
**The Company**
Concept Life Sciences is a knowledge based, science led business focused on delivering the expertise and capabilities our clients demand. We work in the pharmaceutical, biotechnology, food, environmental, agrochemical, petrochemical chemical and consumer products sectors. Our business is home to Scientists with in-depth experience in their fields, who are enthusiastic about taking on challenges. We employ problem-solvers with a proven track record in life sciences, laboratory based analytical testing and specialist consulting.
**The Role**
The Dundee site based in the Dundee Technopole with a range of service lines including Endocrine, Hepatocyte Toxicology and BioAnalytical. Work at the site focuses on Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) within the Life Sciences sector, complying with MHRA and OECD guidelines.
**Main Duties to**:
Assisting the Quality Manager in:
- Supporting the quality activities of the laboratory areas in accordance with the Quality Management System (QMS), current regulations and guidance for GLP and GCP activities as appropriate.
- Support the quality activities of the Dundee site by maintaining & improving.
- Training personnel in GLP and GCP and associated QMS requirements.
- Support customer/regulatory audits and inspections of the facility and the completion of agreed action plans.
- Maintaining and executing the site inspection schedule
- Maintaining the Supplier oversight programme
Main duties to include:
- Perform inspections as assigned, reporting any deficiencies to the Head of Quality and Operations management for:
- Facilities, equipment, systems (including Computerised systems), procedures, records, data and information.
- Ensure that the document control system is maintained.
- Perform/Review/Approve investigations on non-conformances or deviations.
- Review information and draw conclusions in support of CAPA, customer complaints etc.
- Identify and lead Quality Improvement activities.
**Qualifications/Role Requirements**:
- BSc or similar in an analytical, chemical, life sciences or related scientific field,
- Experience working to regulatory GLP and GCP, including GLP/GCP auditing within Life Sciences.
- Consideration will also be given to applicants who have focussed on Quality with scientists working in the GLP environment or GCP analytical testing requirements (including new graduates with some industrial experience in a regulated environment who wish to develop their career in quality assurance).
- 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.
- Ability to challenge and drive quality and a compliant culture forward.
- Team player.
- IT literate (e.g. Microsoft Office).
- Ability to work unsupervised.
**Working Hours**
Full time 37.5hrs/week. Flexibility is required, some weekend work may be needed and earlier or later start / finish times may also be required to ensure cover on site.
**Job Types**: Full-time, Permanent
**Salary**: £30,000.00-£35,000.00 per year
**Benefits**:
- Additional leave
- Company pension
- Cycle to work scheme
- Employee discount
- Enhanced maternity leave
- Enhanced paternity leave
- Free parking
- Health & wellbeing programme
- Life insurance
- On-site parking
- Referral programme
- Sick pay
Schedule:
- Day shift
- Holidays
- Monday to Friday
Supplemental pay types:
- Bonus scheme
Application question(s):
**Education**:
- Bachelor's (required)
**Experience**:
- working GLP regulations in particular auditing regulations: 1 year (required)
Work Location: In person
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