Job Opportunity – Quality and Regulatory Compliance Officer
- Position: Quality and Regulatory Compliance Officer
- Closing date: 17th of May 2019
- Location: Roslin, Midlothian
- Hours: Full time, 40 hours per week (9 months maternity cover)
- Work pattern: Days
Ingenza is a growing and very well-established Industrial Biotechnology Company based at The Roslin Innovation Centre – a brand new building! We have 40 members of staff and our team are dynamic and multidisciplinary.
Our Quality team are critical to ensuring consistency of products and services in all projects at Ingenza, ranging from R&D through to manufacture of toxicology materials and medical devices. We would like someone to join our Quality team to provide 9 months cover for maternity leave.
In return you will get the opportunity to work with a fun group of people who enjoy lots of sporty activities and socialising. Our state-of-the-art laboratories and brand-new offices provide wonderful views of the Pentland Hills not to mention the lovely coffee and cakes served up next door in Dolly’s Café where we all go for lunch! We have an onsite gym and free onsite parking as well as a regular bus route into the city centre and surrounding areas.
What will the role involve?
- Maintaining and managing the quality management system (QMS) according to principles of GMP and ISO13485
- Ensuring all documents are updated and issued in adherence to controlled document protocols (such as SOPs, RAs, policies, batch records, deviations etc). Liaising with Ingenza’s Health and Safety Officer, Heads of Department, QP and consultants to ensure documents are fully compliant.
- Ensuring adherence of all staff with procedures related to quality through auditing and monitoring.
- Ensuring compliance of materials and consumables for manufacturing processes and releasing these for use.
- Approval of QC data generated during manufacturing processes and release of batches (batch review), ensuring impact of deviations is reviewed/actioned and liaising with Ingenza’s QP for batch release of product
- Project management within the biologics and medical devices production programmes to ensure deadlines are met and all quality requirements are adhered to
- Communication of quality issues company wide as required
- Training of staff and students in relation to the QMS
- Involvement in Health and Safety committee as representative for quality and manufacturing
What Qualifications or Qualities are required?
- Minimum 1-2 years’ experience working in a GxP environment, in a laboratory or QA function
- Bachelors or Masters degree in a scientific discipline
- Exceptional attention to detail and works to a high standard of compliance, setting an example for all other staff to follow in relation to quality matters.
- Be self-motivated, driven and able to work in a multi-disciplinary team
- Have excellent communication skills, across all levels of the business
- Excellent organisation and planning skills
If you think you are a suitable candidate please email your C.V along with an attached covering letter to our recruitment office — email@example.com