Location – Oxford, UK
We are looking for a proactive and hands-on individual to provide operational support for the execution of GCP QA activities within the company, including management and maintenance of the internal QMS system, working closely with internal & external stakeholders to advise, support and develop key QA GCP processes in line with regulatory and organizational requirements.
- Contribute to the development and maintenance of the company QMS including writing and reviewing GCP SOP’s, ensuring company wide training compliance, managing GCP change control procedures, deviations, reports and investigations as well as conducting GCP trend analysis and quality improvements.
- Conducting GCP one to one training to staff members.
- Managing the GCP audit program.
- Support the delivery of QA project plans & KPI’s and reporting GCP activities to senior management.
- Participating in regulatory inspections and providing admin support to the QMS system.
- Developing quality project plans to ensure they run to schedule & within cost.
- Assist in collating Quality KPI’s and act as a subject matter expert for GCP QA topics.
- Work collaboratively with key functional areas to ensure compliance.
- Lead continuous GCP process improvements within the organization.
- Third party QA – support appropriate vendor selection.
- Oversee GCP activities for service providers (develop and manage audit program and report findings) as well as overseeing complaints, investigations and ensuring appropriate resolutions.
With demonstrable experience of managing GCP compliance activities, you should have some
experience of GCP auditing and hold a biology, pharmacy or related life science degree. An understanding of ICH-GCP & clinical quality regulations is essential as well as experience of reviewing (and ideally writing) GCP SOP’s and progressing them through the document process. The ideal candidate will have worked collaboratively across teams providing consultation and training on quality systems and GCP. Experience in CSV auditing would be advantageous. With excellent communication skills, you should be confident to work on your own initiative in a fast-paced, multi-disciplinary environment and have a strong commitment to upholding quality standards.
We offer a competitive salary, excellent pension and benefits package, flexible working hours and opportunities for development within the role and progression of your career. We have a strong and inclusive company culture, in a recent Employee Survey results show that BerGenBio employees appreciate their colleagues, working environment and want to continue being a part of the team.
We are an equal opportunities employer and ensure that all applications are treated appropriately and fairly and that, all things being equal, no candidate is rejected because of their age, gender, race, sexuality or any other protected characteristic.
To apply please send your CV and a covering letter, including your current salary and package details. To apply you must have eligibility to work in the UK and not require sponsorship. No agencies please.