This role will focus on the setup and maintenance of a GCP system within the existing Quality Management System, as well as other QA related activities as required.
Accountable to the Director of Quality for assisting in the delivery and setup of a complete GCP system, required for sponsoring clinical trials.
The successful candidate will:
1. Generate GCP documents and maintain the internal document system.
2. Ensure that the company’s GCP activities and associated quality management system complies with relevant regulatory requirements and business expectations
3. Ensure all GCP related Quality Management System activities are progressed in accordance with the agreed Quality Plan. This will include: internal and external audits, supplier/subcontractor approvals, contractual agreements, change controls, quality issues/investigations and CAPA management.
4. Adhere to a stand-alone audit schedule, ensuring that all audits are carried out in a timely manner.
5. Identify in-house training needs and areas that are non-compliant.
6. Working closely with PBLs training department, ensure that all necessary staff have up-to-date training in GCP and keep accurate track of GCP training records.
7. The post holder will be in charge of the quality oversight of all subcontracted GCP activities.
MAIN DUTIES AND RESPONSIBILITIES
- To participate and contribute to any Quality related activities within as required
- To design and deliver the GCP quality system.
- To ensure the GCP system is compliant with relevant regulatory frameworks and evolves to assimilate any regulatory changes in the future
- To organise GCP QA activities to meet tight clinical trial deadlines
- To ensure all necessary staff are trained in GCP, and support training department to ensure that all GCP training is recorded and kept up to date
- To promote and uphold the highest standard of professionalism in order to create, maintain and enhance the reputation of the business, divisions and amongst its customers and stakeholders both nationally and internationally
Masters qualification or equivalent in a life science subject
Considerable GCP QA experience in a senior management role, capable of conducting vendor and site audits
Demonstrable experience of QA activities within a GMP environment
Expert knowledge of UK CTIMP, ATMP and clinical investigation legislation and regulations, research governance and GCP requirements
Experience in ISO9001, ISO14155 and ICH-GCP
Experience in CRO and clinical trial unit selection
QA / MANAGER / QUALITY ASSURANCE / GCP / CLINICAL / GMP / GLP / SCIENTIFIC / HEALTHCARE / MEDICAL / PHARMA / PHARMACEUTICALS / BIOPHARM / BIOTECHNOLOGY / BIOPHARMACEUTICALS / QUALITY MANAGEMENT / CAPA / HEAD OF / SUPERVISOR / MANAGEMENT / WILTSHIRE / OXFORDSHIRE / HAMPSHIRE / BASINGSTOKE / LONDON / SLOUGH / BERKSHIRE / NEWBURY / MAIDENHEAD / GOOD CLINICAL PRACTISE / GCP / GCP MANAGER
- Quality Assurance
- Pharmaceutical Industry
- Scientific Background
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