Quality Assurance (OPERATIONAL GMP)
- Reference: JLS QA
- Location: Cardiff
- Salary: £30000-£40000
- Type: Full time
Just Life Sciences are the Independent Life Sciences Recruiter based in Cardiff, and are seeking a Quality Specialist who has substantial GMP Operational experience, to take on a newly created role.
Pharmaceutical products are manufactured under the most stringent regulatory and GMP requirements, and the job holder will be required to understand and interpret regulations of MHRA/EU/FDA.
Quality must be built into the design of the facilities and the processes contained within those facilities. The job holder must be pro-active in influencing business unit colleagues up to Director level in circumstances where conflicts arise. The GMP elements of Quality Assurance are essentially "on-plant" activities however there may be a need to discuss issues/interface with clients.
The job holder is responsible for the interpretation of cGMPs for all manufacturing and packaging activities including development, clinical, commercial and unlicensed products.
Qualifications, Skills and Experience
- To play a lead role in the interpretation of business and regulatory guidelines and QA systems for input into compliance enhancement projects for facilities, processes and products, and to approve experimental and validation reports / protocols where appropriate.
To promote a sense of quality throughout the site departments so as to raise commercial manufacturing performance and eliminate waste caused by unnecessary compliance errors.
To conduct internal performance audits and follow up actions within site business units.
To lead nominated regulatory compliance projects and to ensure that the business meets its regulatory commitments through satisfactory completion of these projects.
To assist in the hosting of Client audits.
To review non-compliance identified by audit, deviations and complaints, and use technical / professional judgement to make the appropriate product quality decisions (in association with Quality Management), and to initiate and promote quality improvements to prevent re-occurrence.
To ensure the review and approval of all documentation relating to manufacturing to support their continued processes to meet the business needs.
To ensure that products were manufactured in accordance with specified requirements and cGMP.
To play a lead role in the efficient review and approval of batch documentation to ensure deadlines are met and where required, effective and efficient correction of QP review comments.
To provide statistical trending reports on quality key performance indicators and to initiate corrective and preventive actions based on this data. To generate a monthly report on the key activities and key performance indicators for the area.
To liaise with the operational groups regarding relevant compliance topics.
Person / Experience
- Educated to degree level or equivalent in a science or quality assurance related discipline, and ideally be a member of a professional body as recognised by the UK MHRA. (A lower level aligned qualification plus significant QA pharma industry experience would also be considered).
- The job holder will have significant experience in the pharmaceutical industry, with a diverse knowledge of various dosage form manufacturing and experience of staff supervision.
- Experience of working within a Quality Department within a cGMP/pharma environment.
- Excellent written and verbal communication skills are required by the job holder as in the course of the duties. The job holder will need to communicate with personnel outside of the Quality group, with external clients, regulatory bodies and consultants.
- The job holder will need to have excellent analytical problem solving abilities and be able to lead by example and get results through persuasion and co-operation.
- Experience of GMP auditing to relevant quality standards with potential to perform audits.
- People management experience.
- If you are interested in this or any other role with the Life Sciences sector then please email justyn withey at justlifesciences dot com
Just Life Sciences
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