(Pharmaceutical Operations / Quality Management Systems)
£28,000 - £35,000
We are working with a Pharmaceutical company in South Wales, they provide services in drug development, clinical trials and commercial packaging. This allows for quicker product development to market studies, approval and patients. They are seeking Quality Specialists. These roles are in Pharmaceutical Operations, and also Quality Management Systems (QMS).
What you’ll do:
- To assist the Quality Management team in ensuring that all activities are in compliance with current Good Manufacturing Practice standards and in accordance with company policies to meet business requirements.
- To work with primarily, the Manufacturing and Packaging departments to provide Quality Assurance (QA) guidance and expertise in the resolution of quality issues.
- The job holder may have direct people management responsibilities for team members and ensuring that all KPIs, targets and any other deadlines are met individually and by the team.
- Ensure pharmaceutical products manufactured are manufactured under the most stringent regulatory and GMP requirements and must be produced to the highest ethical standards. The job holder will be required to understand and interpret regulations of MHRA/EU/FDA.
- The job holder is responsible for this in his/her areas of responsibility and therefore the required educational and practical/technical experience is extremely important.
- 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 current Good Manufacturing Practice (cGMP) for all manufacturing and packaging activities including development, clinical, commercial and unlicensed products.
- The job holder makes a number of quality decisions which directly affect the release of materials. Whilst operating under such pressure to meet business deadlines, the job holder must evaluate complex data and in the absence of prescribed rules, assist in making professional judgments which could have considerable impact on the compliance and profitability of the business.
- The scope of the Quality Specialist role covers all manufacturing and packaging areas across site.*(*subject to entry and working practices and related SOPs)
- 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.
On this occasion, LiCa Scientific is acting as an employment agency.