An industry leading clinical and commercial pharmaceuticals manufacturing group with a network of global locations is looking to hire a Quality Assurance Specialist for their team in Tredegar. Following continued growth, the role has been newly introduced and will be a key lead for QA manufacturing operations reporting into the site Qualified Person.
The position will be responsible for interpreting changing regulatory guidelines and quality systems to support QA improvement projects for the site processes and products, and to approve new protocols. The QA Specialist will have management responsibility for QA Officers.
The business offers a broad range of contract development and manufacturing services for clinical and commercial products. Whilst not an immediate requirement for the role, you will be offered the opportunity to develop and train to become a Qualified Person.
Your key purpose of the Quality Assurance Specialist:
Assist the Quality Management team in ensuring that all activities on multiple sites are in compliance with current Good Manufacturing Practice standards To work with manufacturing and packaging departments to provide QA guidance and expertise in the resolution of quality issues. People management responsibilities for team members to ensure that targets are set and reached. To understand and interpret regulations of MHRA/EU/FDA. To be pro-active in influencing business unit colleagues up to Director Level Responsible for the interpretation of cGMPs for all manufacturing and packaging activities including development, clinical, commercial and unlicensed products. Evaluate complex data and make professional judgments that impact the compliance and profitability of the business.If you have experience in the above areas and can support this with the below background, then you would be a great fit for this position:
Significant experience in the pharmaceutical industry, with a diverse knowledge of manufacturing Experience of working within a Quality Department within a cGMP/pharma environment. Experience of GMP auditing to relevant quality standards with potential to perform audits. Ideally qualified to Degree level in a science, engineering or similar fieldThis is a well-rounded role that will allow you to develop and hone your QA experience whilst helping to grow a leading pharmaceuticals group.
A salary of £40,000 to £45,000 is on offer for the Quality Assurance Specialist with flexibility to increase on this to secure the right person.
This position is an important hire, so the intention is to begin interviewing from early November. Please apply as soon as possible to be considered. You can also contact James Ivall at Goodman Masson should you have any questions or want to discuss the role in more detail prior to applying