QA Manufacturing Specialist

Team Horizon is seeking an experienced QA professional to join our client’s aseptic facility as a QA Manufacturing Compliance Specialist. This is an important role within the business and will provide quality and compliance oversight and assistance to the Operations function.

Why you should apply:

• Opportunity to provide real-time shop floor oversight to Aseptic operations, both manufacturing, sampling and testing, partnering with Site colleagues to create an environment of the highest performance standards and drive continuous improvement on site.


• This is an excellent opportunity to join a company who put their people & their patients first and make a lasting impact that's felt within healthcare and beyond

What you will be doing:

• Ensure that all products leaving facility meet the standards required for marketed and investigational drug products.


• Ensure that products and aseptic process simulations manufactured meet the requirements of the end users, regulatory authorities and of the company.


• Providing quality and compliance oversight and assistance to the Operations function of the company to manufacture products in compliance with all site policies and procedures.


• Provide quality oversight during the aseptic processing of products, including aseptic intervention observation.


• Leading / Assisting in investigations arising out of product or manufacturing processes non-compliance.


• Review/Audit of completed Batch Records.


• Review of Manufacturing Logs as required.


• Completion of quality review of operations documentation (SOPs, JSTMs, Risk Assessments)


• Completion of Line Clearance activities.


• Completion of Incoming Raw Material checks, including product status maintenance (as required).


• Provide Stability Program Support, e.g. sample pulls, weekly checks, protocol generation (as required).


• Finished product status maintenance, including labelling as required.


• Administration of Quality Logs, e.g. QA Hold, Sample Request.


• Lead operations floor daily walk around of manufacturing areas.


• Drive continuous improvements and simplify site processes and procedure, specifically relating to the Operations function to ensure compliance is maintained at all times.


• Other support as deemed necessary.

What you need to apply:

• Third level degree in a science, quality or engineering discipline.


• Ideally previous experience in a quality role


• A minimum of three years’ experience in a quality/operations role in a highly regulated GMP environment. Experience in biologics manufacturing is highly desirable.


• Experience in aseptic processing gained within either a quality or operations role is highly desirable.


• A strong knowledge of regulatory requirements is required.