Our client partner based in Arklow are currently looking to recruit an experienced QA Operations candidate.
The QA Operations Specialist will be responsible for the following tasks:
Carrying out the review of batch manufacturing documentation relating to oral solid dose production
Preparing documentation for QP release in a timely manner
Investigating and close out of deviations while working in close co-operation with other departments
Identifying and implementing corrective and preventative actions
Participate in, and lead, relevant Quality Risk Management Assessments.
Participating in internal and external audits as required
Being involved in the continuous improvement of Quality systems
Providing QA support to other departments.
This is a dynamic role where the applicants must be able to demonstrate “subject matter” expertise in their area along with a strong understanding of cGMP, compliance systems and processes.
In order to be successful in this role, candidates will be expected to be qualified with a scientific discipline. Solid communication and interpersonal skills are also required. Display a proven ability to effectively work as part of a team. Strong attention to detail will be required, with the ability to critically review data and to write professional technical reports. Refined planning and organisation abilities with a proven track record of multi-tasking, working to tight deadlines are essential. A hands-on, proactive approach will be required.
A minimum of two years’ experience in a similar Quality role within the Pharmaceutical/Medical Devices Industry is required. Candidates should hold a Degree level qualification in a scientific or relevant discipline. Qualification to act as a Qualified Person would be desirable.
All interested candidates should send their CV in Word Format (not pdf if possible). Alternatively, to discuss the position further please call Breda on 012744459/44