Reporting to the QA Operations Manager and working as part of the QA Operations team, the successful candidate will be expected to carry out the role and responsibilities of the job function in an autonomous and responsible timely manner to meet all related targets and deadlines while maintaining good relations with, and flexibility within your team and other departments.
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.
Position Requirements
Essential:
* Degree in Chemistry/Analytical Science/ Pharmaceutical Science or Forensic Science
* Strong IT skills
* Strong attention to detail
* Demonstrate strong use of initiative/self-motivation and a disciplined approach
* Good communication skills
* Strong positive attitude is essential for this position.
Skills:
* Quality Assurance
* Documentation
* Quality Management
Benefits:
* Pension
* VHI
* Paid Holidays
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