Quality Assurance Specialist

4 weeks ago


Longford, Ireland Hunter Savage Full time
Position: Quality Assurance Specialist

Department: Quality Assurance

Immediate Supervisor: Quality Assurance Assistant Manager (or designee in their absence)

Top 3 things to know about this job

- Progressive company
- Positive working environment and culture.
- Job security along with continuous training and development

Job Outline

Duties

- Maintenance of the Quality Management System (QMS) and the use of its associated software (Pragma and Adhoc)
- Review of manufacturing and cleaning records
- Review of shipment documentation and containers prior to release
- Issuance of materials to production
- Performance of the Good Manufacturing Practice (GMP) Walkthroughs as scheduled
- Provision of proactive reporting, investigation and response to quality related issues
- Liaison with the Quality Assurance Assistant Manager on matters such as those related to the QMS, audits, documentation, etc.
- Preparation of quality documentation such as product quality reviews
- Performance of cleaning visual inspections
- Provision of training to others as required
- Provision of assistance with audit preparation and the performance of internal audits as required
- Provision support to other departments for quality related issues and to the Quality Assurance Assistant Manager to ensure site adherence to current GMP
- Perform other duties as assigned by their supervisor (or designee in their absence)

Responsibilities

- To adhere to cGMP and EHS practices at all times
- To liaise with supervisors to ensure the rapid communication of issues and the progression of projects, material release, etc.
- To ensure the QMS is maintained as per cGMP including but not limited to change controls, deviations, corrective and preventative actions, controlled documentation, etc.
- To prepare quality documentation including but not limited to product quality reviews, quality risk assessments, etc. To critically review and approve updated documentation as required
- To critically review manufacturing, cleaning and shipment documentation to ensure their adherence to cGMP and to address any outstanding issue prior to release
- To ensure that all material meets the relevant requirements, and all issues are resolved prior to approval and release
- To support the Quality Assurance Assistant Manager with audit preparation and to participate in audits
- To assist other department members with issues as required
- To assist with periodic reviews of the QMS and its communication to site management and the Corporate Quality Assurance and Regulatory Affairs Director
- To have a general interest in quality assurance activities and the desire for improvement opportunities

Working Conditions

This position is primarily an office-based role in the Quality Assurance with some duties performed within the GVW areas such as production, quality control and the warehouses. The company will provide workplace conditions in which its personnel can function safely and efficiently. All personnel are required to comply with current standard operating procedures and cGMP as required.

Work Performance

The employee's performance will be monitored by the Quality Assurance Assistant Manager and will be assessed as per the following criteria:

- General timekeeping and attendance
- Work output
- Quality of workmanship
- Compliance with agreed work schedule and programme
- Compliance with Health, Safety and Environmental and Quality practices
- Ability to work in a team environment
- Ability to work independently
- Work attitude
- Training and self-development
- Contribution to improving the department
- Overall team performance

Next Steps

Click apply to start the process today or reach out to Conor O'Hagan at Hunter Savage for further information.

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