JOB DESCRIPTION

Corporate Quality Assurance and Regulatory Affairs Director

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

• Effective management of the department to ensure high quality product is provided to customers in a timely manner Supervision of the Quality Assurance department
• Ensure site and all department's adherence to cGNfP and regulatory requirements
• Liaison with the Corporate Quality Assurance Regulatory Affairs Director on matters related to the site Quality Management System
• Co-ordination of site activities related to audit preparation, lead during audits and follow-up as required
• Creation, review and approval of quality documentation such as master batch records and validation documentation
• Training of other personnel and contractors in relation to site policy, quality and regulatory matters as required Maintenance and management of the Quality Management System
• Ensure the facilities equipment and instrumentation are maintained and operated under validated conditions
• Final release of material
• Communication with customers and regulatory authorities as required
• Cooperation with other departments to achieve site objectives
• Other duties as assigned by their supervisor

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 ensure investigations are performed in a timely manner and the implementation and follow-up of necessary actions as required
• 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 regulatory requirements, and all issues are resolved prior to approval and release
• To lead site audit preparation and to act the site quality representative during audits
• To approve quality documentation
• To ensure personnel are trained as per company policies and regulatory requirements
• To assist other department members issues as required

JOB DESCRIPTION

• To ensure effective communication with customers and regulatory authorities as required
• To perform periodic reviews of the QMS and its communication to site management and the Corporate Quality Assurance and Regulatory Affairs Director
• To monitor company performance with respect to its manufacturing authorisations and reporting to the Plant Director and regulatory authorities as required
• 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 GMP areas such as production, quality control and the warehouses and some supervisory duties. This position acts as the site lead for quality related matters and the liaison with the Corporate Quality Assurance and Regulatory Affairs Director and Regulatory Affairs department.

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 and Regulatory Affairs Director and/or the Site Plant Director 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