2022/674 – QA Technical Specialist – Waterford Contractor

This is a 12-month contract with a view to extension. This is a hybrid role.

Purpose:

The QA Technical Specialist reports to the QA Manager providing leadership, knowledge and expertise, and hands-on support for the introduction of a new MES system on site. The position works closely with Operations & MES functions to design, install, evaluate and qualify an MES system fit for use.

Responsibilities:

• Perform the QA representative role in the development and implementation process of the Manufacturing Execution System (MES) project.

• Review of MES documentation, recipes and process flows; supporting MES change control

• Complete the QA oversight to ensure the design and validation of the MES system meets cGxP, data integrity, and site requirements

• Review and approval of MES validation documents

• Authoring, reviewing, and Approval of cGMP Documentation associated with the MES project

• Act in a lead capacity providing quality support to an MES project working with other functions to deliver the project on time and in compliance

• Support the development and implementation of Master Batch Records and procedures for existing product platforms (e.g. Auto-Injector).

• Support the project team with defining strategies for change controls, risk assessments, and UAT testing documentation

• Perform timely review of documentation/process maps/reports highlighting and assisting in the resolution of concerns commensurate with the risk.

• Liaising with both internal and external customers on quality issues.

• Participate in the preparation and review of procedures and batch documentation.

• Preparing and supporting MES systems for batch release.

• Provide training support to site TMs on quality-related aspects of the MBR process

and actively participate in change management activities.

• Working as part of a project team on-site ensuring products are manufactured, by cGMP.

• Ensure that all work carried out complies with the required standards conforming to company, cGMPs, cGLPs, SOPs, regulatory regulations, and guidelines.

• Review and approval of deviation, CAPA’s, quality events, change controls, and tasks.

• Acts as Quality Point person providing guidance/feedback on quality

• issues/concerns.

• Analysing, identifying, and implementing quality and operations process improvements that will improve process capability and performance.

• Actively contribute to continuous improvement initiatives.

• Safely conduct duties and report all safety issues or concerns.

Minimum Qualifications & Requirements:

• Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering)

• Minimum 5 years in the international Pharmaceutical and/or Medical Device industry with an increased level of responsibility.

• Experience in a similar QA role.

• Extensive experience in batch review and EBR experience.

• Knowledge of Change Control processes and QA projects.

• Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels.

•  Excellent accuracy and attention to detail.

• Excellent Planning and organizing skills are required.

• The individual in this position is expected to represent the company Pharmaceutical’s interests, objectives, and policies responsibly and professionally.