Quality Officer

Quality Officer
- Reach your career goals with Eirgen Pharma, your future could be here _

Would you like to be part of a company that has the courage, innovation, and capability to
improve and enhance patient lives across the globe?

Eirgen was founded in 2005 and since then we have continually grown and now employ over 180
employees at our site in Waterford. Our strengths lie in our capability to rapidly introduce new
products and add additional volume to existing products - ensuring supply for new product launches
and expanding market opportunities.

What makes us different is that while we continue to grow our business we have still maintained that
small company feel to our culture which enables us to ensure that our employees are always front
and center in everything we do. By creating a progressive and dynamic working environment, where
hard work and enjoyment aren’t mutually exclusive, we have created a high performing, people
- centric culture which allows us to work in an environment where the focus is always on ensuring that
the patient comes first.

The Person

You are qualified to degree level incorporating Quality Management (QM) and or possess degree qual
- ification in a science or engineering related discipline. You have at least 3-5 years’ experience in a
EDMS - Electronic Document Management System QUMAS, SAP, MRP system, and Trackwise eQMS)
along with Lead Auditor Training would be an advantage.

You possess a good knowledge of cGMP requirements for Oral Solid Dose to support the role. You
show excellent accuracy and attention to detail. You are customer focused with strong communica

• tion and presentation skills. You are accurate and timely in producing results and can manage tasks
  and schedules effectively. Experience in performing and assessing risk/impact assessment is an ad
• vantage.

The Role
You will support all functions of the organisation through collaboration and continuously seeking

solution based decision making with regards to supplier management practices and procedures. You

will ensure compliance to the required customer and regulatory requirements and regulations and

build simple effective site systems to support same.

You will:

• Manage all aspects of the Supplier Management Quality System, including:

• Initial Qualification which includes the assessment of the requirements based on the

type of service of material being sought,

• Continuous management such as ensuring periodic reviews of the supplier files are as
• signed and completed.
• Managing change notifications and ensuring the correct ownership of same is assigned

on site and tracked for completion and risk.

• Managing the supplier complaints process and communication of status of same
• Managing the supplier audit schedule and ensuring that relevant trained personnel are

scheduled and the audits are completed on time

• Ensure all excipients for site meet regulatory requirements through the use of the excipi
• ent risk assessment process to ensure all risks are mitigated.
• Manage the QTA process and ensure new QTA’s are completed as per templated re
• quirements and QTA periodic reviews are monitored and completed on time
• Perform critical / constructive review of procedures and documents on site to ensure no lost

time for all operations and Programmes.

• Utilise the Electronic Documentation Management System - QUMAS
• Check own work and that of others for accuracy prior to ‘QA Authorisation’ of docu
• mentation.
• QA reviewer of Trackwise Change Controls
• Progress Trackwise change control actions and attach evidence as required.
• Perform internal audits as scheduled by Eirgen
• Ensure that all work carried out in Eirgen is in compliance with the required standards conform
• ing to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environ-mental
  guidelines.
• Actively contributes to continuous improvement initiatives at the site.
• Operation of Eirgen SAP (ERP System) Quality function as per procedures.
• Liaise with Quality Control on the progression of OOS/OOT and KLE investigations as per proce
• dures.
• Identify and make recommendations for improvements as part of a team within or outside the

department in order to ensure continuous improvement.

• Assist in the preparation for customer/ regulatory inspections.
• Attends team meetings, regular 1:1’s, represent quality at cross functional meetings and actively

manage own performance development.
- Define, manage and maintain key metrics for supplier management, ensuring site visibility and

trending to support continuous improvement.

• Perform additional team tasks as agreed to support effective running of the Business.
• Compile and deliver quality based training with the company.
• Conducts all activities in a safe manner and report any site hazards as you identify them.

Perform additional team tasks as agreed to support effective running of the Business.

Compile and deliver quality based train