Quality Systems Specialist

Desired Skills: SAP,ERP,QMS,Veeva,TrackWise,SOPs,Purchase Orders

KEY RESPONSIBILITIES

· Provide direct support to Process Team Leads across Commercial & Clinical products (Small Molecules, Biologicals, Drug Substance, Drug Product and Packaging operations on targeted/prioritized activities.

· Manage and execute all transactional ERP aspects for production efforts at CMOs (includes executing production transactions, updating work order dates, receipting of purchase orders, inter organizational transfers etc.)

· Own and manage prioritized change controls and deviations within the Quality Management System (QMS) to effective on time closure and no impact on supply.

· Consolidation and issuance of key performance metrics per Process Team

· Provide back-up support for Process Team Leads where necessary (e.g. holidays)

· Support selected continuous improvement activities aligned to the site business plan objectives with clear and measurable time and money savings.

· Work cross-functionally to perform rigorous root cause analysis, to understand issues and implement corrective actions as appropriate.

· Document key business processes in a standard format (e.g., Best Practice Document or Standard Operating Procedure).

· There may be a need for this person to execute operation tasks with a view to eliminating or reducing the number of touchpoints associated with a task.

· This list of support responsibilities may change depending on business needs and employees are expected to be adaptable and flexible where this need arises.

EXPERIENCE & SKILLS:

Minimum requirement of 5 years’ experience within an Operations and regulated environment.

Relevant 3rd level qualification.

Required skills needed to accomplish the responsibilities/essential functions include:

• Will have a working understanding of ERP systems (e.g. SAP)

• Will have a good working understanding of the processes/unit operations assigned to the team.

• Ability to engage cross functional teams in the resolution of short-term issues and sustained performance for long-term goals.

• Experience in lean/six sigma/continuous improvement tools and techniques.

• Excellent written and verbal communication skills.

• A high level of initiative and drive, as well as excellent organizational skills, are key role requirements.

• Ability to work independently.

Please click the link below to apply or alternatively send an up to date CV to howie.leahy@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***