Doc Specialist

Desired Skills: MS Office Suite,Engineering,Science,Doc control,Documentation,admin

The Role

PE Global are recruiting for a Documentation Specialist for our pharmaceutical client based in Swords, Co. Dublin This is an initial 12-month contract role. *Fully onsite*

Job Responsibilities

• Support Shift Operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g., EHS metrics, Production Plan, OEE, compliance and team training, including coordination of daily production activities.
• Manage & track creation & updates to Standard operating Procedures (SOPs) Work Instructions (WI’s) for New Product Introduction
• Ownership of CAPAs
• Support compliant operations through management of materials used in Upstream Operations.
• Data analysis supporting operations in safety quality delivery and cost
• Link to finance department for monthly materials reporting and approvals
• Liaise with stakeholders including Shift Operations, Tech Ops, Quality Assurance
• Collate and analyse downtime tracking data and link to problem solving.
• Provide Communication updates to manufacturing shift teams.
• Co-ordinate and support Audits including preparatory work.
• Coordinating and authoring Quality Notifications and Corrective and Preventive Actions (CAPAs). Ensuring accurate and timely documentation and updates to maintain compliance with quality standards and regulations.

Education and Experience

• Degree or 3rd level qualification (Science, Engineering).
• Working knowledge of SAP
• Experience with Qualified Document Management systems
• Self-motivated with excellent organizational skills
• Ability to interact with multiple stakeholders across numerous departments.
• Ability to work independently and as part of a team.
• Advanced soft skills e.g. MS Word, Excel, PowerPoint to generate metrics, presentations as applicable
• Working knowledge of Upstream processes is highly desirable.
• Knowledge of Lean Six Sigma and Lean methodologies, with an understanding of regulatory requirements

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up-to-date CV to aisling.oleary@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***