Documentation Specialist

The Role

PE Global are recruiting for a Document Specialist for our pharmaceutical client based in Co. Carlow. This is an initial 11-month contract role. *Fully onsite*

Responsible for supporting the Quality Control Department in the management of laboratory GMP documentation, and in supporting the various administrative duties. Ensuring that objectives are effectively achieved to, consistent with requirements to ensure Compliance, safety and reliable supply to our customers. This is a day role, Mon-Friday based on site.

Job Responsibilities

• Be a document system expert for the Quality Control Department; this will include document generation and review and document system work-flow expedition where applicable – examples include Standard Operation Procedures, Work Instruction, Policies, Safety procedures, Annual Product Reviews, electronic logs.
• Format, write and deliver necessary documentation in line with Policies, Procedures and Guidelines, regulatory requirements.
• Support laboratory administration activities through documentation generation, documentation filing, tracking and auditing.
• Manage and complete department specific assignments, including periodic review of documents.
• Support continuous improvement by active participation and engagement with laboratory team for document updates out of investigations and corrective actions.
• Contribution to Kaizen events and documentation improvement projects as appropriate.
• Ensure timely completion of all assigned documents to meet site metric requirements.
• Work collaboratively to drive a safe and compliant culture in Carlow.
• Participate in QC daily meetings and ensure effective communication of assigned tasks/projects etc.
• May be required to perform other duties as assigned.

Education and Experience

• Degree preferred; ideally in a related discipline
• Experience and/or a particular skill set in their area of expertise that adds value to the Business, preferably GMP setting.
• Proficiency in Microsoft word, Office, excel and electronic data management systems
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
• Report, standards, policy writing skills required
• Understanding of Lean Six Sigma Methodology preferred
• Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers, in a team orientated manner
• Ability to work with teams and escalate issues to management in a proactive manner

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***