QC Documentation Coordinator

Role Summary:

• Our client based in Co. Carlow, is looking for an experienced QC Documentation Coordinator to join their busy pharmaceutical site.
• The successful candidate will be 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, consistent with company requirements to ensure Compliance, safety and reliable supply to their customers.
• This is a day role, Mon-Friday based on site.

Core Duties and 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 Company Global 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.

Minimum Qualifications 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
• Customer service
• Goal/results orientated
• Training skills
• Effective time management and multi-tasking skills
• Proven organizational skills
• Excellent attention to detail
• Self-motivated
• Flexible approach
• Planning and scheduling skills

Please note, we do not require agency assistance with this role.