Documentation Specialist

In partnership with its client Kenny-Whelan & Associates is currently seeking a Documentation Specialist for the Cork area.

The Client:

The Client is a well established multi-national.

Job Responsibilities:

• Provide on-going technical assistance to support API procedures, change control documentation and regulatory submissions.
• Preparation/approval/and issuance of procedural and change control documentation within timelines.
• Co-ordination of area resources to deliver a quality and efficient support service.
• Ensure compliance with cGMP and other business compliance regulations.
• Preparation/tracking and issuance of CAPA's, deviations and change control documentation.
• Updating of business unit batch records.
• Review of batch records and recording of incidences of corrections made to batch records.
• Participate in cross functional teams to ensure that business unit and site goals are achieved.
• Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up CAPA's assigned
• Ensure compliance with SHE, cGMP and other business regulations.

Job Requirements:

Scientific/Engineering qualification and relevant experience in a pharmaceutical manufacturing environment

Advanced ECDL

Excellent systems experience/knowledge eg: Regulus, Trackwise, SAP

Key Skills:

• Technical knowledge
• Ability to respond to changing priorities
• Problem solving skills
• Communication Skills
• Technical Knowledge

All applications will be treated with the strictest confidence

Kenny-Whelan Contact:

For further information please contact Carmel Egan on 021 4665405 or send your updated CV to cegan@kenny-whelan.ie