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