Production Documentation Management Assistant

Production Documentation Management Assistant

Kenny-Whelan & Associates are hiring a Production Documentation Management Assistant to join one of our Global Life Sciences Companies in Cork.

Contact: Carmel Synnott on email : [email protected] or call on 087 7422268

Profile of the Role:

The Production Documentation Management Assistant will assist in management of Production Batch Records, GMP Documentation and Electronic Systems associated with the Site Production Teams.

Main duties and responsibilities:

·      Routing of new and revised procedures/, batch records and compliance documents in Regulus.

·      File documents in physical and digital records and ensure appropriate storage

·      Review and maintain the accuracy of the records, editing where necessary to ensure they are up to date

·      Management of Regulatory Documents, ensuring their accuracy, quality and integrity and compliance with version control

·      Upload documents in line with site SOP’s – appropriate templates used etc.,

·      Routing of new and revised procedures/, Batch Records and Compliance documents in Quality Doc Documentation Management System

·      Supporting Data Integrity- specifically the issuing, controlling and reconciling of procedural attachments.

·      Track documentation errors and highlight common problem areas.

·      Maintain confidentiality around sensitive documentation

·      Assist on internal and external audits

Requirements:

·      Proven interest in working within production and understanding the Pharmaceutical Industry’s business processes.

·      Demonstrated excellent Documentation Practices and compliance with procedures.

·      Demonstrated high level of IT skills.

·      Strong interpersonal and communication skills with a willingness to help others.

·      Proven ability to deal with unexpected issues using a problem-solving skills.

·      Self-motivation with the ability to operate without close supervision.

Education and Experience:

• Degree in Science, Engineering discipline or equivalent
• Advance ECDL / Full MS Office Suite
• Regulus experience very desirable
• Experience of EDMS

Please note:      

Monday to Friday and occasionally some non-scheduled call-in time to respond to operational needs.

All applications will be treated with the strictest confidence

Kenny-Whelan Contact:

For further information please contact Carmel Synnott on 00 353 21 4665405 / 087 7422268 or send your updated CV to [email protected]