Documentation Controller (6-Month Contract)
About Chanelle Pharma:
Chanelle Pharma is Ireland’s largest indigenous generic pharmaceutical manufacturer of both medical and veterinary products.
Serving customers in 96 countries worldwide, Chanelle Pharma is a partner of choice in the development and manufacturing of pharmaceutical products to the world’s leading human generic and animal health multinationals and distributors. We are passionate about understanding and addressing the challenges facing our medical and veterinary customers and bringing them innovative and effective products and solutions.
The Opportunity:
This is an opportunity to be part of a dynamic team within the Quality Assurance function. We are looking for individuals who will support and drive Chanelle Pharma’s vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers.
Reporting to the Senior QA Compliance Manager, the main objective of this role is to support the control and issuing /circulating of documents for Chanelle Pharma.
You will also be required to support in additional administrative activities for QA department
KEY RESPONSIBILITIES:
- Maintain and update an efficient documentation system which is compliant with company quality system and
- GMP guidelines for all controlled documents using the most up to date techniques in word processing and software packages.
- Preparation, circulation and control of new and updated procedures, e.g SOPs, Forms, work orders etc,, ensuring that agreed target dates are met.
- Provide support and training when needed, to personnel on the essential elements the documentation system
- Archive Room – Set up logs with document names, batch no’s and location within. Control of access to room ensuring known whereabouts of documents.
- Maintain and update the Jordan documentation folder on the system with current revisions of documents, thus informing them when documents are revised/obsoleted.
- Issuing document numbers to controlled documents, SOP’s, Forms, MWO’s, PWO’s etc. for use within
- Tracking of controlled documents – when review is due following up with
- Carry out all administration duties functions, such as filing, typing, and record keeping, archival of completed documents ensuring all administrating duties are kept up to
- Updating current and obsolete contents pages and folders on system and ensure that filing/record keeping is kept up to date.
- Ensure that existing quality procedures are followed in all areas and where appropriate suggestions / change notices are prepared such that the quality system can continually be
- Proficient in ii word and excel
- Ensure timely feedback on queries as
- Ensure that work area is kept tidy and
- Training Administrator for the Quality Assurance department – updating the versatility sheet
- Updating HR with Training Hours from QA
- Shelf life forms – creation, additions, updates and validation on veterinary and medial shelf life forms
- Master Packaging Work Orders – approval of new and updated work
- Reject Notices- Updating figures on VM board and following the closure of reject notices
- Any other duties as assigned by your manager.
COMPETENCIES:
- Excellent written and verbal communication skills.
- Excellent organization, strong attention to detail and IT skills.
- The ability to be self-driven and capable of working on own initiative.
- Proven capability of team participation and be proactive and flexible.
QUALIFICATIONS:
- A Bachelor’s degree in a Science related discipline.
- Desirable a minimum of 3 years’ experience of working in a similar Quality Assurance related role in the Pharmaceutical Industry.
- Knowledge of EU quality-related pharmaceutical regulations.
WORK ENVIROMENT:
- Office
