CLS is Ireland’s leading provider of sampling, analysis and on-contract analysts to the food, environmental, pharmaceutical and medical device industries. Founded in 1994, CLS is renowned for delivering high-quality laboratory data, always on time and in the most customer-focused way.
CLS is currently going through an unprecedented and exciting period of growth and development and is now looking for a committed and motivated Document Controller to join our Quality Department in Galway City.
This role will primarily be working within the Quality Unit in Galway city.
As a member of the Quality team within operations, this role will be responsible for supporting the implementation of an electronic Quality Management System – a paperless Quality Management System, and various other administrative duties which will drive efficiencies and the effectiveness across the Quality Department.
Essential Duties & Responsibilities
- Use of standard systems including MS Word, Excel, PowerPoint, Outlook and various company specific software.
- Format, track and issue controlled cGMP documents including protocols, test records and forms.
- Check for accuracy and edit files
- Copy, scan and store documents
- Create templates for future use
- Assisting the QA Manager and Supervisors on a daily basis to ensure the documentation is checked, correct and implemented in a timely, efficient and effective manner daily.
- Compliance with GMP, ISO17025, and CLS internal quality and technical procedures
- Ensure effective and efficient communications with all levels of the organisation
- Providing administrative assistance to the wider team/department.
- Carry out project work as required.
- Update forms and procedures as appropriate, working closely with Microbiology and Chemistry departments
- Assist with documentation for new projects ensuring all quality standards are met
- Preparation and management of documentation, ensuring their accuracy and quality
- Co-ordinate sign-off and training of procedural documentation
- Generate change control requests, deviations and CAPA’s
- Control the flow of documentation with responsibility for generating, authoring and reviewing GMP documentation
- Produce reports/metrics as required
- One year experience in an administrator or documentation role within a medical device/pharmaceutical company.
- Knowledge of cGMP practices and regulations desirable.
- Proficient in Word, Excel and Microsoft Outlook
- Knowledge of Q-pulse a distinct advantage
- Ability to work independently and efficiently.
- Ability to take instruction and deliver results in a timely and efficient manner.
- Strong alphabetical and numerical aptitude with excellent attention to detail.
- Good time management with the ability to prioritize and multitask effectively.
- Ability to adapt to changing circumstances, ensuring flexibility to support stakeholder needs.
- Strong leadership and problem-solving skills.
- Excellent communication and interpersonal skills with the ability to keep all stakeholders informed.
If you would like to apply for this role, please send your CV into email@example.com
Diversity and inclusion are essential to our mission and achieving our vision at CLS. The diversity we foster is one of our greatest strengths in delivering excellence through collaboration, respect, quality and integrity without compromise.
CLS is an Equal Opportunity Employer.
We will only be replying to those progressing to the next stage of the recruitment process.