Document Controller
Posted 2 days ago by ESS Ltd
Title - Document Controller
Location: Cork
Department: Quality Assurance/Validation
Reports To: Operations Manager
Job Type: Full-Time
Who we are;
Established in 2001, Eirdata are specialists in cleanroom validation, commissioning & compliance. We provide these range of services to the pharmaceutical, medical devices and healthcare sectors primarily. In 2013, Eirdata was acquired by ESS Group.
ESS Group includes three companies – Engineering Support & Services Ltd. (ESS), Eirdata Environmental Services Ltd. (Eirdata), and the newly joined Critical Airflow Europe (CAE).
- ESS are experts in asset management and maintenance reliability through people.
- Eirdata are specialists in cleanroom validation, commissioning and compliance, HVAC systems, indoor air quality and building wellness.
- CAE are the European leader in delivering safe energy efficient laboratory control and critical airflow applications. Critical Airflow Europe Ltd represents Phoenix, Strobic and Aircuity.
Summary of the Role
The Document Controller will be responsible for managing and maintaining the documentation system in a validation company. This role ensures all documents are properly controlled, updated, and distributed in compliance with regulatory standards and company procedures. The ideal candidate will have a keen eye for detail, excellent organizational skills, and experience in a regulated environment.
Duties & Main Responsibilities
Compliance:
Ensure all documentation complies with regulatory standards and company policies.
Conduct regular audits of the document management system to ensure ongoing compliance and efficiency.
Assist in preparing for regulatory inspections and audits, providing documentation as required.
Support and Training:
Provide training and support to staff on document control processes and use of the document management system.
Assist in the creation and revision of standard operating procedures (SOPs) and work instructions related to document control.
Quality Assurance:
Collaborate with the Quality Assurance team to ensure all validation documents are accurate, complete, and up to date.
Participate in quality improvement initiatives and contribute to the continuous improvement of the document control process.
Coordination:
Work closely with project managers, validation engineers, Planner and other stakeholders to ensure all project documentation is correctly managed.
Coordinate the review and approval process for validation protocols, reports, and other related documents.
Experience:
Minimum of 3 years of experience in document control within a regulated environment, preferably in the pharmaceutical, biotechnology, or medical device industries. Familiarity with regulatory standards such as FDA, EMA, and ISO guidelines.
Education & Qualifications
Level 5/6 qualifications (e.g., Life Sciences, Engineering, Quality Management) or equivalent experience.
Required Skills
- Proficient in using document management systems and software.
- Excellent organizational and time management skills.
- Strong attention to detail and accuracy.
- Effective communication skills, both written and verbal.
- Ability to work independently and as part of a team.
- Proficient in Microsoft office (excel, word, PowerPoint)
Benefits
Eirdata offer support that enables you to never stop growing. Your reward at Eirdata is not just your salary, we believe in investing in our people's personal, professional development and empowering their work-life balance to enable continuous growth. We offer supports and benefits that suit you, wherever you are in life, including Health care, pension, training, coaching.
- Pension
- VHI
- Laptop
- Paid Hols
Cont'd Education Program
- Type:
- Permanent
- Contract Length:
- N/A
- Contact Name:
- Login or register to view
- Job Reference:
- 180624EIR
- Job ID:
- 221938413
- Applications:
- Less than 10
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