A Document Controller is required by CareerWise Recruitment for our Cork based pharmaceutical client. This would be an 11-month contract position and It would be based in Cork. There would be a possibly of a hybrid position after the 6 months.
THE ROLE:
- Creating, editing, and formatting of SOPs, Work Instructions, and other documents on the EDMS system from material supplied by the Vaccine IPT SMEs.
- Liaison with key stakeholders e.g., Quality, Change Control, SMEs etc. to ensure compliance, correctness, content, and delivery.
- Lead the tracking and maintaining of the project document delivery schedules for the team (using Excel).
- Engage with Change Control and the wider project team to ensure documents are prepared and updated in time for different stages of C&Q execution and production.
- Provides to the site knowledge and experience in Quality Documentation Systems.
- Responsible for use of the Site Documentation System including Issuance, reconciliation, storage, archiving and retrieval of cGMP documentation to support the manufacture & testing of our products.
- Responsible for maintaining the Site Master file for current effective cGMP documents on site.
- Uses knowledge to improve Quality Documentation Systems, solve problems, provide continuous improvement, and execute tasks.
- Provides compliance contribution to project teams and leads small projects.
- Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
- Part-take in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT
- Ensure compliance with site EHS policy, cGMP and other business regulations and support Technical IPT input to risk assessments, audits, regulatory inspections, and incident investigations.
- Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
REQUIREMENTS:
- 4 years’ experience in the Medical Device Industry.
- Minimum of a primary degree in an Engineering or Technical Discipline
- Excellent interpersonal skills with demonstrated decision making competencies.
- Very strong organizational, Project Management and communication skills.
- Experience in Process characterization, Validation and statistical methods.
- Meticulous attention to detail with a methodical and analytical approach to problem solving.
- Flexibility to travel to vendor sites to support service and project activities.
- Moulding process knowledge an advantage.
Please call Louise Mulligan today for further information on 0949003979 or email: lmulligan@careerwise.ie
CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.
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