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 possibility of a hybrid position after 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.
#J-18808-Ljbffr