Our client, a pharmaceutical company in Mayo are currently looking to recruit an Associate Documentation Analyst for their Westport site on a contract basis.
Associate Documentation Analyst is a member of the DCC (Document Control Centre) Department. The DCC department in turn forms part of the QA group locally. The DCC group is responsible for the processing of all CORAL Documentation for the Westport site. The DCC Department must maintain compliance with local, regulatory and legislative requirements with regards to Safety, Housekeeping, GMP and support and comply with internal environmental health and safety requirements, procedures and policies. It achieves these functions by interaction with QA, EHS, Compliance and regulatory affairs to ensure all internal procedures reflect current requirements.
This is a list of Core Duties and must not be taken as a definitive list. You may be asked from time to time to undertake other duties, either in or out of your area of responsibility
- Control, distribute, maintain, update and obsolete SOPs, Controlled Forms, Project Documents and Manufacturing Records on CORAL
- Initiate training on all SOPs using LMS/Compliance wire system.
- Distribution of WWQA Documentation both internally and externally to vendors where relevant.
- Update and distribution of internal department documentation.
- Run CORAL and LMS reports relating to DCC and other departments as required.
- Submission of CORAL Access requests for new and updated CORAL accounts.
- Maintain all current KPI metrics at or above targets.
- Ensure DCC is in compliance with all procedures at all times.
- Deal with Internal and External customer queries under the guidance of the department Supervisor.
- Dry-Running/Real Time Execution of OQ/PQ scripts where applicable.
- Associate Director Quality Control
- Quality Systems Supervisor
- DCC Administrators
- Business Unit Operations Management Teams
- QPs in Business Units
Education and Experience/Knowledge
- Proven track record in a quality discipline in the Pharma/Medical Device environment.
- Microsoft Office Word and Excel is essential.
- Clear understanding of working within a regulated environment
- Excellent communication skills
- Ability to use sound judgment to make effective decisions within appropriate timeframes
- Relationship Building: Establishing excellent working relationships with Quality Systems Supervisor and department colleagues.
- Communication: Excellent communication and presentations skills, both written and oral. Articulate quality requirements in a clear and concise manner.
- Planning & Organising: Excellent analytical skills. Ability to plan and schedule.
- Decision Making: Identify and understand issues, problems and opportunities whilst providing a viable solution.
- Adaptability; Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints.
- Passion for results: Drive, high energy, maturity, and ability to work under pressure and deliver results; get things done (an action-oriented approach); overcome obstacles.
- Receptivity to feedback - Receptive to the ideas of others and welcome and accept constructive feedback, display humility where appropriate.
- Culture fit: Uphold the values and ethos of the company.
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