PE Global are currently recruiting for a Documentation Controller for our Biotech client site in North Dublin:
Operations Documentation Specialist Role
Responsibilities:
- Responsibility for the timely, accurate and efficient management of documents including access and revision control.
- Manage “Live” Documentation updates from the Operations floor
- Turnaround and issue documentation as per Operations Schedule
- Manage and implement on the floor documentation control system
- Drive the Documentation Life Cycle System to ensure documents are approved in as per Scheduling requirements.
- Work with various Subject Matter Experts to ensure technical documentation updates are approved.
- Creation and revision of Standard operating Procedures (SOPs) Work Instructions (WI’s) as required
- Work closely with QA, Supply chain and Operations core functions
- Ensure compliance with all regulatory GMP, Safety and Environmental requirements.
Qualifications:
At minimum level 6 in a relevant Qualification
Key Competencies & Experience:
- Self-motivated with excellent organizational skills
- Experience Working in a Pharmaceutical GMP regulated industry desirable
- Excellent verbal and written communication skills
- Ability to work independently and as part of a team in a cross functional collaborative environment
- High level of attention to detail
- Experience working with GMP Documentation Management Systems
- Proficient in Microsoft Office Tools (word/excel/PowerPoint )
Interested candidates should send their CV to Audrey McCarthy at Audrey.mccarthy@peglobal.net or call 0214297900
Key Competencies & Experience:
- Self-motivated with excellent organizational skills
- Experience Working in a Pharmaceutical GMP regulated industry desirable
- Excellent verbal and written communication skills
- Ability to work independently and as part of a team in a cross functional collaborative environment
- High level of attention to detail
- Experience working with GMP Documentation Management Systems
- Proficient in Microsoft Office Tools (word/excel/PowerPoint )
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