Documentation Specialist - Operations - Biopharma
New build Biologics facility have a contract requirement for a Documentation Specialist. Working within operations you will be responsible for the efficient management of documents including access and revision control.
Duties will include:
- Manage 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 as required.
- Work closely with QA, Supply chain and Operations core functions.
- Ensure compliance with all regulatory GMP, Safety and Environmental requirements.
- Experience Working in a Pharmaceutical GMP regulated industry.
- 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 )
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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