QC Documentation Specialist - Pharmaceutical
Large scale Biologics manufacturing facility have a contract requirement for a experienced Technical Writer /Documentation Specialist
Working within a growing and busy QC department, with responsibility for commercial product release and
stability testing we are looking to recruit a QC Documentation Specialist on an initial 6 month contract.
The role & responsibilities:
You will be involved in continuous improvement process mapping events and translating the output of those events into Standard Operating Procedures (SOP's) and Work Instructions (WI)
- Active participation in Continuous Improvement Projects.
- Writing and revision of SOP's
- Track documents through approval process and work with approvers to deliver documents in line with QC project plans
- Identify process improvements
- Comply with internal SOP’s, standards and associated training
- Support the Quality Control, with responsibility to develop processes
- Responsible for assigned CAPA’s, Change Controls & Deviations program and initiate Corrective Action plans in the Alexion Quality Management System, TrackWise
- Maintain regular and proactive communication with all stakeholders.
Skills experience required:
- At least 4 years’ working in Pharmaceutical quality operations
- Degree in science/pharmaceutical related subject
- Knowledge and understanding of GMP/GDP standards
- Familiar with continuous improvement initiatives
- Experience of SOP authoring and document management processes
- Highly Computer literate, with MS Office (Word, Excel)
- Experience of provision training to others
- Experience of working in a GMP Quality Control Laboratory or Quality Assurance Unit
Call me to discuss this vacancy in further detail
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
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