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Quality Control Analyst
4 months ago
Quality Control Analyst – 9 months contract – Liverpool - £18.50 per hour Umbrella - Biotechnology company
Ready to make your application Please do read through the description at least once before clicking on Apply.
Overview:
Supports the QC Compliance and Improvement Manager in providing compliance support across QC activities.
Initiate innovations and improvement projects across QC and be involved with their execution and timely completion.
Participate in site improvement project teams, drive quality decisions, and provide advice and technical support where required.
You will deal with internal and external contacts.
Internal contacts – Data inputs from Supply Chain, Operational Teams, and Project and AS&T teams, which must be reviewed and interpreted to maximise laboratory resources in line with site objectives. Works closely with the QC Managers, QC labs, and SME’s.
External contacts- Global Quality Systems and Compliance for changes in Health Authority expectations. Daily interaction with VWR who manage site consumables and reagents via in-plant personnel.
Responsibilities:
- Work closely with the labs to lead Deviations, CAPA’s, and Change Controls through to on-time completion.
- Participate in lab improvement projects.
- To ensure appropriate standards of cGMP, Housekeeping, Health, Safety and Environment are applied in all activities, in accordance with current regulations and procedures.
- Ensure QC compliance with Company Policies
- Support QC labs with respect to sample delivery from across the Liverpool sites to the labs in a timely manner.
- Keep oversight of and facilitate on time completion of DR’s, CAPA’s, Change Controls and SOP Updates
- Monthly and annual report writing for EM, Bioburdens and Endotoxin results, including annual product review.
- To collate data relating to site and organisational changes that will impact the efficient running of the laboratories.
- Manage the completion of DR’s, CAPA’s, Change Controls and SOP updates working closely with the QC labs.
- Attendance at and presentation at DRB.
- CAPEX project submissions and management.
- Invalid reporting.
- Maintenance of QC metrics.
- PPS problem-solving.
Must haves:
- cGMP background in the Pharmaceutical industry
- Experience of Quality Control / Microbiological testing techniques and industry practices
- Knowledge and understanding of Lean Lab principles.
- Good understanding of the QC labs
- Knowledge of continuous improvement techniques and advanced root cause analysis techniques
- Report writing skills.
- Proven time management skills
- Proven communication skills both written and verbal.
- Academically trained to a minimum of degree standard in a relevant scientific discipline
