Job Title: QC Method Validation Specialist (Plasma Operations Quality & Validation Specialist)
Location: Liverpool, UK
Hours: 37.5 p/w
Salary: £135 per day inside IR35 via Umbrella
Please note: this role does not offer any VISA sponsorship, to be eligible for the role you must have the right to work in the UK.
i-pharm consulting is working with one of the world's leading influenza vaccine companies, operates cutting-edge manufacturing facilities across three continents with a global supply chain. Their comprehensive influenza vaccine portfolio caters to the needs of healthcare professionals and their patients. They are a global partner in pandemic preparedness and influenza control and are looking for a plasma operations quality & validation specialist to join them on-site.
Reporting to the Analytical Science and Technology manager, the role is accountable for Quality Control method validation lifecycle management and method standardisation/robustness. The validation specialist is an SME in testing methodology, able to troubleshoot technical issues, develop current and existing methods and be current with the latest analytical testing technologies. The role requires the execution of intra site method transfers and SME input into regulatory filings/audits. The role will involve GMP execution of development and technical assays in support of both egg and cell characterisation samples.
Essential Duties and Job Functions
- Maintain the compliant status of QC method validation lifecycle.
- Trouble shoot technical challenges with QC test methods.
- Execution of method standardisation and robustness program
- Development of current and new test methods. Engaged with the latest testing technologies
- Execution of intra site method transfers and SME input into regulatory filings/audits
- Responsible for experimental design on key projects that involve new technologies and processes to QC
- Responsibilities in the project management of AST studies.
- The employee is required to review data generated from validation activities and bring to the attention of Management any detrimental trend or deviation identified.
- Maintains industry knowledge and awareness of new methods, equipment and techniques.
- Development of new methods. Able to identify improvements which have a positive impact to the business.
Knowledge, Experience and Skills
- Sc. in Scientific Subject
- 2 years cGMP background in the pharmaceutical industry
- Experience of Quality Control testing techniques and industry practices
- Proven time management skills for planning and schedule of work
- Proven Communication skills both written and verbal
- Knowledge of continuous improvement techniques and advanced root cause analysis techniques
If you are interested in finding out more about this role or others, please contact Manpreet Bhullar at email@example.com or call +44020 7551 0802