A leading pharmaceutical client is searching for aa QC Analyst to join their team in the UK. The company specialises in various therapy areas including oncology, neurology and gastroenterology, and employs several thousand across the globe.
- To test all materials according to agreed specifications and procedures.
- To qualify (URS, IQ, OQ, PQ) all laboratory equipment.
- To maintain and calibrate all laboratory equipment according to approved procedures.
- To maintain all laboratory Quality Systems and Quality Management Systems in compliance according to approved procedures.
- To write under supervision, all SOPs associated with QC support.
- To support the internal and external audit process and audit schedules as appropriate.
- To support the preparation and hosting of competent authority inspections.
- To raise and support the investigation of deviations and associated CAPA's.
- To support technology transfer projects and in particular any QC aspects of these.
- To support the implementation of change control activities.
- To support the process for data collection for PQR's.
- To support the collection of data for reporting Quality Assurance Performance Indicators.
- To support the implementation and management of stability programmes.
- To perform any other appropriate duties at the request of the QC Head.
Skills and Requirements:
- Ability to establish and maintain effective working relationships and communication links within EML, affiliated organisations, and other customers.
- Extensive knowledge of Quality Control, Quality Assurance, Quality Systems, GMP, Regulatory Compliance, and manufacture and packaging of pharmaceutical products.
- Good technical and scientific judgement.
- Ability to interpret complex data and present key findings.
- Demonstrated Knowledge, understanding and application of GMP Guidelines and Regulations
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Alexander Coltman at +44 2038542472 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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