QC Analyst

Piramal; Falkirk; On-site; GBP 30,000 - 40,000; Full time

Job summary

Une entreprise de biopharmaceutique recherche un QC Analyst pour ses laboratoires au Royaume-Uni. Ce poste engage des responsabilités dans des études de stabilité, le contrôle de qualité et un rôle actif dans l'amélioration continue des processus. Le candidat idéal est diplômé en sciences et possède de l'expérience en laboratoire tout en respectant les normes GMP.

Qualifications

• Expérience en laboratoire QC dans un système de qualité reconnu.
• Connaissance des directives GMP et des organismes de réglementation.
• Capacité à organiser le travail dans un laboratoire occupé.

Responsibilities

• Effectuer des activités de disposition des lots et de contrôle de la stabilité.
• Responsabilité des équipements de contrôle qualité et maintenance des systèmes d'information.
• Préparer et mettre à jour les SOPs et autres documents de contrôle qualité.

Skills

Attention to detail

Effective communication

Understanding of scientific and technical processes

Reliability

Education

Degree in a Science Discipline

Job description

Key Roles and Responsibilities:-

• Perform batch disposition and stability activities in a proactive and timely manner which includes Quality Control testing and reporting of raw materials, in process, bulk drug substance, final products and
• stability products to GMP and in accordance with Annex 11 Computerised Systems and 21CFRpart11 Good
• Documentation Practices for Electronic Data.
• Perform stability study programme activities, storage of in process, and final products samples and retention sample management
• System owners of QC equipment, assisting in equipment periodic reviews, monitoring and maintaining calibration status of equipment within the Quality Control department.
• Ownership and accountability of deviations, investigations and laboratory investigations and timely completion of these documents
• Preparation and update of SOPs, instructions and protocols and other Quality Control documentation
• Checking and reviewing of data in compliance with Data Integrity requirements
• Actively contribute to department and site audit readiness requirements including any continuous improvement initiatives.
• Calibration of equipment and instruments used to perform QC testing and informing relevant personnel in a timely manner of any failure of calibration
• Maintain Quality Control information systems
• Maintain a technical ability, knowledge and understanding of relevant regulatory requirements for GMP, safety and environmental policies required in order to perform role as QC Analyst
• Assist in investigation of quality incidents and other problem solving forums and complete QMS documentation in a timely manner.
• Attend internal and external scientific and technical meetings and conferences where appropriate
• Carry out general maintenance and house keeping of equipment and laboratories
• Available to provide cover for other departments within the organisation as required
• Available to undertake any other duties as requested by the QC Manager in accordance with Company requirements.

Key Competencies:-

• Attention to detail
• Reliability
• Effective communication
• Understanding of scientific and technical processes

Qualifications

Essential Qualifications:-

Degree qualified in a Science Discipline is desirable.

Essential Experience:-

• Experience within a QC laboratory working to GMP within a recognised quality system.
• Ability to organise work within a busy laboratory with experience of writing and working to SOP documentation.
• Knowledge of GMP guidelines and regulatory bodies