QC Analyst

Key

Roles and Responsibilities :

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• 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 21
  
  CFRpart
  11 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:

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

Essential

Qualifications:

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Degree qualified in a Science Discipline is desirable.

Essential

Experience:

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• Experience with in 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