QC Analyst

2 weeks ago

Falkirk Central United Kingdom Piramal Group Full time £35,000 - £55,000 per year
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

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