Quality Control Specialist

1 month ago

Falkirk, Falkirk, United Kingdom Piramal Group Full time
Job Description

Job Title: QC Analyst

Job Summary:

We are seeking a highly skilled QC Analyst to join our team at Piramal Group. The successful candidate will be responsible for performing batch disposition and stability activities in a proactive and timely manner, including 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 Computerised Systems and CFR part Good Documentation Practices for Electronic Data.

Key Responsibilities:

  • 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 to perform the 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 housekeeping of equipment and laboratories
  • Available to provide cover for other departments within the organisation, as required

Competencies:

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

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