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Quality Control Specialist

2 months ago

Falkirk, Falkirk, United Kingdom Piramal Group Full time
Job Title: QC Analyst

At Piramal Group, we are seeking a highly skilled and detail-oriented QC Analyst to join our team. As a QC Analyst, you will play a critical role in ensuring the quality of our products and processes.

Key Responsibilities:
  • Perform 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.
  • Perform stability study programme activities, storage of in-process, and final products samples, and retention sample management.
  • System ownership 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.
  • Available to undertake any other duties as requested by the QC Manager, in accordance with Company requirements.

Competencies:

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