QC Analyst

3 days ago


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

Piramal Group is seeking a highly skilled Quality Control Specialist to join our team. As a key member of our Quality Control department, you will be responsible for ensuring the quality and integrity of our products.

Key Responsibilities:
  • Batch Disposition and Stability Activities: 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, in accordance with Good Manufacturing Practices (GMP) and regulatory requirements.
  • Stability Study Programme Activities: Perform stability study programme activities, including storage of in-process and final products samples, and retention sample management.
  • Equipment Management: System owners of QC equipment, assisting in equipment periodic reviews, monitoring, and maintaining calibration status of equipment within the Quality Control department.
  • Deviation and Investigation Management: Ownership and accountability of deviations, investigations, and laboratory investigations, and timely completion of these documents.
  • Documentation and Data Integrity: Preparation and update of SOPs, instructions, and protocols, and other Quality Control documentation, while ensuring compliance with Data Integrity requirements.
  • Audit Readiness and Continuous Improvement: Actively contribute to department and site audit readiness requirements, including any continuous improvement initiatives.
  • Equipment Calibration and Maintenance: Calibration of equipment and instruments used to perform QC testing, and informing relevant personnel in a timely manner of any failure of calibration.
  • Quality Control Information Systems: Maintain Quality Control information systems.
  • Regulatory Compliance: Maintain a technical ability, knowledge, and understanding of relevant regulatory requirements for GMP, safety, and environmental policies required to perform the role as a QC Analyst.
  • Problem-Solving and Investigation: Assist in investigation of quality incidents and other problem-solving forums, and complete QMS documentation in a timely manner.
  • Scientific and Technical Meetings: Attend internal and external scientific and technical meetings and conferences, as appropriate.
  • General Maintenance and Housekeeping: Carry out general maintenance and housekeeping of equipment and laboratories.
  • Cover and Additional Duties: Available to provide cover for other departments within the organization, as required, and 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


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