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Quality Assurance Specialist

2 months ago

Central Inverclyde, United Kingdom Piramal Pharma Solutions Full time
Job Summary

Piramal Pharma Solutions is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and processes, and maintaining compliance with regulatory requirements.

Key Responsibilities
  • Quality Control and Assurance
    • Perform batch disposition and stability activities in a proactive and timely manner, including Quality Control testing and reporting of raw materials, in-process products, bulk drug substance, final products, and stability products to GMP and in accordance with Annex 11 Computerised Systems and 21 CFR part 11 Good Documentation Practices for Electronic Data.
    • Conduct stability study programme activities, store in-process and final products samples, and manage retention sample storage.
  • Equipment Management
    • System ownership of QC equipment, assisting in equipment periodic reviews, monitoring, and maintaining calibration status of equipment within the Quality Control department.
  • Documentation and Compliance
    • Ownership and accountability of deviations, investigations, and laboratory investigations, and timely completion of these documents.
    • Prepare and update SOPs, instructions, and protocols, and other Quality Control documentation.
    • Check and review data in compliance with Data Integrity requirements.
  • Continuous Improvement
    • Actively contribute to department and site audit readiness requirements, including any continuous improvement initiatives.
    • Calibrate equipment and instruments used to perform QC testing and inform relevant personnel in a timely manner of any failure of calibration.
    • Maintain Quality Control information systems.
  • Regulatory Knowledge
    • 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 Communication
    • Assist in the 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.
    Requirements
    • Experience within a QC laboratory working to GMP within a recognized quality system.
    • Ability to organize work within a busy laboratory with experience of writing and working to SOP documentation.
    • Knowledge of GMP guidelines and regulatory bodies.