Quality Assurance Specialist

1 month ago

Grangemouth, Falkirk, United Kingdom Piramal Pharma Solutions Full time
Job Title: Quality Control Analyst

About the Role:

We are seeking a highly skilled Quality Control Analyst to join our team at Piramal Pharma Solutions. As a Quality Control Analyst, you will be responsible for executing defined and trained Quality Control department tests for the release of raw materials, in-process products, bulk drug substance, final products, and stability products according to defined procedures and protocols and in accordance with best cGMP work practices, Quality standards, and metrics.

Key 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 21 CFR part 11 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 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.

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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