QC Analyst

Piramal Group; Falkirk; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical company is seeking a QC Analyst to perform batch disposition and stability activities. The role involves Quality Control testing, ensuring compliance with regulatory requirements, and managing equipment calibration. Ideal candidates will exhibit strong attention to detail and effective communication skills, with a sound understanding of scientific processes. This position is based in Falkirk, United Kingdom.

Qualifications

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

Responsibilities

• Perform batch disposition and stability activities timely.
• Act as system owner of QC equipment.
• Own and account for deviations and investigations.
• Prepare and update SOPs and Quality Control documentation.
• Check data compliance with Data Integrity requirements.
• Contribute to audit readiness and continuous improvement.
• Calibrate QC testing equipment.
• Maintain Quality Control information systems.
• Assist in quality incident investigations.
• Attend scientific and technical meetings.
• Maintain equipment and laboratories.

Job description

Key Roles and 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 Computerised Systems and CFR part Good Documentation Practices for Electronic Data.




• Perform stability study programme activities, storage of in-process and final product samples, and retention sample management.




• Act as system owner of QC equipment, assisting in equipment periodic reviews, monitoring and maintaining calibration status of equipment within the Quality Control department.




• Own and be accountable for deviations, investigations and laboratory investigations, and ensure 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.




• 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.




• Maintain a technical ability, knowledge and understanding of relevant regulatory requirements for GMP, safety and environmental policies required in order 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.




• Be available to provide cover for other departments within the organisation as required.




• Be available to undertake any other duties as requested by the QC Manager in accordance with Company requirements.

Key Competencies

• Attention to detail




• Reliability




• Effective communication




• Understanding of scientific and technical processes