Quality Control Specialist
5 days ago
Job Title: QC Analyst
Job Summary: We are seeking a highly skilled QC Analyst to join our team at Piramal Group. The successful candidate will be responsible for performing 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.
Key Responsibilities:
- 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.
- 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
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