QC Analyst
Piramal Group
Date: 1 week ago
City: Falkirk
Contract type: Full time
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 11 Computerised Systems and 21CFRpart11 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 in order to perform 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 house keeping 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.
Key Competencies:-
- Attention to detail
- Reliability
- Effective communication
- Understanding of scientific and technical processes
- 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 21CFRpart11 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 in order to perform 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 house keeping 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.
Key Competencies:-
- Attention to detail
- Reliability
- Effective communication
- Understanding of scientific and technical processes
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