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Job Description
To execute 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 according with best cGMP work practices, Quality standards and metrics
Find out more about the daily tasks, overall responsibilities, and required experience for this opportunity by scrolling down now.
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 andstability 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
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