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
Qualifications
Essential Qualifications:-
Degree qualified in a Science Discipline is desirable.
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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