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.
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