Key Roles and Responsibilities:-
1. 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
2. stability products to GMP and in accordance with Annex Computerised Systems and CFRpart Good
3. Documentation Practices for Electronic Data.
4. Perform stability study programme activities, storage of in process, and final products samples and retention sample management
5. System owners of QC equipment, assisting in equipment periodic reviews, monitoring and maintaining calibration status of equipment within the Quality Control department.
6. Ownership and accountability of deviations, investigations and laboratory investigations and timely completion of these documents
7. Preparation and update of SOPs, instructions and protocols and other Quality Control documentation
8. Checking and reviewing of data in compliance with Data Integrity requirements
9. Actively contribute to department and site audit readiness requirements including any continuous improvement initiatives.
10. Calibration of equipment and instruments used to perform QC testing and informing relevant personnel in a timely manner of any failure of calibration
11. Maintain Quality Control information systems
12. 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
13. Assist in investigation of quality incidents and other problem solving forums and complete QMS documentation in a timely manner.
14. Attend internal and external scientific and technical meetings and conferences where appropriate
15. Carry out general maintenance and house keeping of equipment and laboratories
16. Available to provide cover for other departments within the organisation as required
17. Available to undertake any other duties as requested by the QC Manager in accordance with Company requirements.
Key Competencies:-
18. Attention to detail
19. Reliability
20. Effective communication
21. Understanding of scientific and technical processes