QC SPECIALIST
Purpose of the Job
To ensure continuous improvements and maintenance of QC department’s processes and operations by investigating QC incidents and out-of-specification results, identifying new analytical methods and LIMS improvements and co-ordinating and monitoring analytical method development and validation in compliance with the client quality management system, cGMP and regulatory requirements and in line with industry developments.
Minimum Requirements
o Bachelor’s science degree in Biochemistry / Chemistry / Analytical Chemistry or related field
o 7 years analytical laboratory experience of which 3 years laboratory supervisory experience
o At least 3 years method or equipment validation experience
o Computer literacy MS Office (Word, Excel, Power Point and Outlook)
o Project management experience is a key requirement
o Laboratory Information Management System (LIMS) experience is a critical requirement
o Experience of using software such as SAP and Minitab is an added advantage
o Good understanding of GLP / cGMP
Specific Operational Requirements
o The successful candidate will be required to work an 8 hour shift between 6h00 to 18h00 as rostered
o The successful candidate may be required to work outside normal working hours to meet business needs
o The successful candidate may be required to work overtime to meet the business needs.
Key Performance Areas
o Identify, validate and implement QC analytical methods and systems
o Qualification studies QC programme implementation and monitoring
o QC OOS and OOT investigations and CAPA monitoring
o Quality management, including cGMP compliance
o LIMS/SAP QM administration
o Quality Control Systems maintenance and reporting
Competencies
o Planning and organizing
o Follow-up
o Teamwork
o Attention to detail and analysis
o Quality orientation and awareness
o Technical/professional knowledge and proficiency
o Technical writing skills
o Good verbal and written communication skills