Responsibilities
: Ensures that new SOPs/records or any SOP amendments are updated on the QMS portal to reflect current practice as per relevant SOP Assists in ensuring that current processes are consistent with established QMS and applicable regulations Ensure document compliance throughout the departments and QMS Assists with corrective actions and root cause problem-solving to ensure adherence to the QMS Conducts internal and external audits of suppliers as per the applicable audit schedules Assist with the necessary facets of the QMS and GMP compliance within the organization Ensures that equipment Calibrations are conducted as per the master Calibration schedule monthly Ensure that calibrations are conducted on time with no delays Reports irregularities and other non-conformities relating to CGMP which form part of the continuous quality improvement process
Key Skills: Decisive, People Handling Skills, Analytical skills, Logical, Self-motivated, Attention to detail, Accuracy, Computer Skills.
Qualifications: Matric, Scientific Tertiary Qualification Minimum 3-5 years’ experience in a Quality Assurance /Production Environment Minimum two years experience in calibrations Experience in administering Standard Operating Procedures Knowledge and experience in ISO/PICS/GMP Standards i.e. 9001/22716/SAHPRA Experience in third party and internal auditing
