is treated with confidentiality and the highest level of security. Should you not be shortlisted for the marketing and regulatory affairs. Functions Assists QA Manager with overseeing that vendors including service the schedule planned. Internal Audits Assists QA Manager with overseeing that internal audits are carried and assist in management of the quality system. Assist with training for desired level of GMP/annual Documentation Control Ensures change control procedure is managed and controlled according to SOP P016 QAP and other
is treated with confidentiality and the highest level of security. Should you not be shortlisted for the marketing and regulatory affairs. Functions Assists QA Manager with overseeing that vendors including service the schedule planned. Internal Audits Assists QA Manager with overseeing that internal audits are carried and assist in management of the quality system. Assist with training for desired level of GMP/annual Documentation Control Ensures change control procedure is managed and controlled according to SOP P016 QAP and other
an appropriate PV, vigilance system, and Risk Management to ensure appropriate oversight for products responsibilities. Ensure the pro-active Benefit Risk Management throughout product life cycle translating global Medical Safety Responsibility & Benefit Risk Management: Establish Product knowledge with a focus on of AE/PQC material, where needed. PV contract management: Support LSO/CSTL with the local Pharmacovigilance Impact assessments and action as required on a local level Provide content to the Pharmacovigilance System
an appropriate PV, vigilance system, and Risk Management to ensure appropriate oversight for products responsibilities. Ensure the pro-active Benefit Risk Management throughout product life cycle translating global Medical Safety Responsibility & Benefit Risk Management: Establish Product knowledge with a focus on of AE/PQC material, where needed. PV contract management: Support LSO/CSTL with the local Pharmacovigilance Impact assessments and action as required on a local level Provide content to the Pharmacovigilance System
risk & environmental-related topics (noise levels, use of machinery, spillages, Health, security and coach where applicable.
development, implementation and management of a standardized integrated SHERQ management system as per the required ensure quality control and compliance. Provide management and staff training Ensure that all traceability risk registers Communicate risk control and risk management information by analyzing data, developing indictors and presenting required reports and advising management accordingly. Liaise with external bodies eg. produce and present required reports to advise management accordingly. Engage with external bodies (eg
development, implementation and management of a standardized integrated SHERQ management system as per the required ensure quality control and compliance. Provide management and staff training Ensure that all traceability risk registers Communicate risk control and risk management information by analyzing data, developing indictors and presenting required reports and advising management accordingly. Liaise with external bodies eg. produce and present required reports to advise management accordingly. Engage with external bodies (eg
Health & Safety Act, National Environmental Management Act and related Regulations Registered as per Company Health, Safety and Environmental Compliance. Manage all H&S requirements on site. Establish safety accidents and near-misses. Management of all IOD cases and liaising with FEM. Management of Sites HSE functions
Health & Safety Act, National Environmental Management Act and related Regulations Registered as per Company Health, Safety and Environmental Compliance. Manage all H&S requirements on site. Establish safety accidents and near-misses. Management of all IOD cases and liaising with FEM. Management of Sites HSE functions
awareness training and provide coaching.