Health & Safety Act, National Environmental Management Act and related Regulations Registered as per Ensure full internal Company Health, Safety and Environmental Compliance. Manage all H&S requirements accidents and near-misses. Management of all IOD cases and liaising with FEM. Management of Sites HSE functions functions and job hazard analyses. Assist company subcontractors to comply with legislation standards. Audit
Health & Safety Act, National Environmental Management Act and related Regulations Registered as per Ensure full internal Company Health, Safety and Environmental Compliance. Manage all H&S requirements accidents and near-misses. Management of all IOD cases and liaising with FEM. Management of Sites HSE functions functions and job hazard analyses. Assist company subcontractors to comply with legislation standards. Audit
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 Pharmacovigilance training for Local Operating Company employees, and Adverse Event and Product Quality of AE/PQC material, where needed. PV contract management: Support LSO/CSTL with the local Pharmacovigilance
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 Pharmacovigilance training for Local Operating Company employees, and Adverse Event and Product Quality of AE/PQC material, where needed. PV contract management: Support LSO/CSTL with the local Pharmacovigilance
policies and measures and update in accordance with Company guidelines and legal requirements.
and measures and update them in accordance with Company guidelines and legal requirements.
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
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 reports. Quality Systems Input and assist in management of the quality system. Assist with training for Documentation Control Ensures change control procedure is managed and controlled according to SOP P016 QAP and other operating procedures. Human Resources Advises QA Manager on requirements for overtime/shifts when deemed
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 reports. Quality Systems Input and assist in management of the quality system. Assist with training for Documentation Control Ensures change control procedure is managed and controlled according to SOP P016 QAP and other operating procedures. Human Resources Advises QA Manager on requirements for overtime/shifts when deemed