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
following: Calculation and management of technical provisions Calculation and management of the regulatory and interpersonal skills Ability to prioritise and manage multiple deadlines Above average excel skills,
following: Calculation and management of technical provisions Calculation and management of the regulatory and interpersonal skills Ability to prioritise and manage multiple deadlines Above average excel skills,
in eCTD. Expertise in Information and document management technology and electronic/paper publishing software technologies. Expertise in Information and document management technology and electronic/paper publishing software license maintenance. Proven successful project management experience. Proficiency in communication is essential business support. Provide regular feedback to the RA Manager and cross functional team and marketing teams on of delay emerge. Proactively identify issues and manage risk, taking appropriate action as required on
in eCTD. Expertise in Information and document management technology and electronic/paper publishing software technologies. Expertise in Information and document management technology and electronic/paper publishing software license maintenance. Proven successful project management experience. Proficiency in communication is essential business support. Provide regular feedback to the RA Manager and cross functional team and marketing teams on of delay emerge. Proactively identify issues and manage risk, taking appropriate action as required on
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 Operating Company level including adequate record management. Job Requirements Qualification & Experience
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 Operating Company level including adequate record management. Job Requirements Qualification & Experience
products.
stakeholders, including clients, subcontractors, and management, to provide updates on project status and address skills, with the ability to prioritize tasks and manage time effectively.
Comprehensive
Compile QA/QC report/s on findings for the site management team Support the Regulatory/Data team with periodic accountability for tasks and demonstrate effective self-management Follow through to ensure that quality and productivity work even when under pressure Effective self-management, resourcefulness, and initiative to solve problems