release process communicate the correct formulation, method of manufacturing. Confirm that the process is indicate the different phases of the product, in-process, release and shelf life and analytical methods GLP requirements. Ensure during the QA release process that the COA's are in line with the products specifications
Compliance with PV regulatory obligations; managing the process for root cause analysis and implementing corrective Committee – signal detection and risk evaluation process for Client medicinal products in the product's and drug development and approval regulatory processes as they pertain to the role. Knowledge of pharmacoepidemiology PV procedures is preferred. Experience with PV processes and global PV regulations. Ability to present
Compliance with PV regulatory obligations; managing the process for root cause analysis and implementing corrective Committee – signal detection and risk evaluation process for Client medicinal products in the product's and drug development and approval regulatory processes as they pertain to the role. Knowledge of pharmacoepidemiology PV procedures is preferred. Experience with PV processes and global PV regulations. Ability to present
requirements on Regulatory technical format including processes and technologies. Expertise in Information and requirements on Regulatory technical format including processes and technologies. To ensure legal compliance with Practice (GRP) Ensure that all the regulatory processes are performed timeously and in line with GRP. Maintain GRP standards in the following process areas: Marketing Authorization Applications License through the company, Global Labelling Business Process. Co-ordinate the operations of Gazelle through
requirements on Regulatory technical format including processes and technologies. Expertise in Information and requirements on Regulatory technical format including processes and technologies. To ensure legal compliance with Practice (GRP) Ensure that all the regulatory processes are performed timeously and in line with GRP. Maintain GRP standards in the following process areas: Marketing Authorization Applications License through the company, Global Labelling Business Process. Co-ordinate the operations of Gazelle through
Practice (GRP) Ensure that all the regulatory processes are performed timeously and in line with GRP. Maintain GRP standards in the following process areas: Marketing Authorization Applications License through the Company. Global Labelling Business Process using the GAZELLE system. Co-ordinate the operations matrix. Review of the Quality Manual and its processes for accuracy. Review of registration status & requirements on Regulatory technical format including processes and technologies. Expertise in Information and
FSSC22000 Audit Requirements Duties Ensure statistical process control implementation and capability to improve
mechanisms to be used in the testing process Suggest improvement to process Direct audit activities to production
limited to: Plan, develop and implement techniques, processes and procedures for controlling the desired level
limited to: Plan, develop and implement techniques, processes and procedures for controlling the desired level