Quality Assurance Officer - 3 Month Contract
A pharmaceutical company is looking for a QA Officer to join its team on a contact basis for 3 months. You will be responsible for the execution and the implementation of the product quality review program. You must hold a degree in life sciences and have previous experience working in QA for a pharmaceutical company to apply for this role.
- The execution and the implementation of the PQR program, working under the supervision of the PQR project coordinator.
- Complying with the PQR planning established by the QA manager and the PQR project coordinator, authoring the PQRs and ensuring elements are completed within the set timelines.
- Compiling the data made available by other departments (e.g. Production, QC, RA…), as per the requirements stated in the chapter 1 of the EudraLex volume 4, by ensuring all key quality system owners and business process owners provide data and information on time and in full to meet regulatory and internal timelines.
- Perform a first assessment and submit to the QA Manager for review. This includes data interpretation of analytical, manufacturing, compliance and regulatory data and drawing conclusions from real time data and statistical reports, verify the consistency of existing processes and highlight any trends, provide a documented review of key quality indicators to determine the need for changes in product or process specifications, manufacturing, or quality procedures and ensuring alignment with filing.
- Implementing comments raised by the QA manager and the QP and use it in the next documents worked out.
- Ensuring all the relevant documents and data are properly archived in the correct folders and are easily retrievable.
- Working in compliance with the company's SOPs.
- Candidates are required to have a degree in life sciences.
- Previous experience in the pharmaceutical industry, working on PQR.
- Knowledge and understanding of the pharmaceutical industry guidelines including but not limited to the Eudralex volume 4, EMA guidelines and ICH guidelines (to a workable level).
- Good level of professional English (written and spoken).
- QA - PQR - Product Quality Review - QC - RA - SOPs
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