Daily Duties: You will plan commissioning/qualification and validation activities and implement them at our customers. To do this, you will create and review the associated documentation. In risk management with a focus on sterile manufacturing processes, you will support the respective departments. You are our first point of contact for computer system validation (CSV). Whenever […]
Read moreYour duties as the CQV Engineer will be: Coordinate and support CQV change management, punch management, and non-conformance management. Manage dashboard and KPI reporting for CQV activities. Provide CQV document/admin training and oversee calibration and maintenance. Act as a Subject Matter Expert, offering expertise and coordination to ensure C&Q activities are completed safely, on schedu...
Read moreSummary Deputy Responsible Person for the maintenance of applicable Operational Licenses. Responsible for the implementation and maintenance of Quality Management System required as per local regulations and standards. The Responsible Person is the main contact for Quality Assurance (QA) topics to distributors and external bodies. Responsibilities To ensure Quality Assurance related compliance ...
Read moreI am representing a huge player within the Pharmaceutical Industry who are looking for someone to join their CSV team, supporting the team for 10 months. Your tasks are: Advice and support in the validation of computer-aided systems including checking and approval of documentation, maintaining / managing the overview list of computer-aided systems Support for […]
Read moreSummary: The focus of this task is on the release/certification of clinical investigational medicinal products. In addition to in-house training, you will be involved in specific customer projects. These projects are carried out both independently and together with our customers. Accompanying or carrying out audits is another part of your job. Our common goal is […]
Read moreResponsibilities Develops guidelines and ensures the uniform and timely processing of adverse event reports Oversee the medical monitoring of ongoing clinical trials, with a focus on safety and efficacy. Provides medical evaluation of adverse event reports Participate in cross functional trial team meetings and Medical Monitoring focused meetings Contribute to clinical development plans and tri...
Read moreMy client is looking for an energic consultant with a technical scientific background and initial (at least 2 years) experience in GMP/ GDP area (Packaging Labelling, Quality Operations and or Quality System) for a contracted role till end of the year. Daily Responsibilities: Reviewing the Batch Record of the CMO with the intent to ensure […]
Read moreAssociate Director – Safety Operations (12 month contract) Location – Zurich Switzerland Company – A small-medium sized bio-pharmaceutical company focused within unmet medical needs in the rare disease space is looking to expand. They have grown 20% in the last year alone, across both the US and in Europe! They have one product with both […]
Read moreAboutThis role provides an opportunity to embed & sustain continuous improvement processes/programs aligned with the companies standards and help with growth over multiple sites. Experience Degree or equivalent qualification in Science, Technology, Engineering or Mathematics. Strong cross-functional business judgement and demonstrated ability to lead the delivery of cross functional project...
Read moreJob description Provide clinical and technical support to healthcare and to internal customers, helping address medical inquiries *Composing and maintaining standardized response letters *Perform continual independent review of medical/scientific literature on pharmaceutical products (and versus competitor’s, when applicable) *Critically evaluate medical/scientific literature and provide ...
Read moreAs Director you will be responsible for managing operational and strategy for Quality Control and Quality Assurance departments for the site. Another major element of this role will also be people management with your direct and indirect reporting line being 50+ across both teams. Responsibilities of the role Provides leadership in developing and directing quality […]
Read moreA global Pharmaceutical company are looking for multiple Supplier Quality Specialists to join their team on a remote basis to perform Supplier Quality activities associated with external suppliers. This role performs activities to maintain compliance with procedures and policies outlined in the Supplier Quality Management program. As Supplier Quality Specialist you will also work closely [&hell...
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