Quality Assurance Engineer
Posted on Mar 12, 2019 by Experis AG
Quality Assurance Engineer
Experis is the global leader in professional resourcing and project-based workforce solutions. Our suite of services range from interim and permanent recruitment to managed services and consulting, enabling businesses to achieve their goals. We accelerate organisational growth by attracting, assessing and placing specialised professional talent.
On behalf of our client, a global biotechnology company, we are looking for a Quality Assurance Engineer, with proven experience in quality management systems. Are you a passionate Quality Assurance Engineer who is looking for a new and exciting challenge?
If yes, then please have a look at the details below:
Overview of the project:
Responsible for supporting our quality management system on review and approval of validation and engineering documents, test protocols, CAPAs, deviations, change controls and any technical documentation where QA needs to approve before implementation and upon completion. Furthermore, advice the project groups as appropriate and be an active member of the groups where the quality input is needed.
- QA oversight with respect to QE tasks:
- Qualification and validation
- Adaptation and implementation of procedures
- Continious improvement
- Engineering and automation
- Reviewing GMP documents and raw data for compliance to applicable regulatory and corporate guidance documents, such as CAPAs, deviations, operational procedures, etc.
- Review/approval of change control documents and activities associated with change control implementation.
- Keep up to date on cGMPs and regulatory requirements as well as global procedures, guidelines and policies
- Proactively identify and propose resolution to both technical and compliance issues/gaps, as well as development and implementation of Quality Systems
The skills and experience needed for these positions are:
- This position requires co-operation with people at every level of the organization
- The position will have global as well as local contacts and will be required to make compliance decisions about facility, utility and equipment validation, changes, deviations etc. Supporting new employees in skill development
- Be confident in making technical decisions.
- Must be able to prioritize tasks, be flexible and able to keep many activities running at a time.
- Good communication skills in English, verbally and written.
- Technically orientated role including experience of the validation of laboratory, production equipment and knowledge of production methodology involved in biopharmaceutical drug substance production.
- Self-driven, take ownership and responsibility for own assignments
- Able to communicate in German is a plus
Interested in this opportunity? Kindly send us your CV today through the link in the advert. However should you have any questions please contact Urim Berisha