- Reviewing validation documentation and additional protocols and reports
- Reviewing GMP documents and raw data for compliance to applicable regulatory and corporate guidance documents, such as CAPA´s, 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 requirement s 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.
- Responsible for GMP assessment on quality engineering documents.
- 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 advise the project groups as appropriate and be an active member of the groups where the quality input is needed.
- BA or M.Sc. in physical or biological sciences.
- A minimum of three years experience from biotech or pharmaceutical industry is required.
- Confident in making technical decisions.
- Able to prioritize tasks, you are flexible and able to keep many activities running at a time.
- Technically orientated role including experience of the validation of laboratory, production equipment and knowledge of production methodology involved in biopharmaceutical drug substance production.
- Previous experience working with complex technical documentation is mandatory.
- Good communication skills in English, verbally and written.
- Self-driven and take ownership and responsibility for own assignments.
- Value teamwork at all levels, performs work with an open-mind and ability to value input from colleagues and peers.
- Knowledge of automation systems like Delta V, Syncade or similar is a real asset for this role.
This position requires co-operation with people at every level of the organization and from multiple functions, including engineers, Manufacturing personnel, SME’s on equipment and knowledge of biotechnology API production.
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.