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Qualified Person (m/f/d) (DE)
[6128]
Our client is a NASDAQ listed biotechnology company with the global Headquarter in Germany. The companies focus is the research and development of new medicines for the treatment of inflammatory diseases within a global development approach. Our client stands out for an excellent team of highly motivated and skilled individuals who put strong emphasis on a team effort. To support our team we are looking for a Qualified Person (m/f/d) Your tasks ·Ensure that the (investigational) medicinal products have been manufactured and checked in accordance with applicable laws and in accordance with EU-Good Manufacturing Practice (GMP) principles and guidelines ·Evaluation, confirmation, and certification of batches based on GMP compliant manufacture and testing according to the EU GMP guidelines, Annex 16 ·Act/perform the tasks of a Qualified Person (QP) in accordance with Annex 16 of the EU GMP Guidelines and the Code of Practice for Qualified Persons for products manufactured or packaged by contracted manufacturing organizations ·Review of batch records and disposition of batches as a QP under EU Directive 2001/83/EC and comply with all the applicable GMPs, national legislation and requirements of the relevant Quality Agreement ·Monitoring the compliance with pharmaceutical regulations ·Evaluation of CMC related deviations and changes ·Support, develop and maintain the CMC related processes in the Quality Management System (QMS) ·Perform vendor CMC related selection, maintenance & for cause audits (contract manufacturers, testing facilities, raw material suppliers, etc.) ·Primary resource for pharmaceutical product release, ensures batches meet manufacturing authorization requirements and fulfil requirements in Quality and/or Technical agreements as applicable ·Assist in the drafting and approval of master batch manufacturing records ·Review and approve SOPs, validation protocols, change requests, annual Product Quality Reviews and Planned Process Variations in accordance with company procedures and guidelines ·Provide support in the preparation and hosting of regulatory inspections ·Accompanying product related regulatory vendor inspections Your qualifications ·Degree in pharmacy with license to practice as a pharmacist or equivalent ·Qualification/legibility to perform the duties as QP in accordance with §15 AMG ·Three or more years’ experience performing the duties of a QP with expertise (practical experience) in the release of multiple licensed and unlicensed dosage forms (biologics and sterile product manufacture and supply) ·Thorough understanding of US, EU and local regulatory requirements governing the duties/role of a QP, sterile (biological) product manufacture, testing and release ·Previous experience in implementation of quality management systems and processes supporting the development of large molecule biologics ·Thorough understanding of national and international laws, regulations and guidelines regarding GMP If you feel attracted by this job feel free to get in touch with Lea Stolle at Optares Medical via lea.stolle@optares.de or by phone under +49 441 21879-42
- Ensure that the (investigational) medicinal products have been manufactured and checked in accordance with applicable laws and in accordance with EU-Good Manufacturing Practice (GMP) principles and guidelines
- Evaluation, confirmation, and certification of batches based on GMP compliant manufacture and testing according to the EU GMP guidelines, Annex 16
- Act/perform the tasks of a Qualified Person (QP) in accordance with Annex 16 of the EU GMP Guidelines and the Code of Practice for Qualified Persons for products manufactured or packaged by contracted manufacturing organizations
- Review of batch records and disposition of batches as a QP under EU Directive 2001/83/EC and comply with all the applicable GMPs, national legislation and requirements of the relevant Quality Agreement
- Monitoring the compliance with pharmaceutical regulations
- Evaluation of CMC related deviations and changes
- Support, develop and maintain the CMC related processes in the Quality Management System (QMS)
- Perform vendor CMC related selection, maintenance & for cause audits (contract manufacturers, testing facilities, raw material suppliers, etc.)
- Primary resource for pharmaceutical product release, ensures batches meet manufacturing authorization requirements and fulfil requirements in Quality and/or Technical agreements as applicable
- Assist in the drafting and approval of master batch manufacturing records
- Review and approve SOPs, validation protocols, change requests, annual Product Quality Reviews and Planned Process Variations in accordance with company procedures and guidelines
- Provide support in the preparation and hosting of regulatory inspections
- Accompanying product related regulatory vendor inspections
Your qualifications
- Degree in pharmacy with license to practice as a pharmacist or equivalent
- Qualification/legibility to perform the duties as QP in accordance with §15 AMG
- Three or more years’ experience performing the duties of a QP with expertise (practical experience) in the release of multiple licensed and unlicensed dosage forms (biologics and sterile product manufacture and supply)
- Thorough understanding of US, EU and local regulatory requirements governing the duties/role of a QP, sterile (biological) product manufacture, testing and release
- Previous experience in implementation of quality management systems and processes supporting the development of large molecule biologics
- Thorough understanding of national and international laws, regulations and guidelines regarding GMP
If you feel attracted by this job feel free to get in touch with Lea Stolle at Optares Medical via lea.stolle@optares.de or by phone under +49 441 21879-42
Lea Stolle