QMS Manager in der Städteregion Aachen
PAION AG - Vollzeitbeschäftigung
Start ab sofort - Online seit dem 15.06.2022
PAION with its headquarter in Aachen, Germany, is a publicly listed specialty pharmaceutical company with innovative drugs to be used in hospital-based sedation, anesthesiacritical care services.Our mission is to be a leading specialty pharmaceutical company in the fields of anesthesia critical care by bringing novel products to market to benefit patients, doctors and other stakeholders in healthcare.We are looking for a QMS Manager for our team in Aachen. Main purposes are:
Ensure the design, implementation, maintenanceimprovement of assigned Quality Assurance Systems of PAION as system owner.
Ensure the documentation systemadministration of SOPs as well as their trainingdistribution within the PAION organization.
Monitor product / contractor performance in accordance with PAION metrics system.
Promote Quality awarenesshelp to develop a Quality culture.
Supply KPI data for metricssupport in the preparation of the Quality Management Review.
Manage the QA-Improvement plan to improve the quality culturesystems within the PAION organization.
Manage the Quality-SOP documentation systemprovide trainingassistance for GMDP compliance within the PAION organization.
Design, Implementation, MaintenanceImprovement of assigned Quality Systems as system owner according to EU-GMP:
Write/ review the CAPA plan as result of auditas result of complaint trend confirmed for improvement of deficiencies. Follow up on corrective actionsfinal implementation with effectiveness check,applicable.
Change Control System
Chair the CCB (Change Control board) meetings. Assist the QA team in raising change requests, perform quality impact assessmentperform QA approval of changes. Take careimprove the Change Control processdocumentation.
Contractor Qualification System
Ensure the qualification status of contract manufacturerscontract laboratories (contractor qualificationre-qualification evaluation,of manufacturing authorizations, GMP-certificates, Audit plan, etc ) according to PAION procedures.
Managetrack PQRs with CMOs. Compilewrite PAION PQR reports for all assigned products.
Quality Risk Management System
Support the Quality team in the preparation of Quality Risk assessments in relation to deviations, whenever necessary.
Lead auditor for self-inspection audits as well as GMDP supplier audits according to the annually agreed plan. Organize, coordinateparticipate in the GxP-inspections of business partners as well as health authorities in order to ensure that PAION site Aachen maintains the manufacturing authorization.
University degree in Life Sciences
5 years of experience in the Pharma industry with QM-Systems management
Thorough knowledge of GMP regulationslocal German legislation in special EU-guidelinesGMDP (ICH-Guidelines, AMGAMWHV)
EnglishGerman for business proficiency
A permanent position with an innovative employer
A great deal of creative freedomcareer opportunities
30 days vacationtrust-based working hours
Short communication channels, open doorshelpful, committed colleagues
Flexible working hours with partial home office for a good work-life-balance
State-of-the-art IT equipment with Dell equipmentApple iPhones
A brand new office with employee showers for athletesunderground parking spaces in Aachen in a very good location directly on the A44 freeway
Daily fresh fruit basket, free coffee, teawater
Bitte geben Sie bei Ihrer Bewerbung die Referenznummer acjobs-st-144833an.