QC Manager (m/f/d) in der Städteregion Aachen
PAION Deutschland GmbH - Vollzeitbeschäftigung
Start ab sofort - Online seit dem 13.11.2020
PAION is a publicly listed specialty pharmaceutical company focused on developingcommercializing innovative drugs for out-patienthospital-based sedation, anesthesiacritical care services. PAION’s lead compound is remimazolam, an intravenous, ultra-short-actingcontrollable benzodiazepine sedative/anesthetic. Remimazolam is partnered in multiple territories outside of Europe. Remimazolam was approved in the U.S. for procedural sedation in July 2020was approved in Japan for general anesthesia in January 2020. In China, licensee Yichang Humanwell received market approval in procedural sedation in July 2020in South Korea, licensee Hana Pharm filed for market approval for remimazolam in general anesthesia in December 2019.
In Europe, PAION is seeking approval of remimazolam for general anesthesiafor procedural sedation. PAION submitted a Marketing Authorization Application (MAA) for procedural sedation in November 2019. Results of a Phase III trial in general anesthesia are expected in the second half of 2020.
Together with PAION QA, review QC documentationQC-related parts of manufacturingensure manufacturing / testing activities are conducted in-timein accordance with current GMP guidelines, PAION specificationsPAION procedures.
Drawing up of Specifications in coordination with relevant PAION departmentsCMOs
Perform Life Cycle Management of analytical methods by establishingexecuting an analytical method validation master planfollow up of required periodicalad-hoc measures in cooperation with other departmentsPAIONs CMOs.
Review and/ improve analytical methods as appropriate, including changes / updates of pharmacopoeia’s methods (Ph.Eur., USPother).
Ensure overall compliance of PAION with ICH requirements, especially ICH Q1, ICH Q2ICH Q6
Manage samplesreference materials together with Supply Chainexternal partners
Manage QC related change controlsdeviations internally as well as externally with PAIONs vendors.
Provide support to PAION’s licensees in QC related topicsapplicable, including the organisationsupport of method transfer programs.
Draw up, reviewmaintain internalexternal QC-related documents i.e. validation reports, shelf life justifications as well as SOPs.
Provide technical support with the drawing upmaintenance of PAION's registration documentation.
General managementcontrol of external vendors of PAIONco-ordination of interactions with these vendors in all QC related topics.
Provision of subject matter expertise to support audit of manufacturing / testing facilities in accordance with GMP, current guidelinesPAION procedures.
Master degree / Diplomaideally a post graduate in Pharmacy, Pharmaceutical Sciences, ChemistryLife Sciences, preferably with a focus on analytical methods / analytical chemistry
At least 5 years practical industrial experience working in pharmaceuticalbiotechnology industriesin threemore of the following areas associated with industrializationmanufacturing of pharmaceutical products: analytical method's developmentvalidation, method lifecycle management, quality control, stability testing with a focus on analytical chemistry.
Deep-rooted knowledge of regulatory requirements, including ICH requirementsnational EU / US regional requirements like national pharmacopoeias (analytical method developmentvalidation (ICH Q2), QC analysis, method lifecycle management).
Proven knowledge of Good Manufacturing Practisesof working within a Quality Management System. Experience in managing change controls, deviationsOOS.
Proven Experience with commercial manufacturingon-time release of APIdrug products as technical expert in cooperation with a QA team.
Proven knowledge of method validation.
Knowledge of risk management
Fluent in EnglishGerman
Knowledge of additional national regulatory requirements outside EU / US (e.g. Japan, Korea, Brazil) as well as their national pharmacopoeias
Experience of technical managementsdirection of external vendors would be extremely beneficial as the company works with a network of vendors.
Additional experience in microbiologicalsterility testing
Bitte geben Sie bei Ihrer Bewerbung die Referenznummer acjobs-st-70762an.