Sr. Quality Release Lead

For our client, an international company in Solothurn, we are looking for a Senior QA Release LeadStart date: End: Extension: must be discussedWorkplace: BaarWorkload: 100%
Job Summary

Act as Responsible Person (RP) delegate for Commercial Biologics Drug Substances (DS), Parenteral Drug Products (DP), Parenteral Finished Goods (FG) technical release or Active Pharmaceutical Ingredients (API), Pharmaceutical Drug Products, Pharmaceuticals Finished Goods (FG) technical release, and perform the certification of Finished Goods for the identified Market as well as import/export release to Switzerland as per Swiss Regulation and European Directive 2001/83/EC, 2017/1572 as well as delegated regulation 2017/1569. The RP release delegate is responsible for ensuring that each individual batch has been manufactured in compliance with laws in force in the country of destination, in accordance with the requirements of the marketing authorization (MA) and with Good Manufacturing Practice (GMP). Act as RP Release delegate (fachtechnisch verantwortliche Person) for Switzerland, in the meaning of articles 5, 10 and 14 of the Swiss Ordinance on authorizations relative to medicinal products As such Responsible Person, she / he is authorized to give directives (also towards management) in her / his area of responsibility. The incumbent can also serve as a disposition package and CoC Preparer to support other RP delegates or QPs in product certification. The incumbent also serves as a Release Quality representative for change control evaluations and Release Quality decisions on deviations records. This position covers all externally manufactured products ensuring maintenance of product supply to the market

Tasks & ResponsibilitiesAccountable on ready-for-use and not-ready-for-use product review and releaseReview and verification of batch release documentation according to local procedures and product specific checklistPreparation and approval of the certificates of conformance and market-specific release documentationQuality-relevant Status changes of the inventory in Biogen systemsInfluence the strategy of the manufacturing of our products at the CMOs and to sustain without disruption of the supply chain.Contribute to launches, commercialization, technology transfer or improvements projects through release process adjustmentsCollect & Perform Key Process Indicators analyses including feedback from other departments (for example planning).Manage Stakeholder as RP delegate for the release activities through SME assessment and decision makingIdentify and communicate timely to the management any supply risk or risk of batch rejectionAble to clearly communicate expectations to internal/external customers as well as direct reports and managementAble to report status of ongoing activities to the manager/stakeholder and highlight any time/resources constraints and propose action/time reallocation to the managerDevelop and sustain an internal and external networking
Must haves:
Minimum Bachelor's degree, Master degree preferred, in a scientific topic (Pharmacy, Chemistry, Biology, Biochemistry etc.)A minimum of 6 years of experience in similar position in pharmaceutical or biotechnology industriesExperience in the pharmaceutical industry (small molecules and/or biotechnology and/or aseptic filling). Sound knowledge of cGMP requirements, EU/FDA regulations and compliance.Experience in clinical products manufacturing and/or
regulatory is an asset. Knowledge of medical device regulations and manufacturing is a plus.Ability to develop effective working relationships with internal/external sites and cross-functional project teams.Able to identify and drive improvements/updates of the GMP documentation related to Release activities and CMO oversight from release perspective.Able to identify any compliance gap in Biogen processes and identify appropriate stakeholder to fix the issueSupport local Quality system (change control, deviations, CAPAs,...) as requiredEnsure adherence to serialization and data integrity requirements

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