Overview
Mid-Senior level position located in Visp, Valais, Switzerland. This is a maternity leave replacement role within Quality Assurance.
Responsibilities
Support continuous improvement programs to establish an effective Quality Management System.
Represent Quality Assurance in cross-functional teams, establish and maintain interfaces with Manufacturing, QC, Support Functions, and Project- and Site Engineering; support technology transfer to effectively execute tasks related to Drug Product processes.
Assess, review and approve quality records (e.g., deviations, change control, CAPAs, investigations, effectiveness checks, extensions) in line with current local SOPs.
Author, review and approve GMP-relevant documents and SOPs.
Present Drug Product QA topics during customer audits and regulatory inspections within DP.
Participate in internal audits as required by the organization.
QMS: Organize and manage monthly Quality Council and Risk Register; KPI reporting of key Quality indicators on a monthly basis in QA staff meetings; monthly updates of quality KPIs.
Gap assessment for HA/Audit observations at other MODULES/Lonza facilities.
Tracking and follow-up on daily updates of HOSHIN Tier 1 and Tier 2.
Back-up of Head of QA DPS in daily HOSHIN 2.
(B) Project-specific QA functions within Drug Product: Act as point of contact for Drug Product QA related questions and issues related to the manufacturing operations; Support and approve project/product specific risk assessments; Review and release product specific documentation such as process descriptions and workflows, recipes, manufacturing protocols, transfer documents, test plans, parameter lists, etc.; Review and approve executive batch records, prepare batch release for the responsible person (FvP), including recommendation on disposition status.
(C) QA responsibilities for customer contact: Customer contact in regards to QA topics; support and manage interactions in cases of changes, deviations, technical complaints, out of specification results and others.
(D) QA responsibilities for Release: Delegate of FvP for Batch Disposition of DP; Delegate of the FvP for conditional release according to CHVI-4553 and CHVI-265873 Zuständigkeiten von Sonderfreigaben.
Contact: Alba Jansa
Whatsapp Business: +41 76 811 63 99
alba.jansa(at)experis.ch
Job Functions
Other, Project Management, and Quality Assurance
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