Overview
Senior Quality Assurance Manager Jobs in Visp, Valais, Switzerland at PE Global
Title: Senior Quality Assurance Manager
Company: PE Global
Location: Visp, Valais, Switzerland
PE Global is recruiting for a Senior Quality Assurance Manager on behalf of our pharmaceutical client in Switzerland. This is an initial 12-month contract hybrid role.
General QA functional responsibilities:
Support continuous improvement programs to establish an effective Quality Management
System.
Represent Quality Assurance in cross-functional teams, establish and maintain interfaces with the Manufacturing teams, QC, Support Functions, Project- and Site Engineering project / 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.
Responsible to present Drug Product QA topics during the conduction of all customer audits and regulatory inspections within DP.
Participate in internal audits as required by the organization.
QMS : Organize and manage monthly Quality Council & Risk Register
KPI reporting Tracking of key Quality indicator on a monthly basis in QA staff meeting
Monthly update of FLYING CARPET of Quality related KPIs.
Gap Assessment for HA/Audit obs at other facilities
Tracking and follow-up on daily update of HOSHIN Tier 1 and Tier 2
Back-up of Head of QA DPS in daily HOSHIN 2
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.
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.
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”.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Paul Wheatley on 083 094 0199 or alternatively send an up-to-date CV to [email protected]
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
