Overview
QA Project Manager (w/m/d) Jobs in Visp, Valais, Switzerland at Real
Title: QA Project Manager (w/m/d)
Company: Real
Location: Visp, Valais, Switzerland
QA Project Manager (w/m/d)
Location: Visp, Switzerland
Duration: 01/06/2025 to 31/12/2025 + possibility of an extension
Key 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 MODULES and clients 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
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.
Customer contact in regards to QA topics. Support and manage interactions in cases of changes, deviations, technical complaints, out of specification results and other
Delegate of FvP for Batch Disposition of DP.
Delegate of the FvP for conditional release according to CHVI-4553 and CHVI-265873
Key Requirements
Bachelor’s or advanced degree in Biotechnology, Chemistry, Pharmacy, or a related field.
Several years of experience in Quality Assurance within the pharmaceutical or biotechnology industry.
In-depth knowledge of GMP and other relevant regulatory requirements.
Proven experience in drug product processes and quality management systems.
Strong communication and presentation skills for representing QA in cross-functional teams and during audits.
Excellent customer service orientation and problem-solving skills.
Strong organizational and project management skills.
Meticulous attention to detail for reviewing and releasing product-specific documentation and batch records.
Ability to perform gap assessments and effectiveness checks.
Familiarity with conditional release protocols (e.g., CHVI-4553 and CHVI-265873).
In Switzerland, for contract roles it is mandatory for the candidate to be a Swiss citizen or a European passport holder.
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.
