Company logo

QA Project Manager IBEX

Randstad (Schweiz) AG
Visp

1M

pixel

QA Project Manager IBEX

We are looking for a QA Project Manager for Lonza AG in Visp.

Responsibilities:

  • Owns all quality related responsibilities for the manufacturing processes of biopharmaceutical products for clinical and commercial supply. This includes oversight of QC/logistic/supply chain related activities.
  • Represents QA in project/tech transfer organizations for new biotech manufacturing processes.
  • Coordinates QA interests during the different project phases.
  • Has the authority to make quality decisions for the respective projects in internal and external meetings.
  • Responsible for review and final release of records such as Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, Material Specifications, Deviations, CAPAs, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc.
  • Performs assessments for all product-related changes, assesses relevance to regulatory filings, decides to implement and provide change controls for approval to customers where required.
  • Directs the investigations of customer product complaints and assures the completion of the appropriate documentation.
  • Ensures an efficient cGMP compliant life cycle management of all products manufactured.
  • Identifies emerging QA relevant topics, communicates to the IBEX QA organization and works actively on their development into new or already established Quality and Compliance strategies and/or standards.
  • Authoring of SOPs
  • Batch record review
  • Involvement in generation of Annual Product Quality Reviews
  • Participates to Quality Risk Assessments
  • Enhances the quality knowledge by following the quality standards and by visiting specific training courses/conferences
  • Participates and supports regulatory inspections and customer audits
  • Supports cGMP training programs
  • Trains and mentors junior Lonza employees to better accomplish and perform in their duties as quality professionals
  • Actively supports the Quality culture as a role model
Qualifikation
  • Bachelor's or master's degree in biotechnology, biology, chemistry, life science or related field
  • More than 5 years of experience in the area of biopharmaceutical manufacturing, preferably in a QA function
  • Strong background in cGMPs
  • Broad knowledge biotechnological manufacturing processes, validation approaches and risk management
  • Sound experience in representing Quality and Compliance in projects
  • Good communication skills and experience in interaction with all kind of interfaces within the organization and with regulatory agencies (Swissmedic, FDA etc.)
  • Ability to oversee project execution to identify non-compliance from quality standards.
  • Ability to prioritize and manage work to critical project timelines in a fast-paced environment.
  • Excellent verbal, written and interpersonal communications skills
  • Excellent organizational skills
  • Excellent written and spoken English
  • Knowledge of written and spoken German would be an advantage
  • Strong team orientation
  • Solution- oriented

Randstad (Schweiz) AG
Rottenstrasse 6
3930 Visp