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Quality Assurance Manager (Computer Systems)

Posted on Dec 3, 2019 by Experis AG

Basel, Switzerland
19 Dec 0016
Annual Salary

Quality Assurance Manager (Computer Systems)

Experis IT is Europe's leading IT recruitment agency. We are dedicated to connecting talented individuals with Business opportunities across several professional sectors, with IT being at the heart of our operations.

One of our clients, a leader in the pharmaceutical industry, is looking for a Quality Assurance Manager with experience in Computer Systems. This is initially a 3-month contract, with a planned extension located in Basel, Switzerland.

Job summary

You will join a team that is currently responsible for ensuring that all global GMP computer systems are compliantly delivered and maintained. In addition, this team is establishing quality standards that support pharmaceutical manufacturing, testing and releasing processes. Within this team, your role will be to perform tasks around Computer Systems Validation of global computerized systems.

Tasks & responsibilities

  • Perform quality assurance tasks regarding validation of global computerized systems according to the GMP Inventory and regarding projects (ie PT strategic projects and smaller projects).
  • Align quality assurance tasks across the organization within the department as well as with other global or local functions.
  • Provide guidance for local quality departments.
  • Assure compliance of systems according to the GMP Inventory by providing templates, support in creation of CSV documentation, review and approval of SOPs.
  • Support Quality Assurance tasks regarding validation of computerized systems, including review and approval of validation life cycle documents, review and approval of validation reports and release systems according to CSV, approval of change requests and owning discrepancies.
  • Support interpretation of the company Policy and Directives as well as external guidelines

Must haves

  • 8 to 10 years of relevant experience in the pharmaceutical or biopharmaceutical industry with sound knowledge of cGMPs or equivalent regulations
  • Demonstrated expertise with Computer System Validation (CSV) and risk management, change control, and discrepancy/CAPA management
  • Experience working in validated or controlled environments and ability to propose pragmatic quality approaches while maintaining full compliance to regulations and standard
  • Knowledge of manufacturing, cGMP's and compliance
  • Proven experience working with SAP/ERP/Serialization Systems
  • Experience working with HP ALM
  • High quality orientation with attention to detail; drives for excellence and positive business outcomes
  • Excellent collaborator with proven ability to work well with others in a proactive, positive and constructive manner
  • Strong self-motivator who can manage multiple priorities
  • Demonstrated influencing and interpersonal skills with strong written and verbal communication skills; ability to communicate effectively with all levels of the organization
  • Fluent in English
  • S. or B.A. degree, preferably in Life Science
  • Former pharmaceutical experience

General information

  • Start date: On-boarding in Dec/ASAP
  • Real start date: 06.01.2020
  • End date: 31.03.2020
  • Extension: Extension planned
  • Workload: 100%
  • Work location: Basel
  • Remote: max. 50%
  • Team: 10 persons in equal positions

Reference: 805598274

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