Job Description

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Global QA Manager IT/CSV (w/m/d) 100%

Miesbach, Germany

Acino AG in Miesbach is part of the Acino Group. Acino is a Swiss pharmaceutical company, leader in advanced drug delivery technologies. We have a clear focus on selected emerging markets in the Middle East, Africa, the CIS Region, and Latin America, and we operate in some of the most dynamic countries of the world.  We value courage, commitment, trust, and empathy and provide an environment that supports initiative and effort. We are proud to be action-oriented and open-minded, with a strong focus on quality and product availability, even in remote and hard to reach areas of the world.

Responsibilities

  • Active support of CSV- and qualification efforts for global GxP relevant systems used across different functions and locations
  • Safeguard GxP-compliance of computerized systems with health authority regulations and internal standards
  • Develop, review and approve validation deliverables, i.e. user requirements, risk assessment, test plans, validation protocol, validation reports
  • Initiate, revise, and review corporate Quality Management System documents according to the master plan; provide trainings upon request
  • Manage and coordinate global CSV governance together with Acino global IT and Acino regional sites
  • Prepare and review changes to GxP related systems through a formal change control process
  • Develop, implement and follow up the global data integrity concept alongside the Information Security Framework (ISMS)
  • Support authority inspections and external audits in the area of CSV and data integrity
  • QA representative for IT deviation management and remediation activities (CAPA)
  • User access administration and execution of user trainings for global GxP systems
  • Continuous improvement of CSV processes and technology solutions to promote digitalization, compliance and productivity

Skills

  • Master or B.S. degree in a life science field, engineering or computer science
  • Minimum 5 years pharmaceutical industry experience with Computer System validation (CSV) and data integrity, preferably in a quality unit (quality assurance, quality control)
  • In-depth knowledge of EU GMP Annex 11 and GAMP 5 best practices
  • Good knowledge of general GxP requirements
  • Project management experience
  • High level of accuracy, diligence and self-organization in a strongly regulated environment
  • Self-motivation, flexibility and a high level of individual responsibility
  • Ability to communicate effectively and proactively with superiors and peers

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you! Please send us your complete application to – preferably via e-mail into one PDF document -, to Ms. Sandra Gamboni, HR Responsible / Telephone +41 61 338 60 00 / personal.hr@acino.swiss / We are looking forward to the opportunity to get to know you.  / Only direct applications are considered.

Apply & Futher Information

If you are interested in working for a company that offers such challenging opportunities, we invite you to send your application along with all pertinent documents – preferably via e-mail in one PDF document – to Sandra Gamboni, HR Business Partner Germany.

Sandra Gamboni, HR Business Partner Germany.

Phone +41 61 338 60 00

Sandra.Gamboni@acino.swiss

We are looking forward to meeting you in person. Only direct applications are considered.

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