Qualified Person/ Quality Assurance for Clinical Trial Supplies / Clinical Pharmacy – Lisbon

Location: Portugal - Amadora

Function: Technical Operations

Company: Vifor Pharma

Thomas Lemercier

International Talent Acquisition Manager

+41 58 851 82 73

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About You

At this position you will report directly to the Quality Director and your tasks will be:
  • Ensure availability of documents  for QP release
  • Review batch records
  • Issue / review / approve documents
  • Manage documental system
  • Manage and investigate deviations and / or complaints. Investigation of root causes.
  • Participate in projects according to Quality objectives
  • Participation and support during audits; Participation on internal and supplier audits.
  • Perform training sessions
  • Elaboration / revision / approval of SOPs and instructions
  • Review of PQRs
  • Implementation, maintenance and improvement of QA systems
  • Maintenance and improvement of databases
  • Management of software related with Quality Management
  • Communication (verbally and in writing) to answer inquiries and provide information, supporting the Quality Management
  • Definition and management of CAPAs
  • Elaboration of Quality Reports based on Risk Analysis approach
  • Elaboration / Support QAG compilation

Minimum Requirements:

  • University degree pharmaceutical
  • Qualified person
  • Good knowledge of English (written and spoken).
  • Knowledge of Microsoft tools (e.g.: Word, Excel, PowerPoint)
  • Knowledge in Investigational medicinal products (IMP) is favored.

Preferred Requirements:

  • Knowledge of French / German is favored
  • Experience in working with Quality Software (e.g. document management)
  • Knowledge of statistic tools
  • Knowledge of Lean 6 Sigma training/qualification
  • Have auditors’ course
You describe yourself as a detail oriented person, with strong organizational skills, able to work effectively in a team, customer and results driven with high resistance to stress.

About Us

Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives. Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world. The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.

Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.

For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are.

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