QUALITY ASSURANCE AND DEPUTY RESPONSIBLE PERSON- ROMANIA

Location: Romania - Cluj

Function: Quality Management

Company: Vifor Pharma

Elena Voigt

International Senior Talent Acquisition Consultant

+41 58 851 80 40

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About You

Due to the growth of our Romanian affiliate, we are now looking for a Quality Assurance and Deputy Responsible Person to join our team in Cluj. In this newly created role, you will be responsible for acting as a deputy to the qualified/responsible person onsite as well as ensuring GDP compliance.  You will also be responsible for the following tasks:

  • Develop  procedures and establish effective processes in relation to all Vifor Pharma Romania activities
  • Ensure that medicinal products are procured, held and supplied in a way that is compliant with the requirements of GDP
  • Ensure products are delivered to the right recipients within a satisfactory time period
  • Ensure that initial and continuous training programmes are implemented and maintained
  • Ensure self-inspections/ internal audits are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place
  • Establish a change control system and incorporates quality risk management principles
  • Measurement of the achievement of quality system objectives;
  • Assessment of performance indicators used to monitor the effectiveness of processes within the quality system, such as complaints, deviations, CAPA, changes to processes; feedback on outsourced activities; self-assessment processes including risk assessments and audits; and external assessments such as inspections, findings and customer audits
  • Coordinate and provide quality documents to clients
  • Deal with relevant customer distribution and product quality complaints, returned, rejected, recalled or falsified products
  • Approve returns
  • Ensure suppliers and customers are approved
  • Keep appropriate records of all distribution activities
  • Comply with the PD on National Regulatory Product Information regarding the revision of Product Information in accordance with local procedure and local regulatory requirements
We are looking for a flexible, results-oriented and proactive person. To be successful in this role, you bring the following profile:
  • Qualified Pharmacist
  • 3 to 5 years of previous distribution experience within the pharmaceutical industry
  • Knowledge of the Good Distribution Practices and the Romanian Law
  • Experience working with quality systems
  • Audit training and certification
  • Very good communication skills in English and fluent Romanian

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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