Quality Assurance Responsible/Responsible Person

2 weeks ago

ClujNapoca, Cluj, Romania CSL Full time €40,000 - €60,000 per year

We are currently looking for a Quality Assurance Responsible/Responsible Person to join our team in Romania. In this position you will be directly reporting to the General Manager Romania. The position is office-based and is a temporary contract until the end of 2027.

Key Responsibilities

  • Under general supervision, maintains Quality Assurance System to ensure compliance with company and cGMP / GDP standards
  • Responsible for maintaining audit program, investigating deviations relevant to area of responsibility
  • Ensures standard operating procedures (SOP's) stay current and align with corporate and regulatory requirements
  • Executes training/awareness related to GMP /GDP standards

The QA/RP shall oversee all quality and distribution activities related to products from VPRO portfolio. He/she has overall responsibility for the establishment and maintenance of the VPRO QA/GDP system and therefore shall have sufficient authority to influence the set-up and performance of the quality system as well as GDP activities and to promote, maintain and improve compliance with the legal requirements without the necessary accountability for the execution of the various activities. The QA/RP needs to have full oversight of the GDP system and its related quality management system.

The QA/RP Will Be Responsible For

  • GMP / GDP compliance and meeting the public service obligations.
  • Appropriate involvement in all stages of the wholesale distribution activities of medicinal products.
  • Maintaining a quality system setting out responsibilities, processes and risk management principles in relation to VPRO activities.

Your Profile

  • University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
  • At least 1 year experience in activities related to handling, storing and distribution of medicinal products or in activities such as procurement or commercialization of medicinal products
  • Appropriate knowledge of the Good Manufacturing Practices / Good Distribution Practices and the Romanian Law 95/2006
  • Member of the professional college (Colegiul Farmacistilor sau Medicilor din Romania)
  • Experience in working with and within a Quality System.
  • English Proficiency
  • Holder of a Qualified person Certificate is a plus

Are you interested? We are looking forward to receiving your online application.

About CSL Vifor
CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). The parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries.

We want CSL to reflect the world around us
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.

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