Quality Assurance Responsible/Responsible Person
Quality Assurance Responsible/Responsible Person
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Salary Not Disclosed
1 Vacancy
Job Description
We are currently looking for a Quality Assurance Responsible/Responsible Person to join our team 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 (SOPs) 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 irondeficiency 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 companyCSL headquartered in Melbourne Australia employs 32000 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.
Do work that matters at CSL Vifor!
Employment Type
Full-Time
