Information about the position

Job description, responsibilities and duties
15! That is for how many years our biosimilars have been used in clinical practice in more than 100 countries.

Sandoz, a Novartis division, is a pioneer and a global leader in biosimilars. We were the first pharmaceutical company to receive approval for a biosimilar in Europe, Japan, and the United States.

The purpose of a Quality Assurance Specialist would be to manage Quality aspects and projects within the area of responsibility. This role ensures and supports overall GxP conformity and Compliance with the Quality Management Systems.

Your key responsibilities:

Your responsibilities include, but are not limited to:

• Ensuring that Change requests are managed according to the SOPs from receipt, through to implementation and closure.

• Conducting GxP monitoring on all sections, conducting QA investigation for noncompliance, follow up on the corrective actions. Archive relative documentations.

•... Coordinating implementation of quality systems and procedures for the implementation of the Quality Manual and quality agreements.

• Ensuring that all aspects of the handling and distribution of pharmaceutical products in the country comply with the requirements of the Quality Manual and Policies and meet all relevant cGMP regulatory and legislative requirements.

• Maintaining current knowledge of local and international regulatory and legislative requirements and trends to ensure that technical support on all quality-related matters is provided to the country; being the key contact for the Country Health Authorities (SUKL).

• Establishing a good working relationship with the Supply Chain Management (SCM), DRA, and Medical departments.

• Ensuring that all incoming drug products are inspected prior to release to the market in accordance with the current in-place procedures, registered specifications, and

local/international regulations.

• Managing complaints, recalls, counterfeits, and product tampering according to the Corporate Quality Manual and local written procedures. Support / participate in BCP (Business Continuity Plan) as required.

What you’ll bring to the role:

• Proficient Slovak and English

• Degree in a Scientific or Technology field (e.g.

• Pharmacy, Chemistry, Biotechnology, Veterinary, or another medical field

• At least 1 year of experience in Quality Assurance/ Regulatory

• Good Documentation Practice

• Awareness of Regulations & Guidelines in Slovakia
Employee perks, benefits
You’ll receive:

• Competitive salary starting at 1 600 Eur/month. The final salary depends on experience and level of expertise. Other benefits are based on company policy.

Requirements for the employee

Candidates with education suit the position
University education (Bachelor's degree)

University education (Master's degree)

Postgraduate (Doctorate)
Educational Specialization
Scientific or Technology (e.g. Pharmacy, Chemistry, Biotechnology, Veterinary, or another medical field)
Language skills
Slovak - Proficiency (C2) or English - Upper intermediate (B2)
Experience in the position/sector
Quality Assurance/ Regulatory
Number of years of experience
1
Personality requirements and skills
Communicative, team player, action oriented
Bratislava Slovakia

Salary Criteria