Expert Associate in Impurity Risk Assessment Team

Vor 5 Tagen

Bad Vilbel, Deutschland STADA Arzneimittel AG Vollzeit

**Hemofarm** is a member of STADA Group, one of the largest global generic pharmaceutical companies, which successfully operates in both the markets of Serbia and Western Balkans. Hemofarm produces high quality pharmaceutical products within the leading pharmacotherapeutic groups, observing the key corporate values: Agility, Integrity, Entrepreneurship and ONE STADA.- STADA Global Quality Compliance Team is looking for:
**Expert Associate in Impurity Risk Assessment Team**

**Place of work: Vršac/Belgrade**

**Requirements**:

- Faculty of Chemistry, Pharmacy or Technology; especially with advanced knowledge of organic synthetic chemistry
- First experience in the chemistry and analysis of (potentially genotoxic) impurities in low concentrations or quantities (ppm, ppb) preferred
- Active knowledge of the English language - B2 mandatory, C1 level advantage
- Advanced level of knowledge of MS Office package;
- Excellent communication and negotiation skills;
- Ability to work in a fast-paced, dynamic, environment;
- Team-oriented, precise, analytical, responsible, independent;
- Fast learner and easily adaptable to changes

**Role & Responsibilities**:

- Active participation in Quality system processes, Maintaining and compiling GMP documentation, such as initial preparation and updates of risk assessments in regard to possible formation of genotoxic impurities in active ingredients, raw materials, finished dosage forms and others;
- Evaluating documentation from manufacturers and suppliers in line with the applicable ICH and EMA guidelines
- Ensure ongoing abidance by industry regulatory and quality requirements;
- Drive improvements in Quality Documentation and processes;
- Inspect data to detect areas for improvement;

**We offer**:

- Dynamic and responsible position;
- Continuous learning environment;
- Chance for a professional and personal development;
- Good working conditions and positive working atmosphere

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