Quality Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7dv1rm

**Work Schedule** Standard Office Hours (40/wk) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office **SCOPE OF THE POSITION/RESPONSIBILITIES**: - Assure that the pharmaceutical production of sterile injectables follows current regulations (US and EU GMP) and company quality standards via prevention, constant control, and improvement interventions. **SPECIFIC TASKS/PRIMARY ACTIVITIES**:
**Supervision**
- Continuously lead all aspects of the production lines of sterile forms (cleaning, mix-up, operation, defects) to ensure that all processes adhere to the latest regulations and maintain the quality standards of the company. **Quality**
- Assist in coordinating and leading all aspects of machinery testing and validation tasks, ensuring compliance with existing regulations and the quality criteria set by the company.
- Participate in the execution of self-audits and in the implementation of any corrective actions in compliance with current regulations and company quality standards.
- Participate in the analysis and definition of actions striven to remove the causes of defects and complaints.




- Based on the results of controls and monitoring, propose GMP training courses suitable for production activities and take part in them as a trainer. **Procedures**
- Contribute to the creation and editing of procedures and processing sheets, verifying their usage in operations. **RELATIONSHIPS**:
**INTERNAL**
- QA/QC
- Technology Transfer
- Warehouses
- All department heads
- Engineering **EXTE**RNAL**
- Suppliers of machinery and systems **REQUIREMENTS AND QUALIFICATIONS**:
**(a) Essential**: - ** Studies/Diplomas/Training courses**: - Diploma with validated experience or degree
- **Technical and IT knowledge**: - Knowledge of machinery, equipment, and methodologies for the production of drugs
- In-depth knowledge of GMP regulations
- Knowledge of the problems related to aseptic production
- Ability to use the main information systems
- **
Professional experience**: - Consolidated experience in QA/Production in pharmaceutical companies
- **
Languages**: - English
- **
Personality traits**: - Tidiness
- Observation skills
- Relational skills
- Critical thinking **(b) Desirable**: - Experience in manufacturing sterile injectable drugs and oral drugs

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7dv1rm