Quality Assurance Specialist Bardi

Quality Assurance Specialist
Bardi
Emilia Romagna, Bardi

Explore your next opportunity at a Fortune Global 500 organization.

Envision innovative possibilities, experience our rewarding culture, and work with talented teams that help you become better every day.

We know what it takes to lead UPS into tomorrow—people with a unique combination of skill + passion.

If you have the qualities and drive to lead yourself or teams, there are roles ready to cultivate your skills and take you to the next level.

**Responsibilities**:

- Assist with the implementation and maintenance of the Quality Management System in accordance with ISO 9001 and 13485 standards, and in compliance with the EU GMP and EU GD Guidelines.

- Provide support to ensure compliance with local and regional legal requirements and regulatory authorities.

- Provide support to ensure the license verification is performed for customers, suppliers and anyother entities working within UPS facilities (Pharmacy, GMP Area etc.

).

- Provide training, ensure the training needs are met and coordinate the trainings for the staff.

- Monitor, conduct and coordinate self-inspections to ensure compliance with GMP, GDP and ISO 9001 and 13485 requirements.

- When delegated to do so by Healthcare Compliance (QA) Management or RP/QP, provide assistance in external audits.

- Participate and assist in supplier audits and provide evaluation of suppliers.

- Provide support for investigation into non-conformances and customer complaints.

- Creates Change Controls for any significant changes and communicates them internally and to clients.

- Follow-up on all Corrective Actions and Preventive Actions (CAPAs).

- When delegated to do so by Healthcare Compliance (QA) Management or RP/QP, decides on the final disposition of finished products, returned and rejected products.

- Assist in the maintenance of documentation in accordance with the EU GMP/ EU GDP Guidelines, and the relevant standards.

- Own/ write/ review Procedures, Work Instructions, and technical documents as assigned to do so.

- Ensure that the operations performed at the facility (reception, inspection receipt, storage, picking and shipping) are made in accordance with the approved procedures/ work instructions and in compliance with the EU GMP/ EU GDP guidelines.

- Under the supervision/direction of the Healthcare Compliance (QA) Management, conducts Management Reviews.

- Provide support for validation activities.

- Ensure equipment calibration and maintenance program are met.

- Collection of Temperature Data and Monitoring of the temperature environmental conditions.

- Promote a "quality" culture within the company

**Qualifications**:

- Preferrable Bachelor's Degree Studies in Pharmacy, Chemistry, CTF

- Good knowledge of English.

- Basic knowledge of Microsoft Office.

- Experience with ISO 9001 and/or ISO 13485 standards is an advantage.

- Knowledge of GMP and/ or GDP guidelines is an advantage.

- Required mínimum 2 years of experience in companies such as manufacturer/laboratories/ distributors of pharmaceutical products, food and feed.

**Skills**:

- Ability to prioritize decisions which may have a significant risk for the company.

- Identify potential gaps in the processes and make recommendations for possible improvements.

- Identify and eliminate barriers to get an effective risk management and risk assessment.

- Co-ordination of improvement projects throughout the company.

- Implementation of new processes having a quality critical impact on the business.

- Recommend training opportunities.

- Flexible in working hours.

- Knowledge of electronic Quality Management System and/or Warehouse Management

System (WMS, GWS etc. )

is an advantage.

**Employee Type**:

Permanent

UPS is committed to providing a workplace free of discrimination, harassment, and retaliation.