Qa Specialist Lazio

Qa Specialist
Roma
Lazio, Lazio

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**Job Summary

This position monitors the overall Quality System status of the distribution center.

This position acts in compliance to drug, medical device, and local regulations.

Ensures quality processes are maintained through the implementation of procedures, training, and regular inspections.

**Responsibilities**:

JOB PURPOSE AND KEY 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 GDP

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 any

other 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

KNOWLEDGE AND EXPERIENCE

Education level:

- Preferrable Bachelor's Degree Studies.

- Preferable Degree in Pharmacy, Chemistry, CTF

- Preferrable Degree in Food studies.

- Good knowledge of English.

- Basic knowledge of Microsoft Office.

Specialised Knowledge:

- 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

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