Qa Specialist Milano

Qa Specialist
Milano
Lombardia, Milano

Job Description:

At Ferring Pharmaceuticals, we help people around the world build families and live better lives.

We are entrepreneurial and innovative, with a growing global team focused on scientific advances in the areas of reproductive medicine and maternal health, gastroenterology and urology.

By working together and sharing ideas we can bring science to life for patients around the world.

Making a difference in the lives of millions of people means we succeed by working together.

Our diverse backgrounds, experiences, expertise, and perspectives enable us to find solutions to even the most challenging problems, and our success is tied to each team member's contributions.

Imagine the power of your career when it's Ferring + You.

For our Regulatory Affairs Department in Milan we are searching for a QA SPECIALIST.

The resource will be included in the Quality and Regulatory team and will be responsible for supporting the maintenance of the local Quality Management System ensuring that the Quality System is effectively implemented in accordance with applicable regulation, internal standards and local and global procedures.

This role supports on going excellence in GxP and other areas of the business requiring Quality Assurance.

May act as delegate Qualified Person.

- Create and update the documentation of the Quality Management System, managing the QMS standards implementation activities based on CSOPs and monitor the ongoing compliance status

- Collaborate with all local and global functions so that the Quality Management System is effective

- Perform QA related tasks within defined area of the business.

- Perform or participate in internal audits (as lead auditor or auditor) and external audits (as lead auditor or auditor)

- Audit final report; prepare and sign QA Statements to be included in the final reports.

- Manage and monitor the progress of non-conformities (internal and suppliers) and CAPA plans.

- Collect, analyze and monitor KPIs.

- Contribute to the Risk Management definition and monitoring

- Provide training on QA and auditing as needed.

- Records creation in TrackWise, management and follow-up of CAPAs, Complaints, Change Controls and Deviations in collaboration with other stakeholders.

- Management of Quality Technical agreements with suppliers and TPCs.

- Management of suppliers for QA aspects (selection, training, CAPA, follow-up, records).

- Local SOPs management.

Write Quality Assurance/GxP SOPs.

Minimum Requirements

Scientific Master's Degree (CTF or Pharmacy)

Good knowledge of English (at least B2)

At least 2 years of experience in a similar role in a Pharmaceutical company

Proven Experience in managing CAPA and deviations

Knowledge of current GMP's, GDP's, pharmaceutical legislation and regulatory and Code of Practice requirements

Ability to work in cross-functional teams and collaboration with internal functions and external functions

Additional Skills/Preferences

Good interpersonal and communication skills

Excellent data collection and analysis skills.

Strong attention to detail

Proactive nature and goal-oriented approach

Awareness, understanding and ability to pragmatically interpret GxP and Code of Practice requirements relevant to the own responsibilities

WHAT WE OFFER

- Opportunity for professional growth and development.

- Exciting projects and challenges.

- The balance between work and personal life is a flexible schedule (smart working policy and flexible hours in the office).

- Flexible benefits (AON)

- Meal voucher

- Competitive salary

Across Ferring, we are all working together to change lives for the better and to help people build families.

This means empowering, innovative and rewarding careers - we are motivated to make a difference.

Help us grow as an organization and develop your own career at the same time.

Join us, and together we can make life and work better!

**Location**:

Ferring Italy