Qa & Regulatory Officer - 12 Months Ftc Milano

Qa & Regulatory Officer - 12 Months Ftc
Milano
Lombardia, Milano

WE PUSH THE BOUNDARIES OF MEDICINE.

**LEAPING FORWARD TO MAKE PEOPLE SMILE

Everything we do at KKI, is rooted in the idea of leaping forward to make people smile.

We are committed to innovation, for the benefit of the patients who count on us to support them.

From medicines for rare and underserved diseases, to the support families need when facing a life-changing diagnosis - our team is proud of all we deliver, but also humble in knowing how much more needs to be done.

By listening to patient stories, we gain a better understanding of the obstacles patients and their families face - so we can work to better meet their unique needs.

The real proof of our impact is in the smiles we see on patients' faces, when we have helped answer a need, or improved their well-being through our work.

While the journey is not easy, it is one that is filled with purpose.

**Job Purpose**:

An operational role to ensure GxP compliance at Kyowa Kirin S. r. l.

in Italy. The incumbent will be supporting regulatory inspections in Italy, further regulatory inspections, Kyowa Kirin audits and customer audits. Continuous training and development to fulfil company objectives, policies and procedures.

**Key Responsibilities**:

Work closely with relevant members of cross functional groups in Kyowa Kirin as appropriate (e. g.

Project Management, Regulatory Affairs, Pharmacovigilance, Medical, Supply chain and Business

**Quality Assurance

Support the continuous improvement of established Quality Management Systems (QMS) at Kyowa Kirin S. r. l.

for the distribution, supply and marketing of pharmaceutical products in Italy.

- Support to ensure continued and adequate supplies to the Italian market, such that the patient needs are covered and that any anticipated restriction in supply is escalated to management.

- Support in implement of all Kyowa Kirin QA Global Policies and Global/Regional Procedures relevant to the Kyowa Kirin S. r. l.

activities.

- Prepare, update and review the technical/quality agreement between KKI, KKH and Kyowa Kirin S. r. l. .

- Prepare, update and review any technical/quality agreement between Kyowa Kirin S. r. l.

and any local supplier or contractor involved in GxP activities.

- Support in supervising the performances of the activities 3PLs of Kyowa Kirin S. r. l.

in relation to GDP requirements and agreed services.

- Support in oversight of fulfilment of Italian regulations on importation, warehousing and distribution of controlled drugs.

- Support in external audits at local service providers and local contractors for Kyowa Kirin S. r. l. .

- Perform approval and qualification activities of suppliers and customers for Kyowa Kirin S. r. l. .

- Maintain, update and archive the local QMS documentation (e. g.

procedures, records, etc.

).

- Actively participate in the local training program on GDP for Kyowa Kirin S. r. l.

employees and strongly advocate the KK quality culture.

**Regulatory Affairs

- Compliance with local regulatory legislation and guidelines, and company procedures, including:

- Timely packaging component artwork review and approval, following KKI processes and systems, to ensure that all relevant local legislation is met, e. g.

'blue box' requirements

- Local downstream communication of regulatory procedure outcomes on receipt of notification from HQ-RA

- Ensure any local regulatory submissions are prepared, peer-reviewed and submitted within agreed internal timelines and/or external deadlines, as necessary

- Provision of local regulatory advice and support to HQ Regulatory Affairs, cross-functional teams, affiliates and partners, as necessary

- Maintain electronic records for all submissions and communications with regulatory authorities, together with any supporting documentation

- Author, review and train relevant staff on local regulatory Standard Operating Procedures.

- Act on new safety information received in an appropriate and timely manner

***Pharmacovigilance - Interim**:

- Support the oversight and management of, and collaboration with, the external PV vendor

- Support the management of appropriate PV-related agreements and clauses with affiliate 3rd parties

- Perform Individual Case Safety Report reconciliation with internal departments and with the PV vendor

- Support any authority GVP inspection or partner PV audit of the affiliate

- Liaise with Medical Affairs and Commercial to ensure awareness of all organized data collection systems being performed in Italy

- Collaborate with and update Global PV with regard to PV activities in Italy.

***Position Requirements**:

- Degree in life science or equivalent with a minimum of 2 years' experience in Quality in the Pharmaceutical Industry.

- Knowledge of Good Distribution Practice

- Effectively working with cross-functional teams.

- Good technical writing and editing skills.

- Fluent in Italian and English - both verbal and written.

**Physical Requirements**:

- As this can be a sedentary position the individual needs to be able to withsta