Site Qualified Person Bardi

Site Qualified Person
Bardi
Emilia Romagna, Bardi

Careers that Change Lives

We are currently seeking an ambitious and organized Site Qualified Person for the Renal Care Solutions (RCS) business; part of Medtronic's General Surgery and Market Access (GS&MA) manufacturing network.

We employ approximately 80 people in Italy (HbioFluids - Tovo di Sant'Agata - SO) who are all directly engaged in the manufacture of pharmaceutical and medical device.

This position is based in Italy in Tovo di Sant'Agata (Sondrio).

**A Day in the Life

Qualified / Responsible Person is responsible for the supervision of all pharmaceutical activities and for the certification (release) of lots to the market.

Main responsibilities include:

- The supervision of all pharmaceutical operations of the company, including (contract-) manufacture, receipt, release or non-release, storage and distribution of the pharmaceuticals.

- The check of samples, batch manufacturing documents and quality control documents of each manufactured batch, prior to batch-release for European distribution.

For each batch such documents may also include certificates of analysis from the non-EU manufacturing sites as well as certificates of analysis issued by a recognized European pharmaceutical quality control laboratory.

- The supervision of correct archiving of all records relating to batches manufactured, released, stored and distributed.

- The supervision of standard operating procedures in the manufacturer's European Good Manufacturing & Distribution Practices (GMP&GDP) quality system related to pharmaceutical manufacturing to ensure they are respected, and the performance of internal audits to verify this.

Likewise, performs periodical external audits at contract manufacturers and contract laboratories, if applicable.

- Certifying and releasing any batch prior to its distribution outside the company.

- Reviewing and evaluating any proven or suspected quality defects and deciding accordingly on the disposition of the concerned products.

- Deciding on all aspects with respect to the manufacture, receipt, storage and distribution of the products that relate to the GMP&GDP for medicinal products.

QP is authorized to take decisions independent from management.

- Ensure compliance with the chapter 1. 7. 1 to 1. 7. 21 of the Annex 16 of the Eudralex vol. 4

- As QP/RP, has the authority to issue directives including towards upper management.

- In cooperation with competent authorities, make decision on product recalls; manages product recalls.

**Education/experience/knowledge

- Bachelor degree or higher in a life science discipline, preferably Pharma related.

- Education must meet the requirements for a Qualified Person as laid out in directive 2001/83/EC, articles 48 and 49 and with article 52 of Legislative Decree n. 219 from April 24th 2006

- Must be bilingual English-Italian

**Experience**:

- Mandatory for the QP role: experience on terminally sterile products manufacturing and in quality control.

- Minimum of 5 years' experience as a QP in a pharmaceutical environment with a minimum of 2 years people management experience in a pharmaceutical environment.

- Experience with European and Italian Competent Authorities inspections (AIFA).

- Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.

Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

**About Medtronic

Together, we can change healthcare worldwide.

At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.

We challenge ourselves and each other to make tomorrow better than yesterday.

It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.

Let's work together to address universal healthcare needs and improve patients' lives.

Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile.

The employee is also required to interact with a computer, and communicate with peers and co-workers.

Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

(ADA-United States of America)