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Site Quality Manager and QP (HBiofluids - Sondrio)

Medtronic
Tovo di Sant'Agata, Lombardia 23030
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Site Quality Manager and QP (HBiofluids - Sondrio)

Location:

Tovo Di SantAgata, Sondrio, Italy

Requisition #:

20000B1C

Post Date:

Aug 10, 2020


**Site Quality Manager and Qualified Person**


**OVERVIEW:**


Site Quality Manager and Qualified Person for the Renal Care Solutions (RCS) business; part of Medtronics Minimally Invasive Therapies Group (MITG). We employ approximately 80 people in Italy (HbioFluids Tovo di SantAgata SO) and France who are all directly engaged in the manufacture of pharmaceutical and medical device fluids and concentrates used in the dialysis procedure. This position is based in Italy in Tovo di SantAgata (Sondrio).


**RESPONSIBILITIES AND ACCOUNTABILITIES:**


Qualified / Responsible Person is responsible for the supervision of all pharmaceutical activities and for the certification (release) of lots to the market. His or her 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, independently and without any interference of third persons or third parties.


The check of samples, batch manufacturing documents and quality control documents of each manufactured batch, prior to his/her 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. Based on these compiled documents the QP issues, for each batch, a batch certificate.


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


The supervision of standard operating procedures in the manufacturers European Good Manufacturing Distribution Practices (GMPGDP) quality system related to pharmaceutical manufacturing to ensure they are respected, and the performance of internal audits to verify this. Likewise he/she performs periodical external audits at contract manufacturers and contract laboratories, if applicable.


Monitoring of, and getting acquainted with, relevant professional developments and if there are consequences for the company, ensuring that appropriate measures are taken.


Respecting the secrecy of company data and not using any data, obtained as a result of the supervision, for the benefit of him/herself.


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 insofar these relate to the GMPGDP for medicinal products. QP is authorised 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.


Site Quality Manager is responsible for ensuring that:


HBIOfluids Quality System is developed, implemented, maintained, enforced and improved in line with international (e.g., US, EU and Italy) pharmaceutical and medical device regulations, standards and management guidelines as well as with Medtronic Corporate Policies, in coordination with all involved country entities.


The Quality department works closely together with the Quality Manager and project groups in all concerned Business Units to establish and maintain alignment with Corporate and Business Unit Quality Management Systems where possible.


He/she stays up to date on international legislation, guidelines and standardization requirements.


An appropriate documentation system is deployed and implemented including the archiving.


An appropriate training system is in place for the training of HBIOfluids employees.


Systems are maintained in a validated status.


An appropriate CAPA process, using appropriate problem-solving tools is deployed and implemented.


An appropriate quality risk management system is maintained, reviews and approves risk management plans for product and processes.


Change request are reviewed, assessed and implemented as defined in the action plan


Supplier monitoring is in place and efficient


Internal audits are performed annually


Complaint are registered and handled appropriately in a timely manner


He /she is also responsible for


Managing the Quality team


Leading relations with competent authorities for all GMPGDP aspects, including inspections.


Leading Management Reviews.


Approving Product Quality Reviews for products for which HBIOfluids is the Marketing Authorization Holder.


Approving Quality Agreements with other internal and external entities (contract-manufacturers, API suppliers etc.).


Approving Stability protocol for finished products


Other tasks:


Promotes continuous improvement throughout the organisation.


Represents HBIOfluids key decision meetings.


Acts as pharmaceutical quality expert within Medtronic


Develop team members to promote motivation and retention of employees as well as to ensure required knowledge is kept up to date.


**JOB REQUIREMENTS:**


Education:


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


Language:


Must be bilingual English-Italian


Experience:


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


Minimum of 10 years Quality Management System experience in the Healthcare industry with a minimum of 5 years 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**


At Medtronic, you will find a diverse team of innovators who bring their unique backgrounds and their individual life experiences to work every day. We work hard to cultivate a workforce that reflects our patients and partners, we believe its the only way to drive healthcare forward. We want to attract a diverse workforce, regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, veteran status, or any other characteristic protected by state or local law. Join us and bring the power of your point of view to our culture of collaboration and innovation. It is through strong diversity, inclusion and engagement that we can remain a leader in medical technology and solutions. And by embracing everything you have to offer your unique perspectives, talents and contributions we can live up to the promise of our Mission.


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. Lets 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)Physical requirements that may be specific to each role. (ADA-United States of America)
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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Posted: 2020-08-13 Expires: 2020-10-19
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Site Quality Manager and QP (HBiofluids - Sondrio)

Medtronic
Tovo di Sant'Agata, Lombardia 23030

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