About this role
<p> <style type="text/css">table.MiTabla { max-width: 1020px;!important </style> </p> <table border="0" cellpadding="0" cellspacing="0"> <tbody> <tr> <td><img align="top/" alt="" src="https://staticweb.grifols.com/documents/675849/2554718/SSFF_04_SC.jpg/49578aa8-332f-ed12-fb9a-5335a6228990?t=1636640426088"></td> </tr> <tr> <td> <p style="text-align:justify">Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.</p> </td> </tr> <tr> <td><img src="https://staticweb.grifols.com/documents/675849/2554709/SuccesFactors_1020x93_jobposting_line_test.png/e2cffc87-a707-9e08-b5ef-081cae1f1ecf?t=1636640341637" width="100%"></td> </tr> </tbody> </table> <p style="text-align:justify"><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt"><strong><span style="color:#333333">We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.</span></strong></span></p> <p style="text-align:justify"> </p> <p style="text-align:justify"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif"><span style="color:#333333">Progenika Biopharma is looking for a<em> Quality Assurance Specialist</em>, to join Quality department.</span></span></p> <p style="text-align:justify"> </p> <p style="text-align:justify"><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt"><strong><span style="color:#333333">What your responsibilities will be</span></strong></span><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif"> </span></p> <p style="text-align:justify"> </p> <ul> <li><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Ensure proper handling of complaints:</span></li> </ul> <p><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Manage product complaints.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Analyze complaints, including risk assessment and determination of reportability to Health Authorities.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Conduct and document investigations related to customer complaints.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Create and maintain Quality procedures related to complaints.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Define and follow up on corrective actions arising from complaints.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Perform audits to ensure that cases logged by technicians are correctly classified.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Prepare trend reports and monitor complaints.</span></p> <p> </p> <ul> <li><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Maintain the vigilance and post-market surveillance system in accordance with applicable regulations:</span></li> </ul> <p><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Report adverse events to Health Authorities.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Manage product recalls, Field Safety Corrective Actions (FSCA), and Field Safety Notices (FSN) in line with applicable regulations.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Participate in the definition of vigilance system procedures.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Develop post-market plans, procedures, and reports in compliance with applicable regulations.</span></p> <p> </p> <ul> <li><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Maintain a Quality System ensuring compliance with applicable regulations (ISO 13485, IVDR, MDSAP):</span></li> </ul> <p><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Actively participate in projects aimed at improving the effectiveness of the Quality System and its operational efficiency.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Participate in external quality audits.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Generate and monitor post-market indicators within the Quality Management System.</span></p> <p> </p> <ul> <li><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Shipment and logistics support:</span></li> </ul> <p><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Manage temperature excursions in shipments.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Handle documentation required by distributors for shipments.</span></p> <p> </p> <ul> <li><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Supplier Management:</span></li> </ul> <p><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Participate in the evaluation and qualification process of product and service suppliers, including audits and technical visits.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Draft quality agreements with suppliers.</span></p> <p> </p> <ul> <li><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Carry out general duties of a Quality Assurance Supervisor:</span></li> </ul> <p><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Actively participate in projects aimed at improving the effectiveness of the Quality System or productivity, ensuring compliance with applicable GMPs (ISO 13485, 21 CFR 820, 21 CFR 600, MDSAP, or others) and internal procedures.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Plan and propose the acquisition of new resources necessary for the proper execution of assigned responsibilities.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Ensure that all documentation related to assigned tasks is always current.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Coordinate and supervise the activities of team members, if applicable.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Support the Head of Department in various tasks to ensure the effectiveness of the Quality System.</span><br><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt">Provide user support for the Document Management System (LSQM) and act as a key user for the application.</span></p> <p> </p> <p style="text-align:justify"><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt"><strong><span style="color:#333333">Who you are</span></strong></span></p> <p style="text-align:justify"> </p> <p style="text-align:justify"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif"><span style="color:#333333">To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).</span></span></p> <p style="text-align:justify"> </p> <ul> <li style="text-align:justify;font-family:arial, helvetica, sans-serif;font-size:10.0pt"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif"><span style="color:#333333">Bachelor's Degree in Health Sciences (Biology, Chemistry, Pharmacy, Biotecnology, Biochemistry or similar). </span></span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif;font-size:10.0pt"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif"><span style="color:#333333">Desirable to have 3 years of experience in a similar tasks, being in Quality Department of pharma company.</span></span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif;font-size:10.0pt"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif"><span style="color:#333333">High level of English.</span></span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif;font-size:10.0pt"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif"><span style="color:#333333">High knowledge of Office package.</span></span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif;font-size:10.0pt"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif"><span style="color:#333333">Detail and procedure oriented and prioritization skills.</span></span></li> <li style="text-align:justify;font-family:arial, helvetica, sans-serif;font-size:10.0pt"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif"><span style="color:#333333">Proven collaboration and communication skills as well as ability to work as a team member.<br><br></span></span></li> </ul> <p style="text-align:justify"><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt"><strong><span style="color:#333333">What we offer</span></strong></span><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif"><span style="vertical-align:baseline"> </span></span></p> <p style="text-align:justify"> </p> <p class="paragraph" style="text-align:justify"><span style="vertical-align:baseline;font-family:arial, helvetica, sans-serif;font-size:10.0pt"><span style="color:#333333">It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.</span> </span></p> <p class="paragraph" style="text-align:justify"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif"><span style="vertical-align:baseline"> </span></span></p> <p class="paragraph" style="text-align:justify"><span style="vertical-align:baseline;font-family:arial, helvetica, sans-serif;font-size:10.0pt"><span style="color:#333333">Information about Grifols is available at </span><a style="color:#0782c1;text-decoration:underline" href="https://www.grifols.com./" target="_blank" rel="noopener"><span style="color:#333333"><span style="text-decoration:none">www.grifols.com.</span></span></a><span style="color:#333333"> If you are interested in joining our company and you have what it takes for such an exciting position, then don’t hesitate to apply!</span> </span></p> <p class="paragraph" style="text-align:justify"><span style="vertical-align:baseline;font-family:arial, helvetica, sans-serif;font-size:10.0pt"><span style="color:#333333">We look forward to receiving your application!</span> </span></p> <p class="paragraph" style="text-align:justify"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif"><span style="vertical-align:baseline">G</span></span><span style="vertical-align:baseline;font-family:arial, helvetica, sans-serif;font-size:10.0pt"><span style="color:#333333">rifols is an equal opportunity employer.</span> </span></p> <p style="text-align:justify"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif"> </span></p> <p style="text-align:justify;background-color:white;margin:0.0cm;font-size:12.0pt;font-family:'Times New Roman', serif"><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt"><strong><span style="color:#333333">Schedule:</span></strong><span style="color:black"> </span><span style="color:#333333">Monday-Thursday 7-10 to 16-19h and Friday 8-15h (with the same flexible start time).</span></span></p> <p><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt"><strong><span style="color:#333333">Flexibility for U Program: </span></strong><span style="color:#333333">Occasionally remote</span></span></p> <p style="text-align:justify"><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt"><strong><span style="color:#333333">Benefits package</span></strong></span></p> <p style="text-align:justify"><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt"><strong><span style="color:#333333">Contract of Employment:</span></strong><span style="color:#333333"> Permanent position</span></span></p> <p><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt"><span style="color:#333333"><img id="Imagen_x0020_3" style="width:425.5pt;height:16.5pt" src="http://www.grifols.com/documents/239901/1137346/SuccesFactors_1020x93_jobposting_line_test.png/ec7da48f-8161-41cb-b53a-7a36f6a376a6" alt="http://www.grifols.com/documents/239901/1137346/SuccesFactors_1020x93_jobposting_line_test.png/ec7da48f-8161-41cb-b53a-7a36f6a376a6"> </span></span></p> <p><span style="font-family:arial, helvetica, sans-serif;font-size:10.0pt"><strong>Location: </strong>Derio (Bilbao)</span></p> <p><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif"><a style="color:#0782c1;text-decoration:underline" href="http://www.grifols.com/"><span style="color:#005887">www.grifols.com</span></a></span></p><p><img src="https://staticweb.grifols.com/documents/675849/2554709/SuccesFactors_1020x93_jobposting_line_test.png/e2cffc87-a707-9e08-b5ef-081cae1f1ecf?t=1636640341637" width="100%"></p> <p><b>Location: <span>SPAIN : España : Derio</span>:<span>[[cust_building]]</span></b> </p> <p> </p> <p><a href="http://www.grifols.com/es/web/international/home" target="_blank">Learn more about Grifols</a></p> <p> </p>