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<h1>(post-marketing) Pharma EU-QPPV (f/m/d) Praha/Bratislava/Vienna/EU</h1><a>min. EUR 5.000,-- gross p.m.</a><a href="https://www.isg.com/jobs/applications/applyForJobEntry.jsf?inseratnummer=104105&amp;refererId=625" target="_blank">APPLY</a>Our client is an internationally active, well established, further growing Austrian pharma SME with an Rx portfolio in various indication areas including ophthalmology, ICU, CV, and some OTC products. The company is searching now for the management of the post-marketing PV/safety responsibilities of the group an internationally experienced EU-QPPV based in Czechia, Slovakia, Austria, or eventually another EU country.<h2>Responsibilities: </h2> 
<ul> 
 <li>Key functions are the formal EU-QPPV &amp; Head of PV Management roles with responsibility for a small team of local PV managers and as the contact person to local external PV partners and authorities</li> 
 <li>Responsibilities according to Regulation (EC) No 726/2004 Articles 23ff including the establishment and maintenance of the PV system (incl, rRMMs), the preparation of PV reports as defined by regulations, answering requests from health authorities, and providing health authorities with any other information relevant to product safety</li> 
 <li>Representation of the group at audits, inspections, and response processes to any relevant post-marketing PV matters, acting as point of contact for the regulatory authorities on a 24-hour basis and as the contact point for PV inspections</li> 
 <li>Expediting ICSR reporting and aggregate reports (PSURs, RMPs, PASS studies …) in relation to quality, focusing on accuracy, completeness, and timeliness</li> 
 <li>Safety databases management, training of personnel in relation to PV</li> 
 <li>Ensure together with RA the appropriate medical input to PV reports including ICSRs and PSURs as well as for the registration documents, providing the safety contribution to regulatory authority submissions</li> 
 <li>Management of (potential) AEs including the corresponding monitoring of the relevant literature in cooperation with local PV managers and external partners respectively</li> 
 <li>Safety assessments and drug safety reports for signals or other issues, e.g. product quality, or in response to health authority (HA) requests</li> 
 <li>Based on individual experience and qualification additional support as MA Manager for matters such as approval of marketing material, medical literature analysis/input for marketing et al and as MIO</li> 
</ul> 
<h2>Requirements:</h2> 
<ul> 
 <li>MD preferred or advanced science degree in Life Sciences is required</li> 
 <li>High level of experience and expertise in PV in the EU, including aspects of medical safety, ideally also as EU-QPPV or deputy EU-QPPV</li> 
 <li>Excellent knowledge of European regulatory requirements relating to PV</li> 
 <li>PV systems experience (covering compliance, databases, procedures, QA, training)</li> 
 <li>Experience with audits/inspections</li> 
 <li>Fluent English proficiency (C2), further EU language skills are an advantage</li> 
 <li>Highly reliable, communicative, entrepreneurial personality who is motivated to develop the PV system and stringently manage strategy and operation of all safety related tasks, issues, documentation, and reporting for a dynamic, internationally active pharma SME with flat hierarchies</li> 
</ul> 
<h2>The Offer:</h2> The company offers a fixed monthly gross salary at a minimum of EUR 5.000,-- with possible overpay depending on qualification, experience, and local standards and besides the regular respectively defined EU-QPPV post-marketing tasks an interesting role with the opportunity to participate as part of the HQ management team also actively in the strategic development of the company. 
 
<br>Please send your application including CV and motivation letter under Kennnummer 104&nbsp;105 preferably on our application portal <a href="https://www.isg.com/jobs/applications/applyForJobEntry.jsf?inseratnummer=104105&amp;refererId=625" target="_blank">ISG-Karriereportal</a> or per eMail to <a href="mailto:bewerbung.seligo@isg.com" target="_blank">bewerbung.seligo@isg.com</a>. 
<p>Visit us at <a href="https://www.isg.com/jobs/search" target="_blank">isg.com/jobs</a> - with our accurate job offers.</p><a href="https://www.isg.com" target="_blank"></a>ISG Personalmanagement GmbH 
<br> A-1010 Wien, Universitätsring 14 
<br> Dr. Roman Seligo, T: +43 1 512 35 05 
<br> @:<a href="mailto:bewerbung.seligo@isg.com" target="_blank"> bewerbung.seligo@isg.com</a>

ISG Personalmanagement GmbH

Wir sind die ISG

EU-QPPV (f/m/d)

<h1>Senior Quality Planner / Technologist - Car Displays 
<h2>- sportcars production in Bratislava</h2></h1><a href="https://www.isg.com/jobs/applications/applyForJobEntry.jsf?inseratnummer=103652&amp;refererId=625" target="_blank">APPLY</a>Are you ready to drive your career forward? We are looking for a highly skilled and motivated Senior Quality Planner / Technologist — a position where you'll have the opportunity to collaborate with top-tier automotive premium brands and contribute to the evolution of the automotive landscape. Our client is a well-known international company that is a key partner of the world's most prestigious car manufacturers. The foundation of the company's success is its top know-how and a superb, dedicated team of employees. To expand and strengthen this team (located in Bratislava), we are looking for a new colleague for our client, for the position of an Senior Quality Planner / Techonologist for car displyas.In this position, you will play a crucial role in ensuring the superior quality of display components used in high-performance vehicles. By collaborating closely with global suppliers, production teams, and other stakeholders, you will maintain and enhance our quality standards, driving excellence and innovation in car display technology. Some of your key responsibilities will be: 
<li>Develop and implement robust quality control processes for car display components.</li> 
<li>Conduct regular quality audits and inspections at supplier sites, primarily in Europe and Asia.</li> 
<li>Establish and maintain quality standards that meet both company and industry requirements.</li> 
<li>Work collaboratively with suppliers to ensure adherence to our stringent quality standards and specifications.</li> 
<li>Provide technical guidance and support to suppliers to swiftly resolve quality issues.</li> 
<li>Monitor supplier performance and conduct regular performance reviews to ensure continuous improvement.</li> 
<li>Perform thorough technical evaluations of display components to ensure they meet required standards.</li> 
<li>Develop and execute comprehensive testing protocols to ensure product reliability and performance.</li> 
<li>Analyze test results meticulously and implement corrective actions when necessary.</li> 
<li>Identify opportunities for quality improvements within the production process.</li> 
<li>Stay abreast of the latest industry trends and advancements in display technology to continually enhance our processes.</li> 
 Requirements: 
<li>Master´s / Bachelor's degree in Engineering, Quality Management, or a related field.</li> 
<li>Minimum of 4 years of experience in quality assurance, preferably in the automotive industry with a focus on electronic displays or consumer electronics (e.g., TV displays).</li> 
<li>Familiarity with the production processes and components of display manufacturing.</li> 
<li>Strong understanding of display technologies and automotive quality standards, including the challenges in the manufacturing process.</li> 
<li>Awareness of common errors, issues, and customer complaints related to display components.</li> 
<li>Proficiency in quality management tools and methodologies (e.g., Six Sigma, FMEA).</li> 
<li>Experience in supplier quality management and conducting audits.</li> 
<li>Excellent communication and interpersonal skills.</li> 
<li>Fluent English or German, additionally to fluent Slovak/Czech</li> 
<li>Strong analytical and problem-solving abilities.</li> 
<li>Ability to work independently and as part of a collaborative team.</li> 
<li>Willingness to travel frequently to supplier sites, particularly in Europe and Asia</li> 
 Our offer: 
<li>Opportunities for personal and professional growth within a leading technology company.</li> 
<li>A culture of innovation that empowers you to contribute to the future of automotive technology.</li> 
<li>A dynamic and collaborative work environment with a team of passionate experts.</li> 
<li>A competitive monthly salary of approximately 4.000+ EUR, commensurate with experience.</li> 
 
<br>If you are interested in this challenging position we are looking forward to receiving your comprehensive application for ref.no. 103,652 via e-mail to <a href="mailto:pliesovsky@isg.sk" target="_blank">pliesovsky@isg.sk</a>, or via our <a href="https://www.isg.com/jobs/applications/applyForJobEntry.jsf?inseratnummer=103652&amp;refererId=625" target="_blank">ISG career portal</a>. 
<p>We value diversity and inclusivity and are proud to be an equal opportunity employer.</p><a href="https://www.isg.com" target="_blank"></a>Dipl.Ing. Peter Pliesovsky 
<br> ISG s.r.o., executive search 
<br> Štefánikova 47, SK-811 04 Bratislava 1 
<br> T/F: +421 910 600 654 
<br> @:<a href="mailto:bewerbung.pliesovsky@ISG.com" target="_blank">bewerbung.pliesovsky@ISG.com</a>

2 Vollzeit Jobs in Bratislavský kraj