<div id='hrsky-content' style='margin-bottom:5px'> <h1>Corporate Quality Compliance Supporter - Digital QMS/IT Validation</h1><h2>- We are looking for a Supporter within Digital QMS/IT Validation for our newly established Corporate Quality Compliance department.</h2> <p><span><span><span>Do you want to support in setting the standards and creating a global setup across Orifarm? If you are motivated by assisting in optimisations of processes and in establishing new ways of working in a growing company, then this is a great opportunity to work across all Orifarm business units. Our aim is to set up new global standards for quality, create robust and scalable processes, and, at the same time, to find the right level of compliance.</span></span></span></p> <p><span><span><span>As Orifarm is on a growth journey, we are looking for a Digital QMS/IT Validation Supporter who will support in defining polices, processes, governances and frameworks for the different tracks within Corporate Quality Compliance.</span></span></span></p> <p><span><span><span><strong>About the job </strong></span></span></span></p> <p><span><span><span>As a Corporate Quality Compliance Supporter within Digital QMS/IT Validation, you will support the Digital QMS &amp; IT Validation track owner to manage, engage, develop and implement the CQC tracks. This assistance includes to support the track owner to improving the quality and compliance level on both a corporate &ndash; and local level. Moreover, you will support the track implementations across sites as well as implement consistent improvements.</span></span></span></p> <p><span><span><span>Further, your responsibilities include: </span></span></span></p> <ul> <li><span><span><span>Coordinating and performing &ldquo;train the trainer&rdquo; training to the entire staff</span></span></span></li> <li><span><span><span>Support in managing, engaging and developing the Corporate Quality Compliance tracks</span></span></span></li> <li><span><span><span>Ensuring that the process is compliant and fit for intended use in accordance with applicable Standard Operating Procedures (SOPs)</span></span></span></li> <li><span><span><span>Supporting in validation of IT systems across Orifarm</span></span></span></li> <li><span><span><span>Providing support and guidance to lead adhering to regulatory and legal requirements</span></span></span></li> </ul> <p><span><span><span><strong>Who are you?</strong></span></span></span></p> <p><span><span><span>We expect you to have a structured mindset and a detailed understanding of Quality Systems Standards and legislations, for instance GMP, GDP, ISO 9001 etc.</span></span></span></p> <p><span><span><span>Additionally, we imagine that you possess:</span></span></span></p> <ul> <li><span><span><span>Experience working within the quality management team in a global and corporate organisation</span></span></span></li> <li><span><span><span>Knowledge of GxP, Annex 11, GAMP 5, CSV and CSA and 21 CFR Part 11 (US)</span></span></span></li> <li><span><span><span>The ability to travel both domestically and internationally</span></span></span></li> </ul> <p><span><span><span>Experience with the Veeva platform will be an advantage.</span></span></span></p> <p><span><span><span><strong>Who are we?</strong></span></span></span></p> <p><span><span><span>Corporate Quality Compliance is a newly formed business area within Orifarm, currently consisting of 13 people with many different backgrounds. We have a people- oriented focus with a high focus on employee well-being and creating abilities for you to grow as a person, both professionally and personally.</span></span></span></p> <p><span><span><span><strong>About Orifarm</strong></span></span></span></p> <p><span><span><span>Starting out with a strong entrepreneurial mission, Orifarm was founded in 1994 by Birgitte and Hans B&oslash;gh-S&oslash;rensen. The underlying explorer spirit still characterises the company, and with high ambition, we are constantly looking for new opportunities and business areas to invest in. Our purpose of being is to create competition and provide important savings for society and to ensure better value for money for consumers. We strive to make this happen while insisting on being good colleagues, improving together, helping each other, and innovating.</span></span></span></p> <p><span><span><span>We operate within seven business areas: Over the Counter (OTC), Consumer Healthcare, Generics, Promotional Rx, Unlicensed Medicines, Parallel import and Clinical Trials Supplies (CTS). We are the largest parallel importer of pharmaceuticals in Europe as well as the largest supplier of pharmaceuticals in Denmark. We hold a strong position in Generics in the Nordics, being the largest producer of over-the-counter medicine in Denmark. Our portfolio contains well-known brands such as Pamol, Kodimagnyl, and Apovit. Moreover, within New Bizz, we aim to expand our business by exploring new opportunities within pharmaceuticals.</span></span></span></p> <p><span><span><span><strong>We offer</strong></span></span></span></p> <p><span><span><span>In Orifarm we place great emphasis on both your professional and personal development and on giving you the opportunity to bring all of your skills into play.</span></span></span></p> <p><span><span><span>We offer a competitive compensation and benefits package and our staff canteen offers a variety of healthy menus every day. Physiotherapy will also be at your disposal.</span></span></span></p> <p><strong><span><span><span>Location</span></span></span></strong></p> <p>You have the opportunity to be affiliated with either our office in 5260 Odense or 2860 S&oslash;borg.</p> <p><span><span><span><strong>Need further information?</strong></span></span></span></p> <p><span><span><span>If you need further information about the job please contact Head of Corporate Quality Compliance Governance, Trine Lomholt Hall, at +45 81886832, or Head of Corporate Quality Compliance Management, Anja Sandal Gr&oslash;nskov, at +45 81883352.</span></span></span></p> <div class="block"> <p style="margin-bottom: 5px !important"> <strong>Application deadline:</strong> </p> As soon as possible </div> <div class='contacts' style='margin-top:20px'> </div> <script> var rollState = 'down'; window.addEventListener( "message", function (e) { if(e.origin !== 'https://hr-skyen.dk'){ return; } if(e.data == 'rollup'){ 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</fieldset> <fieldset class="fieldset fieldSet5"> <legend>Profile overview</legend> <div class="cb"></div> <div class="inputrow title"> <label for="text-title-CVTitle"><span class="requireddot" aria-hidden="true">*</span><span class="label-text">CV Title</span></label><input type="text" autocomplete="organization-title" name="CV[f0][title]" id="text-title-CVTitle" class="required" aria-required="true" required="" value="" onblur='fieldValidate(this, "CV", "title")'> </div> <div class="inputrow experience"> <label for="select-experience-Yearsofexperience"><span class="label-text">Years of experience</span></label><select name="CV[f0][experience]" id="select-experience-Yearsofexperience"><option value="0">Select <option value="0-2 years">0-2 years <option value="3-5 years">3-5 years <option value="6-10 years">6-10 years <option value="more"> more</select> </div> <div class="inputrow eduname"> <label for="text-eduname-Educationname"><span class="label-text">Education name</span></label><input type="text" autocomplete="off" name="CV[f0][eduname]" id="text-eduname-Educationname" value="" onblur='fieldValidate(this, "CV", "eduname")'> </div> <div class="inputrow eduyear"> <label for="text-eduyear-Graduationyear"><span class="label-text">Graduation year</span></label><input type="text" autocomplete="off" name="CV[f0][eduyear]" id="text-eduyear-Graduationyear" value="" onblur='fieldValidate(this, "CV", "eduyear")'> </div> <div class="inputrow edulevel"> <label for="select-edulevel-Levelofeducation"><span class="label-text">Level of education</span></label><select name="CV[f0][edulevel]" id="select-edulevel-Levelofeducation"><option value="0">Select <option value="Basic education">Basic education <option value="Secondary school">Secondary school <option value="Short higher education">Short higher education <option value="Higher education">Higher education <option value="PhD">PhD</select> </div> </fieldset> <fieldset class="fieldset fieldSet6 fieldSet7 fieldSet8"> <legend>Your CV</legend> <div class="cb"></div> <label style="padding:0px;padding-left:20px;height:24px;clear:both;line-height:24px;display:inline-block;" class="switch"><input type="radio" onclick='displaybox("box29",this);' checked="" name="radio29" style="vertical-align:middle;margin:0px;margin-right:5px;" aria-expanded="true" aria-controls="box29">I want to upload my CV</label><label style="padding:0px;padding-left:20px;height:24px;clear:both;line-height:24px;display:inline-block;" class="switch"><input type="radio" onclick='displaybox("box33",this);' name="radio29" style="vertical-align:middle;margin:0px;margin-right:5px;" aria-expanded="false" aria-controls="box33">I want to write my CV</label><fieldset class="fieldset" id="box29" style="display:block"> <legend class="visuallyhidden">I want to upload my CV</legend> <div class="cb"></div> <div id="filefield-id-CV-cvfile" class=" cvtemplatefieldid-"> <div class="filenames filesrequired"></div> <label><span 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title="Other documents" style="height:61px;width:260px;"></iframe> </div> <div class="inputrow userreferrer"> <label for="select-userreferrer-Howdidyoufindus"><span class="requireddot" aria-hidden="true">*</span><span class="label-text">How did you find us?</span></label><select name="Application[f0][userreferrer]" class="required" aria-required="true" required="" id="select-userreferrer-Howdidyoufindus"><option value="0">Select <option value="Our website">Our website <option value="LinkedIn"> LinkedIn <option value="Jobindex"> Jobindex <option value="Farmakonom.dk"> Farmakonom.dk <option value="MedWatch"> MedWatch <option value="ITWatch"> ITWatch <option value="ITjobbank"> ITjobbank <option value="Graduateland"> Graduateland <option value="SDUjobbank"> SDUjobbank <option value="KU Projekt &amp; Job"> KU Projekt &amp; Job <option value="BS CareerGate"> BS CareerGate <option value="ITU Job- og Projektbank"> ITU Job- og Projektbank <option value="AU Job- og Projektbank"> AU Job- og Projektbank <option value="[Other]"> [Other]</select> </div> </fieldset> <fieldset class="fieldset termsAgreeWrapper fieldSet12"> <legend>Terms &amp; Conditions</legend> <div class="cb"></div> <hr> <div class="consent"> <div class="termsWrapper" id="consent-388"> <p><strong>Privacy policy for online application</strong><br> Thank you for your interest in our online job posting.<br> &nbsp;<br><strong>The protection of your personal information is very important to us.</strong><br> Therefore, we will inform you below about the collection, processing and use of your data in the context of the online application, in accordance with the relevant data protection regulations.<br> &nbsp;<br><strong>Purpose of data collection / dissemination</strong><br> The collection and processing of your personal application data is exclusively earmarked for the filling of positions within our company. Your data will only be forwarded to the in-house bodies and specialist departments of our company responsible for the concrete application process. A transfer of your personal application data to other companies of the Orifarm Group will not take place without your prior express consent.<br> Any further use or transfer of your application data to third parties will not take place.<br> &nbsp;<br><strong>Retention period of the application data</strong><br> A deletion of your personal application data takes place automatically 6&nbsp;months after completing the application process, unless you have explicitly agreed to a longer storage.<br> &nbsp;<br><strong>Storage for future job postings</strong><br> If we are unable to provide you with a current vacancy, but your profile suggests that your application may be of interest for future job postings, we will store your personal application information for six months, provided that you expressly consent to such storage and use. We would contact you in advance.<br> &nbsp;<br><strong>Right to information and revocation</strong><br> If you have questions about the collection, processing or use of your personal data, or in cases of information, correction or deletion of data, as well as revocation of granted consent, please contact:<br> &nbsp;<br><strong>Orifarm Group A/S</strong><br> Energivej 15 - CVR: 27347822</p> <p>+45 63952700, info@orifarm.com<br> &nbsp;<br> &nbsp;<br> To continue with the application, please accept the following required field with the asterisk *.</p> </div> <label class="longlabel" aria-describedby="consent-388"><span aria-hidden="true" class="requireddot" style="display:inline;">*</span><input type="checkbox" name="acceptedconsents[]" class="terms termsrequired" value="388" id="consentrequired"><span class="checkmark"></span>I agree with the terms &amp; conditions</label> </div> </fieldset> </div> </div> </div></div> <div style="clear:both;" class="tabbottom"><button type="button">Next<span class="visuallyhidden"> page</span></button></div> <div class="cb"></div> </form> <div class="cb"></div> </div> <div class="cb"></div> <script type="text/javascript"> $('.termsAgreeWrapper').appendTo(".fieldSet3"); </script> </div>

Corporate Quality Compliance Supporter - Digital QMS/IT Validation

- We are looking for a Supporter within Digital QMS/IT Validation for our newly established Corporate Quality Compliance department.

Do you want to support in setting the standards and creating a global setup across Orifarm? If you are motivated by assisting in optimisations of processes and in establishing new ways of working in a growing company, then this is a great opportunity to work across all Orifarm business units. Our aim is to set up new global standards for quality, create robust and scalable processes, and, at the same time, to find the right level of compliance.

As Orifarm is on a growth journey, we are looking for a Digital QMS/IT Validation Supporter who will support in defining polices, processes, governances and frameworks for the different tracks within Corporate Quality Compliance.

About the job

As a Corporate Quality Compliance Supporter within Digital QMS/IT Validation, you will support the Digital QMS & IT Validation track owner to manage, engage, develop and implement the CQC tracks. This assistance includes to support the track owner to improving the quality and compliance level on both a corporate – and local level. Moreover, you will support the track implementations across sites as well as implement consistent improvements.

Further, your responsibilities include:

  • Coordinating and performing “train the trainer” training to the entire staff
  • Support in managing, engaging and developing the Corporate Quality Compliance tracks
  • Ensuring that the process is compliant and fit for intended use in accordance with applicable Standard Operating Procedures (SOPs)
  • Supporting in validation of IT systems across Orifarm
  • Providing support and guidance to lead adhering to regulatory and legal requirements

Who are you?

We expect you to have a structured mindset and a detailed understanding of Quality Systems Standards and legislations, for instance GMP, GDP, ISO 9001 etc.

Additionally, we imagine that you possess:

  • Experience working within the quality management team in a global and corporate organisation
  • Knowledge of GxP, Annex 11, GAMP 5, CSV and CSA and 21 CFR Part 11 (US)
  • The ability to travel both domestically and internationally

Experience with the Veeva platform will be an advantage.

Who are we?

Corporate Quality Compliance is a newly formed business area within Orifarm, currently consisting of 13 people with many different backgrounds. We have a people- oriented focus with a high focus on employee well-being and creating abilities for you to grow as a person, both professionally and personally.

About Orifarm

Starting out with a strong entrepreneurial mission, Orifarm was founded in 1994 by Birgitte and Hans Bøgh-Sørensen. The underlying explorer spirit still characterises the company, and with high ambition, we are constantly looking for new opportunities and business areas to invest in. Our purpose of being is to create competition and provide important savings for society and to ensure better value for money for consumers. We strive to make this happen while insisting on being good colleagues, improving together, helping each other, and innovating.

We operate within seven business areas: Over the Counter (OTC), Consumer Healthcare, Generics, Promotional Rx, Unlicensed Medicines, Parallel import and Clinical Trials Supplies (CTS). We are the largest parallel importer of pharmaceuticals in Europe as well as the largest supplier of pharmaceuticals in Denmark. We hold a strong position in Generics in the Nordics, being the largest producer of over-the-counter medicine in Denmark. Our portfolio contains well-known brands such as Pamol, Kodimagnyl, and Apovit. Moreover, within New Bizz, we aim to expand our business by exploring new opportunities within pharmaceuticals.

We offer

In Orifarm we place great emphasis on both your professional and personal development and on giving you the opportunity to bring all of your skills into play.

We offer a competitive compensation and benefits package and our staff canteen offers a variety of healthy menus every day. Physiotherapy will also be at your disposal.

Location

You have the opportunity to be affiliated with either our office in 5260 Odense or 2860 Søborg.

Need further information?

If you need further information about the job please contact Head of Corporate Quality Compliance Governance, Trine Lomholt Hall, at +45 81886832, or Head of Corporate Quality Compliance Management, Anja Sandal Grønskov, at +45 81883352.

Application deadline:

As soon as possible
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