Junior Life Science Consultant Document Management Apply
<p style="text-align:justify; margin-bottom:11px"> </p> <div> <p align="center" style="margin-bottom:14px; text-align:center"><b>We are looking for enthusiasts</b></p> KVALITO Consulting Group is a strategic partner and global Life Science network for regulated industries with a focus on quality. Headquartered in Basel, Switzerland, we have subsidiaries in Germany, Czech Republic, Ireland and Malaysia. With our enthusiasm for progressive technologies and our in-depth knowledge of industry best practices and regulations, we drive effective and efficient project delivery to keep our industry-leading clients ahead of the competition. Our leadership and consultants combine decades of experience in enterprise environments. To cover all essential technical areas in the field of digital and mobile, KVALITO works with reliable Technology Partners worldwide. For more information, please visit us at <a href="http://www.kvalito.ch/" target="_blank">www.KVALITO.ch</a> <b>Junior Life Science Consultant, Document Management</b> <div> <p><b>Location: Spain (Remote)</b></p> <p>The purpose of the role is to work with our clients to understand their needs, offer advice, solve problems, manage change, and improve efficiency.<br /> <br /> <b>Responsibilities:</b> </p> <ul> <li> <div style="font-style: italic;">Qualified individuals will be responsible for the design, implementation, and maintenance of the Quality Assurance Documentation and Change Management.</div> </li> <li> <div style="font-style: italic;">Responsibility for issuance, tracking, and control of Standard Operating Procedures, Master Batch Records, Test Records, Forms, Protocols, Amendments, and Final Reports including formatting, editing, and revisions. </div> </li> <li> <div style="font-style: italic;">Serve as administrator current and future quality documentation systems and or software systems.</div> </li> <li> <div style="font-style: italic;">Individual will assist the QS Manager in maintaining a complete Quality Management System (QMS) in compliance to cGMPs.</div> </li> <li> <div style="font-style: italic;">Create, revise, and maintain company standard operating procedures (SOPs) as required.</div> </li> <li> <div style="font-style: italic;">Format, track, and issue controlled cGMP documents including protocols, test records, and forms.</div> </li> <li> <div style="font-style: italic;">Assist in the review of cGMP-controlled documents as necessary</div> </li> <li> <div style="font-style: italic;">Issuance of batch production records, tracking of master batch records, tracking of all batch production records, and lot number issuance.</div> </li> <li> <div style="font-style: italic;">Maintain validation files (validation protocols, validation summary reports, engineering change controls).</div> </li> <li> <div style="font-style: italic;">Interface with other departments regarding documentation requirements.</div> </li> <li> <div style="font-style: italic;">Participate in and support quality audits (internal and external), troubleshooting efforts, and other Quality System processes.</div> </li> <li> <div style="font-style: italic;">Provide backup and support to the Quality Assurance Manager</div> </li> <li> <div style="font-style: italic;">Initiate, carry out, and maintain change control documents</div> </li> </ul> <div style="font-style: italic;"><b>Minimum Qualification and Experience</b><br /> <b>Education</b></div> <ul> <li style="text-align:justify; margin-bottom:11px"> <div style="font-style: italic;">Bachelor or Master degree in Life Sciences, Chemistry, Computer Science, Engineering or similar.</div> </li> </ul> <div style="font-style: italic;"><b>Language</b></div> <ul> <li style="text-align:justify; margin-bottom:11px"> <div style="font-style: italic;">Fluent in English</div> </li> </ul> <div style="font-style: italic;"><b>Work experience</b></div> <ul> <li style="margin-bottom:11px"> <div style="font-style: italic;">1 -3 years' experience in manufacturing cGMP environment performing Quality Documentation duties.</div> </li> </ul> <div style="font-style: italic;"><b>Hard Skills</b></div> <ul> <li style="text-align: justify;"> <div style="font-style: italic;">Knowledge and expertise in principles and practice of current Good Manufacturing Practices (cGMPs).</div> </li> <li style="text-align: justify;"> <div style="font-style: italic;">Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirements are met.</div> </li> <li style="text-align: justify;"> <div style="font-style: italic;">Solid computer skills using Word, Excel, and PowerPoint</div> </li> <li style="text-align:justify;"> <div>Knowledge as a Veeva user is a must, and any other document management system is a plus</div> </li> <li style="text-align: justify;"> <div style="font-style: italic;">Solid computer skills using Word, Excel, and PowerPoint</div> </li> <li style="text-align: justify;"> <div style="font-style: italic;">Practical experience in and passion for information governance, IT quality, administration, and service management.</div> </li> <li style="margin-bottom: 11px; text-align: justify;"> <div style="font-style: italic;">Familiar with compliance requirements (e.g.,FDA, EMA GMP, GLP, GCP, Records Management)</div> </li> </ul> <div style="font-style: italic;"><b>Soft Skills</b></div> <ul> <li style="text-align: justify;"> <div style="font-style: italic;">Excellent people management, leadership, and decision-making skills.</div> </li> <li style="text-align: justify;"> <div style="font-style: italic;">Ability to facilitate a holistic perspective and understand business needs.</div> </li> <li style="text-align: justify;"> <div style="font-style: italic;">Motivated to continuously expand her/his knowledge of the life science industry.</div> </li> <li style="text-align: justify;"> <div style="font-style: italic;">The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems.</div> </li> <li style="text-align: justify;"> <div style="font-style: italic;">The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision without neglecting attention to detail</div> </li> <li style="text-align: justify;"> <div style="font-style: italic;">The ability to enable and drive change while being focused on internal and external customers.</div> </li> <li style="text-align: justify;"> <div style="font-style: italic;">Strong communication and problem-solving skills.</div> </li> <li style="text-align: justify;"> <div style="font-style: italic;">Ability to work globally to coordinate the work of associates at all levels.</div> </li> <li style="text-align: justify;"> <div style="font-style: italic;">Capable of managing multiple priorities</div> </li> <li style="text-align: justify;"> <div style="font-style: italic;">Considerable organization awareness (e.g., the interrelationship of departments, business priorities)<br /> including experience in working cross-functionally and in global teams across cultures.</div> </li> </ul> <div style="font-style: italic;"><b>We offer great benefits</b> </div> <ul> <li style="text-align:justify;"> <div style="font-style: italic;"> Flat hierarchies and responsibility from the beginning </div> </li> <li style="text-align:justify;"> <div>People-oriented culture </div> </li> <li style="text-align:justify;"> <div>Diversity and inclusion-focused environment </div> </li> <li style="text-align:justify;"> <div>Global client projects in a multinational environment </div> </li> <li style="text-align:justify;"> <div>Flexible working hours and home office </div> </li> <li style="text-align:justify;"> <div>Involvement in global conferences </div> </li> <li style="text-align:justify;"> <div>Individual professional development, training, and coaching </div> </li> <li style="text-align:justify;"> <div>Unlimited full employment contract </div> </li> <li style="text-align:justify;"> <div>Excellent remuneration package consisting of a competitive salary plus a substantial bonus </div> </li> </ul> <div style="font-style: italic;"><b>Contact</b> </div> <div style="font-style: italic;">If you have the necessary background and experience and would like to join a small team responsible for a truly global operation, then please send your application to recruiting(at)kvalito.ch including your: </div> <ul> <li style="text-align:justify;"> <div style="font-style: italic;">CV, cover letter, and supporting documents (i.e., diplomas, certificates, references) </div> </li> <li style="text-align:justify;"> <div>Availability - earliest start date </div> </li> <li style="text-align:justify;"> <div>Salary expectations </div> </li> <li style="text-align:justify;"> <div>Location preference </div> </li> </ul> <div style="font-style: italic;"><b>We are looking forward to your application. </b> <br /> Your KVALITO Team. </div> </div> </div>
