Offre d'emploi: senior specialist international fill finish (temp - 12 months):Randstad.chJob description:
job detailspublié . 26. septembre 2021 lieu . basel, bâle-ville secteur . life sciences type d'emploi . temporaire référence . 16525 contact . angèle atlan, bâle professionals health care & life sciences téléphone . 058 201 54 40 appliquer > description du posteDo you have good communication skills and strong experience in the bio-pharmaceutical industry?Are you experienced working with partner organizations (CMOs)?In this case you should have a look at this opportunity!To work for our client, a pioneering biotechnology company, we are looking for a: Senior Specialist, International Fill Finish Location: Basel Contract duration: to start asap for 12 months Here?s What You?ll Do: . Support the (Associate) Director, International Fill Finish in various tasks related to the buildup of GMP production at Fill Finish Contract Manufacturing Organizations (FF CMOs). . Act as a counterpart for FF CMOs team members to ensure on-time and in-full deliveries. Partner with Quality, Technical Development, Manufacturing Science and Technology, and Regulatory colleagues on specific aspects of the relationships with the FF CMOs. . Ensure operational related activities at the FF CMOs are conducted to meet Company?s requirements (Compliance, Meeting Orders, Dispute resolution, Production Planning, Materials Management, Technology Issues, OpEx). . Ensure externally manufactured drug products are produced and stored according to the appropriate documentation in order to obtain the required quality. . Ensure that instructions relating to external production operations are strictly implemented by the CMOs. . Ensure in collaboration with quality that the appropriate qualification, maintenance, training and validations are performed to meet the appropriate Company requirements. . Support and perform the reviews for process performance at FF CMOs. . Monitor Key Performance Indicators of FF CMOs. . Support preparation of periodic business and operations review meetings. . Drive for and implement agreed continuous improvements at FF CMOs. . Coordinate reviews and approvals of various documentations from FF CMOs. . In collaboration with Quality coordinate investigations and troubleshooting efforts at FF CMOs . Write or revise the appropriate GMP documentations. . Frequently visit and maintain presence at the external partners? sites and build strong interdependent relationships with the CMO Counterparts in order to assess the as is state & risks for action-oriented improvement plans. . Performs other administrative duties as required. Here?s What You?ll Bring to the Table: . Bachelor's Degree with 5-8 years of experience in biopharmaceutical operations or a Master?s Degree with 2-5 years industry experience; Degree in Engineering or Life Sciences is preferred. . Proficiency in English required. Spanish and German are a plus. . Good communication skills (verbal and written) to collaborate with other CMC team members and managers in a dynamic, cross-functional matrix environment. . Ability to work with members of partner organizations (CMOs). . Well organized ? a natural ability to be organized in how you think, communicate and conduct your work. . You drive for results ? you set a high bar for yourself and others. . Good critical thinker that can anticipate the needed next step and therefore can work independently. . A curious mindset that allows you to constantly learn and challenge the status quo. . Ability to navigate through ambiguity and rapid growth and adapt to change. You would like to contribute to a fast-thinking and innovative company, changing the industry ?Apply now! Please note that a valid Swiss work permit or Swiss or EU-25/EFTA citizenship is required for this position Skills:
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