Senior QA Transversal Projects Expert
vor 3 Wochen
Hello. We’re Haleon . A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us.
With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge, and expertise, we’re uniquely placed to do this and to grow a strong, successful business.
This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special.
About the Role
Act as QA representative expert of our Validation & Qualification program for new equipment/new product & transversal project and be the guaranty of the Validation & Qualification strategy on the site in close collaboration with Qualification/Validation team.
Key Responsibilities
Based on the internal requirements, current regulations and Guidelines such as EU & FDA GMP, ICH and GAMP, oversee Nyon validation/qualification activities to ensure that Equipment, Facilities, Utilities and Processes (process and cleaning) used in Manufacturing of Pharmaceutical products and API are prospectively qualified & validated prior to commercial distribution. Be the guaranty of the Validation & Qualification strategy on the site As QA representative & expert, oversee the qualification activities (for equipment, utilities and facilities) including approval of the qualification documents (protocols and reports) and the process validation activities (manufacturing and cleaning processes) including approval of protocols and reports for new equipment installation/new product introduction or transversal & complex project. These activities might be also coordinated with QA end to end expert. Ensure that Change, Deviation and CAPA records related to Qualification & Process/Cleaning validation are in full compliance with internal requirements and regulatory guidelines in line with the integrated QA end to end model. Provide coaching and support to other integrated QA end to end experts supporting qualification & validation activitiesMust Have
Bachelor in Sciences (Engineering or Life Sceinces) Proficiency in English Minimum 10 years in the pharmaceutical industry or equivalent, with experience in management of a small team of experts. Mastery in the field of Validation & Qualification with good knowledge of Statistics and related regulationsNice to Have
Ability to demonstrate leadership Be an expert in the 4 following areas of validation / qualification: Equipment Qualification / Facilities-Utilities Qualification / Process Validation / Cleaning Validation Ability to demonstrate proficiency and thorough knowledge of applicable European & US legislations, Health authorities and/or industry groupsLocation : Nyon Switzerland
Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/
At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon’s compliance to all federal and state US Transparency requirements.
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