Quality Specialist, Merck Group

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Your Role:

The Quality Assurance specialist reports to Quality Manager/Supervisor. The job holder will carry out the assigned tasks with competence and to undertake any other reasonable duties which are assigned by Quality Assurance Management. To conduct in -process and product quality audits across Operations areas to ensure compliance to the Quality Management System, GMP or GLP Regulatory Standards, relevant Standard Operating Procedure (SOP's), and customer specification. Constantly work within Operational departments to reduce the risk of quality findings. Quality is the foundation of our business, and the Quality Assurance Auditor role is to promote and integrate quality into every aspect of our business. The role involves the development and maintenance of the quality system. It is necessary to ensure that department is operating in full compliance with sound scientific practice, GXP and standard operating procedures. In addition, the Quality Assurance Auditor will ensure that individual and company goals and objectives as they apply to the Quality function are met.

Ensure duties are carried out according to the principles of GLP and GMP. Perform the review /approval of GXP documents, including protocols, technical specification (TS), batch records, workbooks, SOPs, validation protocols, and all other QMS documentation. Perform data audit and approval of completed manufacturing or testing documentation as they comply with the stated regulatory standard and the approved TS, protocol or SOPs. Interacts with other departments to ensure compliance with internal procedures. Perform internal audits as required. Participates in projects, as assigned. Support the operating and maintaining the systems required to perform the core site activities of the Quality Management Systems. Review and close Events.

Who You Are:

Must have as minimum Degree or equivalent in Biological Science or Quality Management. The ideal candidate will have experience of working within a laboratory environment. Previous experience of working within quality driven systems and/or a regulated environment (GLP/GMP). Highly motivated, self-starter demonstrating ability to use initiative with respect to scheduled work activities. Ability to plan and organize own workload to ensure all deadlines are met or exceeded Excellent attention to detail is essential. Ability to work in a fast paced and changing environment. Excellent oral and written communication skills. The Quality Assurance Specialist will have minimal of travel. Travel to other site to perform QA duties may be required. This role would be based on shift work of Mon-Fri 2-10pm local time.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of our diverse team!