Qms Specialist

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.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

**FUNCTIONAL AREA**

Roles that are responsible for the analysis, development, and operation of quality and risk management systems. Activities include developing standards for quality, documentation, and processes as well as continuous improvement and preventive activities.

**YOUR ROLE**:

- Prepare, review, update, and coordinate with external vendor for creation of Quality Technical Agreement.
- Prepare and coordinate for external vendor audit, prepare regular monitoring status, and follow up CAPA of external vendor audits.
- Maintain the validity of the Supplier Master List which applied in site for Raw Material, Packaging Material, and Contract Services.
- Prepare and coordinate with related department to create Self-Inspection Program and participate as auditor.
- Coordinate the GMP Audit preparation either from Health Authority Inspection or Customer Audit with related department and prepare the Observation and CAPA Plan afterwards.
- Ensuring that observations from inspections are shared with the network to be translated (if applicable) and implemented in all the sites as Global Response Team
- Manage the Change Control implementation in site include handle and monitor its CCP Action through TrackWise System
- Quality Risk Management coordinator.
- Data Integrity support.
- Prepare all Standard Operating Procedure as above responsibilities, review periodically and ensure the validity
- Prepare monthly and annual status reporting for all above mentioned responsibilities
- Responsible to perform investigation for deviation management, complaint management and any other investigation related to GMP Support and actively participate site continuous improvement program, EHS and 5R
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**WHO YOU ARE***:
- Graduate degree in Pharmacy, Chemistry, Chemical Engineering, and any related field
- Minimum of 2- 3years of experience, in a similar role
- Shows a desire and motivation to work in a Quality and regulated environment.
- A proactive approach to all aspects of Quality.
- Fluent in both written and spoken English.
- Good communicator, dealing directly and effectively with operational teams and site QA and lab colleagues routinely.
- Strong analytical and problem-solving abilities.
- Organized and logical in defining workload and delivering projects.

**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