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Quality Assurance Specialist
A career at our company is an ongoing journey of discovery: our around 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
We are looking for you in Bogotá, Colombia:
¿Who you are?
If you have a bachelor´s degree as a Pharmaceutical Chemist with more than two years and half of experience in quality assurance in pharmaceutical companies and you have an English level B2. We are interested in your profile.
¿What you do?
Will be responsible for develops and implements programs to establish and maintain quality standards of existing products and services, as well as developing programs to focus employees on quality improvement.
- Manage the Complaints Process including the investigation process. Maintenance of all appropriate documentation, recording, and investigation of customer complaints via the complaint database TrackWise; return of complaint samples to manufacturing sites for investigation purposes and provision of information to complainants as required (complaint responses).
- Adherence to the Change Control and Deviation procedures including data entry into the electronic system, TrackWise.
- Responsible for the compilation, tracking, and sharing of trend reports, working with stakeholders to propose appropriate CAPAs.
- Assist with the creation and maintenance (periodic review) of Quality Standard Operating Procedures and Work Instructions and ensuring procedures are available via Mango.
- Product Release: responsible for the release of shipments including documentation review of shipping documents, product certificates, and temperature loggers (as applicable).
- Participate in the Right First Time objective as part of product release activities and work with stakeholders to share the information and improve local processes as necessary.
- Assist with preparing training presentations as needed e.g. for relevant GxP SOP’s & WI’s.
- Assist with audit management planning and execution including the tracking of CAPA plans through to closure.
- Assist with Risk Management activities.
- Actively participate in the Merck Performance Management Process and Personal Development plan.
- Work within company Standard Operating Procedures, industry guidelines, and apply Merck Values and Code of Conduct in daily duties and activities.
- Perform other functions and duties that may be assigned by the Quality Manager.
If your profile adjusts what´re we looking for, please send us your curriculum vitae. We´re looking for you
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com