- Main Quality responsible with production and engineering to ensure entire operational readiness for the manufacturing process and adequate technology transfer process.
- Work with the production and engineering departments creating, reviewing and approving product related procedures.
- Certification and Batch release of the production and packaging batches.
- Ensures that products are manufactured and tested according to valid methods and batches meet specifications prior to release. Coordination and approval of deviation investigations related to the product.
- Support revision of qualification and validation protocols and reports, change applications and Product Quality Reports.
- GMP support to production department including GMP Continuing Training Program
- Responsible to hire, train, guide and lead quality inspectors and trainers.
- Provide appropriate initial and continuing training for the quality inspectors and trainers.
- Any other duties can be delegated once training is provided, if required.
- Licenciate Degree in Pharmaceuticals (need to belong to the Colegio de Farmacéuticos de Costa Rica).
- Advanced writing and speaking English level in order to understand, interpret, do and communicate fluidly general instructions and techniques in English to Spanish
- 3 years of experience in production or quality assurance departments in the Pharmaceutical or Medical Device Industry.
- Knowledge of EU GMP, national and international pharmaceutical regulations are required (FDA, EU GMP, RTCA Demonstrated advanced problem-solving abilities.
- Ability to multi-task in a fast-paced work environment and to self-direct, as required.
- Ability to be flexible in changing daily workload priorities as directed. Ability to work in a team environment.
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Quality Specialist AP - Heredia, Costa Rica - Bayer
Descripción
Quality Specialist AP
When you show proactivity and ambition, we'll harness it through a variety of opportunities and challenges in the diverse areas of our business – all with a strong and meaningful purpose. Where do you want to go? What do you want to do? How do you want to make a difference? The choice is yours, and we'll help you get there. Be better together. Be Bayer.
YOUR TASKS AND RESPONSIBILITIES
WHO YOU ARE
At Bayer we believe in diversity, equity and inclusion. We aim to create an environment in which everybody can feel authentic, respected and equally valued. Every day we strive to reflect our values through our people unique capabilities, self-experiences, and aspirations. We, intentionally seek diversity, to enable our people bring their fullest potential out and encourage others to likewise do so. Our company wins, when we leverage our capabilities to lead the cultural transformation in our business, positively impacting the society. Candidates who meet the requirements based on the job profile will be considered for employment regardless of physical disability, race, color, religion, sex, age, sexual orientation, gender identity and will not be at a disadvantage if unemployed.
Application Period: 29/04/ /05/2024 Reference Code: Division: Pharmaceuticals Location: Costa Rica : Heredia : Heredia Functional Area: Quality Work Time: Full Time Employment Type: Regular Work Time: Full Time Contact UsAddressE-Mail Alajuela, Costa Rica.COM
Job Segment: Pharmaceutical, Quality Assurance, QA, Medical Device, Science, Technology, Healthcare, Quality
