Quality Specialist AP - #7490691
Bayer
Fecha: hace 2 semanas
ciudad: Heredia, Heredia
Tipo de contrato: Tiempo completo
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
Application Period: 29/04/2024 - 06/05/2024 Reference Code: 816352
Division: Pharmaceuticals Location: Costa Rica : Heredia : Heredia
Functional Area: Quality Work Time: Full Time
Employment Type: Regular Work Time: Full Time
Contact Us
Address E-Mail
Alajuela, Costa Rica
[email protected]
Your Tasks And Responsibilities
- 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 11.03.42.07). 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.
Application Period: 29/04/2024 - 06/05/2024 Reference Code: 816352
Division: Pharmaceuticals Location: Costa Rica : Heredia : Heredia
Functional Area: Quality Work Time: Full Time
Employment Type: Regular Work Time: Full Time
Contact Us
Address E-Mail
Alajuela, Costa Rica
[email protected]
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