QA Specialist (Quality Engineer)

QA Specialist (Quality Engineer)

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

• Ensure quality overview and regulatory adherence during qualification and validation activities.
• Act as Risk Management SME .
• Work together with other internal functions and SMEs in the development of validation packages (FAT, SATs Challenge runs, IQ, OQ, SV, PQ, test methods transfer among others).
• Provide input and execute computerized system validations in compliance with FDA 21 CFR Part 11.
• Ensure quality oversight and regulations adherence of GMP processes including maintenance, calibration, on process verification, computerized system, and pest control processes.
• Support cost savings/ Six Sigma projects.
• Use of statistical tools to perform analysis and data trending.
• Collaborate with engineering, manufacturing, supply chain and quality control departments in the development of risk assessment, deviation investigations, and the use of quality tools.
• Define and ensure the compliance of the department`s KPI.
• Identify opportunities to proactively assure compliance with all applicable internal and external regulations.
• Work with interdisciplinary teams defining process improvement projects based on company goals, both externally and internally or as required.
• Any other duties can be delegated once training is provided if required.

WHO YOU ARE

• Engineering, or another related scientific field degree.
• At least of 3 years of experience in the quality department of Pharmaceutical or Medical Device Industry.
• Spanish (Native) and advanced English level both written and spoken (Mandatory).
• Knowledge of the following standards: Costa Rican, FDA and EU Pharmaceutical Regulations and general Quality System Regulations (Mandatory).
• Knowledge of quality philosophies, principles, systems, methods, tools, and standards.
• Skills Innovation mindset and coaching skill Team player and self-motivated.
• Ability to multi-task in a fast-paced work environment and to self-direct.
• Demonstrated advanced problem-solving abilities.
• Strong communication and presentation skills.

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.