Quality Specialist AP

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Provides specialized knowledge and technical support in quality assurance and control processes within the organization. This position involves analyzing quality data, developing best practices, and advising teams on compliance with industry standards and regulations. Quality Expertise collaborates with various departments to implement quality improvement initiatives, conduct training sessions, and ensure that all products and processes align with established quality benchmarks.

YOUR TASKS AND RESPONSIBILITIES

• Serve as the quality responsible, collaborating with production and engineering to ensure operational readiness and effective technology transfer for manufacturing processes.
• Create, review, and approve manufacturing and product-related procedures, operational instructions, and process documentation.
• Evaluate assembled, sterilized, and packaged batches on the production floor, ensuring products are manufactured and tested according to validated methods.
• Approve (release) assembled, sterilized, and raw material batches, ensuring all requirements are met before release.
• Participate in investigation teams for evaluation and approval of deviations, events, CAPAs, OOS, OOL, OOT, and events related to manufacturing and raw materials.
• Review and approve validation and qualification protocols and reports related to product manufacturing.
• Review and approve change applications, risk assessments, memorandums, work requests, and product quality reports.
• Provide GMP support to production, including the GMP Continuous Training Program and technical guidance to local Quality Assurance Inspectors.
• Support MES implementation projects and provide technical support on product quality aspects.
• Provide QA support for sterilization.
• Oversee document frameworks (Batch Release, Visual Inspection, Gowning, MALs, Hygiene Plan).
• Review reports of inappropriate cleanroom behavior and manage disqualification processes.
• Provide on-floor support and be present in cleanrooms to assist production teams and ensure compliance with quality standards.

Other Responsibilities:

• Perform core document changes to align processes with company practices within QMS boundarie
• Any other duty upon completion of the corresponding training
• Provide information to maintain key performance indicators per quality objectives.

WHO YOU ARE

Educational Requirements:

• Pharmacist. (Mandatory).
• Needs to belong to Colegio de Farmacéuticos de Costa Rica. (Mandatory).

Experience Requirements:

• A minimum of 2 years of experience in the Quality or Production departments in the Pharmaceutical Industry.
• Knowledge of the following National and International pharmaceutical regulations: General Quality System Regulations, RTCA 11.03.42.07, FDA and EU GMP (Mandatory).
• Internal auditor (preferred).

Languages:

• Spanish (Native)
• English Proficiency (Mandatory)

Competences:

• Leadership skills, team player and self-motivated.
• Demonstrated advanced problem-solving abilities.
• Ability to multi-task in a fast placed work environment and to self-direct.
• 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’s unique capabilities, self-experiences, and aspirations. We intentionally seek diversity, to enable our people to 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 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.