Quality Assurance Pharmacist

Be Part of the Team That’s Transforming Healthcare

At Farma Keio Outsourcing, we’re reshaping the idea of healthcare. We believe medicine should go beyond masking symptoms to uncover and treat the root cause. Every formula we create is designed to restore balance, vitality, and the freedom to live well.

This role requires a profound commitment to detail. You will be meticulously reviewing production activities and documentation as part of the Quality Unit. Ensuring medications designed to restore individual balance and vitality are produced according to the highest quality standards. This precision is the foundation of the patient’s comeback story.

This role performs independent quality oversight and batch disposition activities, and leads or supports core quality systems (deviations/nonconformances, OOS/OOT, change control, CAPA, complaints/recalls, validation/qualification, supplier/material quality, and inspection readiness) to maintain compliance with FD&C Act 503B requirements, applicable USP standards, and cGMP (21 CFR Parts 210/211).

Environmental Monitoring and Testing

• Oversee environmental monitoring, air and surface bioburden, temperatures, and particle counts.
• Collect and document environmental monitoring samples and results.
• Submit samples for testing.

Documentation and Record Keeping

• Review and maintain batch records, and product test results.
• Review quality records, including equipment calibration, maintenance logs, and cleanroom records.
• Support, as needed, other quality documentation requirements.

Validation and Qualification

• Support validation and qualification efforts for equipment, processes, and systems.
• Perform final review of test data and reports; approve or reject product batches as per established standards.

CAPA (Corrective and Preventive Action) Processes

• Assist with root cause analysis and recommend corrective and preventive actions (CAPA) for quality-related issues, including deviations, complaints, and audit findings.
• Use CAPA processes to drive quality improvements and respond to process or service issues.

Compliance and Audits

• Ensure compliance with USP , USP , FDA regulations, and cGMP standards for all quality processes.
• Assist with regulatory audits, inspections, and compliance reporting.

Cross-Department Collaboration

• Collaborate with other departments to identify and implement process improvements in compounding, validation, and laboratory operations.

Safety and Cleanliness

• Implement and enforce safety protocols in laboratory and production areas to maintain compliance.
• Oversee control of product labeling and ensure label accountability.

• Valid Pharmacist License
• Must meet legal and regulatory requirements for handling-controlled substances, including passing a background check and drug screening as required by applicable laws.
• Strong analytical, problem-solving, and critical thinking abilities.
• Excellent attention to detail and organizational skills.
• Ability to work independently and collaboratively as part of a team.
• Effective communication skills for engaging with cross-functional teams, regulatory bodies, and management.
• Proven ability to analyze complex data and troubleshoot effectively.
• Skilled in maintaining accurate and precise documentation to ensure data integrity.
• Proficient in operating and maintaining laboratory instruments and software.
• Commitment to staying current with emerging technologies and industry advancements.

• Climate controlled environment. Appropriate personal protective equipment (PPE) must be worn while performing certain tasks.
• Limited exposure to hazardous substances; safety protocols minimize risk.

• Close visual acuity needed for computer work and visual inspection activities.
• Frequent use of hands for keyboarding and handling small components.
• Frequent standing, walking, and sitting; prolonged standing may be required.
• Occasional lifting of up to 50 pounds.
• Regular verbal and auditory communication required. Fluent ability to speak and read English.
• Reasonable accommodation is available for individuals with disabilities.

• U.S. College Degree in…