Quality Engineer - Pharmacy Operations

Description

About Us

At Gifthealth, we’re revolutionizing the way people experience healthcare by simplifying the process of managing prescriptions and health services. Our mission is to provide a seamless, personalized, and efficient healthcare experience for all our customers. We’re a dynamic, innovative, and customer‑centric company dedicated to making a positive impact on people’s lives.

The Quality Engineer is responsible for supporting and maintaining quality systems within a pharmacy environment, with a strong focus on equipment qualification, process validation, environmental monitoring, and cold chain quality oversight. The ideal candidate has hands‑on experience with IQ/OQ/PQ, process validation, environmental monitoring, and cold chain shipping in regulated and distribution operations, and is comfortable driving investigations, risk assessments, CAPAs, and continuous improvement activities.

• Support and oversee qualification and validation activities for facilities, utilities, equipment, and dispensing processes in accordance with regulatory requirements.
• Define validation scope, approach, responsibilities, acceptance criteria, and requalification/revalidation strategy for facilities, utilities, equipment, processes, and computerized systems as applicable.
• Develop, review, execute, and approve validation lifecycle documentation, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and process validation protocols and reports.
• Ensure qualification and validation activities are scientifically sound, risk‑based, and compliant with internal procedures and regulatory expectations.
• Support ongoing process validation and continued process verification activities through data collection, trending, and analysis.
• Review and trend process performance data to identify risks, deviations, and opportunities for improvement.
• Manage or support the environmental monitoring program for classified or controlled manufacturing areas, including viable and non‑viable monitoring review, trending, excursion assessment, and follow‑up actions.
• Investigate environmental monitoring excursions, nonconformances, and deviations, support root cause analysis and effectiveness checks for corrective and preventive actions.
• Author, review, and revise SOPs, work instructions, protocols, and technical reports related to quality engineering, validation, monitoring, and distribution quality activities.
• Participate in change control assessments related to equipment, processes, manufacturing areas, utilities, monitoring systems, and distribution processes.
• Partner with the Gifthealth Supply Chain team to support quality requirements for storage, handling, packaging, and distribution of temperature‑sensitive materials and products.
• Provide quality oversight for cold chain shipping processes, including shipper qualification, packaging configuration review, temperature monitoring requirements, lane assessments, and excursion management.
• Support development, implementation, and continuous improvement of procedures and controls for cold chain distribution to ensure product quality and compliance are maintained throughout transport.
• Review and assess temperature excursion events, support investigations, perform risk assessments, and help define appropriate corrective and preventive actions.
• Collaborate with internal stakeholders and external logistics partners to ensure compliant cold chain practices and documentation.
• Support internal and external audits and regulatory inspections by providing documentation, technical rationale, and subject matter expertise.
• Collaborate with site teams to ensure compliance with GMP, data integrity, contamination control, quality risk management principles, and applicable distribution requirements.
• Drive continuous improvement initiatives that enhance product quality, process robustness, distribution reliability, and operational compliance.

• Education
  :
  Bachelor’s degree in engineering, Quality, Microbiology, Chemistry, Lifesciences, or a related technical field.
• Experience
  : 3‑7 years of experience in a regulated…