Quality Assurance Officer

The successful candidate will be based in Cebu and assigned to RDC Cebu. This role will work closely with the warehouse operations team and will report directly to the Senior Manager for Quality Assurance (QA) and Regulatory Affairs (RA) based in Manila. The position will also serve as the facility's Pollution Control Officer (PCO), with primary responsibility for securing and maintaining required permits and regulatory compliances.

KEY RESPONSIBILITIES

Quality Systems

• Works with the Senior Manager for Quality and Regulatory Affairs in the design, development, and implementation of Quality Assurance in all Distribution Centers, works as the Internal Audit Team Leader and with the counterpart Quality Officer of Business Partners for their documentation requirements. Cascades the same to internal interested parties.

Quality Audits

• Conducts routine operational audits on ISO 9001:2015, good distribution and storage practices, and current good manufacturing practices compliance for all Distribution Centers including warehouse and QC spot inspections as well as yearly supplier audits and performance evaluation for critical suppliers.

Quality Assurance

• Works with the warehouse operations in addressing non-conformities and implementation of correction and corrective actions, assists external auditors conducting their audits on Getz Healthcare warehouse and operations, implement the guidelines, policies, and procedures in all Distribution Centers and works with the different functional leads or process owner in all Distribution Centers for the yearly review of their process.
• Maintains an updated and organized filing system of controlled and working documents for the Regional Distribution Center - Cebu, in coordination with the Document Controller, adheres to the implementation of quality policy, functional objectives, and process goals of Getz Healthcare and assists in QC operations, in the absence of the QC Officer.
• Verifies temperature monitoring of warehouse operations, documents periodic warehouse temperature mapping and pack-out validation, monitors the attainment of Quality’s functional objectives, and conducts echo training related to warehouse operations (GDSP, cGMP, Cold Chain Management, etc.)

Administrative

• Handles special projects and initiatives related to the quality processes, initiates change control, as needed, including calibration or recalibration of all warehouse equipment.
• Supports Regulatory Affairs in handling Adverse Drug Reaction (ADR) Report and product complaint. responsible in reporting the incidence to the Business Partner/s and to the local FDA and prepares and provides the reportorial requirements of the company and Business Partners as requested.

QUALIFICATIONS:

• Licensed Pharmacist with proven experience in FDA transactions and regulatory compliance, LTO (License to Operate) applications and renewals and other regulatory permit applications and maintenance.
• Minimum 2 years' experience in RA and/or QA, and/or as company pharmacist within retail pharmacy environment.
• Strong understanding of regulatory requirements and compliance processes.
• Proficient in Microsoft Office applications, particularly Excel, PowerPoint and Word.
• Excellent communication, interpersonal, and articulation skills.
• Experience in Quality Assurance and Warehousing Operations (background from healthcare, pharmaceutical, or distribution organizations or similar companies is preferred.
• Previous experience supporting warehouse compliance and quality management systems, an added advantage.
• Candidates who have served as the licensed Pharmacist of Record or whose pharmacist license has been utilized for company or facility operations, licensing, and regulatory applications will be highly preferred.
• Experience acting as the designated license holder for facility permits, regulatory registrations, and operational compliance requirements is a strong advantage.