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GETZ HEALTHCARE Cebu- based facility seeks a licensed Pharmacist to lead Quality Assurance and Regulatory Affairs for its Cebu RDC. The role reports to the Senior Manager in Manila and serves as Pollution Control Officer, ensuring permits and regulatory compliance across Distribution Centers.
The candidate will conduct audits, manage QA documentation, and coordinate with warehouse teams to address non-conformities, ensuring cGMP and GDSP adherence.
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.
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.
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.
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.)
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.
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.
Familiarity with quality assurance processes and industry standards. Familiar with ISO 9001:2015 standard, Good Distribution and Storage Practices, and current Good Manufacturing Practices.
Strong understanding of regulatory requirements and compliance processes.