Guides MDI in the implementation and maintenance of the Quality Management System (QMS) and ISO 9001 ensuring full compliance to all RQA standards and quality agreement with Clients / Clients' standards and regulatory requirements.
DUTIES AND RESPONSIBILITIES: Works together with the QMR/QAC Senior Manager in the following key functions of Quality Assurance and Compliance (QAC) Team:
Effective implementation of Zuellig Pharma Regional Quality Management System policies, standards and guidelines.Effective implementation of Internal Quality Audit Program and ManagementEffective implementation of Supplier Quality Management Program and ManagementDrive Facilities Engineering in the effective implementation of Integrated Pest Management ProgramDrive Facilities Engineering and Transport personnel on the effective implementation of the Temp Mapping and Validation of rooms and delivery vehicles respectively.Assists the QMR in the Clients and Third Party Audits.Provides relevant quality training to process owners on quality requirements (ISO, GSDP, GMP, GDP-MDD, Cold Chain, etc.).CAPA closure (verification and effectiveness until sign off by QMR) for IQA, SQM, Integrated Pest ControlQuality Assurance and Quality Control – Cold Chain Management
Conduct regular checking of cold room operation, from receipt, storage, up to delivery and/or returns of cold room products.Checking includes cold room equipment and temperature devices used in cold room operation and deliveries. Ensure that cold room operation adheres to RQA's Cold Room and Freezer Guidelines, Cold Chain Management Guidelines, GSDP / GDP-MDD StandardsAssist and provide guidelines to Warehouse and Distribution Supervisor in conducting temperature mapping of the warehouse, cold rooms and delivery trucks.Assist and provide guidelines to WH Supervisors in conducting validation of cold boxes.Based on observations during regular checks, propose changes to improve processes and/or raise Corrective/Preventive Action Request to the concerned manager, as necessarySubmits monthly report to the QMR based on observations, including proposed changes.Coordinates with the concerned departments for the collection of data/information and preparation of the following reports:
Quality IndicatorsQuality KPIsMonitors and maintains an up-to-date records of the following:
Results of Internal Quality AuditResults of Supplier AuditsWorks together with the QMR in the development, implementation and/or improvement of quality programs (i.e. quality circle etc.), policies and procedures.
Back up / reliever is QA (Systems and Processes) and vice versa
Performs other duties that may be given from time to time by the immediate superior.
Deviation Management
Second person as Quality Hold CoordinatorResponsible person to collate reported deviations especially for cold room sections/transactions including those reported during delivery, and those raised as complaints from various departments, i.e. sales, customer service, etc.Drive process owners on the investigation of reported deviations and helps in the analysis of the CA and PA provided by the process owners.System Management
May be assigned in systems management projects which will require working with a team on review of processes, data collection and analysis and identification of risks. Depending on the assigned project, the work will involve:
making recommendations to improve controls and ensure compliance to company policies and relevant standards and/ordeveloping policies, standards and procedures for operations and systems in MDI.EDUCATION REQUIRED Registered PharmacistLOCATION Amenable to work in Davao City (Pentayium Warehouse No. 14 Davao-Agusan National Road Panacan, Barangay Panacan, Bunawan District, Davao City, Davao del Sur)KNOWLEDGE AND SKILLS REQUIREMENT Must have adept knowledge of the company's operations.Must have basic understanding of ISO 9001:2015Must have good working knowledge of MS Office (especially on Word, Excel and Powerpoint)Must have good oral and written communications skills.Must have initiative and good judgment.Must have good planning and organizational skills.Must be approachable and flexible.Must be proactive and good leader.Must be organized and systematic in handling schedules and workflows.An ability to find out independently how to find out (resourcefulness)
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