Job descriptionJob Description Summary This position is responsible for leading and managing the MoH guidance of Medical Device Good Distribution Practice (MDGDP) Quality Management Systems for BD Indonesia. The Indonesia GDP regulatory requirements to ensure that the Quality System and processes adequately support the activities and priorities to provide an effective and efficient quality system that creates customer value addressing elements critical to Business success, continuity and competitive advantage. Job Description Who We Are
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare sector. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health. Job Function:
- Appointed by the top management of BD Indonesia as the Technical Responsible for Indonesia Medical Device Good Distribution Practice.
- Maintain the validity of licenses related to the warehouse (i.e IPAK license, etc.)
- Oversee quality operations in the DC including, in-coming/out-going inspection, modification (sub-labeling, reconfiguration, kitting, sales bundling, spare part packaging, rework and inspection in DC, MIDC) to ensure compliance with quality assurance/control requirements.
- Ensure that the hygiene and environment in the DC (inclusive of Labeling Room) is controlled adequately in accordance with written procedures.
- Ensure that the method for products status identification is adequate and maintained accordingly to prevent mix-up and, that the indication of product status identification is strictly handled and implemented for products throughout all processes.
- Execute change control process for MIDC and liaise with source plants/legal manufacturer for the required review & approval.
- Maintain and control documents and records in accordance with Quality Management System requirements.
- Ensure, authorize and witness destruction/scraping processes are in compliance with the established procedure.
- Initiate, investigate, track, follow-up and close Non-Conformance Report and Corrective and Preventive Actions.
- Responsible to approve the Adverse Event (AE) Determination completed by regional complaint center, and submission of AE report to local regulatory bodies as appropriate/ assigned.
- Responsible for the execution, follow up and closure of field action, including preparation and submission of relevant FSCA reports to local regulatory bodies as appropriate/ assigned.
- Conduct internal and 3rd party Quality System audit and follow up on the actions arising from the audits.
- Collect and trend DC quality indicators.
- Disseminate quality procedures, conduct and track associated training. 15) Execute any other tasks and/or projects as assigned by Quality Director, Southeast Asia
- Bachelor’s Degree in pharmacy or Chemical Analytic or Pharmaceutical or Health Analytic or Technical Chemistry or Chemistry. Pharmacist with Registered apothecary license will be an advantage
- Minimum 4 to 5 years relevant quality assurance experience in the pharmaceutical or medical device manufacturing industry. Experience in supply chain/warehouse quality systems. Relevant experience in quality systems for complaint management, failure investigation, corrective & preventive action, and document & quality records management. Lead/internal auditing experience/demonstrated knowledge to perform ISO 13485 audits and/or MoH guidance of Medical Device Good Distribution Practice (MDGDP) Quality Management Systems.
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