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  • 1 month ago

jobs description

PT Johnson And Johnson Indonesia Two is recruiting for a Warehouse Pharmacist, located in CCP Pulo Gadung PPG DC.

Based on Food and Drugs Administration Regulation number 9 year 2019 about Technical Guideline of Good Drugs Distribution Practice / Petunjuk Teknis Cara Distribusi Obat yang Baik (CDOB) and number 6 year 2020 about Change of Food and Drugs Administration Regulation number 9 year 2019 about Technical Guideline of Good Drugs Distribution Practice/ Petunjuk Teknis Cara Distribusi Obat yang Baik (CDOB), distributor shall have qualified and competent Responsible Pharmacist who is authorize and responsible to manage and maintain the activities in the warehouses of PT.

Johnson And Johnson Indonesia Two for Pharmaceutical Products and distribution system and ensure the safety, quality, and benefit of the drugs by meeting the requirement of GDP (CDOB) FDA Regulation.

Key Responsibilities:

Manage the Storage and Distribution activities and Maintain Quality Management, including... the following:
• Perform check, review, verify, and ensure proper handling during product receiving (inbound activities), storage, and distribution (outbound).
• Review and verify receiving (inbound) & distribution (outbound) documentation for pharmaceutical product stored in PBF Warehouse.
• Ensure all activities comply with other requirements required for certain drugs in accordance with the regulations (psychotropic & certain drugs ( _Obatobatan _Tertentu _), e.g. Haloperidol & Tramadol).
• Review WH temperature monitoring performed by WH team and recognize cleaning monitoring, pest control report, and calibration, maintenance report in Warehouse (e.g. thermometer, cold room). Inform to Commercial Quality if there is any Non-Conformance in Warehouse.
• Ensure that customer complaints are handled effectively.

Manage and maintain Document Management Systems and processes, including the following:
• To create and/or review warehouse related procedures, organization chart, and documentation based on current practice and regulation (e.g SOPs, training matrix) with collaboration with Commercial Quality.
• To ensure that warehouse personnel related are received training in according to the applicable training matrix, including CDOB training and related procedures.
• Check & review stock records during movement of goods transaction to make sure the product tally physically & by system.

Manage and maintain the Complaint Vigilance and Field Action reporting, including the following:
• Collaborate with all warehouse & office Pharmacist and Commercial Quality team on Recall implementation.
• Coordinate with all warehouse & office Pharmacist and also Regulatory Affairs & Commercial Quality team on Field Actions reports to Health Authority (HA): Ministry of Health (MoH) and _Badan Pengawas Obat dan Makanan _(BPOM)

Manage and maintain the Audit system, including the following:
• Collaborate with all warehouse & office Pharmacists and Commercial Quality to ensure that the self-inspection is conducted to evaluate the quality system in a timely manner, including on the frequency, scope, and required checklist for self-inspection. All inspection reports should be documented and create corrective action and preventive action as an outcome.
• Raise/follow up and closure of CAPAs generated from Internal Audits/selfinspection if any.
• Acting as main auditee during Health Authority audit/inspection and being responsible as a coordinator on the followup actions as required, in the collaboration with other related functions.

Manage and maintain Non-conformance products and destruction processes, including the following:
• To ensure damaged product while receiving, storage, and overdue/near expiry date, should segregate in dedicated storage. Should there is any other discrepancy (e.g damage type not included in the guideline) Responsible Pharmacist may liaise with Commercial Quality team to provide a final disposition.
• For Non-Conformance products other than physical damage or nearly expired (e.g Recall, Stop Shipment, complaint samples, temperature excursion, etc.), Responsible Pharmacist should liaise with Commercial Quality for final disposition.
• Review/ witness final product destruction at destruction company, if needed.

Perform PBF enterprise:
• Support annual inventory count Pharm
• Support Self inspection and audit readiness for unannounced audit
• Support update SOP related to PBF to comply with the latest regulations
• Perform inspection of product on inbound activities (MAH under IHI)
• Make a PO for incoming product

Perform KFA update:
• Update the data in the KFA system whenever there is a change on drug information (MAH under IHI)

Perform invoicing Pharm
• Attach the E-Meterai on invoice if the value over IDR 5,000,000
• Maintain record management at office:
• Archive of all documents received at the office (DO, invoices, etc.)

Perform KPI report related to Pharm invoices
• Ma
Jakarta Indonesia

salary-criteria

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