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Quality Manager North Asia/Regional GDP Manager APAC

Date: 06-Feb-2019

Location: Singapore, Singapore

Company: Panalpina

Req ID: 155896
Job Function: Quality
Full-Time/Part-Time: Full-time
Contract Type: Permanent
Job Level: Professional
Purpose of the position

* To support the Regional Head of QHSE to drive and improve Quality Management system within the North Asia cluster, with Area of Responsibility (AR) consisting of Japan and Central China District

* To ensure GDP compliance for the relevant Business Units, processes and staff within the Region/Geographical cluster used for GDP relevant Healthcare customers

Key Tasks

Quality specifics:

* Monitor and support the achievement of the Global Quality Objectives & Targets;

* Ensure the adherence to the global corrective and preventive action standards as well as being actively involved in the root cause analysis and agreement of corrective and preventive actions for severe and reoccurring incidents, audit findings, KPI deviations etc.;

* Support countries in the AR during external audits against ISO 9001;

* Support the implementation of the global incident handling standards within the AR;

* Perform tasks as QHSE responsible in CAPA process

* Support Products in regards to continuous improvement initiatives using tools like Lean Six Sigma or others;

* Ensure that the countries are aware of and can use the IMS. Where necessary, organize and execute training and make training material available, thereby ensuring governance in line with the global IMS;

* Drive BCP walkthroughs in the AR

* Ensure, unless local legal or similar requirements dictate, global standards are either implemented or challenged for improvement via Regional Head QHSE;

* Support the implementation of the key quality industry certifications (e.g. SQAS);

* Support on tenders and customer audits in regards to quality requirements in the AR;

* Perform internal QHSE audits and QHSE subcontractor audits according to the regional audit plan

* Participate in external QHSE or related audits according to the regional audit plan.

* Ensure all risks & opportunities are identified within the quality function;

* Meet at regular intervals with Quality Managers of key customers to exchange information relating to quality management systems and to share ideas and knowledge;

GDP specifics:

* Ensure that a Quality Management System is implemented and maintained based on:

* Panalpina GDP Standards, applicable GDP guidelines (WHO/EU/FDA) and local regulations.

* Signed Customer Service Level Agreements.

* Support the Business Unit in appointing a qualified and trained BU GDP Responsible Person (RP).

* Evaluate regulatory changes potentially impacting Panalpina GDP activities and communicate them to the BU GDP RPs;

* Support the Business Unit in the certification process and Panalpina´s GDP certification strategy;

* Ensure that the GDP relevant subcontracted activities and suppliers are approved, Quality Agreements are signed and Audits/Assessments are carried out in cooperation with the product;

* Ensure that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary actions are put in place;

* Adequate monitoring, trending and reporting on quality objectives for GDP are established;

* Review and follow up all relevant GDP CAPAs within the Region, the Risk Assessments and Change Controls related GDP, as well as the GDP relevant SOPs and documents;

* Ensure that the recalls of the medicinal products are performed following the customer requirements where needed;

* Ensure that the relevant GDP systems/equipment are part of the qualification/Validation plan; Involve the Corporate QA & Regulatory Manager in case of any GDP CAPA related the following topics: Temperature excursion, product contamination and any other incident or customer complaint considered relevant and in case of any necessary advice related GDP compliance, training, certification process, CAPAs, Customer complaints, Subcontractor approval process and any other GDP topic;