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1 job found in Dundee, Scotland

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    • dundee, scotland
    • temp to perm
    • randstad inhouse services
    Do you want to work and contribute to the reaserch and devlopement of products within a global leading healthcare company? Do you want to work in a vibrant and state if the art labaratory? We are looking Then see below: The principle functions/responsibilities of a Product Support Investigator (PSI) are to:- Process Customer Complaints- Process Supplier Corrective Actions (SCARs)- Perform On-Market Surveillance studiesIn addition to these principle functions/responsibilities, a PSI will also perform 'in-house' DesignValidation, product dating studies and bespoke studies in support of Scientific Marketing activities.During execution of their duties, a PSI is required to work in a manner that is compliant to necessarystandards/regulations; Quality, H&S and Environmental, and is in alignment to the behaviouralstandards and culture of the Dundee site. The individual will display a strong drive and commitment toward maintaining a safe and compliantwork environment, whilst ensuring the manufacture of safe and quality products which meet / exceedcustomer expectations.The individual will be aware of their expectations and display autonomy and accountability for theiractions. Addressing H&S issues must be given priority and upholding a good example is important.They must be sufficiently open-minded to react to changes in workload as priorities change. Theyshould display an ability to communicate effectively to their audience both internally and externally.The individual should be self-motivated with the ability to deliver appropriate results, having goodtime management and facilitation skills.The individual should have experience of working practice within regulated or quality areas e.g.ISO13485, 21CFR820. They should ideally have awareness on the requirements of at least one of thefollowing areas; complaint handling, adverse event reporting, SCAR processes, on-market surveillence.An awareness of current industry state of the art, manufacturing processes, differing IVD productcomplexities, would be an advantage. Principle Functions/Responsibilities- Complaint and Supplier Corrective Action Processing- Log and acknowledge all alleged product deficiencies received from customer, includingSCARs, as complaint records.- Ensure each complaintive is updated on a regular basis (minimum target is weekly) untilcomplaint is resolved.- Investigate, establish cause and resolve complaint with customer.- In conjunction with operational unit, develop and track corrective action(s) and effectivitychecks. Issue regular progress reports to customer in accordance with contractualrequirements/quality agreements.- Perform the above in compliance with cGMP with special reference to record completionand timeliness in accordance with current procedure and metrics.On-Market Surveillance Studies- Perform all aspects of on-market product stability testing; time point scheduling, assay, dataanalysis, transcription and result reporting.- Perform all aspects of testing in support of External Quality Assurance (EQA) schemes;scheduling, assay, data analysis, transcription and result reporting.- Perform the above in compliance with cGMP with special reference to record completion inaccordance with current procedures, and result reporting as in accordance with Customer Quality Agreements and the requirements of each EQA scheme.Additional Functions/Responsibilities (Performed on an 'as required' basis)- As required, perform in-house Design Validation studies in support of new productcommercialisation.- As required, perform stability studies to (re) establish product dating. As required, perform bespoke Marketing studies designed by the Sales and Marketing Team.- Housekeeping Activities- Maintain laboratory equipment ensuring that no item of responsibility becomes overdue.- Participate in 5s to ensure work place standards are sustained.- Complete training requirements in a timely manner.-Be familiar with, and adhere to the Company's Health and Safety Policy.
    Do you want to work and contribute to the reaserch and devlopement of products within a global leading healthcare company? Do you want to work in a vibrant and state if the art labaratory? We are looking Then see below: The principle functions/responsibilities of a Product Support Investigator (PSI) are to:- Process Customer Complaints- Process Supplier Corrective Actions (SCARs)- Perform On-Market Surveillance studiesIn addition to these principle functions/responsibilities, a PSI will also perform 'in-house' DesignValidation, product dating studies and bespoke studies in support of Scientific Marketing activities.During execution of their duties, a PSI is required to work in a manner that is compliant to necessarystandards/regulations; Quality, H&S and Environmental, and is in alignment to the behaviouralstandards and culture of the Dundee site. The individual will display a strong drive and commitment toward maintaining a safe and compliantwork environment, whilst ensuring the manufacture of safe and quality products which meet / exceedcustomer expectations.The individual will be aware of their expectations and display autonomy and accountability for theiractions. Addressing H&S issues must be given priority and upholding a good example is important.They must be sufficiently open-minded to react to changes in workload as priorities change. Theyshould display an ability to communicate effectively to their audience both internally and externally.The individual should be self-motivated with the ability to deliver appropriate results, having goodtime management and facilitation skills.The individual should have experience of working practice within regulated or quality areas e.g.ISO13485, 21CFR820. They should ideally have awareness on the requirements of at least one of thefollowing areas; complaint handling, adverse event reporting, SCAR processes, on-market surveillence.An awareness of current industry state of the art, manufacturing processes, differing IVD productcomplexities, would be an advantage. Principle Functions/Responsibilities- Complaint and Supplier Corrective Action Processing- Log and acknowledge all alleged product deficiencies received from customer, includingSCARs, as complaint records.- Ensure each complaintive is updated on a regular basis (minimum target is weekly) untilcomplaint is resolved.- Investigate, establish cause and resolve complaint with customer.- In conjunction with operational unit, develop and track corrective action(s) and effectivitychecks. Issue regular progress reports to customer in accordance with contractualrequirements/quality agreements.- Perform the above in compliance with cGMP with special reference to record completionand timeliness in accordance with current procedure and metrics.On-Market Surveillance Studies- Perform all aspects of on-market product stability testing; time point scheduling, assay, dataanalysis, transcription and result reporting.- Perform all aspects of testing in support of External Quality Assurance (EQA) schemes;scheduling, assay, data analysis, transcription and result reporting.- Perform the above in compliance with cGMP with special reference to record completion inaccordance with current procedures, and result reporting as in accordance with Customer Quality Agreements and the requirements of each EQA scheme.Additional Functions/Responsibilities (Performed on an 'as required' basis)- As required, perform in-house Design Validation studies in support of new productcommercialisation.- As required, perform stability studies to (re) establish product dating. As required, perform bespoke Marketing studies designed by the Sales and Marketing Team.- Housekeeping Activities- Maintain laboratory equipment ensuring that no item of responsibility becomes overdue.- Participate in 5s to ensure work place standards are sustained.- Complete training requirements in a timely manner.-Be familiar with, and adhere to the Company's Health and Safety Policy.

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