GXP Compliance Specialist

6 days ago

Hillerød, Denmark FUJIFILM Diosynth Biotechnologies Full time
GXP Compliance Specialist

Apply locations Hillerod time type Full time posted on Posted 2 Days Ago job requisition id JR2309

Do you thrive in an environment where stakeholder relations are key?

And do you work with an important level of independence?

Then we hope you will join our service-minded Supply Chain Team as soon as possible

We are looking for a new colleague to help us provide the best support in all compliance GMP related matters.

Your New Role

You will join a well-established Supply Chain, GxP Master Data Chain Compliance Team of currently six people. The Team is part of a larger team managing SAP Master Data and Digital Collaboration/Integration (15 people). The entire Supply Chain Department consists of 60+ dedicated and brilliant colleagues.

Main tasks

Deviations:

  • Initiate and coordinate Deviations (Deviation Management)
  • Lead/perform Root Cause investigations when required for deviations exceptions impacting warehouses, 3PL and other Supply Chain processes
  • Initiate and coordinate Supplier Complaints (Vendor Complaints)
  • Support the Customer Complaints process.
  • Establish and implement corrective and preventive actions to mitigate risks, prevent re-occurrence and improve compliance.
  • Track and trend on deviations and the efficacy of corrective/preventive actions.
  • Support deviation management to ensure timely action and closure of records.

Change Control:

  • Initiate and coordinate Change Controls (Change Management) and assess impact/risk of exceptions and Change Management Requests impacting Supply Chain processes, including warehouses and 3PL.
  • Initiate and coordinate VCNs (Vendor Change Notifications)
  • Lead investigations when required for exceptions impacting warehouse and other Supply Chain processes

Compliance:

  • Guidance and support to Stakeholders regarding GDP
  • Guidance and support to Stakeholders regarding GMP
  • Ensure compliance of Supply Chain GMP Documents and improvement of the compliance level of Supply Chain processes in accordance with the requirements defined in the Pharmaceutical Quality System (PQS)
  • Facilitate GMP/GDP awareness/re-fresher Training sessions within Supply Chain
  • Track and trend on exceptions and efficacy of corrective actions and support management to ensure timely action and closure of records.
  • Establish and implement corrective and preventive actions to mitigate risks, prevent re-occurrence and improve compliance.
  • Support the Customer Complaints process
  • Support Supply Chain preparation for audits and inspections.
  • Support optimization projects and drive smaller optimization projects to ensure continuous improvement (Cis) of Supply Chain processes.
  • Key quality systems superuser representing Supply Chain, working in close cooperation with the Quality Assurance Department to ensure alignment on interpretation of GMP issues.
  • Support compliant Supply Chain Business Process Development

Skills & Knowledge, we hope you possess

  • Bachelor or master’s degree within Pharmaceutical Sciences, Process Engineering, or similar area
  • Preferred is a minimum of 2 years of GMP and compliance experience from the Pharmaceutical or Biotech industry. Warehouse, 3PL and Vendor compliance experience preferred.
  • Work independently on compliance related issues, deviations, Change Controls, and smaller optimization projects.
  • Knowledge and experience with the interface/interaction between Supply Chain, QA, and Manufacturing.
  • Excellent level of technical writing skills and excellent communication skills in English and Danish (spoken and written).

We hope you are

Energized, goal oriented and initiative driven. We hope you thrive working independently, and are able to prioritize your tasks and meet your deadlines. You work analytically and structured with a quality mind set while being able to see the big picture in the tasks.

Your New Team & Department

You will be part of a trusted & competent team within Supply Chain that covers Planning, Sourcing, Strategic Planning & Analytics, Logistic/Shipping, Vendor Changes and Complaints, SAP Master Data, and Warehousing.

Supply Chain Compliance supports all Supply Chain teams with the handling of deviations and CAPA's, document updates, changes controls, internal/external audits, optimization & tech transfer projects. In addition to our colleagues in Supply Chain, we have close collaboration with internal customers spanning across the site, participating and, in some cases, coordinating many cross functional assignments.

The work environment is international and informal. We keep a high pace and focus on a vital life balance while having fun. We put a strong emphasis on psychological safety through trust and empowerment within our teams and hope that this is something that speaks to you as well.

Application

Has this sparked your interest? Then we encourage you to upload your CV and cover letter as soon as possible, as we screen candidates on a continuous basis and call in for interviews.

If you have any questions, please do not hesitate to contact Ass. Manager, Supply Chain GxP Compliance, Susanne Madsen +45 20743332

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