Quality Support

Hiring By - Biostaffic

 BioPharma

Belgium

Job Highlights

Not Disclosed

Associate

Posted 4 months ago
Job details

Quality support to the transportation operational leads - contractor role

Work location: J&J Beerse, Belgium - remote


Organisation/Department:


As Quality support you serve as support to the Transportation Operational Leads and their team members, for Transportation & Temperature Control Quality related matters and liaises with multiple Quality organizations and other stakeholders, including Control Towers and Carriers, to drive timely and appropriate resolution of Quality related issues (e.g. Non-conformance (NC)/Corrective Action Preventive Action (CAPA), Customer Complaints).



Duties & responsibilities:


  • Drives, Implements and Supports projects in Transportation and Temperature Control as the Quality Expert on Compliance and Regulatory requirements, which have a significant supply chain, distribution, transportation and Temperature Control component
  • Must be familiar with current and emerging regulations and to understand the impact to quality and distribution practices
  • Ensures appropriate documentation in compliance with regulations and standards of project activities
  • Central point of contact for Transportation and Temperature Control Quality requirements as it relates to assigned projects.
  • Responsible for transportation and temperature control change control documentation from initiation through implementation and closure.
  • Ensures adherence to temperature control and monitoring requirements during transportation. Supporting for accurate and timely communication of temperature control excursions and other quality issues, including escalations, occurring during transportation to appropriate partners. Ensuring the adequate investigation of temperature control excursions during transport and subsequent remediation activities. Supports to ensure the appropriate handling of transportation related quality issues and customer complaints, including tracking, and trending and mitigating Quality related issues.
  • Supports oversight for the CAPA, NC, change management. Responsible for management of Quality systems, including CAPA process and systems, document management, change control, training management.
  • Supports and coordinates documentation management of Transportation EMEA / CQSS EMEA documents, e.g. truVault document maintenance, update of doc matrix, documentation revision, etc. as applicable.
  • Supports and coordinates QA supplier management activities, change controls, quality agreements and audit requirements. Supports follow-up with suppliers on audit CAPAs and provision of evidence for CAPA execution and updating of respective records.
  • Coordinates information pertaining to Suppliers Reviews, including trending data and present QA slides at QBRs as applicable.
  • Provides support as needed for any audits or inspections which include Transportation activities in scope.
  • Responsible for following up on the status and for the timely and accurately completion of investigation and CAPA records assigned, track their progress, support the investigations, execute/approve corrections and CAPAs as assigned.
  • Remains current on assigned quality system training and seeks out training and knowledge in adjacent areas.
  • Provides detailed or summary communication to QA and cross-functional management on status of key initiatives, projects and issues.
  • Documents rationales which are technically accurate and regulatory compliance focused. Holds business partners accountable for delivering documentation of similar quality.
  • Escalates and/or troubleshoots quality/compliance issues, using experience, resourcefulness, and creativity to provide solutions to a wide range of root causes.
  • Fosters working relationships with internal business partners to understand regional and sector requirements and business challenges.
  • Independently leads and prioritizes complex and diverse workload, ensuring that actions are on-time, accurate, and meet their intended objective.


Experience & Education:


  • Distribution / Transportation / Temperature Control requirements of Medical Devices and/or Pharmaceutical products
  • Understanding the linkages in quality and regulatory compliance within Supply Chain activities
  • Investigation and CAPA experience, Compliance experience, QMS experience, Supplier Management experience
  • Decisive, organized, and able to manage and prioritize a complex and diverse workload
  • Strong communication skills, able to inspire trust and quickly build credibility
  • Strong collaboration and influence skills to partner effectively across functions and operating units
  • Accountability, with a strong desire to commit, be held accountable for delivering results
  • Ability to fit in well culturally in a complex organization
  • High tolerance for ambiguity in a complex environment
  • Able to have big picture approach while paying attention to details
  • Able to lead projects from a quality and compliance point of view within a complex business and supply chain environment
  • Proficient in English
  • Must be able to work hours to support Global meetings (in EMEA: until 6PM CET)


Offer:


You can fill this position through Randstad Professionals as a consultant (with an employee or freelancer contract)


In return for your performance and flexibility, we offer you a salary package with some interesting extras, such as


  • Gross salary according to your experience
  • Lunch vouchers of €7 per day worked
  • Net remuneration of €80 per month
  • Hospitalisation insurance
  • 1 extra day's holiday per month worked
  • End of year bonus
  • Pension Plan
  • ECO vouchers worth €250 (on an annual basis, pro rata)
  • Training opportunities

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Belgium

Experience:

  • Associate

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 17, 2024
Company Overview
Randstad Professionals Belgium
Randstad Professionals Belgium

Current Openings: 0

As professional matchmakers, we empower more than 50 years of experience. Every day we help thousands of people to find a job. A job that makes them grow and that makes them happy. And every day, we offer organizations to support. Support that makes them perform even better. Every day our expert consultants help thousands of candidates find their next role, and they also help clients reshape workforces and deal with talent shortages. In this way, we create added value in the lives of hundreds of thousands of people. This is how we shape the society of tomorrow. We call it shaping the world of work. Randstad Professionals is a leading professional recruiting group, an expert at recruiting qualified, professional and skilled people in finance, sales & marketing, HR, life sciences, interim management … Our goal is to make the right match – always aligned with your career ambitions or company needs. We bring you opportunities, helping you to improve your lives and fulfill your work potential. Find out your opportunity or for more information about our community, offers, and many more, visit www.randstad.be/professionals
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