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Vagas: quality specialist - Ponta Grossa, PR

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1 vaga

Job Post Details

MV01-012524 Specialist Quality Complaints - job post

Validation & Engineering Group
4.4 out of 5
ParanáHome Office

Descrição completa da vaga

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

  • Specialist Quality Complaints

Primary responsibilities include: Supporting the product complaint system through; leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner.

Qualifications:

  • Science or Engineering degree:
    • Doctorate degree or
    • Master's degree and 3 years of directly related experience to the job or
    • Bachelor's degree and 5 years of directly related experience to the job or
    • Associate’s degree and 10 years of directly related experience to the job
  • Experience with:
    • investigations
    • Root Cause Analysis
    • Complaint investigations
  • 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
  • Ability to oversee multiple projects simultaneously
  • Ability to successfully manage workload to timeliness
  • Familiarity with basic project management tools
  • Ability to negotiate a position after taking feedback from multiple sources
  • Demonstrated ability to consistently deliver on-time, and high-quality results
  • Ability to operate in a matrixed or team environment
  • Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device Manufacturing processes)
  • Ensures quality of complaint records, consolidated / trend investigations
  • Facilitate cross-functional meetings to plan and coordinate the plan for closure of records
  • Applies analytical skills and product knowledge to evaluate complex situations using multiple sources of information
  • Executes against prioritized work plans
  • Quickly escalates issues that cold impede the ability to close records according to action plans
  • Maintains compliance with local and global processes
  • Follows procedures and regulatory requirements
  • Reviewing and acknowledging information contained in product complaint records
  • Determining if additional information is required to assign appropriate investigation requirements
  • Determining if return samples are required and following its status
  • Reviewing and approving assessments supporting the investigation
  • Conducting and leading cross functional team meetings to determine investigation requirements to be assigned based on event
  • Completing historical data analysis and trend evaluation assessments
  • Voiding records if required
  • Completing customer feedback records if required
  • Own consolidated/trend investigations until closure, if required
  • Software: Trackwise, Excel, Word, Microsoft office.
  • Must be fully bilingual (English / Spanish) with excellent oral skills.
  • Available to work extended hours, possibility of weekends and holidays.
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