Commissioning, Qualification and Validation (CQV) Engineer

Commissioning, Qualification and Validation (CQV) Engineer

Responsibilities:

  • Provides practical guidance to the client with consideration of the industries regulations and requirements
  • Provides practical guidance to the client on Quality Management and (GxP) regulated processes
  • Executes compliance assessments and conducts investigations with root cause analysis without supervision
  • Executes assignments in an effective & compliant manner conform the (project)plan or job description
  • Identifies and summarizes core problems with root cause
  • Carries out instructional training in activities or procedures as related to critical project, planning and high priority activities
  • Executes technical reporting related to critical QMS projects and/or activities; Develops reports, conducts investigations and reviews data
  • Reviews and analyzes critical-project related result records. Manages necessary related documentation related to execution of CR and CAPA
  • Executes CAPA, CR and Investigations
  • Performs coordination related to work scope without guidance
  • Identifies and explores business opportunities and successfully builds a network in the industry
  • Possesses over excellent time management skills related critical projects and high priority activities. Delivers on time frames as indicated and performs by means of critical project deadlines
  • Keeps up to date in regards of developments in the pharmaceutical business regarding regulations and requirements
  • Takes responsibility for self-development for the achievement of personal and departmental objectives

Profile:

  • Professional level of verbal and writing skills (English and preferably the language of the country of assignment)
  • Bachelor or master’s degree in Life Sciences or comparable
  • Knowledge of regulations, quality standards and a GxP mindset
  • A minimum of 2 years of experience with compliance, in life science industry or an industry with a comparable high regulatory level, is required
  • Competent in MS Office products and experience with Quality Systems

We offer you:

Rescop offers a challenging position in a fast growing international environment where we invest in the personal development of our employees. We create opportunity for professional development, career growth, autonomy, strong rewarding and community impact.

 

 


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