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Capgemini

Global consulting, technology services, outsourcing

Junior QA Batch Record Reviewer

Regulatory & Quality (Life Sciences)Updated on Nov 14
Full-timeOpfikon, SwitzerlandNo salary listed

About the Job

Requirements

  • One to three years of experience in batch record review, preferably electronic batch record review, or in manufacturing.
  • Previous experience in a good documentation practices and good manufacturing practices regulated pharmaceutical or active pharmaceutical ingredient industry.
  • Ability to identify non-compliance and gaps from quality standards.
  • Very good communication skills and ability to interact with different interfaces within the organization.
  • Structured, focused, and well-organized working approach.
  • Ability to produce reliable results under stress.

Responsibilities

  • Perform timely and independent review of executed electronic batch records in MES Syncade.
  • Ensure operations batch records are accurately executed, complete, and ready for quality assurance review.
  • Collaborate with Manufacturing and Quality teams to clarify and resolve documentation issues.
  • Initiate and support the management of quality records, including corrective and preventive actions and deviations, for observations related to batch-record review.
  • Support preparation of documentation packages to enable fast release by quality assurance.

Desired Qualifications

  • Experience in batch record review, preferably electronic batch record review.

About the Company

Capgemini

Global consulting, technology services, outsourcing

Capgemini provides consulting, technology services, and outsourcing to help organizations transform digitally. Its offerings include strategy and transformation consulting, system integration, application development, IT infrastructure management, and managed IT operations. It differentiates itself with a global presence in over 50 countries and a focus on applying AI, cloud, and cybersecurity to real business problems. Its goal is to help clients navigate digital transformation and improve efficiency and innovation through tailored, contract-based or managed services.

Company size
10,001+
Company stage
IPO
Headquarters
Paris, France
Founded
1967

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