QA Analyst — GMP Batch Release Specialist

Boehringer Ingelheim GmbH

United Kingdom

Teletrabalho

GBP 30 000 - 42 000

Tempo integral

há 11 horas
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Resumo da oferta

The Quality Assurance Analyst at Boehringer Ingelheim UK plays a key role in ensuring batch release activities meet regulatory requirements and internal quality standards. The role focuses on review and coordination of batch documentation to support timely product release with data integrity and GMP compliance.

This fixed-term position runs until 31 December 2027 and involves cross-functional collaboration with production, supply chain, quality control and the QP to ensure accurate, compliant

Qualificações

  • Experience with GMP and data integrity in a regulated setting.
  • Familiarity with batch record review processes or QA activities.
  • Proficiency with quality and business systems (LIMS, SAP).
  • Strong attention to detail and ability to review technical documentation accurately.
  • Excellent written and verbal communication skills.
  • DBS check will be required for the successful candidate.

Responsabilidades

  • Prepare and review batch documentation for QP certification and regulatory alignment.
  • Perform batch review activities including production checks and formulation sheet reviews.
  • Execute quality tasks within LIMS and SAP related to batch release.
  • Participate in batch tracking and communicate issues to stakeholders.
  • Support batch record review projects and continuous improvement initiatives.
  • Manage archiving and handling of batch documentation and document control.
  • Provide operational support including deviation management, investigations and change control.
  • Assist with internal audits and quality system maintenance.

Conhecimentos

GMP
Data integrity
LIMS
SAP
Attention to detail
Organisational skills
Communication
MS Office

Formação académica

Scientific degree (advantageous)

Ferramentas

LIMS
SAP

Descrição da oferta de emprego

The Quality Assurance Analyst at Boehringer Ingelheim UK plays a key role in ensuring batch release activities meet regulatory requirements and internal quality standards. The role focuses on review and coordination of batch documentation to support timely product release with data integrity and GMP compliance.

This fixed-term position runs until 31 December 2027 and involves cross-functional collaboration with production, supply chain, quality control and the QP to ensure accurate, compliant

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