Quality Systems & Documentation Specialist

Embecta Corp.

Ireland

Remote

EUR 40,000 - 64,000

Full time

4 days ago
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Job summary

Embecta Corp. in Ireland seeks a detail-oriented quality professional to manage batch records and document control. You will drive document revisions and maintain site documentation systems to support product release and audit readiness in a highly regulated manufacturing setting.

The role requires at least 2 years in medical devices or pharmaceutical manufacturing, experience with QMS, and familiarity with electronic systems including Batch Control, Document Control, and SAP preferred.

Qualifications

  • 2+ years experience in Medical Devices or Pharmaceutical manufacturing.
  • Experience with Quality Management Systems (QMS).
  • Experience with electronic QMS including Batch Control and Document Control; SAP preferred.

Responsibilities

  • Review batch records and ensure documentation complies with approved procedures.
  • Coordinate document revisions and maintain the site’s Documentation System.
  • Support product release and audit readiness in a regulated manufacturing environment.
  • Record batch record review results in the complaint management system.
  • Prepare technical documentation including product certifications for worldwide distribution.
  • Support site audit activities for Regulatory and Customer audits.

Skills

Interpersonal skills
Communication skills
Teamwork
Attention to detail
Willingness to learn

Education

Science/Engineering degree

Tools

SAP

Job description

Embecta Corp. in Ireland seeks a detail-oriented quality professional to manage batch records and document control. You will drive document revisions and maintain site documentation systems to support product release and audit readiness in a highly regulated manufacturing setting.

The role requires at least 2 years in medical devices or pharmaceutical manufacturing, experience with QMS, and familiarity with electronic systems including Batch Control, Document Control, and SAP preferred.

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