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Details

Batch Record Reviewer


Reference:AMC21394 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Documentation Specialist


Electronica Batch Record Reviewer
11 month Contract
Hybrid role - Cork
AMC21394

We are currently on the lookout for a Operations Technical Specialist to support a Vaccine IPT team in a biotechnology manufacturer based in Cork. In this role you will be responsible for completing electronic batch record reviews.

You will have:

  • 1-3 years experience in a n operational role in a pharmaceutical or highly regulated environment
  • BSc in Biochemistry, Microbiology, Chemistry, Engineering or related field
  • Experience in Batch Record reviews
  • Working knowledge of GxP systems eg. GLIMS, eVAL and DeltaV

In this role you will:
  • Manage Batch Record reviews
  • Provide support for troubleshooting and leading SPS for shop floor issues
  • Manage EHS and Quality investigations and oversee batch record reviews
  • Offer technical support for Operations and changes
  • Lead cross-functional teams for troubleshooting and investigations within Vaccines IPT
  • Write technical reports and conduct investigations
  • Complete continuous improvement projects for manufacturing operations
  • Utilize Lean Six Sigma and Lean methodologies
  • Represent the department on project teams
  • Ensure compliance with EHS policy, cGMP, and other regulations
  • Maintain highest standards for Compliance (Quality and Safety)
  • Participate in risk assessments, audits, regulatory inspections, and incident investigations
  • Uphold Quality, Compliance, and Safety standards through compliance with Manufacturing Division QMS requirements, including ownership where applicable.

If interested in this posting please feel free to contact Angela McCauley on +353 (0)87 693 0951 or [email protected] for further information or apply directly by uploading your CV.