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Apply for this job
Details
Batch Record Reviewer
Reference: | AMC21394 | Location: |
Cork |
Qualification: | Degree | Experience: | See description |
Job Type: | Fixed Term Contract | Salary: | 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.
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