Production Data Reviewer SME
Ballydine, Co. Tipperary | 18-Month Contract | €45,000 per annum | Fully On-Site
Hall Recruitment is recruiting a Production Data Reviewer SME (Subject Matter Expert) for an 18-month contract within a pharmaceutical manufacturing environment in Ballydine, Co. Tipperary.
This position focuses on reviewing manufacturing documentation and electronic production data to ensure records are accurate, complete and compliant with Good Manufacturing Practice (GMP) and data integrity requirements.
You'll work with production and quality teams to identify discrepancies, review electronic information, support documentation corrections and improve existing review processes.
You don't need to have previously held a Subject Matter Expert title. We're looking for someone with a good understanding of GMP requirements, strong attention to detail and an interest in developing specialist expertise in production documentation and data integrity.
Key Responsibilities
Production Documentation & GMP Compliance
- Review cleaning, pre-production, subdivision and other manufacturing records.
- Check paper-based and electronic documentation for accuracy and completeness.
- Identify quality-related issues and documentation discrepancies.
- Ensure records comply with GMP procedures and ALCOA+ data integrity principles.
- Liaise with production and quality colleagues to resolve identified issues.
Electronic Data Review
- Review electronic manufacturing data against production records.
- Verify information against defined operating limits.
- Identify and investigate discrepancies.
- Ensure electronic review activities follow established quality procedures.
Orphan Data Review
Orphan data refers to electronic information that may not have been correctly linked to the relevant production or cleaning activity.
- Review electronic systems to ensure relevant manufacturing data is accounted for.
- Identify and investigate missing or unassociated information.
- Document findings and communicate discrepancies.
- Support improvements to electronic and orphan data review processes.
Continuous Improvement
- Identify recurring documentation errors.
- Recommend improvements to production records and review processes.
- Support more accurate and efficient documentation practices.
- Contribute to right-first-time quality and documentation standards.
What We're Looking For
Applicants should demonstrate:
- Understanding of GMP requirements and procedures.
- Knowledge of ALCOA+ data integrity principles.
- Experience working with manufacturing or quality documentation.
- Good computer skills and confidence using electronic systems.
- Understanding of manufacturing activities and production processes.
- Strong attention to detail and analytical skills.
- Ability to identify, investigate and communicate discrepancies.
- Good written and verbal communication skills.
- Strong organisation and time management.
- Ability to follow controlled procedures and work effectively with colleagues.
Experience in pharmaceutical manufacturing, GMP documentation, production support or quality-related activities would be particularly relevant.
Previous experience with electronic data review, audit trails or manufacturing quality systems would be advantageous.
Who Should Apply?
This position may suit someone currently working as a:
- Production Documentation Reviewer
- GMP Documentation Specialist
- Manufacturing Documentation Specialist
- Quality Documentation Specialist
- Production Records Reviewer
- Manufacturing Quality Administrator
- GMP Data Reviewer
- Production Support Specialist
Candidates with relevant pharmaceutical manufacturing experience who want to develop their knowledge of production documentation and electronic data integrity are also encouraged to apply.
Salary & Working Arrangements
- Salary: €45,000 per annum
- Contract: 18 months
- Location: Ballydine, Co. Tipperary
- Workplace: Fully on-site
- Hours: Monday–Thursday, 8:00am–5:00pm; Friday, 8:00am–4:00pm
- Lunch: One-hour break
Apply Now
If you have experience working with GMP-controlled documentation, pharmaceutical manufacturing records or electronic production data, we'd like to hear from you.
Please highlight your experience with GMP, ALCOA+, manufacturing documentation and electronic systems in your application.
At Hall Recruitment, we're dedicated to building diverse and authentic workplaces. We also know that excellent candidates rarely match 100% of a job description. If you meet around 70% of the criteria for this role, please don't hesitate to get in touch.