Production Data Reviewer SME (Production Documentation & Data Integrity) | Ballydine, Co. Tipperary | 18-Month Contract | €45,000 per annum | Fully On-Site
Key Points
- Salary: €45,000 per annum
- Location: Ballydine, Co. Tipperary
- Contract: 18-month fixed-term contract
- Working Arrangement: Fully on-site
- Hours: 39 hours per week, subject to confirmation
- Industry: Pharmaceutical Manufacturing
- Focus: Production Record Review, Electronic Data, GMP Compliance and Data Integrity
- Development: Opportunity to develop specialist expertise in production documentation and electronic data review
Job Summary
Hall Recruitment is recruiting a Production Data Reviewer SME for an 18-month contract within a pharmaceutical manufacturing environment in Ballydine, Co. Tipperary.
In this position, you will review manufacturing records and associated electronic data to ensure production activities have been accurately documented and comply with established quality and regulatory procedures.
Your responsibilities will include reviewing cleaning records, pre-production documentation and other manufacturing records, identifying discrepancies, checking electronic information and ensuring any required corrections are completed.
The position also involves reviewing electronic data that may not have been linked to the relevant production record, investigating discrepancies and supporting improvements to documentation and review processes.
SME stands for Subject Matter Expert. In this role, it refers to developing specialist knowledge of production documentation, electronic data review and data integrity requirements. You should have a good understanding of GMP procedures and be interested in developing your expertise further.
You will work with production and quality colleagues to maintain accurate records, support compliance and improve documentation standards.
Key Responsibilities
Production Documentation Review
You will review manufacturing documentation to ensure records are complete, accurate and compliant with established procedures.
Responsibilities include:
- Review paper-based and electronic cleaning records.
- Examine pre-production and subdivision records.
- Review other documentation associated with manufacturing activities.
- Identify missing information, discrepancies and potential quality issues.
- Check that documentation complies with GMP and data integrity requirements.
- Communicate required corrections to relevant production and quality personnel.
- Follow up to ensure corrections are completed within the required timelines.
What to demonstrate in your application: Experience preparing, maintaining or reviewing manufacturing documentation, particularly within a GMP-regulated environment.
Electronic Data Review & Data Integrity
You will review electronic information associated with manufacturing activities to ensure it is complete, accurate and consistent with production documentation.
Responsibilities include:
- Review electronic production data against relevant manufacturing records.
- Check that recorded information falls within defined operating limits.
- Identify discrepancies between electronic and paper-based information.
- Ensure data review activities follow established quality procedures.
- Apply GMP data integrity requirements, including ALCOA+ principles.
- Communicate potential data integrity concerns to the appropriate personnel.
What to demonstrate in your application: An understanding of electronic manufacturing records, GMP documentation and data integrity principles. Experience using manufacturing or quality systems would be beneficial.
Orphan Data Review & Investigation
You will help ensure that all electronic information associated with production and cleaning activities is accounted for.
This includes reviewing orphan data, meaning electronic records or information that may not have been included or correctly associated with the relevant production or cleaning activity.
Responsibilities include:
- Review electronic data across relevant manufacturing systems.
- Identify information requiring further investigation.
- Check that all applicable data is included within the required review period.
- Investigate and document discrepancies.
- Communicate findings to the appropriate personnel.
- Ensure investigations and reviews follow established quality procedures.
What to demonstrate in your application: Strong attention to detail, analytical skills and experience investigating discrepancies in records or electronic systems.
GMP Compliance & Quality Standards
You will ensure documentation and data review activities meet established Good Manufacturing Practice requirements.
Responsibilities include:
- Follow GMP policies and standard operating procedures.
- Apply ALCOA+ data integrity principles.
- Identify and communicate documentation or quality-related issues.
- Support right-first-time documentation standards.
- Work with quality personnel to resolve identified discrepancies.
- Complete activities in accordance with site safety procedures.
What to demonstrate in your application: Experience working within a GMP-regulated environment and following controlled procedures where documentation accuracy and compliance are essential.
Systems & Continuous Improvement
You will support improvements to production documentation and electronic data review processes.
Responsibilities include:
- Identify recurring documentation errors.
- Communicate opportunities for improvement to the relevant personnel.
- Support improvements to electronic data review processes.
- Assist with developing more effective orphan data review procedures.
- Identify opportunities to improve accuracy and efficiency.
- Contribute to continuous improvement initiatives.
What to demonstrate in your application: Examples of identifying recurring problems, improving documentation practices or contributing to process improvements.
Requirements
Technical Knowledge & Experience
Applicants should demonstrate:
- Understanding of Good Manufacturing Practice (GMP).
- Knowledge of ALCOA+ data integrity principles.
- Ability to follow standard operating procedures and controlled processes.
- Good computer skills and confidence using electronic systems.
- Ability to learn new manufacturing or quality systems.
- Understanding of manufacturing activities and production processes.
- Awareness of manufacturing equipment and associated documentation.
- Strong attention to detail when reviewing technical information.
- Ability to identify and communicate discrepancies accurately.
Experience in pharmaceutical manufacturing, production documentation or quality-related activities would be particularly relevant.
Documentation & Analytical Skills
The successful candidate should have:
- Strong attention to detail and accuracy.
- Ability to identify incomplete or inconsistent information.
- Good analytical and problem-solving skills.
- Ability to investigate discrepancies methodically.
- Clear written communication skills.
- Good organisational and time management skills.
- Confidence working with electronic records and computer systems.
Communication & Teamwork
You should be comfortable working with colleagues across production and quality functions.
We are looking for someone who demonstrates:
- Clear written and verbal communication.
- Ability to organise and prioritise work.
- Confidence following established procedures.
- Ability to work independently and as part of a team.
- Willingness to provide constructive feedback.
- A practical approach to resolving problems.
- An interest in continuous improvement.
- A willingness to develop specialist expertise in production documentation, electronic data review and data integrity.
Who This Role Would Suit
This position may suit candidates currently working as:
- Production Documentation Reviewer
- GMP Documentation Specialist
- Manufacturing Documentation Specialist
- Production Records Reviewer
- Quality Documentation Specialist
- Manufacturing Quality Administrator
- GMP Data Reviewer
- Production Support Specialist
It may also suit someone with pharmaceutical manufacturing experience who has developed strong documentation, compliance and computer skills and would like to specialise in production data review.
You do not need to have previously held a position with “Subject Matter Expert” in the job title. What matters is your understanding of GMP requirements, ability to review information accurately and willingness to develop specialist knowledge.
Salary, Contract & Working Arrangements
Salary: €45,000 per annum
Contract: 18-month fixed-term contract
Location: Ballydine, Co. Tipperary
Working Arrangement: Fully on-site
Working Hours:
- Monday–Thursday: 8:00am–5:00pm
- Friday: 8:00am–4:00pm
- One-hour lunch break
- 39 hours per week
Apply Now
If you have experience working with GMP documentation, pharmaceutical manufacturing records or electronic production data, we would like to hear from you.
Your application should highlight your experience with manufacturing documentation, computer systems, data integrity requirements and any involvement in quality or process improvement activities.
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.
