Manufacturing Operations Support Specialist

Jobtailor; Dublin; On-site; EUR 42,000 - 64,000; Full time

Job summary

Jobtailor, based in Ireland (Dublin), seeks a GMP Operations Support professional to oversee deviations, CAPAs, change controls, and QRM assessments across manufacturing activities.

You will provide technical guidance, support investigations, and ensure compliance with cgmp standards, documentation, and batch records. This role collaborates with QA, Engineering, and Supply Chain to drive continuous improvements and training materials.

Qualifications

• Bachelor's degree in Science, Engineering, or related field.
• 1-2 years of experience in GMP manufacturing, quality systems, or operational support.
• Strong working knowledge of cGMP and quality systems (deviations, CAPA, change control, QRM).
• Experience in technical writing and documentation (investigations, SOPs, reports).
• Experience in biologics or regulated pharmaceutical manufacturing highly desirable.
• Exposure to audit and inspection processes highly desirable.
• Lean / Six Sigma knowledge or experience highly desirable.

Responsibilities

• Execute operational support activities, including deviations, CAPAs, change controls, and QRM assessments.
• Act as a subject matter expert in operational support areas such as investigations, documentation, training, or QRM.
• Support investigations, including root cause analysis and identification of corrective and preventive actions.
• Provide day-to-day manufacturing support, including batch record review, on-floor troubleshooting, issue resolution, area release, and readiness activities.

Skills

Deviations Mgmt

CAPA Mgmt

Change Control

QRM Assessments

Batch Record Review

Investigations

Data Integrity

SOP Development

Technical Documentation

Process Improvement

Attention to Detail

Problem Solving

Organizational Skills

Education

Bachelor's degree in Science, Engineering, or related field

Tools

GMP knowledge

Job description

• Execute operational support activities, including deviations, CAPAs, change controls, and QRM assessments
• Act as a subject matter expert in operational support areas such as investigations, documentation, training, or QRM
• Support investigations, including root cause analysis and identification of corrective and preventive actions
• Ensure assigned tasks are completed accurately, on time, and in compliance with site procedures and regulatory standards
• Provide technical guidance and support to Operational Specialists
• Attend FAT and supplier sites for training and project support where required
• Manage projects as required
• Author and support closure of deviations, CAPAs, change controls, and QRM records
• Maintain compliant SOPs, RECs, OJTs, QRM files, and batch records
• Perform detailed record reviews for completeness and data integrity
• Provide day-to-day manufacturing support, including batch record review, on-floor troubleshooting, issue resolution, area release, and readiness activities
• Escalate issues and risks to the Supervisor
• Support development and improvement of training materials, SOPs, and technical documentation
• Maintain personal training requirements and support team training compliance
• Identify and support process improvements
• Participate in Lean, Six Sigma, and structured problem-solving initiatives
• Collaborate with Manufacturing, Quality Assurance, Engineering, and Supply Chain teams
• Coordinate activities involving contractors and vendors where required
• Maintain records and track KPIs related to deviations, CAPAs, change controls, and documentation timelines
• Provide support during start-up, tech transfer, and campaign execution
• Perform additional duties as assigned

Requirements

• Bachelor's degree in Science, Engineering, or related field
• 1-2 years of experience in GMP manufacturing, quality systems, or operational support
• Strong working knowledge of cGMP and quality systems (deviations, CAPA, change control, QRM)
• Experience in technical writing and documentation (investigations, SOPs, reports)
• Experience in biologics or regulated pharmaceutical manufacturing highly desirable
• Exposure to audit and inspection processes highly desirable
• Lean / Six Sigma knowledge or experience highly desirable
• Strong attention to detail and ability to solve problems effectively
• Good organizational skills with the ability to manage multiple priorities

Core Competencies

Demonstrates expertise in operational support activities, including deviations, CAPAs, change controls, and QRM assessments, while ensuring compliance with regulatory standards and site procedures. Proficient in technical writing, documentation, and process improvements within GMP manufacturing environments.

Highest-signal resume keywords

• GMP Manufacturing Experience
• CGMP Knowledge
• Technical Writing
• Lean / Six Sigma Experience
• Root Cause Analysis

Hard Skills

• Deviations Management
• CAPA Management
• Change Control
• QRM Assessments
• Batch Record Review
• Investigations
• Data Integrity
• SOP Development
• Technical Documentation
• Process Improvement

Soft Skills

• Attention to Detail
• Problem Solving
• Organizational Skills

Industry Keywords

• Biologics Manufacturing
• Regulated Pharmaceutical Manufacturing
• Quality Systems
• Audit Processes
• Inspection Processes