Role Title: Quality Specialist 

Location: Tipperary

Team: Quality Systems Team, Drug Substance & Drug Product Facilities,

Role Functions (Including but not limited to):

Core Quality Systems Responsibilities

• Ensure timely and effective completion of Quality Systems activities schedules and MMD policies.

Subsystem Ownership

• Own designated subsystems as per site System Ownership list.

Quality SME Responsibilities

Process, Cleaning, Water, Equipment

• Lead and support validation standards for Drug Substance & Drug Product (SDI & OSD) facilities.
• Participate in:
• Process Validation Committee (PVC)
• Water Validation Committee (WVC)
• Cleaning Validation Group (CVG)
• Equipment Qualification Validation Committee (EQVC)
• Approve validation documentation and maintain compliance with MMD standards.
• Ensure validation status is maintained post-changes/modifications.
• Support site/capital projects:
• Define validation requirements.
• Provide technical assistance as part of project teams.
• Develop Validation Summary Reports.
• Contribute to Quality Plans for major projects.
• Monitor industry best practices and trends.
• Act as SAP Quality Process Steward.

Change Control

• Act as principal Quality contact for all change requests affecting processing.
• Perform Quality and change analyst review throughout the change control process.
• Assess material control strategies related to process/analytical changes.

Laboratory QA Oversight

• Approve and support systems for laboratory functions, instrumentation, and GLIMS.
• Review and approve:
• Laboratory incidents/investigations.
• Stability reports (Intermediate and API).
• Serve as Microbiology Point of Contact:
• Liaise with site Microbiologist for issues related to water, utilities, environment, excipients, or product.

Quality Agreement Management

• Maintain inventory of Quality Agreements.
• Ensure agreements are:
• Raised, approved, current, and retrievable.
• Communicated with SD&PM, stakeholders, and external parties.

Annual Review Management

• Manage systems ensuring Annual Reviews (AR/APR/PQR) for products and systems (including automation) are completed on schedule.

Documentation Responsibilities

• Create, review, and approve:
• Site Master File
• Validation Master Plan
• Policies and procedures

User Access Reviews

• Approve designated application user access reviews for compliance with site and MMD policies.

Quality Council

• Manage annual Quality Council schedule.
• Coordinate monthly meetings, agendas, minutes, and follow-ups.

Supplier Change Evaluations

• Review and approve Supplier Change Evaluation (SCE) documentation.
• Approve:
• MDS updates post-SCE.
• Supplier Transparency update requests post-SCE.
• Generate supplier quality/technical agreements as needed.

Supplier & Customer Complaints

• Investigate and review internal/external customer complaints within lead-times.
• Investigate and review supplier complaints as per timelines.

Regulatory Support & Filing

• Maintain site licenses and review documentation.
• Provide support for regulatory product filings and respond to CMC requests.

QA Regulatory Data

• Review documentation for regulatory submission.
• Ensure data accuracy and integrity through timely reviews.

Returned Goods

• Manage segregation and disposition of returned goods.

Audit Program

• Support:
• Internal GMP walk-downs.
• Scheduled audits.
• Hosting of Regulatory Inspections.

Special Features

• Operates as part of a self-directed team.
• Monitors CoE performance metrics.
• Participates in initiatives to improve compliance and quality systems.
• Represents Quality in cross-functional teams.
• Promotes GMP awareness site-wide.
• Builds cross-functional relationships.

Experience, Knowledge & Skills

Technical

• In-depth knowledge of:
• MMD and site QA policies
• GMP standards
• Validation principles & guidelines
• Global Engineering Standards
• Plant equipment, layout, and unit operations
• Documentation and lab testing requirements
• System Development Life Cycle (SDLC)
• Business acumen and decision-making aligned with key business drivers.

Business Skills

• Demonstrated MMD core values and behaviours.
• Proficiency in:
• MS Word, Excel, Access
• eLogs, File & Email management
• Meetings management
• Technical writing
• Time management
• Analytical problem-solving
• Continuous improvement tools
• Inclusion behaviours

Leadership & Soft Skills

• Strong written and verbal communication.
• Proactive mindset and planning skills.
• Brainstorming and idea generation.
• Customer service orientation.
• Excellent interpersonal and facilitation skills.
• Teamwork and collaboration:
• Listening, integrating perspectives, contributing to team goals.

Qualifications & Education

• Minimum: Degree or Postgraduate qualification in Science, Pharmacy, or Engineering.