Quality Specialist

Role Title: Contract Quality Specialist - Quality Systems

Location: Ballydine, Ireland

Industry: Our client - a leading pharmaceutical manufacturing company

Work Model: Hybrid - typically 3 days onsite per week

Requirement: QA/QC experience required; Microbiology experience highly desirable; no graduates accepted

Position Summary

The Contract Quality Specialist supports day to day Quality Assurance activities within the Quality Systems Centre of Excellence (CoE). This role ensures compliance with global quality standards, cGMP requirements, and site quality systems while contributing to continuous improvement during a key growth phase.

The position offers excellent variety, covering environmental monitoring, analytical validation, supplier qualification, investigations, audits, and quality systems governance. Ideal for candidates seeking a role where they can actively shape quality processes within a dynamic pharma manufacturing environment.

Key Responsibilities

1. Quality Systems, Investigations & CAPA

• Provide QA oversight for deviations, investigations, and root cause analysis.
• Perform deviation trending and support site improvement initiatives.
• Manage CAPAs ensuring effective definition, execution, and closure.
• Support customer complaint investigations and technical reporting.
• Prepare Annual Product, Process, and System Reviews.

2. Analytical & Microbiological QA Support

• Provide QA oversight for analytical and microbiology labs.
• Review and approve change controls, test specifications, instrumentation updates, and reagent changes.
• Review and approve method validation/verification/transfer protocols (HPLC, GC, wet chemistry, microbiology).
• Support environmental monitoring oversight, OOT investigations, aseptic qualifications, and contamination control.
• Evaluate raw material/API expiry, retest dates, and stability data.
• Coordinate Quality Agreements and Change Agreements.
• Maintain QA/CA registers and perform periodic reviews.
• Support supplier qualification, vendor assessments, and risk evaluations.

4. SAP Master Data & Governance

• Support SAP Master Data creation, updates, and governance.
• Manage material status changes, expiry updates, and quarantine controls.

5. Validation, Equipment & GMP Compliance

• Provide QA oversight for equipment, utility, and facility qualification (IQ/OQ/PQ).
• Review validation protocols, execution data, and reports (Kneat, ProCal).
• Support regulatory submissions and GMP declarations.
• Participate in risk assessments and validation lifecycle activities.

6. Audits, Walkdowns & Metrics

• Lead or support internal audits and GMP walkdowns.
• Compile and analyse site quality metrics.
• Prepare compliance summaries for Quality Councils and leadership teams.

Qualifications & Skills

Education

Degree or postgraduate qualification in Chemistry, Microbiology, Biology, Science, Pharmacy, Engineering, or related technical discipline.

Experience

• 5+ years QA/QC or Microbiology experience in GxP pharma/biopharma manufacturing.
• Experience reviewing analytical/microbiological investigations (OOS/OOT), change controls, stability protocols, EM data.
• Practical knowledge of method validation principles (ICH Q2).
• Experience with microbiological testing (bioburden, endotoxin, growth promotion).
• Exposure to equipment qualification and validation systems (Kneat, ProCal).
• Strong understanding of Quality Agreements, Supplier Qualification, SAP Master Data.
• Lean/Six Sigma or continuous improvement experience preferred.

Core Competencies

• Strong communication and technical writing skills.
• Effective collaboration within cross functional teams.
• Adaptability in a fast paced contract environment.
• High work standards, accuracy, and attention to detail.