Job Title: QC Team Leader Phoenix Healthcare
Department: Quality Control
Reports To: QC Manager
Location: Phoenix Healthcare Unit 31, Second Ave, Cookstown, Dublin, D24 TP60, Ireland.
Contract Type: Full-Time / Permanent (on-site)
Job Purpose
To lead and supervise the day-to-day operations of the Quality Control (QC) laboratory at Phoenix Healthcare. The QC Team Leader is responsible for ensuring all testing activities are conducted to the highest GMP and regulatory standards, providing leadership to QC Analysts, and supporting the QC Manager in maintaining an efficient, compliant, and audit-ready laboratory.
Key Duties and Responsibilities:
Leadership & Team Development
* Supervise, lead, and mentor QC Analysts to ensure competency, efficiency, and compliance.
* Allocate workloads and manage daily priorities to meet testing timelines.
* Conduct training, competency assessments, and staff performance reviews.
* Support the development of a high-performing, motivated QC team.
Operational Responsibilities
* Oversee QC testing of raw materials, intermediates, finished products, and stability samples.
* Ensure laboratory testing is performed according to SOPs, pharmacopeial methods, and regulatory standards.
* Review and approve analytical data, reports, and logbooks.
* Ensure equipment qualification, calibration, and maintenance activities are performed on time.
* Support method validation, transfer, and troubleshooting.
Compliance & Quality
* Ensure QC operations comply with GMP, GLP, HPRA, MHRA, FDA, and other regulatory requirements.
* Maintain full adherence to Phoenix Healthcare SOPs, Quality Management System (QMS), and Data Integrity standards.
* Lead and support investigations (OOS, OOT, deviations, CAPA, change controls).
* Ensure audit readiness and actively participate in regulatory/customer audits.
* Promote continuous improvement within the laboratory.
Documentation & Reporting
* Ensure accurate and timely completion of laboratory records and test documentation.
* Provide updates, reports, and KPIs to the QC Manager.
* Contribute to Annual Product Quality Reviews (APQRs) and trending of stability data.
Cross-Functional Collaboration
* Liaise with QA, Production and Regulatory teams to resolve testing or compliance issues.
* Act as Deputy QC Manager when required.
Person Specification
Qualifications
* Degree in Chemistry, Pharmaceutical Sciences, or related discipline (BSc/MSc).
Experience
* Minimum 5 years’ QC experience within pharmaceutical/healthcare industry.
* At least 2 years’ supervisory or leadership experience.
* Strong knowledge of GMP, ICH guidelines, and pharmacopeial methods.
* Experience with HPLC, GC, UV, FTIR, dissolution, and other analytical techniques.
* Experience of audits (HPRA/MHRA/FDA/customer) desirable.
* Strong leadership and people management skills.
* Excellent communication and interpersonal skills.
* High attention to detail and focus on compliance/data integrity.
* Effective problem-solving and decision-making skills.
* Ability to manage priorities and work under pressure.
Key Performance Indicators (KPIs)
* On-time completion of QC testing and batch release support.
* Compliance with GMP and Data Integrity requirements.
* Effective management and development of QC staff.
* Minimal audit observations relating to QC operations.
* Delivery of continuous improvement initiatives.
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