Περιγραφή εργασίας

We are looking for:

A QC Manager to manage the Raw Materials, Drug Products/Stability, Analytical Science & Technology (AST), Compliance, and Microbiology functions, i.e., the role ensures the delivery of accurate, reliable, and timely analytical results to support product release, stability programs, and ongoing manufacturing operations. It is accountable for maintaining a state of inspection readiness within the laboratories, ensuring adherence to Good Manufacturing Practices (GMP), data integrity principles, and validated analytical methods.

The QC Manager drives continuous improvement in laboratory systems, methods, and processes, while fostering a culture of quality, compliance, and scientific excellence. The role also supports regulatory inspections, method lifecycle management, and cross-functional collaboration to ensure product quality and patient safety.

Works productively for completing the work in the shortest time possible, always within the time limits set by the relevant legislation.

As a QC Manager you will be responsible for:

1. QC Leadership & Laboratory Management

• Lead and manage all QC laboratory functions, ensuring efficient and compliant operations.
• Oversee resource planning, staffing, and capability development across all QC sections.
• Ensure timely delivery of testing results to support production, release, and stability commitments.
• Promote a strong quality, safety, and compliance culture within the laboratories.

2.Raw Materials Testing

• Ensure all incoming raw materials, packaging components, and intermediates are sampled and tested in accordance with approved specifications and procedures.
• Oversee material release processes and ensure timely disposition decisions.
• Ensure compliance with supplier quality requirements and applicable regulatory standards.

3. Drug Product & Stability

• Oversee testing of finished products and in-process samples to ensure compliance with specifications.
• Manage stability programs, including protocol design, sample management, testing, and reporting.
• Ensure timely generation and review of stability data to support shelf-life assignments and regulatory submissions.

4. Analytical Science & Technology (AST)

• Oversee analytical method development, validation, verification, and transfer activities.
• Ensure lifecycle management of analytical methods in line with regulatory expectations.
• Provide scientific and technical expertise to support investigations and continuous improvement initiatives.

5. Microbiology

• Oversee microbiological testing, including environmental monitoring, water testing, and product bioburden/sterility testing (as applicable).
• Ensure microbial control programs are effective and compliant with GMP requirements.
• Support contamination control strategies and investigations related to microbiological issues.

6. QC Compliance

• Ensure all QC activities are conducted in accordance with GMP, data integrity, and regulatory requirements.
• Oversee laboratory investigations, including OOS (Out of Specification), OOT (Out of Trend), and deviations.
• Ensure timely and effective implementation of CAPAs and change controls related to QC activities.
• Maintain inspection readiness and support internal and external audits and regulatory inspections.

7. Data Integrity & Systems

• Ensure adherence to data integrity principles (ALCOA+) across all laboratory systems and processes.
• Oversee the use and compliance of LIMS, laboratory instruments, and computerized systems.
• Ensure systems are maintained in a validated state and aligned with CSV requirements.

8. Continuous Improvement & Performance Monitoring

• Establish and monitor QC KPIs (e.g., turnaround times, right-first-time, OOS trends).
• Drive continuous improvement initiatives to enhance laboratory efficiency, compliance, and robustness.
• Identify and implement best practices and new technologies where appropriate.

9. Cross-Functional Collaboration

• Collaborate closely with QA, Manufacturing, Regulatory Affairs, and Supply Chain.
• Provide QC input for investigations, deviations, change controls, and product impact assessments.
• Support regulatory submissions and responses with analytical and stability data.

10. Training & Development

• Ensure all QC personnel are appropriately trained and qualified.
• Maintain training programs in compliance with GMP and internal requirements.
• Mentor and develop team members to build technical and leadership capabilities.

11. Quality Governance and External Regulatory Relations

• Ensure that, during his/her absence from work, his/her roles and responsibilities are properly delegated to designated substitutes, in order to ensure the uninterrupted operation of the company.
• Participate in Quality Review Meetings and to any other internal committee, as requested by the Head of Quality.
• Keep good relationships with officers at the various health authorities both in Cyprus and abroad as well as with other agencies responsible for quality.

What will you bring:

• Bachelor’s degree in Pharmacy, Chemistry, and/or Engineering is required.
• Training or certification in GxP and Quality Management Systems
• Minimum of 8–10 years of experience in Quality Control within a regulated industry (e.g., pharmaceuticals or manufacturing).
• At least 3–5 years in a supervisory or managerial role within QC laboratories.
• Strong hands-on experience in analytical testing, including chromatographic and spectroscopic techniques (e.g., HPLC, GC, UV, etc.).
• Proven experience managing stability programs, including protocol design, execution, and reporting.
• Experience in analytical method validation, verification, and transfer.
• Strong knowledge of analytical chemistry and/or microbiology principles.
• Deep understanding of laboratory operations, testing methodologies, and equipment.
• Sound knowledge of GMP, GLP, and regulatory expectations.
• Strong expertise in Quality Management Systems (QMS), and compliance frameworks.
• Proficient in Laboratory Information Management Systems (LIMS) for sample tracking, test execution, and results management.
• Strong experience with analytical laboratory instruments software (e.g., HPLC, GC, UV, dissolution systems) and associated data systems (e.g., Empower, Chromeleon).
• Familiarity with electronic Quality Management Systems (eQMS) for deviations, CAPAs, change controls, and investigations (e.g., TrackWise, MasterControl, Veeva).
• Working knowledge of Computer System Validation (CSV) requirements and maintaining laboratory systems in a validated state.
• Familiarity with ERP systems (e.g., SAP, Oracle) and their integration with quality processes.
• Greek: fluent (written and spoken)
• English: fluent (written and spoken)

What’s in it for you?

• 13th and 14th salary.
• Provident Fund.
• Group Medical Plan.
• Discount scheme.

If you are interested you can apply via our website: QC Manager Job Details | Remedica Limited

Πώς να υποβάλετε αίτηση

Οι ενδιαφερόμενοι υποψήφιοι παρακαλούνται να στείλουν το βιογραφικό τους στον Διευθυντή Ανθρώπινου Δυναμικού στο humanresources@remedica.com.cy.

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Remedica Ltd