QC Manager

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Global Leader in the Biopharmaceutical industry currently based in Co. Dublin is seeking a QC Manager to join their team as part of an exciting expansion of a greenfield project.Your New RoleAs the QC Manager you will be to managing the QC Laboratories for a biologic medicinal product manufactured at this facility.

In your role as QC Manager you will be responsible for the QC testing and Microbiological testing activities. Report into the Head of Quality and other appointed Officers for the facility.Your New CompanyThe Company is highly driven in the research and development of life-changing medicines to bring better health and a brighter future for patients.

Through this they strive to be the leader in innovate products especially in the areas of oncology and gastroenterology.

You will be working in a highly collaborative work environment, where integrity is a core value and diversity is seen as a key player in the creation of an outstanding company culture. Your Duties and Responsibilities as QC Manager- Responsible for the overall management of separate Quality Control laboratories supporting the manufacture of Cell Therapy.

- Ensure that QC laboratories are set up and operate in compliance with current GLP & GMP standards.

- Implement and maintain standards of GLP and analytical practice consistent with current regulatory expectations and Global company standards.

- Supervise QC Executives including training, recruitment, motivation, discipline and performance appraisal.

- Lead the QC work stream of tech transfer and start-up of biologic products assuring the milestones of the project are reached.

- Manage the investigation into any non-conformance, instrument malfunction, accident or other abnormal occurrence (OOS & OOT).

- Manage an effective QC documentation system alongside prepare, review and approve documents.

- Ensure QC operation readiness for HA inspections.

- Ensure the QC department is in an audit ready at all times for both internal and external audits (HPRA, FDA, corporate, customer).

- Actively lead and support major projects, quality initiatives and continuous improvement programmes within the Quality department and other areas. Your Education, Skills & Experience- Degree in Science or other relevant field.

- More than 10 year's experience in the Pharmaceutical/Biopharma industry.

- Minimum of 5 years QC Laboratory Management experience.

Whats in it for You?As part of this opportunity you will be joining a well-established Global Bio-pharmaceutical Company as part a of a growing dynamic team.

Alongside, working with a Company that has a great culture reputation in the market.

You will receive a competitive salary and benefits package. Your next stepIf this sounds like the right role for you, please reply with an updated CV for immediate consideration. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales