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The JobA Global Leader within the Bio-pharmaceutical industry currently based in Co. Dublin are looking for a Quality Assurance Manager to join their site as part of an exciting site expansion. Your New RoleAs the Quality Assurance Manager you will be responsible for the management of all Quality activities for the site.
You will work closely with other Quality department personnel as part of the site Quality department.
In your role as Quality Assurance Manager you will be responsible also for promoting a culture of Regulatory Compliance and Continuous Improvement within the Quality department and across the company's site. 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 a Quality Assurance Manager- Management of the Quality Assurance team, including Qualified Persons.
- Management of batch record review, batch disposition and material status control activities.
- Assisting in, and facilitating, investigations as part of the site Deviation Management System.
- Ensuring effective root cause analysis and assigning of appropriate CAPAs.
- Management of the Change Control process, ensuring controlled implementation of all GMP related changes.
- Management of QA oversight of manufacturing, testing and relating activities to ensure ongoing cGMP compliance.
- Implementation of KPI's within the Quality Assurance area to align with company and global quality objectives.
- Participation in the site Internal/External Audits.
- Participation in the preparation of documentation.
- Ensure timely completion of all SOP, reading, training and assessment. Your Education & Experience- Bachelor's Primary Degree in a Scientific discipline.
- Qualified Person status is highly desirable, not essential.
- +7 year's experience working an aseptic environment in the pharmaceutical industry, desirably in a Biologics company.
- Minimum of 3 year's experience in a people management role. Your Skills & Competencies- Excellent knowledge of Good Manufacturing Practice for aseptic pharmaceutical manufacture as described in current regulations.
- Demonstrable experience managing, motivating and leading a team.
- A high level of own initiative.
- Excellent verbal and written communication skills.
- Strong project management and organisational skills.
- Ability to adapt to changing priorities
What's 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.
Or if you would like to hear more please feel free to contact Ciara McGrath on 01 8883477 or email Your New RoleAs the Quality Assurance Manager you will be responsible for the management of all Quality activities for the site.
You will work closely with other Quality department personnel as part of the site Quality department.
In your role as Quality Assurance Manager you will be responsible also for promoting a culture of Regulatory Compliance and Continuous Improvement within the Quality department and across the company's site. 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 a Quality Assurance Manager- Management of the Quality Assurance team, including Qualified Persons.
- Management of batch record review, batch disposition and material status control activities.
- Assisting in, and facilitating, investigations as part of the site Deviation Management System.
- Ensuring effective root cause analysis and assigning of appropriate CAPAs.
- Management of the Change Control process, ensuring controlled implementation of all GMP related changes.
- Management of QA oversight of manufacturing, testing and relating activities to ensure ongoing cGMP compliance.
- Implementation of KPI's within the Quality Assurance area to align with company and global quality objectives.
- Participation in the site Internal/External Audits.
- Participation in the preparation of documentation.
- Ensure timely completion of all SOP, reading, training and assessment. Your Education & Experience- Bachelor's Primary Degree in a Scientific discipline.
- Qualified Person status is highly desirable, not essential.
- +7 year's experience working an aseptic environment in the pharmaceutical industry, desirably in a Biologics company.
- Minimum of 3 year's experience in a people management role. Your Skills & Competencies- Excellent knowledge of Good Manufacturing Practice for aseptic pharmaceutical manufacture as described in current regulations.
- Demonstrable experience managing, motivating and leading a team.
- A high level of own initiative.
- Excellent verbal and written communication skills.
- Strong project management and organisational skills.
- Ability to adapt to changing priorities
What's 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
