Are you an Senior Quality Assurance Specialist with experience on Pharmaceuticals or Biotechnology plants? Would you like to work for Amgen, a company who provides an outstanding work environment and opportunities for career development? If you have what it takes, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.
Senior Quality Assurance Specialist - Amgen - Dublin
Employer
Our Client is Amgen and the role will be based in their Dun Laoghaire plant. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
Job Description
The successful candidate will report to the Senior Manager QA will be reponsible for the following activities:
Supervise systems associated with Site Quality Review Team.
Acts as QA contact on New Product Introduction Technical Transfer Team
Reviews and approve Master Batch Records.
Write, review and approve Standard Operating Procedures as applicable.
Review and approve bills of material.
Review and approve validation documentation
Review and approve change controls
Provide Quality support for the investigation of all classes of Non Conformances (NCs)
Review and approve all NCs for closure ensuring compliance with appropriate documentation
Participate in appropriate NC related root cause analysis
Collaborate with CAPA owners to ensure CAPA actions address root cause and implementation plan dates are achievable
Provides training and advice to staff in order for them to perform their desired functions.
Ensures that both self and staff operate in a safe manner as defined in the safety statement prepared by the Environmental Health and Safety Department.
They will perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and Amgen requirements, policies and procedures.
Support Lean Transformation and Operational Excellence initiatives and participate in team meetings (i.e. Kaizen; Work Center Teams; etc)
Perform all activities in compliance with Amgen safety standards
Ensure all GMP compliance training is up to date before performing GMP activities
Requirements:
A third level qualification in Science, Engineering or a relevant Quality discipline.
Minimum 5 years experience in a similar role.
Package:
Minimum 6 month contract
Rate ?35 - ?40 per hour
Overtime at 1.5
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
Similar Jobs
Amgen Jobs in Ireland
Are you an Senior Quality Assurance Specialist with experience on Pharmaceuticals or Biotechnology plants? Would you like to work for Amgen, a company who provides an outstanding work environment and opportunities for career development? If you have what it takes, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.
Senior Quality Assurance Specialist - Amgen - Dublin
Employer
Our Client is Amgen and the role will be based in their Dun Laoghaire plant. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
Job Description
The successful candidate will report to the Senior Manager QA will be reponsible for the following activities:
Supervise systems associated with Site Quality Review Team.
Acts as QA contact on New Product Introduction Technical Transfer Team
Reviews and approve Master Batch Records.
Write, review and approve Standard Operating Procedures as applicable.
Review and approve bills of material.
Review and approve validation documentation
Review and approve change controls
Provide Quality support for the investigation of all classes of Non Conformances (NCs)
Review and approve all NCs for closure ensuring compliance with appropriate documentation
Participate in appropriate NC related root cause analysis
Collaborate with CAPA owners to ensure CAPA actions address root cause and implementation plan dates are achievable
Provides training and advice to staff in order for them to perform their desired functions.
Ensures that both self and staff operate in a safe manner as defined in the safety statement prepared by the Environmental Health and Safety Department.
They will perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and Amgen requirements, policies and procedures.
Support Lean Transformation and Operational Excellence initiatives and participate in team meetings (i.e. Kaizen; Work Center Teams; etc)
Perform all activities in compliance with Amgen safety standards
Ensure all GMP compliance training is up to date before performing GMP activities
Requirements:
A third level qualification in Science, Engineering or a relevant Quality discipline.
Minimum 5 years experience in a similar role.
Package:
Minimum 6 month contract
Rate ?35 - ?40 per hour
Overtime at 1.5
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
Similar Jobs
Amgen Jobs in Ireland
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
