Are you a Senior Quality Assurance Specialist with experience in New Product Introductions? Have you strong Project Management and communication skills.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.
5 x 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 QA Specialist will be a member of the ADL plant QA team that will provide on-the-production-floor support for the start-up activities, new product introductions and commercial manufacturing associated with unit operations in component preparation, formulation, syringe filling, and inspection.
This person will serve as the Quality reviewer and approver batch documentation, non-conformance and CAPA documentation, change control documentation, maintenance work order and job plan approval and other GMP documents pertinent to ADL.
The site is focused on continuous improvement of all work processes and practices and all colleagues are required to be flexible in this regard. This means that they may be asked to carry out additional work functions that are not described in this specification but are associated with their role.
This position requires the ability to work shifts in support of the production schedule. The position will report to a Quality manager and will be located in Dun Laoghaire, Ireland.
Key Responsibilities:
Perform all activities in compliance with Amgen safety standards and SOP’s
Ensure all GMP compliance training is up to date before performing GMP activities and participate in training of new colleagues
Production Floor Duties
Observe and provide real-time support for production unit operations, including observation and assessment of interventions on aseptic fill line
Perform VI AQL inspections
Collaborate with operations to resolve compliance discrepancies
Review production batch records in real-time
Provide Quality representation for triage of non-conformance (NC) events
Review and approve cGMP records (e.g., electronic batch record, change controls, design qualifications, SOP)
Regulatory Inspections/Audits
Interact w/ internal & external regulatory agencies and provide technical expertise as necessary during audits/inspections
Participate in external and internal audits
Support the development of regulatory responses
Quality Management Systems
Participate in site activities associated with QMS programs (e.g., Validation, Complaints, Change Control)
May assist staff in execution of activities with QMS programs
Write, review and approve Standard Operating Procedures in accordance with Amgen Policies
Review and approve Master Batch Records
Participtate in Quality Risk Assessments
Participtate in site quality management review meetings
Non-Conformance and CAPA
Provide Quality support for the investigation of all classes of 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
Validation
Review and approve validation documents and summary reports
Support execution of validation protocols by timely response to quality issues during execution
Change Control
Provide Quality oversight of change control records; ensure scope of record is clear and implementation activities are completed according to plan
Approve pre and post implementation plans
May provide Quality perspective at Change Control Review Board (CCRB)
Operational Excellence
May support Lean Transformation and Operational Excellence initiatives
Requirements:
Basic Qualifications
University degree. Engineering or Science related discipline preferred
Significant experience (8yrs +) working in the pharmaceutical or biotechnology industry
Preferred Qualifications
Excellent written and verbal communication skills
Experience working with dynamic cross-functional teams and influencing decisions
Experience working in aseptic operations, protein formulation, syringe filling
Experience working with isolator and e-beam technology
Experience with ASTM 2500 approach to equipment commissioning and qualification
Understanding/experience with Trackwise, Change Control Management System, EDMQ and SAP
Knowledge of applicable Regulatory requirements
Experience with Regulatory inspections
Operational Excellence experience
Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations
Possess key competencies: Team Work, Flexibility, Coaching and Motivation, Role Model
Strong organizational skills, including ability to follow assignments through to completion
Package:
12 – 18 month contract
Rate €45 - €55 per hour
Shift: 2 Cycle (8 hr days and evening rotation)= 20 %:
Mon – Fri, 6am – 2pm & 2pm – 10pm
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
Jobs in Dublin
QA
Are you a Senior Quality Assurance Specialist with experience in New Product Introductions? Have you strong Project Management and communication skills.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.
5 x 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 QA Specialist will be a member of the ADL plant QA team that will provide on-the-production-floor support for the start-up activities, new product introductions and commercial manufacturing associated with unit operations in component preparation, formulation, syringe filling, and inspection.
This person will serve as the Quality reviewer and approver batch documentation, non-conformance and CAPA documentation, change control documentation, maintenance work order and job plan approval and other GMP documents pertinent to ADL.
The site is focused on continuous improvement of all work processes and practices and all colleagues are required to be flexible in this regard. This means that they may be asked to carry out additional work functions that are not described in this specification but are associated with their role.
This position requires the ability to work shifts in support of the production schedule. The position will report to a Quality manager and will be located in Dun Laoghaire, Ireland.
Key Responsibilities:
Perform all activities in compliance with Amgen safety standards and SOP’s
Ensure all GMP compliance training is up to date before performing GMP activities and participate in training of new colleagues
Production Floor Duties
Observe and provide real-time support for production unit operations, including observation and assessment of interventions on aseptic fill line
Perform VI AQL inspections
Collaborate with operations to resolve compliance discrepancies
Review production batch records in real-time
Provide Quality representation for triage of non-conformance (NC) events
Review and approve cGMP records (e.g., electronic batch record, change controls, design qualifications, SOP)
Regulatory Inspections/Audits
Interact w/ internal & external regulatory agencies and provide technical expertise as necessary during audits/inspections
Participate in external and internal audits
Support the development of regulatory responses
Quality Management Systems
Participate in site activities associated with QMS programs (e.g., Validation, Complaints, Change Control)
May assist staff in execution of activities with QMS programs
Write, review and approve Standard Operating Procedures in accordance with Amgen Policies
Review and approve Master Batch Records
Participtate in Quality Risk Assessments
Participtate in site quality management review meetings
Non-Conformance and CAPA
Provide Quality support for the investigation of all classes of 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
Validation
Review and approve validation documents and summary reports
Support execution of validation protocols by timely response to quality issues during execution
Change Control
Provide Quality oversight of change control records; ensure scope of record is clear and implementation activities are completed according to plan
Approve pre and post implementation plans
May provide Quality perspective at Change Control Review Board (CCRB)
Operational Excellence
May support Lean Transformation and Operational Excellence initiatives
Requirements:
Basic Qualifications
University degree. Engineering or Science related discipline preferred
Significant experience (8yrs +) working in the pharmaceutical or biotechnology industry
Preferred Qualifications
Excellent written and verbal communication skills
Experience working with dynamic cross-functional teams and influencing decisions
Experience working in aseptic operations, protein formulation, syringe filling
Experience working with isolator and e-beam technology
Experience with ASTM 2500 approach to equipment commissioning and qualification
Understanding/experience with Trackwise, Change Control Management System, EDMQ and SAP
Knowledge of applicable Regulatory requirements
Experience with Regulatory inspections
Operational Excellence experience
Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations
Possess key competencies: Team Work, Flexibility, Coaching and Motivation, Role Model
Strong organizational skills, including ability to follow assignments through to completion
Package:
12 – 18 month contract
Rate €45 - €55 per hour
Shift: 2 Cycle (8 hr days and evening rotation)= 20 %:
Mon – Fri, 6am – 2pm & 2pm – 10pm
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
Jobs in Dublin
QA
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical