Are you a Quality Assurance Specialist with experience in a biologics / pharmaceutical / medical device setting? Have you experience in material/supplier investigations supporting raw material quality issues? 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 and provide Quality oversight of Warehouse operations, including disposition of raw materials, project support and change control management
Key Responsibilities:
Perform material/supplier investigations supporting raw material quality issues
Perform change control management of supplier initiated changes
May own specifications, non conformance & CAPA records and change records
Manage Raw Material reserve samples
Negotiate quality agreements with suppliers
Collaborate with Global SQM to provide supplier performance feedback (e.g. supplier scorecards, supplier audits, etc.).
May own site quality system(s) and standard operating procedures
May represent ACO on global network teams and support of new initiatives
Metrics compilation and reporting
Provide SAP expertise
Requirements:
Basic Qualifications
University degree gained in Chemistry, Biology or Science related discipline.
Significant experience gained within the pharmaceutical or biotechnology industry.
Preferred Qualifications
Excellent written and verbal communication skills
Experience working with raw material suppliers
Understanding/experience with Trackwise, Change Control Management System, EDMQ and SAP
Knowledge of applicable Regulatory requirements
Experience with Regulatory inspections desirable
Operational Excellence experience desirable
Experience leading cross-functional teams desirable
Experience utilizing Lean principles and a risk-based approach desirable
Experience working with teams and influencing decisions
Package:
Basic rate of €35 - 40 per hour
Minimum Contract duration: 12 months
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
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Amgen Jobs in Ireland
Are you a Quality Assurance Specialist with experience in a biologics / pharmaceutical / medical device setting? Have you experience in material/supplier investigations supporting raw material quality issues? 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 and provide Quality oversight of Warehouse operations, including disposition of raw materials, project support and change control management
Key Responsibilities:
Perform material/supplier investigations supporting raw material quality issues
Perform change control management of supplier initiated changes
May own specifications, non conformance & CAPA records and change records
Manage Raw Material reserve samples
Negotiate quality agreements with suppliers
Collaborate with Global SQM to provide supplier performance feedback (e.g. supplier scorecards, supplier audits, etc.).
May own site quality system(s) and standard operating procedures
May represent ACO on global network teams and support of new initiatives
Metrics compilation and reporting
Provide SAP expertise
Requirements:
Basic Qualifications
University degree gained in Chemistry, Biology or Science related discipline.
Significant experience gained within the pharmaceutical or biotechnology industry.
Preferred Qualifications
Excellent written and verbal communication skills
Experience working with raw material suppliers
Understanding/experience with Trackwise, Change Control Management System, EDMQ and SAP
Knowledge of applicable Regulatory requirements
Experience with Regulatory inspections desirable
Operational Excellence experience desirable
Experience leading cross-functional teams desirable
Experience utilizing Lean principles and a risk-based approach desirable
Experience working with teams and influencing decisions
Package:
Basic rate of €35 - 40 per hour
Minimum Contract duration: 12 months
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