Job Details: Technical Specialist - Materials


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
Technical Specialist - Materials
Technical Specialist -Materials Review Board

An opportunity has arisen for a Technical Specialist to provide expert
technical support on the site Materials Review Board (MRB) team to
support manufacturing and the business priorities of the Vaccines IPT.

The successful candidate will deliver on timely implementations of
Supplier Change Notifications and will be responsible for the delivery
of an effective and efficient MRB support to the Vaccines IPT.

Key Responsibilities

* Ensure highest Quality, Compliance and Safety standards are adhered
to.

* Lead and manage supplier changes assigned. Ensure that key
stakeholders both internal & external are kept informed throughout the
change control lifecycle process.

* Conduct detailed technical assessments of materials and supplier
changes from a Safety, Quality, Technical and Supply perspective and
proactively manage the implementation of changes through the site
change control process.

* Provide ongoing input and support to the MRB team members, support
continuous process improvement initiatives, share their technical
knowledge and promote best practices.

* Participate in problem solving teams as necessary.

* Support the building and fostering relationships with internal and
external stakeholders.

Qualifications and Experience

* Minimum **Apply on the website** years&#**Apply on the website**;
experience in a regulated manufacturing environment - ideally has
worked in either a technical / validation / process engineering
position

* Degree in a Science or Engineering discipline.

* Demonstrated Technical knowledge in pharmaceutical or
Biopharmaceutical operations (e.g. manufacturing, technology,
engineering, quality)

* Understanding of the change control process in a regulated
manufacturing environment.

* Knowledge of material qualification and supplier change
notifications.

* Change management understanding and skills (i.e. Trackwise)

* Knowledge of Quality Supplier systems (i.e. supplier Transparency
system)

* Project Management skills and the ability to lead a project.

* Stakeholder management and management of multi decision makers in
cross functional teams.

* Demonstrated capability to deliver results RFT, in an FDA / HPRA
Regulated production environment.

* Demonstrated high level of problem solving and facilitation skills.

* Working proactively and collaborating across multiple functional
teams.

* Experience dealing with external suppliers/ partners Technical Specialist -Materials Review Board

An opportunity has arisen for a Technical Specialist to provide expert
technical support on the site Materials Review Board (MRB) team to
support manufacturing and the business priorities of the Vaccines IPT.

The successful candidate will deliver on timely implementations of
Supplier Change Notifications and will be responsible for the delivery
of an effective and efficient MRB support to the Vaccines IPT.

Key Responsibilities

* Ensure highest Quality, Compliance and Safety standards are adhered
to.

* Lead and manage supplier changes assigned. Ensure that key
stakeholders both internal & external are kept informed throughout the
change control lifecycle process.

* Conduct detailed technical assessments of materials and supplier
changes from a Safety, Quality, Technical and Supply perspective and
proactively manage the implementation of changes through the site
change control process.

* Provide ongoing input and support to the MRB team members, support
continuous process improvement initiatives, share their technical
knowledge and promote best practices.

* Participate in problem solving teams as necessary.

* Support the building and fostering relationships with internal and
external stakeholders.

Qualifications and Experience

* Minimum **Apply on the website** years&#**Apply on the website**;
experience in a regulated manufacturing environment - ideally has
worked in either a technical / validation / process engineering
position

* Degree in a Science or Engineering discipline.

* Demonstrated Technical knowledge in pharmaceutical or
Biopharmaceutical operations (e.g. manufacturing, technology,
engineering, quality)

* Understanding of the change control process in a regulated
manufacturing environment.

* Knowledge of material qualification and supplier change
notifications.

* Change management understanding and skills (i.e. Trackwise)

* Knowledge of Quality Supplier systems (i.e. supplier Transparency
system)

* Project Management skills and the ability to lead a project.

* Stakeholder management and management of multi decision makers in
cross functional teams.

* Demonstrated capability to deliver results RFT, in an FDA / HPRA
Regulated production environment.

* Demonstrated high level of problem solving and facilitation skills.

* Working proactively and collaborating across multiple functional
teams.

* Experience dealing with external suppliers/ partners

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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