Job vacancies ...

We're looking for people to fill the following positions.

 
Position:
 

Quality Systems Specialist

 
Description:
 

The overall responsibility for this role will be to implement, lead, monitor and support the performance of the Quality Systems at the site according to Takeda and cGMP standards.  This is an important role within the Site Quality leadership organisation to help create value for our patients.

 
Category:
 
Quality Assurance
 
Posted:
 
08-Aug-19
 
Closing:
 
30-Aug-19
 
Web Link:
 
 
 
 
Position:
 

Director, Supply Chain

 
Description:
 

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As the Supply Chain Director working as part of the Site Leadership Team, you will provide leadership and direction in the development of the supply chain function at an expanding site that covers multiple manufacturing technologies including bulk API production, high potent API, finished product and packaging, and biologics. The Supply Chain Director will have overall responsibility for logistics, warehousing, procurement of production materials and consumables, production planning and artwork including establishment, execution and reporting of departmental systems, goals, priorities, schedules, risk analysis, capacities, budgets, metrics and timelines

 
Category:
 
Supply Chain & Planning
 
Posted:
 
08-Aug-19
 
Closing:
 
30-Aug-19
 
Web Link:
 
 
 
 
Position:
 

Quality Specialist - CMO

 
Description:
 

Our Quality CMO team is accountable for oversight of Biologics product manufactured at CMOs on behalf of Takeda.


The scope includes Drug Substance, Drug product and Finished Drug Product CMOs.

 
Category:
 
Quality Assurance
 
Posted:
 
08-Aug-19
 
Closing:
 
31-Aug-19
 
Web Link:
 
 
 
 
Position:
 

Quality Systems and Compliance

 
Description:
 

Our Quality Systems and Compliance team is responsible for Quality Systems and Compliance for Biologics product in Takeda’s external sites and external contract manufacturing and testing organisation for Drug Substance, Drug Product and Finished Drug product manufacturing.

 
Category:
 
Quality Control
 
Posted:
 
08-Aug-19
 
Closing:
 
30-Sep-19
 
Web Link:
 
 
 
 
Position:
 

Quality Control Analyst - Microbiology

 
Description:
 

Quality Control Manager - Dunboyne, Co Meath, Ireland -Technical Operations

 
Category:
 
Quality Control
 
Posted:
 
10-Jun-19
 
Closing:
 
31-Jul-19
 
Web Link:
 
 
 
 
Position:
 

Quality Compliance Specialist

 
Description:
 

The Quality Compliance Specialist is responsible for the coordination of compliance activities within the compliance group and for varying duties as assigned by the Quality Systems and Compliance Manager.

 
Category:
 
Quality Control
 
Posted:
 
10-Jun-19
 
Closing:
 
31-Jul-19
 
Web Link:
 
 
 
 
Position:
 

Auditor – Supplier Qualification-Austria

 
Description:
 

Excuting and planning supplier audits in Europe

 
Category:
 
Quality Assurance
 
Posted:
 
23-Nov-18
 
Closing:
 
20-Dec-18
 
Web Link:
 
 
 
 
Position:
 

PMO Lead

 
Description:
 
The PMO Lead will lead the establishment of PMO for Dunboyne ensuring alignement to the TOLT and BOLT strategic priorities. Also provide day to day support for the delivery of the operational readiness plan providing regular updates to workstream leads, leadership team and external stakeholders for our new state of the art single use multi-product biotech facility in County Meath, Ireland. This facility will manufacture enzyme replacement and antibody-based therapies for Shire, the leading global biotech company focussed on rare diseases . Key responsibility is overall day to day program management integration across Quality, Manufacturing, Engineering, Process Development Technical Services, Business Excellence, Supply Chain, HR, EHS, IT and Finance to ensure all operational systems and processes are in place and integrated with the project delivery schedule.. This role is a critical role within the site Operational Readiness team to create value for our patients
 
Category:
 
Project Management
 
Posted:
 
10-Sep-18
 
Closing:
 
10-Oct-18
 
Web Link:
 
 
 
 
Position:
 

Supply Chain Lead

 
Description:
 
The Supply Planning Lead will lead Supply Chain operations for our new state of the art single use multi-product biotech facility in County Meath, Ireland. This facility will manufacture enzyme replacement and antibody-based therapies for Shire, the leading global biotech company focussed on rare diseases . Key responsibility is all Suppply Chain operations on site. This role is a critical role on the site leadership team to create value for our patients.Directly responsible for supply chain planning team (master planners, production planners, analysts, planner buyers and process owners) and warehouse team.Responsible to oversee all supply chain processes providing leadership and directions to maximize service levels, inventory turns and efficiency. Actively support plant Long range capacity planning (LRCP) and lead monthly plant Sales & Operations (S&OP) processes.
 
Category:
 
Supply Chain & Planning
 
Posted:
 
30-May-18
 
Closing:
 
30-Jun-18
 
Web Link:
 
 
 
 
Position:
 

Global Quality Control Method Introduction And Site Support Lead

 
Description:
 
This role will serve as the site lead for the Global Quality Control (QC) Team for Method Introduction & Site Support (MI&S) for the Shire single use multi-product biotech facility in Dunboyne, Ireland. This facility will manufacture enzyme replacement and antibody-based therapies for Shire.
 
Category:
 
Quality Control
 
Posted:
 
01-May-18
 
Closing:
 
30-Jun-18
 
Web Link:
 
 
 
 
Position:
 

Quality Operations Lead

 
Description:
 
This role will serve as the lead for the Quality Assurance (QA) Operations function at our new ‘state of the art’ single use multi-product biotech facility in Dunboyne, County Meath, Ireland. This facility will manufacture enzyme replacement and antibody-based therapies for Shire, the leading global biotech company focused on rare diseases. The overall responsibility for this role will be to manage, plan and direct the Quality Operations team, ensuring compliance with cGMP and corporate regulations. This is a critical role within the Quality leadership organisation to help create value for our patients.
 
Category:
 
Quality Control
 
Posted:
 
01-May-18
 
Closing:
 
30-Jun-18
 
Web Link:
 
 
 
 
Position:
 

Operational Readiness Lead

 
Description:
 
Key responsibility is overall program management integration across

Quality, Manufacturing, Engineering, Process Development Technical Services, Business Excellence, Supply Chain, HR, EHS, IT and Finance to ensure all operational systems and processes are in place and integrated with the project delivery schedule. This role will lead program management activities to ensure the way we want Piercetown to operate when in commercial manufacture is embedded into the project as an operations deliverable.. This role is

a critical role on the site leadership team to create value for our patients
 
Category:
 
Production & Operations
 
Posted:
 
01-May-18
 
Closing:
 
30-Jun-18
 
Web Link:
 
 
 
 
Position:
 

Associate Director / External Sites Operations Lead

 
Description:
 
The ESO Lead will provide support for various drug product and packaging contract manufacturing needs and manage multiple global CDMO relationships to achieve Shire’s business objectives. They will possess excellent and current knowledge of the Contract Development and Manufacturing domain with specialization in drug product and packaging, keep up to date with changes and developments within this market place, understand where current suppliers sit within this market place and will be expected to make a significant contribution to developing a world-class External Sites Operations organization. The role will be expected to:
 
Category:
 
Supply Chain & Planning
 
Posted:
 
27-Sep-17
 
Closing:
 
26-Oct-17
 
Web Link:
 
 
 
 
Position:
 

Qualified Person IMP (Small Molecule And Biologics Products)

 
Description:
 
To act as a Qualified Person (QP) named on Shire Pharmaceuticals Manufacturing and Import Authorization (MIA) for Investigational Medicinal Products under the direction of the Head of GMP Clinical QA with responsibility for Shire investigational medicinal products in accordance with their Clinical Trial Authorizations (national or European), their Investigational Medicinal Products Dossiers and their Manufacturing Authorizations and the principles and guidelines of GMP as laid down in Directive 2003/94/EC and in accordance with principles and the detailed guidelines of Good Manufacturing Practice for Medicinal Products (The Rules Governing Medicinal Products in The European Community, Volume IV).
 
Category:
 
Quality Assurance
 
Posted:
 
27-Sep-17
 
Closing:
 
26-Oct-17
 
Web Link:
 
 
 
 
Position:
 

Director – Head Of External Site Operations / Small Molecules Drug Products & Packaging

 
Description:
 
The External Site Operations (ESO) Director, either directly, or via a small team of ESL Leads / direct reports, initiates, develops and manages operations at external sites to achieve Shire’s corporate business objectives and accountable for driving significant contribution to developing a world-class ESO capability within the Technical Operations organization. Key focus is delivery of value to Shire and timely supply of medicines to patients.
 
Category:
 
Quality Assurance
 
Posted:
 
27-Sep-17
 
Closing:
 
27-Oct-17
 
Web Link:
 
 
 
 
Position:
 

INTERNAL AUDIT MANAGER

 
Description:
 
Shire’s Global Internal Audit (GIA) function plays a valuable role in protecting and enhancing the organization’s value by providing risk-based and objective assurance, advice, and insights. The function is guided by a disciplined, collaborative approach that is aligned with Shire’s strategy and the IIA standards with a focus on constant innovation and talent development.
 
Category:
 
Financial Management
 
Posted:
 
22-Feb-17
 
Closing:
 
31-Mar-17
 
Web Link:
 
 
 
 
Position:
 

Qualified Person IMP (Small Molecule Products)

 
Description:
 
Technical Operations

We are looking for a Qualified Person (IMP) to be based in our Dublin office. This person will act as a Qualified Person (QP) named on Shire Pharmaceuticals Manufacturing and Import Authorization (MIA) for Investigational Medicinal Products (IMP) under the direction of the Head of IMP-QP & SM GMP Clinical QA EU QP certification activities with responsibility for Shire IMP in accordance with their Clinical Trial Authorizations (national or European), their IMP Dossiers and their Manufacturing Authorizations and the principles and guidelines of GMP as laid down in Directive 2003/94/EC and in accordance with principles and the detailed guidelines of Good Manufacturing Practice (GMP) for Medicinal Products (The Rules Governing Medicinal Products in The European Community, Volume IV).
 
Category:
 
Production & Operations
 
Posted:
 
20-Dec-16
 
Closing:
 
25-Jan-17
 
Web Link:
 
 
 
 
Position:
 

Business Analyst

 
Description:
 
The Business Analyst, Supply Chain (Demand through Customer Invoice) and Quality (product quality, regulatory compliance) analyzes the organization’s need, assesses and documents its processes and systems, and helps define the business model and its integration with technology. The Business Analyst leverages appropriate cross-functional expertise from the service management group, architecture, business experts and IT leadership to develop accurate cost, resource and time estimates for both initial development and ongoing support for a proposed solution.
 
Category:
 
Information Technology
 
Posted:
 
07-Jun-16
 
Closing:
 
07-Jul-16
 
Web Link:
 
 
 
 
Position:
 

Transportation Specialist

 
Description:
 
Oversee distribution lanes to ensure optimum costs while maintaining high customer service levels.
 
Category:
 
Supply Chain & Planning
 
Posted:
 
23-May-16
 
Closing:
 
20-Jun-16
 
Web Link:
 
 
 
 
Position:
 

External Manufacturing Operations Lead

 
Description:
 
The successful candidate will be the lead role responsible for managing, coordinating, and ensuring clinical and commercial manufacturing operations at specific external partner (CMO) sites. Initial focus will include leading and developing a highly complex multi-activity manufacturing operation providing global supply for a key product asset.
The role holder will be the key business relationship owner with the CMO’s, ensuring effective communication with the CMOs and Shire functions.
 
Category:
 
Supply Chain & Planning
 
Posted:
 
02-Apr-15
 
Web Link:
 
 
 
 
Position:
 

Sales and Operations Planning Lead

 
Description:
 
Technical Operations:This role leads the global S&OP processes for a portfolio of products from late stage product development to end of product lifecycle to meet patient demand, achieve business revenue and profit goals, whilst optimizing the cost to serve.
Supports Shire’s global S&OP operating and governance model including: strategy, process, organization, performance metrics, reporting, and technology.
 
Category:
 
Production & Operations
 
Web Link:
 
 
 
 
 
 
 
 
 
 
 

About Us

SURIMS is the new name for Actex Pharma Services which was a consultancy established in 2003, supporting companies in the identification, qualification and management of quality vendors and suppliers in ingredients and formulations.

The Pharmaceutical Services Directory supports the identification and on-boarding of quality suppliers and also incorporates software features that manage relationships between suppliers and their customers. These include the building and deployment of questionnaires and assessments, electronic signatures and sign-offs and project management between vendor/partner and customer.

Access to the features and software is available on a 'pay as you go' basis, or a customised version can be licensed for your company for its own supplier on-boarding and supplier management activities. Further information on our software services please contact Tel: +353 87 294 0436 or email info@pharmaservicesdirectory.com

 
 
 

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info@pharmaservicesdirectory.com.

 
 

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