Job Details: Senior Quality


jobContax

104 Upper Drumcondra Road,
Dublin 9
http://www.jobcontax.com
Please contact: Karen
JobContax was founded in 2001 by Karen McHugh, an engineer passionate about offering quality opportunities to the jobseeker and an intelligent service to the client. Jobcontax has successfully operated as a global market leader and technical specialist within the following sectors:

Construction and Infrastructure

Engineering and Design

Mining - Oil and Gas

Biotechnology and Pharmaceutical

During the past 10 years Jobcontax have expanded our international network across 5 continents. In 2005 we began recruiting for the Australian market and in 2011 we set up our first strategic partnership in WA. In March 2010, we opened our Shanghai office to strengthen our presence in the rapidly expanding Chinese market for highly skilled professionals. JobContax has a strong presence in Canada, Europe and the Middle East.

Jobcontax has built its reputation on its consultative approach. Our understanding of the industries and the businesses and individuals within these industries enables us to facilitate the perfect match between client and jobseeker. From global multinationals to SME?, Jobcontax has become the trusted recruitment partner.
Senior Quality
Job Description




The Senior Quality/Technical Specialist will be suitably experienced in some, or all of the key focus areas for this role. The Senior Quality Technical Specialist will undertake activities suited to their experience and skill level. The Senior Quality Technical Specialist will act as a mentor to the team of Quality Technical Specialists and will be required to cross-train such that areas of responsibility can be rotated or Specialists up-skilled in different areas of responsibility as required by business need. The Senior Quality Technical Specialist will coordinate delivery of client and in-house projects.

 

Service Delivery

To manage and deliver MPI services, such as, the virtual QA service, the HelpDesk and Regulatory Intelligence as required or requested.

 To work on their own initiative and drive the technical support to client and MPI projects, including technical support to MPI consultants as required.

 

Project Management

To provide project management support to MPI projects by liaising with clients to establish their requirements in terms of the technical or regulatory, training or auditing services provided by MPI (or additional services as identified).

To provide support to Consultants by developing client and Associate Project Agreements, based on client needs, terms and timelines.

To project manage assigned MPI projects to ensure project delivery within agreed timelines and budgets.

 

Business Development / Sales & Marketing

To keep abreast of changing regulatory standards, industry best practice and emerging trends to provide input to business development and product development opportunities.

Under the direction of the Business Development/Marketing Manager, participate in business development and marketing initiatives and programmes.

 

Communication

Contribute technical articles to company and external publications.

Contribute technical information to the Company website as required or requested.

 

Budgeting

To input, as requested, into the annual MPI budgeting process.

To input into the development of MPI and client project budgets as required and to manage delivery of all assigned projects within the agreed budget.

 

Customer Service

To deal with internal/external customer contacts and resolve queries and problems in an appropriate, effective and timely manner.

To liaise with Clients, regulatory authorities and other external parties as required / requested on behalf of clients and/ or on behalf of McGee Pharma International.

 

Compliance

To develop and maintain the MPI quality system.

To ensure compliance with all MPI company policies and procedures.


 

Requirements:



3rd Level Qualification in a Science subject, qualification in Quality Management a plus.

Ideally 8 + years experience in the Pharmaceutical Industry in a GMP environment

Ideally experience in Good Distribution Practice or Market Authorisation Holder Compliance

High level computer literacy and competency – Microsoft Office

 

Knowledge, Skills & Behaviours

In-depth understanding of regulatory requirements applicable to the Pharmaceutical Industry, and knowledge of the sources of regulatory information (medical devices and cosmetics industries also considered).

In-depth understanding of the purpose, objectives and scope of Quality Systems

 

Demonstrated ability in:

Effectively resolving compliance issues

Working with third parties

Creation of third party contracts / project agreements

Working in cross-functional teams

Contributing to company programmes or projects

Managing change, influencing stakeholders and delivering results

 

Skills

Strong Communication Skills – strong business English capability

Strong technical writing skills

Project Management Skills

Strong Interpersonal Skills – when working with MPI staff, Associates, clients and external 3rd parties




Package:

Contract rate - Negotiable based on experience

Minimum Contract duration: 6 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

Job Description




The Senior Quality/Technical Specialist will be suitably experienced in some, or all of the key focus areas for this role. The Senior Quality Technical Specialist will undertake activities suited to their experience and skill level. The Senior Quality Technical Specialist will act as a mentor to the team of Quality Technical Specialists and will be required to cross-train such that areas of responsibility can be rotated or Specialists up-skilled in different areas of responsibility as required by business need. The Senior Quality Technical Specialist will coordinate delivery of client and in-house projects.

 

Service Delivery

To manage and deliver MPI services, such as, the virtual QA service, the HelpDesk and Regulatory Intelligence as required or requested.

 To work on their own initiative and drive the technical support to client and MPI projects, including technical support to MPI consultants as required.

 

Project Management

To provide project management support to MPI projects by liaising with clients to establish their requirements in terms of the technical or regulatory, training or auditing services provided by MPI (or additional services as identified).

To provide support to Consultants by developing client and Associate Project Agreements, based on client needs, terms and timelines.

To project manage assigned MPI projects to ensure project delivery within agreed timelines and budgets.

 

Business Development / Sales & Marketing

To keep abreast of changing regulatory standards, industry best practice and emerging trends to provide input to business development and product development opportunities.

Under the direction of the Business Development/Marketing Manager, participate in business development and marketing initiatives and programmes.

 

Communication

Contribute technical articles to company and external publications.

Contribute technical information to the Company website as required or requested.

 

Budgeting

To input, as requested, into the annual MPI budgeting process.

To input into the development of MPI and client project budgets as required and to manage delivery of all assigned projects within the agreed budget.

 

Customer Service

To deal with internal/external customer contacts and resolve queries and problems in an appropriate, effective and timely manner.

To liaise with Clients, regulatory authorities and other external parties as required / requested on behalf of clients and/ or on behalf of McGee Pharma International.

 

Compliance

To develop and maintain the MPI quality system.

To ensure compliance with all MPI company policies and procedures.


 

Requirements:



3rd Level Qualification in a Science subject, qualification in Quality Management a plus.

Ideally 8 + years experience in the Pharmaceutical Industry in a GMP environment

Ideally experience in Good Distribution Practice or Market Authorisation Holder Compliance

High level computer literacy and competency – Microsoft Office

 

Knowledge, Skills & Behaviours

In-depth understanding of regulatory requirements applicable to the Pharmaceutical Industry, and knowledge of the sources of regulatory information (medical devices and cosmetics industries also considered).

In-depth understanding of the purpose, objectives and scope of Quality Systems

 

Demonstrated ability in:

Effectively resolving compliance issues

Working with third parties

Creation of third party contracts / project agreements

Working in cross-functional teams

Contributing to company programmes or projects

Managing change, influencing stakeholders and delivering results

 

Skills

Strong Communication Skills – strong business English capability

Strong technical writing skills

Project Management Skills

Strong Interpersonal Skills – when working with MPI staff, Associates, clients and external 3rd parties




Package:

Contract rate - Negotiable based on experience

Minimum Contract duration: 6 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



We need : English (Good)

Type: Permanent
Payment: package
Category: Pharmaceutical

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