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