Quality Systems Supervisor
Reporting to the Quality Systems and Compliance Manager, the Quality
Systems Supervisor is responsible for management of Documentation
Compliance Manager (DCM) and archiving in relation to QMS systems.
Responsibilities include managing and coordinating the Internal audit
system, managing Change Control system, CAPA system, Supplier
complaints, the process of vendor/service provider qualification and
other activities related to QMS.
Other additional duties may be assigned by the Technical Director/
Quality Systems and Compliance Manager from time to time if required.
Contribution to the continuous improvement of the Quality Management
System is required.
Extensive knowledge and understanding of regulatory requirements and
guidelines.
Experience/certification in auditing will be considered an advantage.
Experience working in an aseptic area and understanding of Annex 1
requirements will be considered an advantage.
Responsibilities
* Management of Documentation Compliance Manager (DCM) system
* Provide Reports to site in relation to Quality Management System
(QMS) Documentation System as required.
* Management of Documentation Archive for QMS documentation.
* Authoring/reviewing of Standard Operating Procedures (SOP&#**Apply
on the website**;s)
* Communicate with cross functional departments
* Communication with the manufacturing sites in relation to QMS
activities where appropriate
* Management and coordination of Internal audit system
* Management and coordination of Change Control system
* Management and coordination of CAPAs
* Management of the Suppler Qualification/Performance assessment
process
* Management of Supplier complaints
* Providing GMP training for personnel working in aseptic and
non-aseptic environment
* Trending and reporting of Quality metrics
* Managing of Annual Product Reports
* Contribution to the continuous improvement of the Quality
Management System
* Management of GMP introductory and annual refresher training for
all employees
* Any other training in relation to Compliance, as required
* Provide support to corporate and health authorities&#**Apply on
the website**; site audits and response to audits&#**Apply on the
website**; findings
* Provide active support to ensure audit readiness and compliance
with regulations and Health Authorities&#**Apply on the website**;
expectations
* Other duties as required by the Technical Director/Quality Systems
and Compliance Manager
`
Skills and Qualifications
* Excellent communication skills
* Competence in Microsoft packages specifically Word, Excel and
PowerPoint
* Ability to work proactively on own initiative
* Ability to work independently
* Excellent technical writing and analytical skills
* Good organizational and time Management skills
* Flexibility
* Results orientated
* Minimum of 5 years&#**Apply on the website**; experience in
Quality Systems/Document Control role.
* Team Leading/Supervising
* Extensive knowledge and understanding of compliance, EU and FDA
GMP guidelines
* Previous experience in managing/coordinating Change Controls,
CAPAs, deviations, supplier qualification, supplier complaints
* Degree in a science, pharmacy or related discipline.
Desirable Experience
* Previous experience and contribution in site&#**Apply on the
website**;s regulatory audits
* Experience/certification in auditing
* Experience in working in aseptic area and understanding of Annex 1
requirements
* Experience of working in a team environment and participating in
Project teams
For more information Contact Ann Marie Corcoran
COMPANY
GRIFOLS is a global company that since **Apply on the website** has
enhanced the health and well-being of people around the world. Our
four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies -
develop, produce and market innovative solutions and services in more
than **Apply on the website** countries.
Grifols Worldwide Operations Ltd. was established in **Apply on the
website** in Dublin, Ireland. It serves as the management center for
the global Bioscience Division overseeing treasury, risk management,
supply and demand planning, regulatory, R&D and commercial
functions.
It also serves as a hub for labeling, packing, final conditioning and
distribution of finished plasma products to Grifols&#**Apply on the
website**; worldwide network of commercial subsidiaries and
distributors, with the exception of Spain and the United States. The
site will also host an Albumin purification plant which is now under
construction. www.grifols.com
FIND US Location Ireland Job Details
Quality Systems Supervisor
Reporting to the Quality Systems and Compliance Manager, the Quality
Systems Supervisor is responsible for management of Documentation
Compliance Manager (DCM) and archiving in relation to QMS systems.
Responsibilities include managing and coordinating the Internal audit
system, managing Change Control system, CAPA system, Supplier
complaints, the process of vendor/service provider qualification and
other activities related to QMS.
Other additional duties may be assigned by the Technical Director/
Quality Systems and Compliance Manager from time to time if required.
Contribution to the continuous improvement of the Quality Management
System is required.
Extensive knowledge and understanding of regulatory requirements and
guidelines.
Experience/certification in auditing will be considered an advantage.
Experience working in an aseptic area and understanding of Annex 1
requirements will be considered an advantage.
Responsibilities
* Management of Documentation Compliance Manager (DCM) system
* Provide Reports to site in relation to Quality Management System
(QMS) Documentation System as required.
* Management of Documentation Archive for QMS documentation.
* Authoring/reviewing of Standard Operating Procedures (SOP&#**Apply
on the website**;s)
* Communicate with cross functional departments
* Communication with the manufacturing sites in relation to QMS
activities where appropriate
* Management and coordination of Internal audit system
* Management and coordination of Change Control system
* Management and coordination of CAPAs
* Management of the Suppler Qualification/Performance assessment
process
* Management of Supplier complaints
* Providing GMP training for personnel working in aseptic and
non-aseptic environment
* Trending and reporting of Quality metrics
* Managing of Annual Product Reports
* Contribution to the continuous improvement of the Quality
Management System
* Management of GMP introductory and annual refresher training for
all employees
* Any other training in relation to Compliance, as required
* Provide support to corporate and health authorities&#**Apply on
the website**; site audits and response to audits&#**Apply on the
website**; findings
* Provide active support to ensure audit readiness and compliance
with regulations and Health Authorities&#**Apply on the website**;
expectations
* Other duties as required by the Technical Director/Quality Systems
and Compliance Manager
`
Skills and Qualifications
* Excellent communication skills
* Competence in Microsoft packages specifically Word, Excel and
PowerPoint
* Ability to work proactively on own initiative
* Ability to work independently
* Excellent technical writing and analytical skills
* Good organizational and time Management skills
* Flexibility
* Results orientated
* Minimum of 5 years&#**Apply on the website**; experience in
Quality Systems/Document Control role.
* Team Leading/Supervising
* Extensive knowledge and understanding of compliance, EU and FDA
GMP guidelines
* Previous experience in managing/coordinating Change Controls,
CAPAs, deviations, supplier qualification, supplier complaints
* Degree in a science, pharmacy or related discipline.
Desirable Experience
* Previous experience and contribution in site&#**Apply on the
website**;s regulatory audits
* Experience/certification in auditing
* Experience in working in aseptic area and understanding of Annex 1
requirements
* Experience of working in a team environment and participating in
Project teams
For more information Contact Ann Marie Corcoran
COMPANY
GRIFOLS is a global company that since **Apply on the website** has
enhanced the health and well-being of people around the world. Our
four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies -
develop, produce and market innovative solutions and services in more
than **Apply on the website** countries.
Grifols Worldwide Operations Ltd. was established in **Apply on the
website** in Dublin, Ireland. It serves as the management center for
the global Bioscience Division overseeing treasury, risk management,
supply and demand planning, regulatory, R&D and commercial
functions.
It also serves as a hub for labeling, packing, final conditioning and
distribution of finished plasma products to Grifols&#**Apply on the
website**; worldwide network of commercial subsidiaries and
distributors, with the exception of Spain and the United States. The
site will also host an Albumin purification plant which is now under
construction. www.grifols.com
FIND US Location Ireland
We need : English (Good)
Type: Permanent
Payment:
Category: Others
