Quality Systems Specialist
NorthStar is the private label generics (Gx) pharmaceutical sourcing program for McKesson.
NorthStar products are manufactured at established facilities that are registered with the U.
S.
Food and Drug Administration (FDA).
We launched our first prescription drugs in September 2007 selling into markets in North America, and more recently into Europe.
Emphasising product quality, regulatory and supply chain excellence, our Cork based operations team consists of highly qualified professionals who have extensive experience in US FDA-regulated pharmaceutical manufacturing.
As a wholly owned subsidiary of McKesson, NorthStar strives to realise McKesson's important and meaningful mission - enabling better health for our patients - and is guided at every step by our ICARE and ILEAD values.
Working for NorthStar, you will have autonomy and empowerment to make decisions that will closely impact the success of the business.
You will learn and grow in a fast-moving, dynamic working environment where excellence, quality and customer service are hallmarks of our ongoing transformation and success.
Quality Systems SpecialistThe post holder, reporting into the Quality Systems Manager, will assist in ensuring that the Quality Management System (QMS), the associated Electronic QMS software (EQMS), Master Control and other validated electronic systems are operated and maintained in accordance with cGMPs, GAMP, Annex 11, 21 CFR Part 11 and other applicable regulations.
The post holder will be the system owner of NorthStar EQMS, liaising and providing support service to other business units (BU's) with respect to the EQMS.
The post holder will liaise with the EQMS vendor.
The post holder will be the EQMS System administrator and assist in monitoring the QMS, analysing and trending data, generate metrics and prepare reports for the Site.
The post holder will support the monitoring of multiple contract manufacturing changes.
Author, review and approve internal and external quality documentation to support the quality department.
Analyse and trend data, generate metrics and prepare reports for the Quality department and management and ensure product, supplier or system issues are escalated and resolved.
KEY RESPONSIBILITIESSystem owner of NorthStar EQMS, (onsite and additional business units), responsible for the development, integration, modification, operation, maintenance, and upgrading of system.
Maintaining compliance in accordance with cGMPs, GAMP, Annex 11, 21 CFR Part 11 and other applicable regulations.
Liaising with McKesson security teams to ensure EQMS is maintained with applicable security requirements.
Quality reviewer/approver for quality processes e.
g.
change controls, deviations, CAPAs, Standard operating procedure (SOP) and other quality related documents.
Ensuring the NorthStar QMS is maintained in a complaint manner.
Co-ordinate Change Control requests and associated documentation from CMO sitesProvide quality support to other departments in relation to validated electronic systemsParticipate in internal audit programCo-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site and preparation for and/or conducting internal auditsEnsure Good Documentation Practices are adhered to in line with current Good Manufacturing and distribution Practices (cGMDP)Conduct GMP training as required, including roll out of multi-disciplinary cross training and training on the electronic QMSDevelopment and/or appraisal of systems for tracking, trending and reporting of Quality/Site Metrics/KPI's.
Participate in regular team project meetings, keeping Quality Management and team updated on issues and actions which impact the businessBe flexible within the Quality function to meet the needs of the growing business; using technical expertise, skills, knowledge and experience as requiredEducation/Training:
Educated to degree level, ideally B.
Sc.
in Chemistry, Microbiology or other scientific discipline.
Experience:
6
years pharmaceutical experience in a progressive multinational organization.
Minimum 4 years in a Quality Assurance role.
Knowledge and Skills:
Prior experience of being a system owner of an EQMS.
Experience of maintaining EQMS MasterControl or similar application (Trackwise, ETQ) on an enterprise level an advantage.
Working experience of GAMP5, 21CFR Part 11, CSV, Project Life Cycle and GxP Regulations.
Including experience in drafting and reviewing validation documentation.
In-depth understanding and knowledge of cGMP standards and Quality Management and regulatory principles in a pharmaceutical environment and the ability to implement appropriatelyExperience of working within an electronic QMS in an established Quality assurance function within pharmaceutical/healthcare industries.
Experience/Qualification in Root Cause Analysis.
e.
g.
six-sigma Yellow/Green beltProven analytical skills and ability to transfer findings into report and presentation formatsExperience of generating/developing reports with Power BI or similar applicationExcellent verbal, written, and interpersonal communication skills with ability to communicate at all levels within the organizationExcellent interpersonal skills, self-motivation and sense of urgency to make decisions based on judgement and integrity, completing assignments on timeAbility to work effectively with others to accomplish goals in a challenging environmentExcellent organisational and time management skills with the ability to prioritise and manage projects within a team environmentPC/Equipment:
Proficient in Microsoft office.
Essential experience of being a system owner of GxP EQMS system.
Working experience of Power BI or similar application while not essential is a desirable advantage.
Work Environment/Physical Demands:
General office environment; however foreign travel may be required from time to time to meet business needs.
Salary:
$8.
35 - $12.
72.
Estimated Salary: $20 to $28 per hour based on qualifications.
NorthStar products are manufactured at established facilities that are registered with the U.
S.
Food and Drug Administration (FDA).
We launched our first prescription drugs in September 2007 selling into markets in North America, and more recently into Europe.
Emphasising product quality, regulatory and supply chain excellence, our Cork based operations team consists of highly qualified professionals who have extensive experience in US FDA-regulated pharmaceutical manufacturing.
As a wholly owned subsidiary of McKesson, NorthStar strives to realise McKesson's important and meaningful mission - enabling better health for our patients - and is guided at every step by our ICARE and ILEAD values.
Working for NorthStar, you will have autonomy and empowerment to make decisions that will closely impact the success of the business.
You will learn and grow in a fast-moving, dynamic working environment where excellence, quality and customer service are hallmarks of our ongoing transformation and success.
Quality Systems SpecialistThe post holder, reporting into the Quality Systems Manager, will assist in ensuring that the Quality Management System (QMS), the associated Electronic QMS software (EQMS), Master Control and other validated electronic systems are operated and maintained in accordance with cGMPs, GAMP, Annex 11, 21 CFR Part 11 and other applicable regulations.
The post holder will be the system owner of NorthStar EQMS, liaising and providing support service to other business units (BU's) with respect to the EQMS.
The post holder will liaise with the EQMS vendor.
The post holder will be the EQMS System administrator and assist in monitoring the QMS, analysing and trending data, generate metrics and prepare reports for the Site.
The post holder will support the monitoring of multiple contract manufacturing changes.
Author, review and approve internal and external quality documentation to support the quality department.
Analyse and trend data, generate metrics and prepare reports for the Quality department and management and ensure product, supplier or system issues are escalated and resolved.
KEY RESPONSIBILITIESSystem owner of NorthStar EQMS, (onsite and additional business units), responsible for the development, integration, modification, operation, maintenance, and upgrading of system.
Maintaining compliance in accordance with cGMPs, GAMP, Annex 11, 21 CFR Part 11 and other applicable regulations.
Liaising with McKesson security teams to ensure EQMS is maintained with applicable security requirements.
Quality reviewer/approver for quality processes e.
g.
change controls, deviations, CAPAs, Standard operating procedure (SOP) and other quality related documents.
Ensuring the NorthStar QMS is maintained in a complaint manner.
Co-ordinate Change Control requests and associated documentation from CMO sitesProvide quality support to other departments in relation to validated electronic systemsParticipate in internal audit programCo-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site and preparation for and/or conducting internal auditsEnsure Good Documentation Practices are adhered to in line with current Good Manufacturing and distribution Practices (cGMDP)Conduct GMP training as required, including roll out of multi-disciplinary cross training and training on the electronic QMSDevelopment and/or appraisal of systems for tracking, trending and reporting of Quality/Site Metrics/KPI's.
Participate in regular team project meetings, keeping Quality Management and team updated on issues and actions which impact the businessBe flexible within the Quality function to meet the needs of the growing business; using technical expertise, skills, knowledge and experience as requiredEducation/Training:
Educated to degree level, ideally B.
Sc.
in Chemistry, Microbiology or other scientific discipline.
Experience:
6
years pharmaceutical experience in a progressive multinational organization.
Minimum 4 years in a Quality Assurance role.
Knowledge and Skills:
Prior experience of being a system owner of an EQMS.
Experience of maintaining EQMS MasterControl or similar application (Trackwise, ETQ) on an enterprise level an advantage.
Working experience of GAMP5, 21CFR Part 11, CSV, Project Life Cycle and GxP Regulations.
Including experience in drafting and reviewing validation documentation.
In-depth understanding and knowledge of cGMP standards and Quality Management and regulatory principles in a pharmaceutical environment and the ability to implement appropriatelyExperience of working within an electronic QMS in an established Quality assurance function within pharmaceutical/healthcare industries.
Experience/Qualification in Root Cause Analysis.
e.
g.
six-sigma Yellow/Green beltProven analytical skills and ability to transfer findings into report and presentation formatsExperience of generating/developing reports with Power BI or similar applicationExcellent verbal, written, and interpersonal communication skills with ability to communicate at all levels within the organizationExcellent interpersonal skills, self-motivation and sense of urgency to make decisions based on judgement and integrity, completing assignments on timeAbility to work effectively with others to accomplish goals in a challenging environmentExcellent organisational and time management skills with the ability to prioritise and manage projects within a team environmentPC/Equipment:
Proficient in Microsoft office.
Essential experience of being a system owner of GxP EQMS system.
Working experience of Power BI or similar application while not essential is a desirable advantage.
Work Environment/Physical Demands:
General office environment; however foreign travel may be required from time to time to meet business needs.
Salary:
$8.
35 - $12.
72.
Estimated Salary: $20 to $28 per hour based on qualifications.
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