* A new opportunity has arisen for a QC Documentation/Administration
Specialist at our client?s pharmaceutical site in Co. Dublin.
* The successful candidate will be responsible for supporting the
Quality Control Department in the management of department
documentation, and support of the QC functions through various
administrative duties.
* The individual will ensure that objectives are effectively achieved,
consistent with the company requirements to ensure compliance, safety
and reliable supply to their customers.
Core
DUTIES AND RESPONSIBILITIES:
* Supporting the management of QC documentation including archival of
executed protocols, true copy of executed protocols/reports/documents,
authoring/updating QC SOP?s and data compilation/review and data
verification as directed
* Support for preparation of trend reports
* Coordination and management of QC eLogs
* Support for 5S, housekeeping and audit readiness for QC Labs
* Placing purchase orders for non VMI QC lab reagents and
coordination/payment of associated invoices
* Management of purchase orders and associated activities related to
budgets and expense reporting
* Understands and applies regulatory / compliance requirements to
their role together with remaining current on upcoming regulatory and
compliance changes.
* Responds to non-standard requests from customer needs.
* Makes decisions within guidelines and policies which impact own
priorities and allocation of time to meet deadlines.
* Use standard systems including MS Word, Excel, PowerPoint, Outlook,
SAP and various company and industry specific software such as
document tracking, work order entry/tracking, procurement,
manufacturing entry/reporting, etc.
* Lead daily tier meetings, and coordinate bi-weekly departmental
updates
* Scheduling, coordinating and monitoring appointments for department
managers
* Monitoring of department training due dates in Learning Management
System (LMS) and supporting system/training requests.
* Coordination of QC Training curricula and manage and maintain area
curricula builds
* QC designee for Learning and Development (L&D) site meetings
* Communicate L&D topics and updates at area weekly tiers/meetings
* Managing learning plan matrices updates when new learning identified
(confirming impacted job roles & assignment) e.g. new SOP/WI resulting
in new learning in area/cross functionally.
* Attend weekly L&D business partner meetings and monthly point of
contact site meeting.
* Share L&D information / updates with QC colleagues and champion a
site agile, Learner-centric Learning culture.
_MINIMUM QUALIFICATIONS_ and
EXPERIENCE:
* Bachelor&#**Apply on the website**;s degree (or higher) in
Chemistry, Biology, Microbiology, Automation, Engineering or
equivalent
* A minimum of **Apply on the website** years? experience in Quality
Control, Quality Assurance or Pharmaceutical or Biological Operations
* Knowledge of EU/US quality related pharmaceutical regulations
* Basic computer literacy, strong communication and organisational
skills
* High level of technical aptitude & motivation and good presentation
skills.
* Demonstrated ability to take initiative and attention to detail
* Excellent knowledge of relevant Quality and GMP Compliance
Guidelines
To Apply:
If you would like to discuss this vacancy or to discuss your career
and other job opportunities in confidence, contact us:
**Apply on the website** Danville Business Park, Kilkenny, Ireland
(phone number removed)
recruitment
Please note, we do not require agency assistance with this role Role Summary:
* A new opportunity has arisen for a QC Documentation/Administration
Specialist at our client?s pharmaceutical site in Co. Dublin.
* The successful candidate will be responsible for supporting the
Quality Control Department in the management of department
documentation, and support of the QC functions through various
administrative duties.
* The individual will ensure that objectives are effectively achieved,
consistent with the company requirements to ensure compliance, safety
and reliable supply to their customers.
Core
DUTIES AND RESPONSIBILITIES:
* Supporting the management of QC documentation including archival of
executed protocols, true copy of executed protocols/reports/documents,
authoring/updating QC SOP?s and data compilation/review and data
verification as directed
* Support for preparation of trend reports
* Coordination and management of QC eLogs
* Support for 5S, housekeeping and audit readiness for QC Labs
* Placing purchase orders for non VMI QC lab reagents and
coordination/payment of associated invoices
* Management of purchase orders and associated activities related to
budgets and expense reporting
* Understands and applies regulatory / compliance requirements to
their role together with remaining current on upcoming regulatory and
compliance changes.
* Responds to non-standard requests from customer needs.
* Makes decisions within guidelines and policies which impact own
priorities and allocation of time to meet deadlines.
* Use standard systems including MS Word, Excel, PowerPoint, Outlook,
SAP and various company and industry specific software such as
document tracking, work order entry/tracking, procurement,
manufacturing entry/reporting, etc.
* Lead daily tier meetings, and coordinate bi-weekly departmental
updates
* Scheduling, coordinating and monitoring appointments for department
managers
* Monitoring of department training due dates in Learning Management
System (LMS) and supporting system/training requests.
* Coordination of QC Training curricula and manage and maintain area
curricula builds
* QC designee for Learning and Development (L&D) site meetings
* Communicate L&D topics and updates at area weekly tiers/meetings
* Managing learning plan matrices updates when new learning identified
(confirming impacted job roles & assignment) e.g. new SOP/WI resulting
in new learning in area/cross functionally.
* Attend weekly L&D business partner meetings and monthly point of
contact site meeting.
* Share L&D information / updates with QC colleagues and champion a
site agile, Learner-centric Learning culture.
_MINIMUM QUALIFICATIONS_ and
EXPERIENCE:
* Bachelor&#**Apply on the website**;s degree (or higher) in
Chemistry, Biology, Microbiology, Automation, Engineering or
equivalent
* A minimum of **Apply on the website** years? experience in Quality
Control, Quality Assurance or Pharmaceutical or Biological Operations
* Knowledge of EU/US quality related pharmaceutical regulations
* Basic computer literacy, strong communication and organisational
skills
* High level of technical aptitude & motivation and good presentation
skills.
* Demonstrated ability to take initiative and attention to detail
* Excellent knowledge of relevant Quality and GMP Compliance
Guidelines
To Apply:
If you would like to discuss this vacancy or to discuss your career
and other job opportunities in confidence, contact us:
**Apply on the website** Danville Business Park, Kilkenny, Ireland
(phone number removed)
recruitment
Please note, we do not require agency assistance with this role
We need : English (Good)
Type: Permanent
Payment:
Category: Others
