IN PARTNERSHIP WITH ITS CLIENT KENNY-WHELAN & ASSOCIATES IS CURRENTLY
SOURCING FOR A DOCUMENTATION SPECIALIST FOR THE CORK AREA.
PROFILE OF ROLE:
The Documentation Specialist will provide compliant, accurate and
timely documentation support to the IPT/COE team.
MAIN DUTIES AND RESPONSIBILITIES:
* The Documentation Specialist is accountable for the smooth
execution of all appropriate documentation associated within the
IPT/COE Team.
* He/she will contribute to the High Performance culture within the
IPT/COE by providing a flexible and accurate service.
* The Documentation Specialist is an active member of the cross
functional IPT/COE Team, providing support, guidance and expertise to
ensure the success of the IPT/COE team.
* He/she will participate and comply with the Quality Management
System (QMS) requirements, including ownership, as relevant to your
role.
PRIMARY ACTIVITIES/RESPONSIBILITIES:
* Updating of procedural documents;
* Preparation of change control documentation;
* Processing of documentation through the Change Control System;
* Review of batch records and recording of incidences of corrections
made to batch records;
* Generation and control of protocols
* Responsible for supporting a culture of Continuous Improvement by
deploying Six Sigma tools within the IPT/COE on projects .
Skills & Experience:
* Demonstrated knowledge of the requirements for entries and
completion of batch records.
* Knowledge and experience of GMP and GDP in a pharmaceutical
environment.
* Demonstrated knowledge in more than one pharmaceutical and/or
chemical manufacturing operation (e.g. Manufacturing, Quality,
Engineering, Tech Services etc).
* At least three years? experience in the Pharmaceutical industry
or a similar operating environment.
* Knowledge of and experience in applying Lean Six Sigma and Lean
methodologies.
EDUCATION AND EXPERIENCE:
* Relevant 3rd Level Qualification (Science, Engineering, Quality,
Production)
* Desirable: Qualification in a biological science subject.
* Desirable: Evidence of Continuous Personal Development.
* Six Sigma Yellow Belt very desirable or working towards it
 MISC:
* Team player
* Meticulous Attention to detail
* Ability to manage workload and prioritise
ALL APPLICATIONS WILL BE TREATED WITH THE STRICTEST CONFIDENCE
KENNY-WHELAN CONTACT:
JOB DESCRIPTION
IN PARTNERSHIP WITH ITS CLIENT KENNY-WHELAN & ASSOCIATES IS CURRENTLY
SOURCING FOR A DOCUMENTATION SPECIALIST FOR THE CORK AREA.
PROFILE OF ROLE:
The Documentation Specialist will provide compliant, accurate and
timely documentation support to the IPT/COE team.
MAIN DUTIES AND RESPONSIBILITIES:
* The Documentation Specialist is accountable for the smooth
execution of all appropriate documentation associated within the
IPT/COE Team.
* He/she will contribute to the High Performance culture within the
IPT/COE by providing a flexible and accurate service.
* The Documentation Specialist is an active member of the cross
functional IPT/COE Team, providing support, guidance and expertise to
ensure the success of the IPT/COE team.
* He/she will participate and comply with the Quality Management
System (QMS) requirements, including ownership, as relevant to your
role.
PRIMARY ACTIVITIES/RESPONSIBILITIES:
* Updating of procedural documents;
* Preparation of change control documentation;
* Processing of documentation through the Change Control System;
* Review of batch records and recording of incidences of corrections
made to batch records;
* Generation and control of protocols
* Responsible for supporting a culture of Continuous Improvement by
deploying Six Sigma tools within the IPT/COE on projects .
Skills & Experience:
* Demonstrated knowledge of the requirements for entries and
completion of batch records.
* Knowledge and experience of GMP and GDP in a pharmaceutical
environment.
* Demonstrated knowledge in more than one pharmaceutical and/or
chemical manufacturing operation (e.g. Manufacturing, Quality,
Engineering, Tech Services etc).
* At least three years? experience in the Pharmaceutical industry
or a similar operating environment.
* Knowledge of and experience in applying Lean Six Sigma and Lean
methodologies.
EDUCATION AND EXPERIENCE:
* Relevant 3rd Level Qualification (Science, Engineering, Quality,
Production)
* Desirable: Qualification in a biological science subject.
* Desirable: Evidence of Continuous Personal Development.
* Six Sigma Yellow Belt very desirable or working towards it
 MISC:
* Team player
* Meticulous Attention to detail
* Ability to manage workload and prioritise
ALL APPLICATIONS WILL BE TREATED WITH THE STRICTEST CONFIDENCE
KENNY-WHELAN CONTACT:
We need : English (Good)
Type: Permanent
Payment:
Category: Others
