Orion Group Life Sciences have an exciting opportunity for a QA
Associate for our Multinational Biotechnology client based in South
Dublin on an initial **Apply on the website**-month contract with the
potential to extend.
Job Purpose
The Plant Quality Assurance (PQA) Snr Associate will be part of the
PQA team and will report to PQA Snr Manager. The QA Snr Associate will
serve as Quality point of contact for Packaging operations. A variety
of shift patterns may be required to support packaging operations, the
current shift pattern is a **Apply on the website**/7 shift pattern.
Main
_RESPONSIBILITIES_ of the role
* Perform all activities in compliance with safety standards and SOPs
* Observe and provide real-time Quality oversight and support for
Packaging unit operations.
* Participates in Customer complaint investigations.
* Perform Packaging check audits.
* Provide Quality support for triage and investigation of all classes
of deviation events
* Review and approval of Deviations and CAPAs for closure ensuring
compliance with appropriate documentation, whilst ensuring that CAPA
actions address root cause and implementation plan dates are
achievable
* Review/approve production batch records, and associated
documentation in preparation for Qualified Person disposition
activities.
* Provides training and advice to staff in order for them to perform
their desired functions.
* Write, review and approve Standard Operating Procedures in
accordance with Policies.
* Support continuous improvement and Operational Excellence
initiatives
* Any other tasks/projects assigned as per manager&#**Apply on the
website**;s request.
Desired Experience and Background of the successful candidate
* University degree required - Engineering or Science related
discipline preferred.
* Relevant experience (3 yrs +) working in the pharmaceutical or
biotechnology industry
* Experience working with dynamic cross-functional teams and proven
abilities in decision making
* Demonstrated ability in problem solving and experience in managing
Root Cause Analysis / Deviation investigations
* Experience working with combination products or devices in
packaging-related or complaint-handling activities
* Knowledge of applicable Regulatory requirements, and ability to
evaluate compliance issues
* Operational Excellence experience
For more information on this role, call Ian Towler on (phone number
removed) or email (url removed) for a completely confidential chat
about this role and other opportunities using the reference number:
TR/(phone number removed)
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing
personnel that reflects the diversity and values of our client base
but also that of Orion Group. We welcome the wide range of experiences
and viewpoints that potential workers bring to our business and our
clients, including those based on nationality, gender, culture,
educational and professional backgrounds, race, ethnicity, sexual
orientation, gender identity and expression, disability, and age
differences, job classification and religion.
In our inclusive workplace, regardless of your employment status as
staff or contract, everyone is assured the right of equitable, fair
and respectful treatment Position: ?QA Associate **Apply on the website**
Orion Group Life Sciences have an exciting opportunity for a QA
Associate for our Multinational Biotechnology client based in South
Dublin on an initial **Apply on the website**-month contract with the
potential to extend.
Job Purpose
The Plant Quality Assurance (PQA) Snr Associate will be part of the
PQA team and will report to PQA Snr Manager. The QA Snr Associate will
serve as Quality point of contact for Packaging operations. A variety
of shift patterns may be required to support packaging operations, the
current shift pattern is a **Apply on the website**/7 shift pattern.
Main
_RESPONSIBILITIES_ of the role
* Perform all activities in compliance with safety standards and SOPs
* Observe and provide real-time Quality oversight and support for
Packaging unit operations.
* Participates in Customer complaint investigations.
* Perform Packaging check audits.
* Provide Quality support for triage and investigation of all classes
of deviation events
* Review and approval of Deviations and CAPAs for closure ensuring
compliance with appropriate documentation, whilst ensuring that CAPA
actions address root cause and implementation plan dates are
achievable
* Review/approve production batch records, and associated
documentation in preparation for Qualified Person disposition
activities.
* Provides training and advice to staff in order for them to perform
their desired functions.
* Write, review and approve Standard Operating Procedures in
accordance with Policies.
* Support continuous improvement and Operational Excellence
initiatives
* Any other tasks/projects assigned as per manager&#**Apply on the
website**;s request.
Desired Experience and Background of the successful candidate
* University degree required - Engineering or Science related
discipline preferred.
* Relevant experience (3 yrs +) working in the pharmaceutical or
biotechnology industry
* Experience working with dynamic cross-functional teams and proven
abilities in decision making
* Demonstrated ability in problem solving and experience in managing
Root Cause Analysis / Deviation investigations
* Experience working with combination products or devices in
packaging-related or complaint-handling activities
* Knowledge of applicable Regulatory requirements, and ability to
evaluate compliance issues
* Operational Excellence experience
For more information on this role, call Ian Towler on (phone number
removed) or email (url removed) for a completely confidential chat
about this role and other opportunities using the reference number:
TR/(phone number removed)
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing
personnel that reflects the diversity and values of our client base
but also that of Orion Group. We welcome the wide range of experiences
and viewpoints that potential workers bring to our business and our
clients, including those based on nationality, gender, culture,
educational and professional backgrounds, race, ethnicity, sexual
orientation, gender identity and expression, disability, and age
differences, job classification and religion.
In our inclusive workplace, regardless of your employment status as
staff or contract, everyone is assured the right of equitable, fair
and respectful treatment
We need : English (Good)
Type: Permanent
Payment:
Category: Others
