activities in order to protect the safety, quality and efficacy of
products, thereby ensuring the availability of correct, safe product
for the Patients, and assuring the security of the company&#**Apply on
the website**;s business and global markets.
This key role must ensure effective interaction with other departments
and locations regarding GMP Document review and finished product
releases. In particular, this will involve partnering with major
stakeholders such as Operations, QC, Facilities, Engineering and
Supply Chain to optimise patient supply.
Role responsibilities:
* Provide quality and cGMP input and oversight for all start-up
project activities through commercial readiness and ongoing product
disposition.
* Provide QA support for risk based verification activities in the
capacity of Quality Assurance Subject Matter Expert. Review and
approval equipment/utilities verification documentation from design to
post execution.
* Participate in verification quality risk assessments and provide
quality oversight to ensure verification quality risk assessments are
effectively maintained/controlled.
* QA support for implementation of Manufacturing Execution System
(MES) computer system validation deliverables.
* Review and approval of engineering functional area documentation
(SOP, Work Instructions, Criticality Assessments, technical report and
protocols).
* Authoring, review and approval of QA-related procedures.
* Oversee the effective documentation and tracking of quality
management system activities including deviations and change controls
and CAPA.
* Review and approve Validation protocols as required. (Examples
include cleaning, process, method validation).
* Support the vendor quality management programme.
* Participate in regulatory inspections as required.
* Develop and report quality metrics.
* Provide quality oversight of calibration and preventative
maintenance criticality assessments as required.
* Represents Quality Assurance to guide various projects and
technical meetings, as needed.
* Responsible for documenting and reporting compliance issues to
management.
* Interface with relevant departments to ensure compliance with
corporate policies, GMP and regulatory requirements.
* Any other duties as expressed by the manager.
Qualifications:
* Min 5 years QA experience in a pharmaceutical manufacture/bio
pharmaceuticals environment. (BDS experience is essential).
* Must have strong process knowledge to include upstream and/or
downstream processing.
* An ability to work independently, as well as a member of a team in
a dynamic, fast-paced environment.
* Excellent communication & presentation skills are essential.
* Excellent time management organizational skills along with a
proven ability to multi-task.
If you are interested in this role and would like to learn more,
please respond to this advert, and I will call you to discuss in more
detail.
*PLEASE NOTE, IN ORDER TO BE ELIGIBLE FOR THIS ROLE YOU MUST HOLD A
VALID EU PASSPORT, OR A STAMP 4/1G VISA*
Please click here to find out more about our Key Information
Documents. Please note that the documents provided contain generic
information. If we are successful in finding you an assignment, you
will receive a Key Information Document which will be specific to the
vendor set-up you have chosen and your placement.
TO FIND OUT MORE ABOUT REAL PLEASE VISIT (PLEASE CONTACT US USING THE
"APPLY FOR THIS JOB POSTING" BOX BELOW).COM
Real Staffing, a trading division of SThree Partnership LLP is acting
as an Employment Business in relation to this vacancy| Registered
office | 1st Floor, **Apply on the website** King William Street,
London, EC4N 7BE, United Kingdom | Partnership Number | OC**Apply on
the website** England and Wales
The QA Validation specialist, based in Dublin, executes the site QA
activities in order to protect the safety, quality and efficacy of
products, thereby ensuring the availability of correct, safe product
for the Patients, and assuring the security of the company&#**Apply on
the website**;s business and global markets.
This key role must ensure effective interaction with other departments
and locations regarding GMP Document review and finished product
releases. In particular, this will involve partnering with major
stakeholders such as Operations, QC, Facilities, Engineering and
Supply Chain to optimise patient supply.
Role responsibilities:
* Provide quality and cGMP input and oversight for all start-up
project activities through commercial readiness and ongoing product
disposition.
* Provide QA support for risk based verification activities in the
capacity of Quality Assurance Subject Matter Expert. Review and
approval equipment/utilities verification documentation from design to
post execution.
* Participate in verification quality risk assessments and provide
quality oversight to ensure verification quality risk assessments are
effectively maintained/controlled.
* QA support for implementation of Manufacturing Execution System
(MES) computer system validation deliverables.
* Review and approval of engineering functional area documentation
(SOP, Work Instructions, Criticality Assessments, technical report and
protocols).
* Authoring, review and approval of QA-related procedures.
* Oversee the effective documentation and tracking of quality
management system activities including deviations and change controls
and CAPA.
* Review and approve Validation protocols as required. (Examples
include cleaning, process, method validation).
* Support the vendor quality management programme.
* Participate in regulatory inspections as required.
* Develop and report quality metrics.
* Provide quality oversight of calibration and preventative
maintenance criticality assessments as required.
* Represents Quality Assurance to guide various projects and
technical meetings, as needed.
* Responsible for documenting and reporting compliance issues to
management.
* Interface with relevant departments to ensure compliance with
corporate policies, GMP and regulatory requirements.
* Any other duties as expressed by the manager.
Qualifications:
* Min 5 years QA experience in a pharmaceutical manufacture/bio
pharmaceuticals environment. (BDS experience is essential).
* Must have strong process knowledge to include upstream and/or
downstream processing.
* An ability to work independently, as well as a member of a team in
a dynamic, fast-paced environment.
* Excellent communication & presentation skills are essential.
* Excellent time management organizational skills along with a
proven ability to multi-task.
If you are interested in this role and would like to learn more,
please respond to this advert, and I will call you to discuss in more
detail.
*PLEASE NOTE, IN ORDER TO BE ELIGIBLE FOR THIS ROLE YOU MUST HOLD A
VALID EU PASSPORT, OR A STAMP 4/1G VISA*
Please click here to find out more about our Key Information
Documents. Please note that the documents provided contain generic
information. If we are successful in finding you an assignment, you
will receive a Key Information Document which will be specific to the
vendor set-up you have chosen and your placement.
TO FIND OUT MORE ABOUT REAL PLEASE VISIT (PLEASE CONTACT US USING THE
"APPLY FOR THIS JOB POSTING" BOX BELOW).COM
Real Staffing, a trading division of SThree Partnership LLP is acting
as an Employment Business in relation to this vacancy| Registered
office | 1st Floor, **Apply on the website** King William Street,
London, EC4N 7BE, United Kingdom | Partnership Number | OC**Apply on
the website** England and Wales
We need : English (Good)
Type: Permanent
Payment:
Category: Others
