recruiting for a Quality Assurance Manager & Qualified Person to take
ownership of quality processes and systems across the business for
batch release operations. This position is based in Dublin.
The business is a leader in its field and partners with global biotech
organisations. They are an innovative and highly regarded organisation
with multiple sites in the UK and multinational operations. They are
busy and growing fast and now need additional QA and QP support.
The Quality Assurance Manager will work with group leaders across
Manufacturing, Quality Control and Engineering to provide technical
expertise across quality related processes and will also support
Quality Assurance functions across the wider group. The Qualified
Person function will support the batch release of sterile products on
a regular basis.
As Quality Assurance Manager, you will:
Quality Systems management across all operations - Approval, change
cont., quality improvement and compliance.
QP release sterile product manufactured on-site
Ensure EU cGMP for all manufacturing operations.
Promote total quality culture throughout site. Link with
manufacturing/QC to improve performance and compliance
Hosting of external audits and inspections at the manufacturing site
and managing responses
Lead compliance projects and ensure the business meets regulatory
commitments
Co-author, review and authorise the content of APR reports
Provide technical support for R & D, clinical research and
regulatoryIf you have the following experience, you would be a great
fit:
Eligible for nomination as a Qualified Person on the site
Manufacturers Licence. Both current Ireland and EU QP&#**Apply on the
website**;s are being considered.
Strong experience in the manufacture of pharmaceutical products,
preferably sterile products. Training in steriles will be provided to
QP&#**Apply on the website**;s with a non-sterile background.
Qualifications to degree level (or equivalent) in chemistry,
microbiology or pharmacy or comparable scientific discipline
Excellent analytical problem-solving abilities and able to lead by
exampleThe salary on offer is ?**Apply on the website**,**Apply on
the website** - ?**Apply on the website**,**Apply on the website**
with the potential to go higher for a great candidate.
The perks and benefits included in the package are excellent and
include bonus scheme and big company benefits.
Interviews are already under way so, if of interest, please apply as
soon as possible to be considered for interview or contact James Ivall
at Goodman Masson for more information.
Look forward to hearing from you A leading sterile pharmaceuticals manufacturing business is
recruiting for a Quality Assurance Manager & Qualified Person to take
ownership of quality processes and systems across the business for
batch release operations. This position is based in Dublin.
The business is a leader in its field and partners with global biotech
organisations. They are an innovative and highly regarded organisation
with multiple sites in the UK and multinational operations. They are
busy and growing fast and now need additional QA and QP support.
The Quality Assurance Manager will work with group leaders across
Manufacturing, Quality Control and Engineering to provide technical
expertise across quality related processes and will also support
Quality Assurance functions across the wider group. The Qualified
Person function will support the batch release of sterile products on
a regular basis.
As Quality Assurance Manager, you will:
Quality Systems management across all operations - Approval, change
cont., quality improvement and compliance.
QP release sterile product manufactured on-site
Ensure EU cGMP for all manufacturing operations.
Promote total quality culture throughout site. Link with
manufacturing/QC to improve performance and compliance
Hosting of external audits and inspections at the manufacturing site
and managing responses
Lead compliance projects and ensure the business meets regulatory
commitments
Co-author, review and authorise the content of APR reports
Provide technical support for R & D, clinical research and
regulatoryIf you have the following experience, you would be a great
fit:
Eligible for nomination as a Qualified Person on the site
Manufacturers Licence. Both current Ireland and EU QP&#**Apply on the
website**;s are being considered.
Strong experience in the manufacture of pharmaceutical products,
preferably sterile products. Training in steriles will be provided to
QP&#**Apply on the website**;s with a non-sterile background.
Qualifications to degree level (or equivalent) in chemistry,
microbiology or pharmacy or comparable scientific discipline
Excellent analytical problem-solving abilities and able to lead by
exampleThe salary on offer is ?**Apply on the website**,**Apply on
the website** - ?**Apply on the website**,**Apply on the website**
with the potential to go higher for a great candidate.
The perks and benefits included in the package are excellent and
include bonus scheme and big company benefits.
Interviews are already under way so, if of interest, please apply as
soon as possible to be considered for interview or contact James Ivall
at Goodman Masson for more information.
Look forward to hearing from you
We need : English (Good)
Type: Permanent
Payment:
Category: Others
