Are you a Biotech Plant Quality Assurance Analyst with4+ years
experience providing real-time quality oversight and support for
production unit operations, extending to formulation, vial and syringe
Fill Finish activities, including media fills and assessment of
aseptic interventions.?
This is a contract role based in Dun Laoghaire, Dublin.
Our client is a leading international Biotechnology company with a
state of the art aseptic manufacturing facility in Dun Laoghaire,
South Dublin.
The plant is one of the most dynamic in Ireland and is currently
undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience into
Ireland&# *;s leading aseptic manufacturing
plant.
The Senior Associate for Plant Quality Assurance (PQA) will report to
the QA Manager, playing a pivotal role in the site&#**Apply on the
website**;s Quality Assurance team.
As the Quality point of contact for manufacturing and inspection
operations, the PQA Senior Associate will contribute to continuous
improvement initiatives by undertaking additional responsibilities
beyond routine QA duties.
Ensure adherence to safety standards and SOPs in all activities.
Review and approve production batch records and associated
documentation for Qualified Person disposition activities.
Provide real-time quality oversight and support for production unit
operations, extending to formulation, vial and syringe Fill Finish
activities, including media fills and assessment of aseptic
interventions.
Conduct inspections of vials and syringes as part of AQLs, annual
reserve inspections, and support complaint investigations.
Offer Quality Assurance support for on-the-floor investigations and
deviations.
Review and approve deviations for closure, ensuring compliance with
appropriate documentation.
Participate in customer complaint investigations.
Conduct routine Quality Assurance walks on the production floor.
Review and issue logbooks, ensuring compliance with procedures.
Provide training and guidance to staff for effective performance.
Review and approve cGMP records, ensuring compliance with appropriate
documentation.
Support continuous improvement and Operational Excellence initiatives.
Undertake other tasks/projects as assigned by the manager.
REQUIREMENTS
University degree in an Engineering or Science-related discipline
(preferred).
Over 4 years of relevant experience in the pharmaceutical or
biotechnology industry or an equivalent combination of experience and
educational background.
Exceptional written and verbal communication skills.
Proven experience collaborating with dynamic cross-functional teams
and strong decision-making abilities.
Robust organizational skills, with a commitment to seeing assignments
through to completion.
Demonstrated problem-solving abilities, particularly in supporting
non-conformance/deviation investigations.
Experience in inspecting vials and syringes and engaging in aseptic
operations.
Familiarity with applicable Regulatory requirements and proficiency in
evaluating compliance issues.
PACKAGE
Contract role - Hourly rate € * - €**Apply
on the website** per hour
Minimum * month contract with the possibility
of an extension.
Onsite role
This */7 shift role demands a **Apply on the
website**-hour shift pattern (4 on, 4 off) to support manufacturing
operations.
Shift Pattern: This */7 shift role demands a
*-hour shift pattern (4 on, 4 off) to support
manufacturing operations.
IMPORTANT: There is an eyesight test that they must pass before we can
proceed with an offer.
.
We need : English (Good)
Type: Permanent
Payment: EUR 30 - 35 Per Hour
Category: Construction
