* Senior Quality Operations Specialist
* to join their team. This is a full-time permanent position, their
office is based in Dublin City Centre and there is Hybrid working!
The Senior Specialist, Quality Operations - GMP/GDP supports Quality
Assurance (QA) activities related to Good Manufacturing Practice (GMP)
and Good Distribution Practice (GDP) compliance for Clinical and
Commercial products, including Named Patient Supply. This involves
working with cross-functional internal teams;
Supply Chain;
Technical Operations;
Regulatory Affairs;
Contract Manufacturing Organizations (CMOs) and Distribution Partners
to implement, manage, maintain, and support quality assurance
activities, including plans that contribute to the company&#**Apply on
the website**;s ability to achieve and maintain regulatory compliance
and ensure product quality for Clinical and Commercial Supplies/Named
Patient Supply.
* ESSENTIAL FUNCTIONS
* Performs QA review and approval of documentation related to contract
storage sites, distribution partners and transportation providers
including but not limited to:
* Distribution Instructions, Named Patient Supply Protocols and Early
Access Program Standard Operating Procedures (SOPs).
* Investigations, incidents, exceptions, deviations and risk
assessments as generated by contract storage sites, distribution
partners and transportation providers.
* Logistical complaints/vendor complaints.
* Evaluation of temperature excursions in accordance with SOPs.
* Ensures the successful submission of required paperwork, releases,
and other related documents to the company&#**Apply on the website**;s
partners for Commercial/Named Patient Supply product.
* Contributes to the conduct of the Customer Approval/re-validation
process. This includes supporting the Responsible Person (RP) in
preparing the required documentation.
* Supports Batch Disposition activities as required, including
maintaining QA trackers/databases related to Batch Disposition.
* Provides support to Corporate QA for complaints, logistical
investigations, APQR&#**Apply on the website**;s etc.
* Contributes to the management of the Change Control System by
generating and reviewing Change Control documents for Clinical and
Commercial product.
* Supports QP&#**Apply on the website**;s and RP&#**Apply on the
website**;s in the completion of routine tasks as required.
* KNOWLEDGE/SKILLS/ABILITIES REQUIRED
* ** Minimum level of education and years of relevant work experience.
* Bachelor&#**Apply on the website**;s degree in a scientific
discipline and a minimum 5 years of experience in QA or related
role(s) in a pharmaceutical, biotechnology or related environment, at
least 2 of which have been in a CMC-focused QA position.
** Special knowledge or skills needed and/or licenses or certificates
required.
* * Detailed/Demonstrated knowledge and understanding of GMP/GDP
regulations and Food and Drug Administration (FDA) requirements.
* Demonstrated proficiency of commercial and clinical batch record
review and experience of working with Contract Manufacturing
organizations/Contract Storage Sites/Distribution
Partners/Transportation partners.
* Experience in Quality Management Systems including Deviation
Management, Out of Specifications, Change Control.
** Special knowledge or skills and/or licenses or certificates
preferred.
* * Experience in ERP systems.
* Analytical lab experience.
* Validation/manufacturing experience.
* For more information and to apply for this role please call Zoe on 1
or e-mail
* * Thornshaw Scientific Recruitment is a leading Irish provider of
specialist Scientific Recruitment. Part of the CPL Group. Tel: 1 * My client, a global biopharmaceutical company, is recruiting for a
* Senior Quality Operations Specialist
* to join their team. This is a full-time permanent position, their
office is based in Dublin City Centre and there is Hybrid working!
The Senior Specialist, Quality Operations - GMP/GDP supports Quality
Assurance (QA) activities related to Good Manufacturing Practice (GMP)
and Good Distribution Practice (GDP) compliance for Clinical and
Commercial products, including Named Patient Supply. This involves
working with cross-functional internal teams;
Supply Chain;
Technical Operations;
Regulatory Affairs;
Contract Manufacturing Organizations (CMOs) and Distribution Partners
to implement, manage, maintain, and support quality assurance
activities, including plans that contribute to the company&#**Apply on
the website**;s ability to achieve and maintain regulatory compliance
and ensure product quality for Clinical and Commercial Supplies/Named
Patient Supply.
* ESSENTIAL FUNCTIONS
* Performs QA review and approval of documentation related to contract
storage sites, distribution partners and transportation providers
including but not limited to:
* Distribution Instructions, Named Patient Supply Protocols and Early
Access Program Standard Operating Procedures (SOPs).
* Investigations, incidents, exceptions, deviations and risk
assessments as generated by contract storage sites, distribution
partners and transportation providers.
* Logistical complaints/vendor complaints.
* Evaluation of temperature excursions in accordance with SOPs.
* Ensures the successful submission of required paperwork, releases,
and other related documents to the company&#**Apply on the website**;s
partners for Commercial/Named Patient Supply product.
* Contributes to the conduct of the Customer Approval/re-validation
process. This includes supporting the Responsible Person (RP) in
preparing the required documentation.
* Supports Batch Disposition activities as required, including
maintaining QA trackers/databases related to Batch Disposition.
* Provides support to Corporate QA for complaints, logistical
investigations, APQR&#**Apply on the website**;s etc.
* Contributes to the management of the Change Control System by
generating and reviewing Change Control documents for Clinical and
Commercial product.
* Supports QP&#**Apply on the website**;s and RP&#**Apply on the
website**;s in the completion of routine tasks as required.
* KNOWLEDGE/SKILLS/ABILITIES REQUIRED
* ** Minimum level of education and years of relevant work experience.
* Bachelor&#**Apply on the website**;s degree in a scientific
discipline and a minimum 5 years of experience in QA or related
role(s) in a pharmaceutical, biotechnology or related environment, at
least 2 of which have been in a CMC-focused QA position.
** Special knowledge or skills needed and/or licenses or certificates
required.
* * Detailed/Demonstrated knowledge and understanding of GMP/GDP
regulations and Food and Drug Administration (FDA) requirements.
* Demonstrated proficiency of commercial and clinical batch record
review and experience of working with Contract Manufacturing
organizations/Contract Storage Sites/Distribution
Partners/Transportation partners.
* Experience in Quality Management Systems including Deviation
Management, Out of Specifications, Change Control.
** Special knowledge or skills and/or licenses or certificates
preferred.
* * Experience in ERP systems.
* Analytical lab experience.
* Validation/manufacturing experience.
* For more information and to apply for this role please call Zoe on 1
or e-mail
* * Thornshaw Scientific Recruitment is a leading Irish provider of
specialist Scientific Recruitment. Part of the CPL Group. Tel: 1 *
We need : English (Good)
Type: Permanent
Payment:
Category: Others
