Manager, Quality Assurance

Dublin - Ireland

Monthly Salary: Not Disclosed

Posted on: 13 hours ago

Vacancies: 1 Vacancy

Job Summary

Career Category

Quality

Job Description

The Amgen International & Distribution Quality team is looking for an experienced Quality Manager with relevant quality/ supply chain/ compliance experience to support a diverse portfolio of regional activities across Europe. If you are looking for your next career step within the Quality field and want to be part of our mission to serve patients which drives all that we do apply or get in touch.

Role overview:

As Manager Quality you will be responsible for supporting projects and programs applicable to International & Distribution Quality (IDQ) operations in support of oversight of supply of pharmaceutical products and ensuring the compliance of Good Distribution Practices (GDP) within the EMEA region for the storage transportation and delivery of medicinal products. Oversee the quality management system (QMS) support audits/self-inspections and Health Authority inspections manage review and approve quality records such as Deviation CAPA CAPA EV Change Control Continuous Improvement initiatives.

You can act as RP/RP back up maintaining full compliance to procedures and appropriate regulationsreport to senior management.

Leverage knowledge and expertise to provide training and guidance to staff and IDQ stakeholders. You will be accountable for Quality activities and oversight of strategic projects for IDQ.

Responsibilities:

Support processes and activities to ensure GDP compliance including but not limited to the following:

Support the Deviations process by acting as owner or quality contact of records within Supply chain and Quality
Support the corrective and preventive process where required to correct deviations and prevent re-occurrence in line with Amgens Quality processes
Support tracking of completion of Quality owned records
Participate in different regional initiatives by providing awareness sessions to Quality and Supply Chain staff owning Deviation/CAPA/EV records to support procedural compliance
Responsible for working collaboratively and cross-functionally with internal and external stakeholders and providing Quality oversight for distribution and transportation activities to ensure pharmaceutical products are distributed according to current Good Distribution Practices (cGDP) and other applicable pharmaceutical regulations to maintain product quality efficacy and safetyProvide Quality oversight to ensure that products are distributed according to current Good Distribution Practices (GDP) and escalate issues when required
Act as quality reviewer and/or approver for controlled documents owned by supply chain
Support to assess planned changes (including but not limited to changes related to Product launches and commit to retire records) and in partnership with country Responsible Persons (RPs) ensure any changes that could potentially impact drug licenses/drug approvals are managed accordingly to ensure continued compliance with regional and local pharmaceutical legislations.
Quality oversight and ownership of continuous Improvement initiatives programs and projects within Quality or Supply Chain organizations.
Alerts senior management of significant quality compliance supply and safety risks and participates in recalls as necessary.

Qualifications and required experience:

In-depth understanding of the: European Pharmaceutical Directive related to Distribution of Medicinal Products Good Distribution Practice (GDP) and Good Manufacturing Practices (GMP) and the Falsified Medicines Directive and Role of the European Medicines Agency (EMA) and Country Health Authorities in EU
Fluency in English language.
Life Sciences degree or degree in an associated disciplinary field
Relevant quality and/or supply chain experience
Strong organizational skills
Ability to multitask and prioritize
High attention to detail and accuracy
Proficient in quality management systems ERP system and Microsoft Office

Required Experience:

Manager

Career CategoryQualityJob DescriptionThe Amgen International & Distribution Quality team is looking for an experienced Quality Manager with relevant quality/ supply chain/ compliance experience to support a diverse portfolio of regional activities across Europe. If you are looking for your next care...

Career Category

Quality

Job Description

Role overview:

You can act as RP/RP back up maintaining full compliance to procedures and appropriate regulationsreport to senior management.

Leverage knowledge and expertise to provide training and guidance to staff and IDQ stakeholders. You will be accountable for Quality activities and oversight of strategic projects for IDQ.

Responsibilities:

Support processes and activities to ensure GDP compliance including but not limited to the following:

Support the Deviations process by acting as owner or quality contact of records within Supply chain and Quality
Support the corrective and preventive process where required to correct deviations and prevent re-occurrence in line with Amgens Quality processes
Support tracking of completion of Quality owned records
Participate in different regional initiatives by providing awareness sessions to Quality and Supply Chain staff owning Deviation/CAPA/EV records to support procedural compliance
Responsible for working collaboratively and cross-functionally with internal and external stakeholders and providing Quality oversight for distribution and transportation activities to ensure pharmaceutical products are distributed according to current Good Distribution Practices (cGDP) and other applicable pharmaceutical regulations to maintain product quality efficacy and safetyProvide Quality oversight to ensure that products are distributed according to current Good Distribution Practices (GDP) and escalate issues when required
Act as quality reviewer and/or approver for controlled documents owned by supply chain
Support to assess planned changes (including but not limited to changes related to Product launches and commit to retire records) and in partnership with country Responsible Persons (RPs) ensure any changes that could potentially impact drug licenses/drug approvals are managed accordingly to ensure continued compliance with regional and local pharmaceutical legislations.
Quality oversight and ownership of continuous Improvement initiatives programs and projects within Quality or Supply Chain organizations.
Alerts senior management of significant quality compliance supply and safety risks and participates in recalls as necessary.

Qualifications and required experience:

In-depth understanding of the: European Pharmaceutical Directive related to Distribution of Medicinal Products Good Distribution Practice (GDP) and Good Manufacturing Practices (GMP) and the Falsified Medicines Directive and Role of the European Medicines Agency (EMA) and Country Health Authorities in EU
Fluency in English language.
Life Sciences degree or degree in an associated disciplinary field
Relevant quality and/or supply chain experience
Strong organizational skills
Ability to multitask and prioritize
High attention to detail and accuracy
Proficient in quality management systems ERP system and Microsoft Office

Required Experience:

Manager

Key Skills

Quality Assurance
FDA Regulations
Food Industry
Food Safety Experience
ISO 9001
Quality Systems
Food Processing
Quality Control
Quality Management
QA/QC
Selenium
HACCP

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About Company

Amgen

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the ... View more

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