QA Specialist

2 weeks ago

Dublin, Ireland Alexion Pharmaceuticals Full time

This is what you will do:

The QA Specialist for External Quality will be responsible, with management support, for providing oversight of quality activities associated with drug substance, drug product and finished product manufacturing processes to contract manufacturing organizations. The Specialist contributes and guides the completion of milestones associated with specific projects and supports ongoing quality assurance responsibilities in support of: Contract Manufacturing oversight and quality systems including Change Control, Deviations and CAPA's. Acts independently to determine methods and procedures on new assignments and provides guidance to lower-level personnel. Performs’ all responsibilities in accordance with company policies, procedures, and regulations.

You will be responsible for:

Serve as Quality Assurance support and SME for Drug Substance, Drug Product and Finished product manufacturing maintaining knowledge of industry standards and regulatory requirements to ensure all drug manufacturing, storage and shipping activities are compliant

Providing oversight of GMP systems completed by CMO's and External Supply Chain function related to Drug Substance, Drug Product and Finished Product.

Provides oversight to continuous quality system improvements and supports implementing improvements at CMO's in compliance, Preventive Maintenance, Deviation Management and Change Control Programs as they impact Alexion

Works closely to build relationships with contract manufacturers quality personnel

Works closely with internal cross-functional impacted areas, such as External Plant Operations, CMO Management, CMC/Regulatory Affairs and Technical Services to resolve open issues in a timely manner resulting from record reviews and deviation events

Responsible for reviewing contractor documents i.e. Batch records, deviations and change controls to ensure that they comply with Alexion procedures and meet Alexion standards

Approve Alexion specific standard operating procedures and controlled documents issued by contract manufacturing organisations

Support contract manufacturing organisation audits, including pre-approval inspections, as necessary

Develop and issue quality metrics pertaining to the process quality activities

Trends and analyses quality aspects of technical transfer activities to measure key performance indicators, identifies areas for continuous process improvements and risk mitigation, compiles and presents analyses at Quarterly Management Review meetings, proposes and leads team implementation of appropriate CAPA

Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending

Review Corrective and Preventive Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness

Represents Quality Assurance to guide various projects and technical meetings, as needed

Responsible for documenting and reporting compliance issues to management

Any other duties as required by management.

You will need to have:

Must have experience/knowledge of drug substance, drug product and finished product manufacturing processes in a cGMP environment

Must have detailed knowledge of industry best practice and current regulatory expectations concerning drug substance, drug product and finished product manufacturing. Minimum of 2-5 years' GMP related experience in biopharmaceutical / pharmaceutical or related industry

Experience working with contract manufacturing organisations

Ability to provide project leadership and guide successful completion of Quality projects

Excellent written and verbal communication and negotiating skills

Risk assessment and risk management

Ability to exercise judgment with defined procedures and practices to determine appropriate action

Ability to prioritize daily activities in order to meet internal and external customer needs on time of established timelines in a fast-paced environment

Ability to monitor and report on assigned tasks, goals, and objectives.

We would prefer for you to have:

Bachelor’s degree required; preference given to candidates with advanced degrees; 2 or more years cGMP experience preferred; consideration will be given to other relevant experience and education.

Date Posted

02-May-2024

Closing Date

23-May-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

  • QA Specialist

    4 weeks ago

    Dublin, Dublin City, Ireland Cpl Full time

    Cpl with our client Pfizer is looking for QA Specialist with lab equipment and computer systems validation experience. PurposeTo effectively guide the implementation of the Site ValidationActivities, working with the engineering, operations and QC teams to oversee the qualification and validation of the computer systems - CSV and lab area. Job...

  • Senior Specialist QA Scientific

    3 weeks ago

    Dublin, Ireland TEAM HORIZON Full time

    Description Team Horizon is seeking a Senior Specialist QA Scientific for our client based in Dublin. The Senior Specialist, Quality Systems, to join the Central Quality Systems and Compliance team. This role serves as a pharmaceutical quality subject matter expert and supports global colleagues across Operations, Commercial, Device, IT and Quality...

  • QA Validation Specialist

    4 weeks ago

    Dublin, Dublin City, Ireland Cpl Full time

    Cpl in partnership with our client Pfizer are currently recruiting for a QA Validation Specialist for an initial 11 months contract based in their Grange Castle Site. To provide a compliance overview of sitewide validation activities. To provide technical QA support to the Engineering function (including Automation), Technical Operations, Technical Services,...

  • QA Specialist

    2 weeks ago

    Dublin, Ireland AstraZeneca GmbH Full time

    This is what you will do: The QA Specialist for External Quality will be responsible, with management support, for providing oversight of quality activities associated with drug substance, drug product and finished product manufacturing processes to contract manufacturing organizations. The Specialist contributes and guides the completion of milestones...

  • QA Manufacturing Compliance Specialist

    6 days ago

    Dublin, Dublin City, Ireland Collins McNicholas Recruitment Full time

    Our client based in Sligo are looking to hire a QA Manufacturing Compliance Specialist on an initial 12 month fixed term contract. Responsibilities: Ensure that all products leaving Company XXX meet the standards required for marketed and investigational drug products. Ensure that products and aseptic process simulations manufactured at Company XXX...

  • QA Validation Specialist

    1 month ago

    Dublin, Ireland Cpl Full time

    Cpl in partnership with our client Pfizer are currently recruiting for a QA Validation Specialist for an initial 11 months contract based in their Grange Castle Site. To provide a compliance overview of sitewide validation activities. To provide technical QA support to the Engineering function (including Automation), Technical Operations, Technical...

  • Senior QA Specialist

    3 weeks ago

    Dublin, Ireland Alexion Pharmaceuticals Full time

    This is what you will do: Responsible for delivery of quality assurance activities at Alexion’s Dublin location to ensure new products are introduced and manufactured in accordance with cGMP, Corporate and Regulatory requirements. The Snr. Quality Assurance Specialist leads all aspects of the execution of the site QA activities in order to protect...

  • German Speaking

    3 weeks ago

    Dublin, Ireland Adobe Full time

    Our Company Changing the world through digital experiences is what Adobe’s all about. We give everyone—from emerging artists to global brands—everything they need to design and deliver exceptional digital experiences! We’re passionate about empowering people to create beautiful and powerful images, videos, and apps, and transform how companies...

  • Process Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland Kenny-Whelan & Associates Full time

    Kenny-Whelan (a specialist division of the CPL group) are hiringa Manufacturing Process Specialist to support Column Packing Operations at Janssen Sciences in Ringaskiddy Contact Jenn Dinan on or email - new role - Feb 2024 The new MPS will be a day-based role to support ongoing operations. They would report into the Column Packing Team Lead The role...

  • Quality Specialist

    4 weeks ago

    Dublin, Ireland SPEEDECK Full time

    Quality Specialist - VLE Therapeutics (Full Time) Dublin, Ireland Description Quality Specialist About VLE Therapeutics Powered by transformation research in APC, VLE Therapeutics Ltd was formed to extend the value chain and deliver science and digital led manufacturing of Vaccines and Advanced Therapeutics. VLE Therapeutics will support GMP clinical...

  • Operations Governance Specialist

    4 weeks ago

    Dublin, Ireland Zurich Insurance Company Full time

    Job Summary ZLAP is looking for an Operations Governance Specialist to provide support to the function across business resilience, third party assurance, data governance, and first line internal controls in meeting governance and assurance requirements. This first line role sits within a newly formed Life Operations Governance function.  The...

  • TikTok Commerce

    7 days ago

    Dublin, Ireland TikTok Full time

    About the team Global E-Commerce's Governance and Experience (GNE) is a global team responsible for ensuring a safe and trustworthy marketplace for not only our buyers, but also our sellers and creators. Service and Moderation Team (SMT) is part of the GNE organization. Our mission is to create the most trustworthy E-commerce platform with a delightful...

  • TikTok Commerce

    1 month ago

    Dublin, Ireland TikTok Full time

    About the team Global E-Commerce's Governance and Experience (GNE) is a global team responsible for ensuring a safe and trustworthy marketplace for not only our buyers, but also our sellers and creators. Service and Moderation Team (SMT) is part of the GNE organisation. Our mission is to create the most trustworthy E-commerce platform with a delightful...

  • TikTok Commerce

    1 month ago

    Dublin, Ireland TikTok Full time

    About the team Global E-Commerce's Governance and Experience (GNE) is a global team responsible for ensuring a safe and trustworthy marketplace for not only our buyers, but also our sellers and creators. Service and Moderation Team (SMT) is part of the GNE organisation. Our mission is to create the most trustworthy E-commerce platform with a delightful...

  • Operations Governance Specialist

    4 weeks ago

    Dublin, Dublin City, Ireland Zurich Insurance Company Ltd. Full time

    Job Summary ZLAP is looking for an Operations Governance Specialist to provide support to the function across business resilience, third party assurance, data governance, and first line internal controls in meeting governance and assurance requirements. This first line role sits within a newly formed Life Operations Governance function. The successful...

  • Operations Governance Specialist

    4 weeks ago

    Dublin, Ireland Zurich Insurance Company Ltd. Full time

    Job Summary     ZLAP is looking for an Operations Governance Specialist to provide support to the function across business resilience, third party assurance, data governance, and first line internal controls in meeting governance and assurance requirements. This first line role sits within a newly formed Life Operations Governance function.  The...

  • Sales & Digital Marketing Specialist

    4 weeks ago

    Dublin, Ireland Abrivia Recruitment Specialists Ltd. Full time

    Sales & Digital Marketing Specialist Global Outsourcing Leader | Dublin Office Attractive Salary + Commission + Healthcare + Hybrid Working Our client, a Global Outsourcing leader are seeking to add a Sales & Digital Marketing Specialist to their talented social media platform team in Dubin, working in a hybrid model. We’re looking for a...

  • QC Microbiology Specialist

    4 days ago

    Dublin, Ireland AstraZeneca GmbH Full time

    This is what you will do: The QC Microbiology Specialist will be responsible for technical and quality oversight for activities within the QC Microbiology Department. The Specialist will provide technical support with regard to method verification. Environmental Monitoring, Utiliities and all other lab based activities. You will be responsible for: ...

  • Analytical Method Development Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland Cpl Full time

    SK biotek Ireland are seeking to recruit an Analytical Method Development Specialist experienced in analytical method development and specifically, chromatographic method development, on a permanent basis. This position is based at the R&D Centre in Swords, Co Dublin. The R&D Centre has co-located technical and operational expertise, including analytical...

  • Analytical Method Development Specialist

    4 weeks ago

    Dublin, Ireland Cpl Healthcare Full time

    SK biotek Ireland are seeking to recruit an Analytical Method Development Specialist experienced in analytical method development and specifically, chromatographic method development, on a permanent basis. This position is based at the R&D Centre in Swords, Co Dublin. The R&D Centre has co-located technical and operational expertise, including...