QC Stability Specialist

Found in: Talent IE C2 - 2 weeks ago

Dublin, Ireland Alexion Pharmaceuticals Full time

Position Summary

QC Specialist-Stability and Retain Management is responsible for maintaining the Stability and Retain Programmes for all products at ADMF and ensures that all activities are fully in compliance with cGMP standards, regulatory commitments and Alexion Standards and Protocols. The QC Specialist-Stability and Retains is responsible for performing key quality tasks.

Principal Responsibilities

• Management of stability and retain inventory (DS, DP and Device) for all commercial and relevant clinical products stored at ADMF.

• Ensuring that stability pulls are conducted on time, in adherence with ADMF level-loading principles and that samples are distributed to ADMF labs within agreed timelines.

• Scheduling of stability pulls and reporting of metrics for pull adherence via Stability Review Board.

• Ensuring that annual retain inspections are conducted on time.

• Authoring Stability Study Documents.

• Enrolling lots into stability and retain studies in LIMS, according to protocols and in partnership with the Stability and QC Sample Management Teams.

• Change management activities in accordance with Alexion procedures.

• Act as stability and retain management SME for Health Authority inspections.

• Identify and implement continuous improvement programs as appropriate.

• Mentoring and training of colleagues, as required.

• Shipment of stability and retain samples, as applicable, for external testing.

• Processing additional sample requests.

• Leading and owning Laboratory Investigations and Deviations relating to management of stability and retain programmes and sample management.

• Support QC Sample Management activities according to business needs (e.g. aliquoting support, sample distribution, shipments).

Qualifications

• Excellent communication, interpersonal and organizational skills.

• Ability to work well both independently and in a team environment with minimal supervision.

• Ability to prioritize work, multitask and escalate as appropriate.

• Conducts work in compliance with cGMPs, ICH guidelines and safety and regulatory requirements.

• Takes a structured, analytical approach to problem solving.

Education

• Degree in chemistry or biological science with a minimum of 5 years experience in the Pharmaceutical/Biotechnology Industry.

• Computer skills (MS Office, MS Excel, MS Project) or comparable word-processing and spreadsheet applications is required.

• Experience in the use of Electronic Document Management and Quality Management Systems is an advantage.

Date Posted

07-Apr-2024

Closing Date

11-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.

  • QC NPI Specialist

    Found in: beBee jobs IE - 1 week ago

    Dublin, Dublin City, Ireland Cpl Full time

    Cpl in Partnership with our client Pfizer are seeking a QC NPI Specialist to join the team for a 12 month fixed term contingent contract in their state of the art site in Dublin, Grange Castle. Job Purpose:· Coordinate the introduction of testing capability for new products within Quality Control.· Lead the qualification/validation and transfer of methods...

  • QC Specialist – QC Equipment Validationp

    Found in: beBee jobs IE - 1 week ago

    Dublin, Dublin City, Ireland Cpl Full time

    Cpl in partnership with our client Pfizer are seeking a QC Equipment Validation specialist to join the team for an 11 month fixed term contract in their state of the art Dublin, Grange Castle Site. Job Purpose:This position is to provide support to Quality Control with instrument and equipment, Data Integrity, validation, and system administration.This job...

  • QC Equipment Specialist

    Found in: Talent IE C2 - 2 weeks ago

    Dublin, Ireland Westbourne IT Global Services Full time

    QC Equipment Specialist Duties & Responsibilities: - Ensure QC equipment complies with all current regulatory data integrity requirements - Ensure that the deliverables of each assigned task are dealt within the timeframes defined, with quality and according to cGMP - Act as part of the QC Support Team within the QC Laboratory - Ensure that...

  • QC Instrumental Specialist

    7 days ago

    Dublin, Ireland Westbourne IT Global Services Full time

    QC Equipment Specialist Duties & Responsibilities: - Ensure QC equipment complies with all current regulatory data integrity requirements - Ensure that the deliverables of each assigned task are dealt within the timeframes defined, with quality and according to cGMP - Act as part of the QC Support Team within the QC Laboratory - Ensure that analytical...

  • QC Technician

    Found in: Talent IE 2A C2 - 5 days ago

    Dublin, Ireland Recruitment by Aphex Group Full time

    This is an 11-month contract, fully onsite. Responsibilities Receive and manage samples that come into the lab for stability, in-process and release testing. Reagent preparation, cleaning, and routine equipment maintenance. Maintain good housekeeping and hygiene within the laboratory. Calibrate and maintain all designated laboratory instruments. Perform...

  • QC Analyst

    Found in: beBee jobs IE - 1 week ago

    Dublin, Dublin City, Ireland Cpl Full time

    Cpl in partnership with Pfizer are seeking a QC Analyst - Sample Management to join the team for a contingent fixed term 11 month contract at their state of the art plant in Grange Castle, Dublin. Quality Control Sample Management AnalystJob Purpose: Responsibility for carrying out sample management tasks pertaining to GC / external site manufactured...

  • QC Analyst

    Found in: beBee jobs IE - 1 week ago

    Dublin, Dublin City, Ireland Cpl Full time

    QC Microbiology Analyst Cpl in partnership with our client Pfizer are currently recruiting for Quality Control Analysts to join their Microbiology team.Job Purpose: To maintain regulatory compliance through established programs for laboratory testing, maintenance, training, and SOPs within Quality Control.Job Responsibilities:· Perform Microbiological...

  • QC Senior Specialist, Microbiology

    2 weeks ago

    Dublin, Ireland AstraZeneca GmbH Full time

    Position Summary The QC Microbiology Senior Specialist is responsible for technical and quality oversight for activities within the QC Microbiology Dept. The Senior Specialist will provide technical support with regard to method verification, Environmental Monitoring, Utilities and all other lab based activities. They will oversee the operation of a QC...

  • QC Digital System Specialist

    Found in: beBee jobs IE - 1 week ago

    Dublin, Dublin City, Ireland Cpl Full time

    Cpl in partnership with our client Pfizer are seeking a QC Digital System Specialist to join the team for an 11 month fixed term contingent contract at their state of the art plant in Grange Castle, Dublin. Role Description:The QC Laboratory Digital Systems Specialist will drive modernization and robustness initiatives at the Grange Castle site by working...

  • QC Analyst

    2 weeks ago

    Dublin, Ireland Cpl Healthcare Full time

    Cpl inpartnership with Pfizer are seeking a QC Analyst - Sample Management to join the team for a contingent fixed term 11 month contract at their state of the art plant in Grange Castle, Dublin. Quality Control Sample Management Analyst Job Responsibilities: •Routinely receive manufacturing test samples and distribute to the appropriate analytical...

  • QC NPI Specialist

    Found in: beBee S IE - 2 weeks ago

    Dublin, Ireland Cpl Full time

    Cpl in Partnership with our client Pfizer are seeking a QC NPI Specialist to join the team for a 12 month fixed term contingent contract in their state of the art site in Dublin, Grange Castle. Job Purpose:·      Coordinate the introduction of testing capability for new products within Quality Control.·      Lead...

  • QC Analyst

    2 weeks ago

    Dublin, Ireland Cpl Healthcare Full time

    QC Microbiology Analyst Cpl in partnership with our client Pfizer are currently recruiting for Quality Control Analysts to join their Microbiology team. Job Purpose: To maintain regulatory compliance through established programs for laboratory testing, maintenance, training, and SOPs within Quality Control. Job Responsibilities: ·Perform...

  • QC Specialist – QC Equipment Validationp

    Found in: beBee S IE - 3 weeks ago

    Dublin, Ireland Cpl Full time

    Cpl in partnership with our client Pfizer are seeking a QC Equipment Validation specialist to join the team for an 11 month fixed term contract in their state of the art Dublin, Grange Castle Site. Job Purpose:This position is to provide support to Quality Control with instrument and equipment, Data Integrity, validation, and system administration.This...

  • QC Specialist – QC Equipment Validationp

    Found in: beBee S IE - 2 weeks ago

    Dublin, Ireland Cpl Full time

    Cpl in partnership with our client Pfizer are seeking a QC Equipment Validation specialist to join the team for an 11 month fixed term contract in their state of the art Dublin, Grange Castle Site. Job Purpose:This position is to provide support to Quality Control with instrument and equipment, Data Integrity, validation, and system administration.This...

  • QC Digital System Specialist.

    2 weeks ago

    Dublin, Ireland Cpl Healthcare Full time

    Cpl in partnership with our client Pfizer are seeking a QC Digital System Specialistto join the team for an 11 month fixed term contingent contract at their state of the art plant in Grange Castle, Dublin. Role Description: The QC Laboratory Digital Systems Specialist will drive modernization and robustness initiatives at the Grange Castle site by...

  • QC Digital System Specialist

    Found in: beBee S IE - 4 weeks ago

    Dublin, Ireland Cpl Full time

    Cpl in partnership with our client Pfizer are seeking a QC Digital System Specialist to join the team for an 11 month fixed term contingent contract at their state of the art plant in Grange Castle, Dublin. Role Description:The QC Laboratory Digital Systems Specialist will drive modernization and robustness initiatives at the Grange Castle site by working...

  • QC Digital System Specialist

    Found in: beBee S IE - 2 weeks ago

    Dublin, Ireland Cpl Full time

    Cpl in partnership with our client Pfizer are seeking a QC Digital System Specialist to join the team for an 11 month fixed term contingent contract at their state of the art plant in Grange Castle, Dublin. Role Description:The QC Laboratory Digital Systems Specialist will drive modernization and robustness initiatives at the Grange Castle site by working...

  • QC Analyst

    Found in: beBee jobs IE - 1 week ago

    Dublin, Dublin City, Ireland Cpl Full time

    QC Chemistry Biosimilars AnalystCpl in partnership with our client Pfizer are currently recruiting for QC Chemistry Analyst - Biosimilars:Pfizer Grange Castle is one of the largest integrated biotechnology plants in the world and is a key part of the Pfizer global manufacturing network. It is an innovative, exciting, and growing organization that has a range...

  • QC Analyst

    Found in: beBee S IE - 3 weeks ago

    Dublin, Ireland Cpl Full time

    Cpl in partnership with Pfizer are seeking a QC Analyst - Sample Management to join the team for a contingent fixed term 11 month contract at their state of the art plant in Grange Castle, Dublin.  Quality Control Sample Management AnalystJob Purpose:  Responsibility for carrying out sample management tasks pertaining to GC / external site...

  • QC Analyst

    Found in: beBee S IE - 2 weeks ago

    Dublin, Ireland Cpl Full time

    Cpl in partnership with Pfizer are seeking a QC Analyst - Sample Management to join the team for a contingent fixed term 11 month contract at their state of the art plant in Grange Castle, Dublin.  Quality Control Sample Management AnalystJob Purpose:  Responsibility for carrying out sample management tasks pertaining to GC / external site...