QA Operations Specialist

1 week ago

Dublin Pike, Ireland QA Full time

Mid-Senior level Not discloses Ireland Dublin, County Dublin, Ireland
20 hours ago
The role:
PE Global is currently recruiting for a QA Operations Specialist on behalf of a leading biotech company based in Dublin North. This is an initial 11-month contract and a 4 cycle shift position.
• Shift will be 4 days on, 4 days off with 12 Hour Shifts (7am - 7pm)

Description:
• The Quality Associate Specialist ensures adherence to Good Manufacturing and Documentation Practices, Quality Manual and local procedures. The Quality Specialist spends significant time on the shop floor in a team environment to provide quality coaching and guidance, to enable documentation to be completed right the first time, and to ensure compliance with cGMPs and regulatory requirements.

Responsibilities
• Provide direct Quality support to production and support areas.
• Provides presence on the shop floor to support compliance and data integrity.
• Review and approve GMP documentation/data for accuracy and completeness.
• Review and approve executed production documentation such as electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures and ensures completion of proper remediation of errors.
• QA support, review and approval of C&Q, Performance qualification (PQ) & Process Validation documents.
• Support sustaining activities such as change management, deviations, CAPAs, equipment requalification, periodic review, site maintenance & Calibration Programs.
• Provides support to internal audits and regulatory inspections.
• Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans.

Education and Experience:
• Bachelor degree, in a scientific or engineering field.
• 3 years of relevant post-degree experience in a GMP environment: manufacturing, laboratory, quality, operations, technical, or regulatory function.
• Knowledge of cGMPs and of regulatory requirements as they apply to the pharmaceutical field.
• Technical writing skills.
• Lean Six-sigma and problem-solving tools.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

#J-18808-Ljbffr

  • QA Specialist-(Batch Release)-Multi Level

    2 days ago

    Dublin, Ireland QA Full time

    QA Specialist-(Batch Release)-Multi Level Mid-Senior level Not disclosed Ireland Limerick, County Limerick, Ireland 15 days ago Performs activities in support of disposition of product while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. As a Typical Day May Include The...

  • QA Operations Specialist

    1 week ago

    Dublin Pike, Ireland Pfizer Full time

    QA Operations Specialist page is loaded## QA Operations Specialistlocations: Ireland - Dublin - Grange Castletime type: Voltijdsposted on: Vandaag geplaatstjob requisition id: 4941178**Use Your Power for Purpose**Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and...

  • QA Operations Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland PSC Biotech® Corporation Full time

    OverviewThe Quality Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Product Team). With guidance from the Associate Director of Quality Operations, the Quality Specialist ensures quality and compliance of products manufactured by the functional area, adherence to Good Manufacturing and Documentation...

  • Apply Now: QA Specialist

    2 days ago

    Dublin Pike, Ireland QCS Staffing Full time

    Overview QA Specialist - Ireland, Dublin - 6 Months Initial Contract Are you a QA Specialist wanting to join an international team working to improve healthcare? Our client is a global health care company specializing in delivering lifesaving medicines worldwide. They are looking for a QA Specialist to join their team. Responsibilities Reviewing and...

  • QA Specialist

    1 week ago

    Dublin, Ireland Quanta Consultancy Services Ltd Full time

    QA Specialist - Dublin, Ireland - 12 Months Contract One of the top 10 best companies to work in Ireland is looking for QA Specialistfor their large-scale new facility in Dublin. Is this you? An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client...

  • Qa Specialist

    4 weeks ago

    Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full time

    QA Specialist - Dublin, Ireland - 12 Months ContractOne of the top 10 best companies to work in Ireland is looking for QA Specialistfor their large-scale new facility in Dublin.Is this you?An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project.This fantastic client offers...

  • QA Operations Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland Pfizer Full time

    QA Operations Specialist page is loaded## QA Operations Specialistlocations: Ireland - Dublin - Grange Castletime type: Voltijdsposted on: Vandaag geplaatstjob requisition id: 4941178**Use Your Power for Purpose**Every day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and...

  • QA Operations Specialist in Dublin, Irelan

    2 weeks ago

    Dublin, Ireland Pharmaceuticalcarrier Full time

    Job Title: QA Operations Specialist Location: Multiple locations in the United Kingdom Pfizer, one of the world’s leading biopharmaceutical companies, is currently seeking a QA Operations Specialist for multiple locations in the United Kingdom. The successful candidate will play a crucial role in ensuring the quality of Pfizer’s products and...

  • Qa Operations Specialist

    2 weeks ago

    Dublin, Ireland Pfizer Full time

    QA Operations Specialist page is loaded## QA Operations Specialistlocations: Ireland - Dublin - Grange Castletime type: Voltijdsposted on: Vandaag geplaatstjob requisition id: 4941178**Use Your Power for Purpose**Every day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients.Our science and risk-based...

  • QA Operations Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland Pfizer Full time

    QA Operations Specialist page is loaded## QA Operations Specialistlocations: Ireland - Dublin - Grange Castletime type: Full timeposted on: Posted Todayjob requisition id: 4941178**Use Your Power for Purpose**Every day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and...