Aseptic MQA

ABBVIE; Waterford; On-site; EUR 60,000 - 82,000; Full time

Benefits offered by this job

Equal Opportunity Employer

Job summary

AbbVie is seeking a Quality professional to provide real-time shop floor oversight to Aseptic operations, including manufacturing, sampling and testing. The role requires shift work and collaboration with site colleagues to uphold the highest performance standards and drive continuous improvement in Aseptic operations.

The candidate will act as SME for Aseptic operations, ensure adherence to site procedures, observe technique, and lead improvements across the aseptic manufacturing and testing

Qualifications

• Third Level Degree in a Science, Quality or Engineering discipline.
• 3+ Years of experience in a GMP Environment with 3+ years of experience in support of Aseptic Manufacturing
• Strong knowledge of Regulatory Requirements.

Responsibilities

• Act as site Subject Matter Expert for Aseptic Operations (Manufacturing, sampling and associated testing).
• Observe Aseptic technique and team behavior, provide feedback, stop operations if needed.
• Drive performance of shift team in aseptic manufacturing, sampling and testing.
• Provide training activities and coach colleagues who work in Cleanrooms.
• Provide input to Site Contamination Control Strategy and EM data trends.

Education

Third Level Degree in Science/Quality/Engineering

Job description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com . Follow @abbvie onLinkedIn, Facebook ,Instagram ,X andYouTube.

Job Description

As amember of the Quality function, provides real-time shop floor oversight to Aseptic operations, both manufacturing, samplingand testing. Partners with Site colleagues to create an environment of the highestperformancestandards of Aseptic operations. Drives continuous improvement in Aseptic Operations on site. This role requires shift work.

Responsibilitiesspecific to Aseptic Manufacturing(in addition toother duties as assigned):

Act as site Subject Matter Expert for AsepticOperations(Manufacturing, samplingand associated testing).

Ensures Aseptic operations are carried out as per Site Procedures.

Continuously observes the Aseptic technique andbehaviorof the shift team, providing feedback as appropriate. Intervention can include a ceasing of manufacturing and testing operations if deemed appropriate. Drives a culture of Speak-Up.

Drives all aspects of Aseptic Performance of the shift team through observation andfeedback.

Drives all aspects of Aseptic performance during sampling and testing.

Partners with Aseptic Mentors and Shift Supervistorsto drive performance of the shift team.

Completes real-time review of Batch Record documentation.

Supports training activities and actively coaches and mentors colleagues who work in Cleanrooms.

Provides Quality Oversight during critical Aseptic activities such as Cleaning,Sanitization, AsepticSet-up,sampling,EM plate handling, sample testingand Interventions.

Participates and provides leadership to the SiteAsepticsteam, highlighting andleadingintroduction of continuousimprovementin Aseptic procedures.

Provides input and guidance on changes related to AsepticManufacturing, samplingandassociatedtesting.

Drives ahigh-performanceAsepticcultureacross the site.

Actively leads and supports investigations.

Reviews and Audits Batch Records real-time

Reviews and Audits Manufacturing and Testing logs as required.

Completion of Line Clearance activities

Participate in routine leadership GEMBAs of Manufacturing andLaboratoryareas.

Provides key input to the development and maintenanceof the Site Contamination Control Strategy.

Provides key input to the assessment of EM data and trends.

Qualifications

Third Level Degree in a Science, Quality or Engineering discipline.

3+ Years of experience in a GMP Environment with 3+ years of experience in support of Aseptic Manufacturing

Strong knowledge of Regulatory Requirements

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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