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Manufacturing QA Compliance Analyst

Job description

Job Title: Manufacturing QA Compliance Analyst 
Job Type: 12 month Contract
Location: Westport, Co. Mayo

We are now recruiting a Manufacturing QA Compliance Analyst to join a diverse Aseptic Quality team in Westport, Co. Mayo, on a fixed term contract. This is a shift based role, requiring the successful candidate to work 12 hour rotational shift to support 24/7 manufacturing areas.

As the newest member of the Aseptic team, as a Manufacturing QA Compliance Analyst, you will provide real-time shop floor oversight to Aseptic operations, both manufacturing, sampling and testing, partnering with Site colleagues to create an environment of the highest performance standards of Aseptic operations and driving continuous improvement in Aseptic Operations on site.

Key responsibilities:
•    Act as site Subject Matter Expert for Aseptic Operations (Manufacturing, sampling and associated testing).
•    Ensures Aseptic operations are carried out as per Site Procedures.
•    Continuously observes the Aseptic technique and behavior of the shift team, providing feedback as appropriate.  Intervention can include a ceasing of manufacturing and testing operations if deemed appropriate.  
•    Drives all aspects of Aseptic Performance of the shift team through observation and feedback.
•    Drives all aspects of Aseptic performance during sampling and testing.
•    Partners with Aseptic Mentors and Shift Supervisors to 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, Aseptic Set-up, sampling, EM plate handling, sample testing and Interventions.
•    Participates and provides leadership to the Site Aseptics team, highlighting and leading introduction of continuous improvement in Aseptic procedures.
•    Provides input and guidance on changes related to Aseptic Manufacturing, sampling and associated testing.
•    Drives a high-performance Aseptic culture across 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 and Laboratory areas.
•    Provides key input to the development and maintenance of the Site Contamination Control Strategy.
•    Provides key input to the assessment of EM data and trends.

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