QA Manufacturing Compliance Analyst

7 months ago

Mayo, Ireland TEAM HORIZON Full time
Description

Team Horizon is seeking an experienced QA professional to join our client’s aseptic facility on a Fixed Term Basis as a QA Manufacturing Compliance Analyst.



Why you should apply:



As the newest member of the Aseptic team, , 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.
This is an excellent opportunity to join a company who put their people & their patients first.
Make a lasting impact that's felt within healthcare and beyond.

What you will be doing:



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 a culture of Speak-Up.
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 area
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.

What you need to apply:



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

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