Aseptic Specialist
Purpose:
As a member of the Operations function, and as an Aseptic Manufacturing SME, ensures that procedures related to Aseptic Manufacturing follow relevant Regulatory requirements and Network Best Practice.
Partners with Site colleagues and other members of the Site Aseptics team, to create an environment of the highest standards of Aseptic Manufacturing. Drives continuous improvement in Aseptic Manufacturing on site.
Responsibilities to be added to Job Description (in addition to other duties as assigned)
- Acts as a site Subject Matter Expert for Aseptic Manufacturing and Microbiology.
- Responsible for ensuring that Operations procedures required for Aseptic Manufacturing are in compliance with relevant Aseptic and GMP Regulatory requirements and Network Aseptic Best Practice.
- Ensures appropriate use of Risk Management tools to drive Aseptic performance/ Sterility Assurance. Responsible for completing operability assessments.
- Partners with other members of the Site Aseptics Team (e.g. Quality SMEs, Engineering SMEs, Aseptic MQA and Aseptic mentors) to ensure required support is provided to manufacturing shifts to ensure safe, quality, and timely completion of product batches in an aseptic manner, assuring sterility of the product.
- Drives a high-performance culture in Aseptic Manufacturing, through communication and colleague engagement. Drives a culture of Speak-Up.
- Routinely observes the Aseptic technique and behavior of the shift team, providing feedback as appropriate, in particular, during critical Aseptic activities such as Cleaning, Sanitization, Aseptic Set-up, EM plate handling and Interventions.
- Actively leads and supports investigations into process/product issues in support of sterility, media fill, environmental monitoring excursions and EMPQ and assists with establishing root cause and CAPA.
- Owns analysis and trending of EM data (Facility and Personnel) including ownership of the EM Visualization tool and it’s standardized use across functions. Develops and executes action plans to address EM trends. Provides key input to EM procedures.
- Represents the site at Monthly Aseptic reviews at the site and network level
- As part of the Site Aseptics Team, drives continuous improvement of Aseptic Manufacturing procedures through:
- Continuously assessing, interpreting, and applying new Aseptic Manufacturing Regulations to Site operations in a timely manner.
- Development and implementation of Best Practices in Aseptic Manufacturing.
- Provides key input into the Site Contamination Control Strategy.
- Co-ordinated and develop annual APS plans and provides key input into site APS strategy.
- Provides key input into Site LRP related to Aseptic Manufacturing.
- Provides key input into Cleanroom/ Equipment/ Utility design, Qualification and Re-Qualification processes, Preventative Maintenance strategies and real-time monitoring.
- Supports regulatory audits as Aseptic/ Sterility Assurance subject matter expert.
- Develops, implements and Supports training of Operations personnel in Aseptic technique and in Aseptic processing related procedures.
- Provides Aseptic SME support to other sites across the network for Operability studies and for major investigations.
About AbbVie
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 at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
- 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
- Strong knowledge of Regulatory Requirements
- Excellent communication skills
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.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
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