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We are currently recruiting a Technical Writer as part of the overall Product Flow function within the Core 1 Business Unit. In this role, you will manage batch-related CAPAs, from initial review through RCA, approval, batch disposition, and delivery of corrective and preventive actions. You will liaise closely with relevant departments and the QA Lead to ensure thorough investigations and timely resolutions.
You will support the management and closure of existing CAPAs, evaluate current corrective and preventive actions, and coordinate with relevant personnel to implement robust actions to prevent reoccurrence. You will also facilitate, support, and generate RCA reports based on your knowledge and previous site experience.
If great benefits, a defined career path, and work-life balance are important to you, read on to learn more:
Your key responsibilities will include:
* Maintaining strong relationships within the Core 1 Process Team, including operations personnel across all shifts, QA, and Technical teams. Articulating requirements clearly and persuasively.
* Collaborating with the BU manager to achieve team goals and objectives.
* Managing requirements to meet KPIs related to the Product Flow function.
* Ensuring effective Corrective Action (CA) and Preventive Action (PA) plans are in place in response to issues raised through QMS systems, including CAPAs and Effectiveness Checks.
* Supporting Continuous Improvement initiatives to enhance Product Flow within the Biologics Business Unit.
* Participating in GEMBA walks and Process Confirmations to identify improvement opportunities.
* Attending daily CAPA and Core 4 Process Team meetings to stay informed of team tasks and support needs.
* Reviewing and approving documentation within One Vault as necessary.
* Coordinating RCA sessions to resolve issues raised through CAPAs.
* Compiling data to support team KPIs as requested.
Qualifications
Education and Experience:
* 3rd level qualification and/or 3+ years of Pharma or Bio Pharma experience.
* Understanding of GMP-regulated industries and biologics/pharma operations.
* Knowledge of Trackwise QMS system is preferred.
* Knowledge of SAP is preferred.
* Excellent communication skills.
* Sound judgment for effective decision-making within appropriate timeframes.
* Self-motivated, self-directed, with the ability to prioritize competing tasks.
* Exceptional technical writing skills; experience with GTW processes such as RCCs, LIRs, and CAPAs is advantageous.
* Ability to generate and update SOPs and Standard Work Instructions.
If this opportunity aligns with your career goals, apply today!
Additional Information:
AbbVie is an equal opportunity employer committed to integrity, innovation, and community service. For more details, visit: https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
Applicants seeking reasonable accommodations can find more information here: https://www.abbvie.com/join-us/reasonable-accommodations.html
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