Technical Writer

at  AbbVie

Company 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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description

EDUCATION AND EXPERIENCE

You will have:

• 3rd level qualification and/or 3+ years Pharma or Bio Pharma experience.
• Understanding of the requirements to work in a regulated GMP industry with knowledge of biologics/pharma operations
• Access to global Trackwise QMS and understanding of the system is preferred
• Knowledge of SAP preferred
• Excellent communication skills
• Ability to use sound judgment to make effective decisions within appropriate timeframes
• Proven to be self-directed, self-motivated and ability to prioritise competing priorities
• Excellent technical writing skills is a requirement for this role and previous experience on GTW i.e. opening RCC’s / LIRs / CAPA’s is preferrable in order to be successful within this role
• Ability to generate / update SOP’s / Standard Work Instructions

• Maintain strong relationships with management and colleagues in the Core 1 Process Team business unit including operations personnel across all shifts and the QA and Technical team. Articulate the necessary requirements in a clear, concise and persuasive manner.
• Work with the BU manager on the delivery of the goals and objectives of the team.
• Manage requirements in order to deliver the KPIs as they relate to the Product Flow function
• Ensure effective CA and PA are put in place in response to issues arising in the business unit which are raised through the QMS systems including CAPA’s / Actions / Effectiveness Checks.
• Demonstrate active support and involvement in Continuous Improvement initiatives to enhance the Product Flow within the Biologics Business Unit
• Participate in GEMBA’s and Process Confirmations to identify further improvement opportunities within the department
• Attend daily CAPA / Core 4 Process Team meetings in order to be aware of all tasks assigned to team members and where help and support is required
• One Vault: Review and approval of assigned documentation as deemed necessary
• Where necessary co-ordinate RCA sessions in order to resolve issues raised through the CAPA’s
• As requested, compile data to support the KPIs for the team
  Qualifications