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 be actively involved and manage the batch related CAPA’s as they arise in the business unit taking them from the initial review state through RCA, approval, batch disposition and delivery of corrective and preventive actions, liaising closely with the relevant Departments and QA Lead to ensure thorough investigation is completed and timely resolution and closure is met.

　　You will assist in the management and closure of existing CAPA’s through the evaluation of the current status of corrective and preventive action and co-ordination with relevant personnel to ensure robust actions are in place to prevent reoccurrence prior to closure, lead and support Continuous Improvement initiatives as required to support the overall goals of the Core 1 Process Team. Based on knowledge and previous site experience, you will also be requested to facilitate, support and generate RCA reports.

　　Your key responsibilities in this role will be:

　　• 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

　　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

　　So if all this sounds like the opportunity you have been looking for, apply today!

　　AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment.

　　AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.