Manufacturing Technician (Documentation Support)

Westport - Ireland

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

People. Passion. Possibilities. Its who we are what we do and what we stand for.

We are currently recruiting a Manufacturing Technician (Documentation Support) as part of the overall Product Flow function within the Core 2/3 Business this role you will be actively involved and manage the batch related CAPAs 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 CAPAs / Complaints 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 2/3 Process Team. Based on knowledge and previous site experience you will also be requested to facilitate support and generate RCA reports.

Please note: This position is day shift initial 6 months contract (cover for leave).

Is this role sound like what you are looking for Then read on to find out more:

Your key responsibilities in this role will be:

Maintain strong relationships with management and colleagues in the Core 2/3 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 CAPAs / Actions / Effectiveness Checks.

Demonstrate active support and involvement in Continuous Improvement initiatives to enhance the Product Flow within the Biologics Business Unit

Participate in GEMBAs and Process Confirmations to identify further improvement opportunities within the department

Attend CAPA / Core 2/3 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 CAPAs

As requested compile data to support the KPIs for the team

Qualifications :

Education and Experience

You will have:

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 RCCs / LIRs / CAPAs is preferrable in order to be successful within this role

Ability to generate / update SOPs / Standard Work Instructions

NOTE: closing date for applications is the 24th of October.

Additional Information :

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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

Employment Type :

Full-time

People. Passion. Possibilities. Its who we are what we do and what we stand for.We are currently recruiting a Manufacturing Technician (Documentation Support) as part of the overall Product Flow function within the Core 2/3 Business this role you will be actively involved and manage the batch relat...