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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) .

Job Description

To provide support to QC labs in change plan, change requests, generation and update of

documents on Documentation system, archiving of QC data and raising purchase orders for QC

consumables and contract testing at our Manorhamilton Road Site in Sligo

Responsibilities:

• Maintain and comply with Laboratory Documentation and Computerized Systems

Data Integrity requirements.

• Understand Regulations and business processes required to maintain Laboratory

Data Integrity.

• Responsible for raising change requests and updating existing documents and writing new

documents for new products and materials.

• Adhere to cGMP and GDP requirements.

• Assist in the resolution of quality problems as required.

• Developing and changing of in-house laboratory procedures as appropriate.

• Training of new staff in documentation, change plan and ordering activities.

• Supports the transfer of new products in documentation (specifications and method

updates, worksheet creation and update, logbook creation and update).

• Raise Purchase Orders (Pos) for QC consumables and contract testing services.

• Maintain the QC budget with Finance and forecast spend in QC each month.

• Management of the site’s retention sample programme. Logging of retention samples on

SAP, archiving off site when required.

• Assisting in internal and external inspection when required.

• Create and issue logbooks.

• Perform monthly GMP review of logbooks.

• Ensure all documentation is inspection ready.

• Raise Change plans for QC related activities as required and ensure tasks are completed

on time.

• Complete CAPAs related to documentation ins a timely manner.

• Assists in the QA Documentation department issuing logbooks, manufacturing records,

archiving of manufacturing data as required.

• Adheres to and supports all EHS E standards, procedures and policies

Qualifications

3rd level qualification in a relevant Science discipline.

Experience operating to cGMP standards utilizing documentation management and

Change plan and CAPA management system.

Previous experience in a pharmaceutical manufacturing environment is desirable but not essential.

Additional Information

AbbVie is an equal opportunity employer and 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.

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