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:
1. Maintain and comply with Laboratory Documentation and Computerized Systems Data Integrity requirements.
2. Understand Regulations and business processes required to maintain Laboratory Data Integrity.
3. Responsible for raising change requests and updating existing documents and writing new documents for new products and materials.
4. Adhere to cGMP and GDP requirements.
5. Assist in the resolution of quality problems as required.
6. Developing and changing of in-house laboratory procedures as appropriate.
7. Training of new staff in documentation, change plan and ordering activities.
8. Supports the transfer of new products in documentation (specifications and method updates, worksheet creation and update, logbook creation and update).
9. Raise Purchase Orders (Pos) for QC consumables and contract testing services.
10. Maintain the QC budget with Finance and forecast spend in QC each month.
11. Management of the site’s retention sample programme. Logging of retention samples on SAP, archiving off site when required.
12. Assisting in internal and external inspection when required.
13. Create and issue logbooks.
14. Perform monthly GMP review of logbooks.
15. Ensure all documentation is inspection ready.
16. Raise Change plans for QC related activities as required and ensure tasks are completed on time.
17. Complete CAPAs related to documentation in a timely manner.
18. Assists in the QA Documentation department issuing logbooks, manufacturing records, archiving of manufacturing data as required.
19. 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.
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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