QC Documentation Specialist
QC Documentation Specialist
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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 inhouse 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 sites 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 AbbVies 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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Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
