QC Compliance Specialist
QC Compliance Specialist
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Job Description
This role will support the day to day running of the QC Laboratory at AbbVie Cork to ensure adherence to quality and safety standards within the Laboratory.
Role & Responsibilities:
Quality Compliance
- Lab Investigation writer in line with SOP requirements
- Complete Human Error investigations
- Support effective CAPA implementation
- Support QC compliance walkdown programme
- Report the outcome of the compliance walkdown programme on a monthly basis
- Support QC department audit readiness for internal and external inspections
- Act as QC representative on site Virtus (Quality Continuous Improvement) Team
- Generation of QC department PQR reports on a biannual basis in line with site PQR schedule
- Management of compendia change process
- Identify and support Continuous Improvement activities within the QC department
- Completion of CAPA Change Plan Audit tasks in line with site timeliness requirements
- Support the preparation and review of QC department reports and metrics as required
- Support QC Snr Support Analyst through Compliance Wire administration and onboarding training as needed
Safety Compliance
- QC Department Safety representative on site Green Button (safety) Team
- Drive the creation of a QC safety team to liaise with site EHS on lab safety improvements
Qualifications :
- Primary degree in analytical science or in an equivalent sciencebased discipline
- 3 years minimum experience in pharmaceutical quality control laboratory. Experience of Trackwise and applicable modules ER CP and audit an advantage.
- Knowledge of QC regulations European and FDA regulations
- Experience with QC analytical methods and procedures
- Knowledge of QC equipment and data integrity principles
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
