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QC Compliance Specialist

1 month ago

Cork, Cork, Ireland Allergan Full time

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.

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

  1. Lab Investigation writer in line with SOP requirements
  2. Complete Human Error investigations
  3. Support effective CAPA implementation
  4. Support QC compliance walkdown programme
  5. Report the outcome of the compliance walkdown programme on a monthly basis
  6. Support QC department audit readiness for internal and external inspections
  7. Act as QC representative on site Virtus (Quality Continuous Improvement) Team
  8. Generation of QC department PQR reports on a biannual basis in line with site PQR schedule
  9. Management of compendia change process
  10. Identify and support Continuous Improvement activities within the QC department
  11. Completion of CAPA, Change Plan, Audit tasks in line with site timeliness requirements
  12. Support the preparation and review of QC department reports and metrics as required
  13. Support QC Snr Support Analyst through Compliance Wire administration and onboarding training as needed

Safety Compliance

  1. QC Department Safety representative on site Green Button (safety) Team
  2. Drive the creation of a QC safety team to liaise with site EHS on lab safety improvements

Qualifications

  1. Primary degree in analytical science or in an equivalent science-based discipline
  2. 3 years minimum experience in pharmaceutical quality control laboratory. Experience of Trackwise and applicable modules ER, CP and audit an advantage.
  3. Knowledge of QC regulations, European and FDA regulations
  4. Experience with QC analytical methods and procedures
  5. 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 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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

https://www.abbvie.com/join-us/reasonable-accommodations.html

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