A Supply Chain Operations Compliance Specialist is required for a biopharmaceutical company in West Dublin.
- Completes QMS investigations in a timely manner, such as Deviations, SCARs.
- Ensures CAPAs are identified as appropriate, are implemented accordingly and have intended effectiveness.
- Working cross-functionally and act as initiator of Change Controls and respective risk assessments.
- Act as a liaison between the different Quality teams (External QA, QA DS, DP and FP, QA Distribution) and the different teams within Supply Chain Operations with respect to the compliance issues that might arise.
- Maintains knowledge of current Good Distribution Practices (GDP).
- Reviewing and maintaining procedures and other instrumental documents with focus on compliance and continuous improvement.
- Pro-actively identify changes and improvement opportunities.
- To collate information and assist preparations of internal and external audit as well as quality management review.
- Supporting with periodic review documentation.
- Develop strong partnerships with vendor’s compliance functions and ensure suppliers investigations are appropriate and have the intended effectiveness.
- Support track and trending of compliance issues and identify gaps and opportunities.
- Reporting to the Compliance Lead any compliance issues and adherence of Supply Chain Operations on the quality records standardised KPIs.
Qualifications & Experience:
- BA/BS Degree Business, Supply Chain, Scientific or other related discipline.
- 3+ years of experience in a similar role.
- Knowledge in aspects of pharmaceutical GDP processes.
- Strong technical writing capabilities and communication skills.
- Ability to manage multiple priorities against agreed timelines.
- Ability to develop internal and external relationships.
- Previous experience with internal and external inspections.
- Proficient in Microsoft Office.
To apply for this job email your details to firstname.lastname@example.org.