Website Ref: TPM03945
A pharmaceutical company located in South Tipperary is looking for a Quality Assurance Specialist to join to their team. The successful candidate will participate as functional expert in the cross functional team that manages production right first time.
- Review and approve batch, cleaning and testing documentation.
- Ensure that all Laboratory Out of Specification (OOS) and process deviations are documented, assessed and associated CAPA identified.
- Provide support to deviation investigations and process performance monitoring. Perform trending on deviations raised as required to identify improvement initiatives.
- Provide detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed.
- Provide guidance on quality requirements to maintain validation status, including participation in process/product Risk Assessments.
- Provide feedback on re-occurring issues ensuring continuous improvement to systems/processes.
- Ensure changes controls raised are documented, assessed and completed.
- Prepare Annual Process and System Reviews.
- Act as lead/team auditor to support the internal GMP walkdown and scheduled audits.
- Participate in the generation and communication of quality metrics.
- Creation, review and approval of quality procedures as required.
Qualifications & Experience:
- Degree or post-graduate qualification in Science, Pharmacy or equivalent.
- 3+ years experience within a similar role.
- Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise).
- Knowledge and demonstrated expertise in Lean / Continuous Improvement.
- Experience and knowledge of GMP Requirements for Electronic /paper free operations.
- Experience in High potency/ Spray drying/Laboratory/Project Management desirable.
- Excellent written and oral communication and interpersonal skills.
To apply for this job email your details to firstname.lastname@example.org.