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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.
What skills you will need: In order to excel in this role, you will more than likely have: Degree or post-graduate qualification in Science, Pharmacy, or equivalent.
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 manufacturing desirable.
Communications: Excellent written and oral communication skills.
Organizes and delivers information appropriately.
Teamwork: Interacts with people effectively.
Able and willing to share and receive information.
Decision Making: Uses sound judgement to make good decisions based on information gathered and analysed.
Adaptability: Adapts to changing work environments, work priorities, organizational needs, and diverse people.
Work Standard: Sets and maintains high performance standards.
Pays close attention to detail, accuracy, and completeness.
Motivation: Displays energy and enthusiasm. xcfaprz
Maintains high level of productivity and self-direction.
Skills: SAP Trackwise Laboratory Out of Specification CAPA
Sprachkenntnisse
- English
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