QA Specialist
vor 2 Wochen
The QA Specialist (m/f/d) will be responsible for continuous improvement, document review and auditing, as well as for providing training in the related fields, by carrying out the following task areas:
- Executes stock checks, stock statuses change and supports global holds and local blocks in SAP.
- Assists the Global QA with communication and follow up on finished good defect investigations and non-conformances noticed on products stored in local distribution centers.
- Ensures sampling process is managed appropriately in cases of quality defects and further investigations.
- Supports stock reconciliation and assists with Value Added Services and rework processes locally.
- Identifies and reviews deviations, determines root cause, and develops CAPAs in collaboration Quality and Distributions staff to address product quality issues and GMP related activities.
- Responsible for QMS document completion and effectiveness (CAPA, deviation, change).
- Investigates critical customer and consumer complaints.
- Disposition out-of-spec materials, as directed.
- Monitors progress against improvement initiatives identified by Quality Engineer and Quality Manager.
- Conducts documentation reviews in the quality team and provides feedback to the distribution as applicable for compliance with existing procedures and instructions.
- Verifies the effectiveness of procedures and instructions versus our client's requirements and needs.
- Performs final (where applicable) review of executed batch records and disposition.
- Initiates, revises, and reviews documentation including procedures, investigations, deviations, and reports.
- Participates in routine GMP, internal and corporate audits.
- Provides training and coaching to Distributions, on topics such as SOP, GMP and root cause analysis.
For this challenging and rewarding position, the ideal candidate should have: ·
- Successfully completed bachelor's degree, ideally in chemistry, logistics or quality
- Minimum 2-3 years of working experience in quality assurance within a regulated industry
- Previous experience in project management would be an advantage.
- Ability to interpret and assess operational compliance against Good Manufacturing Practice Regulations (FDA, KFDA, HC, ISO22716)
- Knowledge and ability to execute statistical sampling, AQL/ANSI interpretation, and read/interpret specifications, drawings, and compounding/assembly instructions.
- Ability to create and review SOP's, GMP reports, batch records and investigations.
- Proficiency in MS Office, Electronic QMS, and SAP systems is preferred.
- Solid English skills, as well as very good German skills (min. B1 Level)
- Excellent communication skills to communicate with stakeholders on different business levels.
- Hand-On mentality and detail-oriented way of working.
- Excellent opportunity to be part of a highly qualified QA team with a regional scope.
- Gaining experience in a Distribution Center environment.
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