Capa Specialist- Internal Investigations (Process Quality Associate)
Gerresheimer
Summary
Independent coordination and processing of internal deviations in collaboration with relevant departments and other interfaces.
Job description
Job Description
Independent coordination and processing of internal deviations in collaboration with relevant departments and other interfaces.
Independent monitoring of on-time processing of internal deviations and defined corrective actions (including long-term CAPAs).
Independent review of 8D reports for consistency, plausibility, adequacy, and clarity, particularly with respect to:
- Definition of affected products or materials.
- Root cause analysis.
- Corrective and preventive actions.
- Effectiveness verification.
Advising production regarding required rework or implementation of changes.
Independent evaluation of blocked stock to determine disposition (e.g., release, rework, scrapping).
Participation in processing customer complaints.
Support continuous improvement initiatives (e.g., 5S).
Perform additional quality assurance tasks in production as assigned (e.g., process monitoring, hygiene checks, sterilization activities, etc.).
Processing time of internal deviations (critical deviations).
CAPA (Corrective and Preventive Actions) overdue rate.
Frequency of recurring errors.
Qualifications
- Very good knowledge of relevant quality management (QM) guidelines.
- Good knowledge of quality management systems.
- Good understanding of production processes and manufacturing methods.
- Strong technical comprehension.
- Good command of English, spoken and written.
- Good IT user skills (e.g., MES/SAP, MS Office).
Additional Information
Knowledge acquired through at least a 3-year technical education program, supplemented by a minimum of 4 years of experience in operational quality assurance.
- Motivation for achievement and innovation.
- Action orientation, conscientiousness, and flexibility.
- Sensitivity and strong interpersonal skills.
- Sociability and team orientation.
- Emotional stability, resilience, and self-confidence.
Requirements
- Very good knowledge of relevant quality management (QM) guidelines.
- Good knowledge of quality management systems.
- Good understanding of production processes and manufacturing methods.
- Strong technical comprehension.
- Good command of English, spoken and written.
- Good IT user skills (e.g., MES/SAP, MS Office).
- Knowledge acquired through at least a 3-year technical education program.
- Minimum of 4 years of experience in operational quality assurance.
Company overview
Gerresheimer is a global leader in pharmaceutical primary packaging, drug delivery systems, and medical device solutions, serving the pharmaceutical, biotech, health, and cosmetics industries. Founded in 1864 and headquartered in Düsseldorf, Germany, the company operates as a comprehensive system and solution provider with over 40 production sites across 16 countries worldwide. Gerresheimer's extensive product portfolio includes pharmaceutical primary packaging such as vials, ampoules, syringes, and cartridges, as well as proprietary drug delivery devices like insulin pens, inhalers, autoinjectors, and on-body devices. The company also provides contract manufacturing services for medical devices and digital solutions for drug delivery and supply chain management. With approximately 13,400-13,600 employees globally, Gerresheimer maintains a strong presence in Europe, America, and Asia, producing locally for regional markets while ensuring the safe and reliable administration of medications to patients. The company's commitment to innovation, quality, and sustainability has established it as a trusted partner for pharmaceutical companies worldwide, with annual revenues exceeding $2.2 billion.