Gerresheimer is an innovative system and solution provider and global partner for the pharma, biotech and cosmetics industries. The company offers a comprehensive portfolio of pharmaceutical packaging, drug delivery systems, medical devices and digital solutions. Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. With around 13,600 employees and over 40 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets.
Job DescriptionJob Purpose:
The CAPA Manager is responsible for independently managing and coordinating the corrective and preventive action (CAPA) processes within the organization. This role is pivotal in handling quality issues, customer complaints, and production deviations, with the goal of maintaining and improving the quality management system through effective problem-solving and cross-functional collaboration.
Key Responsibilities:
Independently coordinate CAPA processes including investigations, root cause analysis, and implementation of corrective and preventive measures.
Lead and present results to internal and external stakeholders, including customers.
Prepare comprehensive documentation such as 8D reports and technical analyses.
Participate in and support audits and customer visits.
Propose and implement optimization measures and assess their effectiveness.
Manage projects related to quality improvements and process enhancements.
Utilize statistical and analytical methods to drive decisions and improvements.
Represent the quality department in cross-functional problem-solving scenarios.
Ensure adherence to regulatory and company-specific quality standards.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Qualifications:
A technical university degree (minimum 3 years) in a field such as plastics technology, glass technology, mechanical engineering, mechatronics, or electrical engineering.
A minimum of 5 years of professional experience in a comparable role within an industrial or pharmaceutical manufacturing environment.
Required Skills and Competencies:
Professional Skills:
Strong knowledge of production and manufacturing technologies.
Deep understanding of quality management systems and methodologies.
Experience with statistical and problem-solving methods (e.g., root cause analysis, 8D).
Advanced project management capabilities.
Proficiency in handling critical customer complaints and production problems.
Methodological Skills:
CAPA process expertise.
Change control management
Quality management manual (QMM).
Document control and data integrity
Hygiene and safety regulations.
Digital Competence:
Advanced user-level IT proficiency.
Familiarity with data analysis tools and quality-related software.
Monday-Friday (8am-5pm)
Why Join Us:
- Be part of a company that values your skills and ideas
- Work in an environment where quality truly matters
- Join a team that supports each other and grows together
- Contribute to products that have global impact
Join us and be part of a forward-thinking team dedicated to innovation and excellence. Together, we will drive digital transformation and achieve remarkable results.
Skills Required
- Technical university degree of at least three years in plastics technology, glass technology, mechanical engineering, mechatronics, electrical engineering, or a related field
- At least five years of professional experience in a comparable role within an industrial or pharmaceutical manufacturing environment
- Strong knowledge of production and manufacturing technologies
- Deep understanding of quality management systems and methodologies
- Experience with statistical and problem-solving methods, including root cause analysis and 8D
- Advanced project management capabilities
- Experience handling critical customer complaints and production problems
- CAPA process expertise
- Change control management experience
- Knowledge of quality management manuals, document control, data integrity, hygiene, and safety regulations
- Advanced user-level IT proficiency and familiarity with data analysis tools and quality-related software
What We Do
Gerresheimer is the global partner for pharma, biotech, healthcare and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging and drug delivery devices. The company is an innovative solution provider from concept to delivery of the end product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence, focus on quality and customers. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 10,000 employees and generates annual sales of more than €1.5 billion. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.
