CAPA Manager

Job Description

Job 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.

Qualifications:
Qualifications

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.

Additional Information

• Monday-Friday (8am-5pm)