CAPA Manager

2 weeks ago

Peachtree City, Georgia, United States Gerresheimer Full time $100,000 - $120,000 per year

*Company Description*
Gerresheimer is the global go-to partner for medicine packaging, drug delivery devices and solutions with the broadest product range for pharma, health, well-being and biotech. We bring every kind of medicine safely, reliably and conveniently to or into the patient. Customers and partners from all over the world approach us with new challenges. We are their solution provider with the absolute will to deliver, from the concept up to the final product. This is how we meet the needs of our customers and their customers – the users.

We are driven to achieve our ambitious goals through a high level of expertise, a focus on quality and the purpose of what we do. Thanks to the involvement of our comprehensive international network and their industrial competence, we know the markets and develop innovative and sustainable solutions.

We play an essential part in people's health and well-being and gladly accept the responsibility for this.

*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*
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.

*Professional Skills:
Required Skills and Competencies:*

  • 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)

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