GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services.
We partner with many of the world's largest life science & have multiple projects that we support, Quality Engineer Quality Assurance Specialist Ensure products meet specifications and site activities follow good manufacturing practices (GMP) and regulatory requirements.
Work within the Quality Team to achieve quality goals and ensure all actions comply with GMP.
Key Responsibilities: Coordinate and ensure compliance with assigned parts of the Quality System.
Participate in quality system audits.
Help investigate customer complaints and implement corrective/preventive actions (CAPA).
Manage the CAPA process: initiation, investigation, correction, and preventative actions.
Track and report on Quality System performance metrics.
Provide necessary quality-related training to plant personnel.
Keep Management informed of system failures for timely corrective/preventive action and product containment.
Verify the effectiveness of corrective/preventive actions.
Ensure compliance with relevant regulatory requirements.
Assist with validation activities at the site.
Maintain thorough, complete, and compliant Quality System documentation.
Ensure training compliance is maintained.
Review lot records for compliance and complete lot release for shipment.
Inspect incoming products and manage supplier quality relationships.
Participate in continuous improvement programs for quality, safety, environmental, and production systems.
Perform in-process and final product testing according to specifications and procedures.
Review batch records for compliance (where required).
Make disposition decisions for batches.
Participate in Risk Management activities as needed.
Essential Requirements: Degree in Engineering, Science, Quality, or a related field.
Experience Required: Minimum 2 years of experience in the daily operation of a quality system in a highly regulated combination product/device manufacturing environment.
Minimum 2 years working knowledge of quality system regulations (ISO13485/ISO9000; CFR 21 Part 820) or specific elements like process validation, design controls, CAPA, auditing, etc.
Job Type: Full-time Schedule: Day shift Work Location: In person To start the process click the Continue to Application or Login/Register to apply button below.