(DSZ538) - Quality Specialist I
- Buenos Aires
- Permanente
- Tiempo completo
- Perform physical inspection, verify related documentation, and strictly control the release of incoming drug/material receipts entering the warehouse in the operational management computer system(s).
- Complete pre, during, and post controls in secondary packaging processes (labeled/relabeled/other) to ensure world-class standards.
- Control the rejection process of medicines/materials by verifying movements, quantities, and corresponding documentation to determine accuracy.
- Generate necessary reports or documentation related to the verification and execution of the different processes.
- Verify and approve records and reports showcasing the accurate performance of GxP building maintenance and in-process controls. Adhere to timelines in approved site Work Plans or Schedules.
- Participate in the detection, prevention, and reporting of deviations and non-conformities related to warehouse operational processes. Actively engage in investigations of deviations, providing truthful information.
- Successfully implement corrective/preventive actions for deviations/customer complaints/observations found during customer audits, self-inspections, or regulatory inspections.
- Contribute to the design and review of existing and new processes for continuous improvement and aid in drafting and training of approved procedures and instructions.
- Support the preparation, review, execution, and documentation of Qualification, Validation, and Thermal Mapping processes of GxP areas and equipment.
- Assist in the preparation of Area Reports and Metrics.
- Ensure that industry records are filed in a secure and orderly manner.
- Align with company quality policies based on good manufacturing, distribution, documentation, and clinical practices, as well as regulatory and customer requirements.
- Perform all activities in an efficient and safe manner.
- Assist in other tasks as necessary to meet Area and business requirements.**Job Requirements**:- Bachelor's degree in Engineering or related field, or equivalent experience (graduated or in process)
- Proven experience in quality assurance within a GxP environment.
- Availability to work evening shift (Monday to Thursday 1:00pm to 10:00pm and Friday 1:00pm to 8:00pm)
- Intermediate English
- Outstanding attention to detail and strong analytical skills.
- Ability to compete and thrive in a fast-paced, ambitious team environment.
- Excellent communication and teamwork skills.
- Ability to strictly adhere to deadlines and regulatory requirements.
- Proficiency in operational management computer systems.
Kit Empleo