Hc QA Governance Associate Manager (Nc/Capa)

UPS Türkiye

We are looking for a Healthcare QA Governance Associate Manager  to work at UPS SCS Healthcare

SUMMARY

The QA Governance Associate Manager - NC,CAPA & Compliants is part of the Healthcare Compliance Governance team, manages key process elements of the Quality Management System and he/she reports to the Senior Manager Healthcare QA Governance

JOB PURPOSE AND KEY RESPONSIBILITIES

·       Assists in development and maintenance of the NC and CAPA handling procedures as well as related processes such as Escalation and Complaints, to ensure continual compliance to regulatory, internal and customer expectations

·       Facilitates monitoring and communicating NC and CAPA trends, risks and process performance of UPS SCS Healthcare operations

·       Responsible to review NCs and CAPAs and train staff on how to effectively review, assess and document NC Events and CAPA – fact finding, conducting investigations and root cause analysis, evaluating risk, developing corrective actions and establishing effectiveness checks

·       Assesses NC events across the UPS SCS Healthcare operations for risk impact and escalation to CAPA process

·       Organizes, prepares and assists with facilitation of the Global Quality Escalation Board (GQEB)

KNOWLEDGE AND EXPERIENCE

·       Must have a Bachelor’s Degree (or internationally comparable degree) in a technical discipline such as Science or Engineering

·       Must have previous QA experience in a cGMP/ISO/healthcare environment

·       Strong understanding and experience working with the various components of Quality Management Systems & cGMP requirements

·       Previous experience in investigations and investigation methodologies, program/project management or quality oversight in cGMP/healthcare environment

·       Experience in Lean Six Sigma methodologies would be an asset

·       Detail Orientation: Captures/documents specific and accurate information; learns subjects thoroughly and in detail; completes work with thoroughness; supplies appropriate details when requested; maintains organized files

·       Analytical skills (science/research or data analysis experience, training or education) · Critical thinking and problem solving skills (science, investigations, complex problem solving or Quality/QA experience, training or education)

·       Communication skills (strong written and verbal – able to communicate at both highest and lowest levels of UPS SCS organization – strong technical writing skills)

·       Demonstrated organizational and time management skills