QA Compliance Manager ESO FDF

Job description

Job Description

• Stability reports and PQR’s, Ensure that the External Supplier provides the required product review or the data as specified in the relevant Quality Agreement on annual basis. Critically assess the performance of the product and process and provide the assessment to the report annually.
• Responsible for assessing quality trends and driving continuous improvement for processes and product quality performance.
• Creation, approval and change management of LIMS specifications.
• Confirmation of SHAPE QM data and management of changes of SHAPE QM data.
• Preparation of QP declaration.
• Performance of regulatory compliance checks.
• Create and maintain 3rd PAP records.
• Support sample management for EU retesting.
• Implement and maintain a local Quality System and Standard operating Procedures defining all the processes for managing of External suppliers.
• Ensure that the coordinated contact is maintained with other functions within Novartis also dealing with External suppliers namely Purchasing, Legal, Supply Chain, Regulatory CMC, Drug Regulatory Affairs, Group Quality Operations (GQO), etc.
• Participate in the ES Quality Plan – ensure that all quality issues at external suppliers are included in this plan.
• Participate in projects as defined and ensure that all aspects are implemented and followed up. Personal development
• Maintain current knowledge of local and international regulatory and legislative requirements and trends.
Change management:
• Support for the on-site and inter-functional evaluation and implementation phases of change requests, considering the most effective implementation strategy, cGMP’s, regulatory requirements, Corporate Quality Manual, Novartis policies and cost effectiveness. Set priorities for change requests at a site level in line with relevant boards.
Complaints:
• Manage complaints according to the Quality Agreement and the Novartis Quality Manual.
Within the organization:
• Support KPI reporting.
• Responsibility for personal and professional development.
• Providing conditions for and control of the implementation of HSE tasks and requirements in the unit.
• Other tasks determined during the annual objectives setting process and by KPIs.
• Other tasks as assigned by the supervisor, and tasks based on a specific appointment.
Position Title

QA Compliance Manager ESO FDF

Desired profile

Minimum requirements

• University degree in pharmaceutical, chemical or other appropriate natural sciences.
• 1 year of working experience would be an advantage.
• Fluent in English.
• Knowledge of Microsoft Office.

We offer temporary employment with a purpose of long term collaboration.

You are kindly invited to submit your application, including CV, by 7th June 2018 on our website www.lek.si/si/o-nas/zaposlitev/.
Job Type

Full Time
Country

Slovenia
Work Location

Ljubljana
Functional Area

Quality
Division

Novartis Technical Operations
Business Unit

NTO QUALITY
Employment Type

Temporary
Company/Legal Entity

LEK SVN