Katarzyna Romaniec

The purpose of the Configuration Management Process is to establish and maintain the integrity of all the work products of a process or project and make them available to affected parties.

Scope of responsibilities:

• training people from configuration management process;
• process improvement for configuration management process;
• prepare configuration management strategy plan and develop for the program and projects;
• assure all configuration items generated by a process or project are identified, defined and baselined according to the configuration management strategy, stored and baselined;
• modifications and releases of the configuration items are controlled;
• modifications and releases are made available to affected parties;
• the status of the configuration items and modifications is recorded and reported;
• the completeness and consistency of the baselines is ensured;
• storage of the configuration items is controlled;
• planning and performing Internal Project Configuration Baselines;
• co-operate with all departments involved in development of supported projects;
• involved in internal and external from the customer (ASPICE level) Quality Audit;
• integrity in relation to the company, customers and associates

Scope of responsibilities:

• prepare configuration management strategy and plans for the projects;
• assure all work items generated by the project are defined, identified,stored and baselined;
• planning and performing Internal Project Configuration Baselines;
• co-operate with all departments involved in development of supported project;
• involved in internal and external (ASPICE level) Quality Audit;
• integrity in relation to the company, customers and associates;
• check and report status of work products and baselines

Scope of responsibilities:

• conducting tests of raw materials, bulk products, packed products, validation tests, stability tests;
• conducting instrumental analysis;
• reporting of analytical results with the requirements of pharmaceutical law;
• conducting laboratory deviations in the TrackWise system;
• practical skills of using SAP system;
• training in new employees from the above laboratory techniques;
• development of documents (e.g instruction) in the Documentum system;

Scope of responsibilities:

• assessment of the correctness of production documentation and analytical data
• assisting in the process of ensuring the Good Practice of Manufacturing and Packaging of Medicinal Products
• coordinating production deviations in the TW system, developing risk analyses
• direct cooperation with the Quality Manager and Qualified Person
• assisting in internal and external with customer audits
• archiving of batches documentation and quality documentation
• defining material settings and developing control plans in the SAP system

Scope of responsibilities:

• conducting tests of raw materials, bulk products, packed products, validation tests, stability tests;
• conducting instrumental analysis;
• reporting of analytical results with the requirements of pharmaceutical law

Scope of responsibilities:

• contacting business clients;
• preparation of offers and documents related to contracts;
• ensure proper circulation of documents in the company