Quality Management Records

The Company
Our clients is one of the leads from the Biotechnology industry who try to improve patients’ lives, by distributing their medicines to hospital and pharmacies in 100 different countries in the world, to over 10 million patients, in Europe, Turkey, Middle East and Africa Regions.

 Role Description
As a Quality Management Records, you will be responsible for identifying root causes, evaluate optimal solutions, recommend improvements, and ensure records are in completed to the highest standards, fully compliant with all regulations and quality Standards.

Responsibilities
– Being the owner of change control / NC/ CAPA records via CCMS (Change Control Management System) Track wise.
–  Facilitating and leading RCAs to resolve issues through expertise in problem-solving methodology.
– Review for completeness of actions and records, accuracy, effectiveness, and timelines.
– Ensuring compliancy and effectiveness of the records.
– Facilitate and coach CCMS owner teams in the application of problem-solving techniques and promote their uses and development (human error reduction, 4-D, 5 Why’s, fishbone diagrams, process mapping, etc.)
– Cooperating with other sites to ensure compliance to global requirements are achieved to improve the CCMS.

 Requirements
– Bachelor’s degree.
– Fluent in English, with advanced technical writing skills, B.L.O.T. writing highly appreciated.
– 1-year experience with Change/NC/CAPA programs within a GMP regulated environment.
– Knowledge of regulations EudraLex Annex 15, FDA CFR 11, 210 and 211.
– Experience in interacting with regulatory agencies highly preferred.
– Six Sigma Green or Black belt preferred.
– Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), Root Cause Analysis (RCA).

Other information
Are you interested? Feel free to contact me!