qc compliance and continuous improvement lead.

For this QC Compliance and Continuous Improvement Lead position the company offers the following benefits:

• commentative remuneration package and benefit package.
• opportunity for further career advancement within a multinational company.
• fostering working environment.

As an QC Compliance and Continuous Improvement Lead your main responsibilities will be the following: 

• Be the independent oversight on QC operations to ensure compliance with regulatory requirements, GMPs/GLPs and data integrity.
• Review and approve investigations resulting from OOS/OOE/OOT and Lab incidents, ensure the root cause is properly identified, and closure with appropriate CAPAs.
• Prepare and perform trend analysis on lab investigations, analyze trends and recurrences and define proper CAPAs to prevent them.
• Perform statistical and trend analysis on analytical data to be used for QC and stability testing to identify OOT/OOE results.
• Prepare GMP/GLP documents e.g. SOPs, protocol, reports, etc.
• Review and approve analytical method transfer/validation protocols and reports.
• Periodic walkthroughs to QC labs to review daily practices and ensure compliance.
• Document any gaps and issues and identify proper CAPAs to prevent them.
• Establish a continuous learning culture to periodically review mistakes, errors and improvement opportunities with QC teams to ensure proper cascading to all impacted personnel.
• Coach QC personnel to ensure they are doing the right things.
• Provide compliance/data integrity training to QC personnel as part of the QA training program.
• Implement lean principles to QC labs to reduce waste and increase efficiency.
• Establish a system to capture improvement ideas and put them in action to realize benefits.
• Identify and lead continuous improvement projects/initiatives to increase compliance, safety and efficiency of QC operations.
• Establish and monitor project plans for all QC related projects and initiatives to ensure all defined actions are completed in full and benefits realized.
• Establish a system to collect, analyze and review QC KPIs related to compliance and efficiency and report periodically to top management.
• Support QC team to excellent performance through a structured system with the use of Operational Excellence tools.
• Follow and comply to all good practices (GMP, GDP), to the Quality Management System, regulatory requirements, internal processes and procedures, company guidelines, the corporate governance code, the Health Safety and Environment (EHS) procedures and good practices and all company policies and regulations, and actively contributes to their improvement.
• Ensure and protect data integrity in every action.
• Contribute to the design of the Data Integrity (DI) principles throughout the QMS, by training the QC personnel on its implementation. 
• Undertake any other project or responsibility that is assigned by the company, within the broader scope of the position’s responsibilities.

The QC Compliance and Continuous Improvement Lead we are looking for should acquire the following: 

• Communication – has excellent communication skills with internal and external partners.
• Problem solving – can effectively perform root cause analysis.
• Time Management - uses time effectively and efficiently; concentrates efforts on the more important priorities.
• Dealing with Ambiguity - can effectively cope with change; doesn't have to finish things before moving on.
• Action Orientated - enjoys working hard; is full of energy for the things sees as challenging.
• Bachelor's or master’s degree in Chemical Engineering, Chemistry, Biology, Pharmacy, or any relevant field.
• Excellent oral and written communication.
• Fluent in Greek & English.

• 5 years of progressive technical experience in QC, regulatory compliance, laboratory inves

Does this role sounds like you or someone you know? We want to hear from you today. Apply online now!

Have some questions first? Call our office at +30 2166001308 and ask for Calypso Aronis. Otherwise, feel free to contact me at caronis@randstad.gr. 

Please note that for transparency and equity reasons, only those applications made online via our site will be assessed. After the screening of all the CVs received, we will only contact the candidates who meet the requirements of the job to arrange an interview. ​ All applications are considered strictly confidential.