Conduct method validation and testing in compliance with all regulatory and technical requirements, and contributes to maintain the QC activities at the required operating level
Duties & Responsibilities
1. Perform activity related with projects, such as analytical method validation, analytical method transfer, analytical testing of bulk holding time, process validation, cleaning validation, comparative dissolution, etc.
2. Coordinate with QC FG Team Leader and QC Admin on the availability of reagent, HPLC column, reference standards, media, glassware and other materials required to support testing analysis
3.Perform testing for raw material, semi finish good and finish good as per applied procedure
4. Report any out of specification (OOS) found to QC Manager or QC FG Team Leader and immediately raise as well in Phenix (ILI)
5. Report any deviation found to QC Manager or QC FG Team Leader
6. Ensure all testing activity is documented properly in ATR and / or logbook , and comply with Good Documentation Practice
7. Ensure all equipments are calibrated and / or qualified
8. Actively involve in continuous improvement program in his / her area
9. Implement HSE practice in the work place as per applied HSE policy
Knowledge, Skills & Competencies / Language
Technical Skill & Competencies/Language
· Basic competency in English
· Practical experience in physical and chemical analysis, experience in modern equipment and methods.
· Strive for result (exceed standard performance)
· Act for change (participating in change)
· Corporate transversally (leverage team work)
· Commit to customer (take responsibility to fulfill customer needs)
· Continuous Learning (Practical & Actual Learning).
· Analytical Thinking (Break Down Issues).
· Committed To Org. Ethic (Act With Integrity)
· Communication (Clear Message).
· Adm, Record, Data Handling, Planning & Organizing (Reporting & Administration Understanding).
· Diploma in chemistry, chemical analyst, biology or pharmaceutical vocational school
· Min 1 year experience as a laboratory analyst in pharmaceutical company
· Experience in running laboratory modern equipment and testing method
· Technical Equipment Know How
Requirements of the job
· Having broad knowledge of GMP, GLP, local pharmaceutical regulations, analytical methodology and product transfer
· Having broad knowledge on pharmaceutical manufacturing process
· Basic communication skills in English
· Aptitude for transversal collaboration and teamwork
· Good knowledge on xls., word and ppt.
· Detail, process oriented and performance focus
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.