Quality Control Analyst At Sanofi Egypt
Quality Control Professional – Validation At Sanofi
Job Purpose:
The main purpose of this job is to perform chemical analysis for validation samples for products according to the approved method of analysis, and prepare relevant documentation as required.
Perform analytical method validation studies, Protocols & final reports.
Perform recovery studies & prepare cleaning validation & verification runs.
KEY RESPONSIBILITIES AND DUTIES:
Performs all physicochemical testing of samples collected during the process validation and record the results in the validation report & Certificates of analysis required and ensures that all obtained results are within the specified approved limit, using valid method of analysis.
Performs the analytical transfer analysis according to respective protocol.
Perform coaching and training for junior analyst for the Analytical method validation and explain the methodology and ensure that all the junior analyst (s) understand the method validation concept and can perform full study independently.
Immediate reporting of out of specification test results or batch deviation reports whenever needed to the Q.C manager.
Perform analytical full method validation studies, Protocols & final reports.
Updating of SOPs & control test methods and maintaining of relevant master files.
Performs Standardization for Raw Materials
Perform Stability testing & routine analysis tasks as assigned.
Perform recovery studies & prepare cleaning validation & verification runs.
Fulfill other task(s) as assigned.
HSE Responsibilities:
Follow the approved HSE policy and requirements.
Following the statutory legislation concerning Health, Safety, and environmental law.
Hydrocarbons/ hazardous substance & waste segregation in accordance with approved waste management system.
HSE Responsibilities in case joining HSE Excellence team:
Ensures HSE approval on any SOP that requires certain HSE precautions.
Ensures HSE approval on any change.
Follow the laboratory safety procedures Commitment to the appropriate PPE use.
Follow the approved HSE policy and requirements. Following the statutory legislation concerning Health, Safety and environmental law. Hydrocarbons/ hazardous substance & waste segregation in accordance with approved waste management system. Implement good calibration program for all instruments.
Others:
● Makes sure that all activities carried on are complying with safety measurements.
● Updates methods of analysis.
● Respect of Company’s Values, Code of Ethics and Social Charter.
● Responsible for applying the HSE related requirements for the company in all working procedures
● Respect Personal Data Protection Charter.
JOB-HOLDER’s ENTRY REQUIREMENTS:
Education:
Bachelor’s degree in pharmacy, or Science related experience:
6 Months – 3 years’ experience in related positions, preferably in multinational company.
Special Knowledge/Skills:
command of English Language
Good computer skills
Familiar with new instrumental analysis techniques
Play to win Behaviors:
Stretch to go beyond the level we have operated at up until now.
Take actions instead of waiting to be told what to do.
Act in the interest of our patients and customers
Put the interests of the organization ahead of my own or those of our team.
Act for Change, strive for results, Cooperate Transversally, Commit to Customer
Think Strategically, Lead Teams, Develop People, Make Decisions