Quality Control Specialist – Micro at sanofi
KEY RESPONSIBILITIES AND DUTIES:
Performs all necessary approved testing procedures of both chemical and microbiological procedures for Cephalosporins materials & products, issues certificates of analysis required and to ensure that all obtained results are within the specified approved limit, using valid method of analysis.
Supervises sampling procedures and analysis for specified products & materials and ensures that all necessary testing is carried out following approved written instructions (each batch) of the assigned products.
Immediate reporting of out of specification test results or batch deviation reports whenever needed to the lab head and the Q.C manager.
Performs daily/weekly/monthly the environmental monitoring of sterile and non-sterile areas. (Water, air, personnel etc.).
Performs sterility, particulate and LAL tests for sterile products. (Each Batch).
Identification of microorganisms.
Performs Environmental monitoring for production areas regarding both viable and non-viable parameters.
Performs testing of insoluble particulate matter in Injectable Products.
Participates and executes process validation periodically of sterile filling area, as stated in the approved local validation protocol.
Release of S.F. products.
Perform Stability testing.
Utilizes, calibrates, maintains the QC equipment in the Chemical Lab according to the local SOP.
Prepares relevant SOPs and follows up the update according to requirements.
Performs other related duties as assigned.
Makes sure that all activities carried on are complying with safety measurements.
Updates methods of analysis.
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:
Facilitate and guide the employees to implement the HSE & En. Policies.
Implement all applicable standards and guides of Sanofi-Aventis in his/her area.
Ensure from complying with all legal and Sanofi-Aventis requirements.
Lead his/her team to implement the HSE & EnMS PASS.
Train his/her team on HSE & EnMS procedures, SOP’s and MSDS.
Report any accidents/incidents in his/her area to the HSE department.
Lead his/her team for investigate accidents/incidents to define the root cause.
Support the area manager for takes the corrective and preventive actions to eliminate reoccurrence of any Environmental or Energy nonconformance.
Support the area manager for takes the corrective and preventive actions to eliminate reoccurrence of any accident/incident.
Sharing for HSE / EnMS inspection program, take the corrective actions for any violations in his/her area.
Lead the team of his/her area for doing full risk assessment and Environmental aspects studies.
Define and control the required PPE’s for his/her area.
Define the list of CMR and it’s operational control for Quality labs.
Control the first aid kits in his/her area.
Leading his/her team for control the significant hazards /aspects and Energy use.
Others:
Perform other duties as assigned.
Respect of company’s values, code of ethics and social charter.
Respect of personal data protection charter.
Responsible for applying the HSE related requirements for the company in all related working procedures.
JOB-HOLDER’s ENTRY REQUIREMENTS :
Education:
Bachelor Degree in Pharmacy, or Science
Related Experience:
3 – 5 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
competencies:
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