Quality Control Specialist – Micro at sanofi
This position is responsible to execute the approved method of analysis for:
Sterile products, products non-required being sterile, microbiological assay of antibiotics, environmental monitoring of sterile & non-sterile areas, testing of insoluble particulate matter in Injectable products and identification of micro-organisms.
Also, it is responsible to participate and to execute all activities necessary for validation of sterile and non-sterile areas.
KEY RESPONSIBILITIES AND DUTIES:
Performs necessary microbiological testing, issues certificates of analysis required and ensures that all obtained results are within the specified approved limit, using valid method of analysis.
Supervises sampling procedures and analyses all assigned products and ensures that all necessary testing is carried out following the approved written instructions.
Performs daily/weekly/monthly the environmental monitoring of clean and sterile area. (Water, air, personnel etc.).
Performs microbiological assay for antibiotic products. (Each Batch).
Performs sterility, particulate and LAL tests for sterile products. (Each Batch).
Performs microbial count for product non-required being sterile following the local approved SOP.
Identification of microorganisms following the approved SOP.
Performs Environmental Zoning and 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.
Immediate reporting of out of specification test results or batch deviation reports whenever needed to the Chemical lab head and the Q.C manager.
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 and production areas.
Control the first aid kits in his/her area.
Leading his/her team for control the significant hazards /aspects and Energy use.
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.
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.
JOB-HOLDER’s ENTRY REQUIREMENTS:
Bachelor Degree in Pharmacy, or Science
3 – 5 years experience in related positions, preferably in multinational company.
command of English Language
Good computer skills
Familiar with new instrumental analysis techniques
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