QC Raw material and packaging section head At Sanofi
JOB PURPOSE:
This position is responsible to execute daily the approved method of analysis for Raw and Auxiliary Materials & supervise the sampling processes for all types of materials ( API , Aux & packaging materials ) as well as Nitrogen Analysis & analysis of primary packaging materials.
KEY RESPONSIBILITIES AND DUTIES:
Conduct sampling operations for raw, auxiliary & Packaging materials and supervise sampling operations insuring its full compliance with relevant SOPs procedures and analysis for Raw and auxiliary materials and ensures that all sampling operations are carried out following approved written instructions (each batch) of material.
Performs all necessary approved testing procedures of the raw and auxiliary materials, and packaging materials issues certificates of analysis required and to ensure that all obtained results are within the specified approved limit, using valid method of analysis.
Immediate reporting of out of specification test results or batch deviation reports whenever needed to the lab head and the Q.C manager.
Follow all external testing for the materials that tested externally
Co-operation with Quality assurance for the certification program and ensure all data requested to be submitted and follow up the certification status in quarter basis
Issues and updates materials specifications, method of analysis.
Analysis of Nitrogen according to method of analysis of pharmacopeia
Release of Raw, Auxiliary & packaging materials on SAP
Participates in product analysis as assigned
Sampling of semi-finished products , and ensures that sampling are conducting in full compliance with GLP and according to the instructions as per the SOP.
Lead QC Material team and set up their annual priorities including individual development plans to support continuous improvement programs.
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.
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.
Assisting in Printed packaging materials testing
Perform APR for Routine and Stability .
Prepares relevant SOPs and follows up the update according to requirements
Prepare relevant batch deviation whenever needed to be approved by Q.C. Manager.
Assures that all activities carried on in are complying with the safety measures
Education:
Bachelor Degree in Pharmacy, or Science
Related Experience:
7 – 10 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
HSE appropriate knowledge