QC Raw and Packaging Material Section Head

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

About the job

Key dimensions - Scope & Scale:

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.

Main responsibilities:

• 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.

• Preparation and standardization of volumetric solutions used in the lab.

• Analysis of Nitrogen according to method of analysis of pharmacopeia

• Implementation of the sampling system, frequency of sampling, and conducting chemical analysis from the water stations.

• Routine Chemical Monitoring of Compressed Air.

• Release of Raw, Auxiliary & packaging materials on SAP

• Participates in product analysis as assigned

• Issue deviations for the coming materials if any observations for the integrity of the pack observed during the sampling process . 

• Lead QC Material team and set up their annual priorities including individual development plans to support continuous improvement programs.

• Assisting in Printed packaging materials testing

• Review PQR for the chapter of raw material and finish product if needed .

• 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.

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 champions  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.

About you

• Education: Bachelor degree in Pharmaceutical Science, or Science

• Experience: Materials analysis in the Quality control 

• Special Knowledge/Skills:

• Good Interpersonal & communication skills.

• Good technical, managerial, & Leadership skills.

• High sense of urgency.

• High organization & planning skills.

• Time management, Good Communication skills, team player, problem solving

Take the Lead Values

• Aim Higher: Focus on what matters, set high standards and move with urgency, learning from setbacks as we go to achieve higher performance.

• Act for Patients: Never compromise on integrity, eliminate barriers and partner with others to go faster and further for patients.

• Be Bold: Take thoughtful risks, seize opportunities and think beyond what's possible to accelerate our science and drive compelling growth.

• Lead Together: Build trust and collaborate openly on our shared goals, celebrate collective wins and foster a sense of belonging.