Quality Assurance Vacancy At Sanofi Egypt
Job Title: Quality Assurance Validation officer
Location: Sanofi Cairo Site
Hiring Manager: Qualification & Validation Section Head
About the Job:
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as Projects Manager within our team will undertake from studies to commissioning the definition and the execution of technical solutions aligned with users’ requirements specifications.
KEY RESPONSIBILITIES AND DUTIES:
Issuing & following up of Validation Master Plan (VMP):
Issuing the VMP.
Archiving of finished document with necessary attachments.
Following up & updating implementation by various departments
Performing of Manufacturing, Packaging Processes Validation:
Reviewing of updates in current SANOFI guidelines to check for changes.
Creating of validation protocols to include validation objective, scope, responsibilities, critical parameters, acceptance criteria, sampling locations to be conducted during validation.
Monitoring & checking the various activities during production processes & ensuring that they are as mentioned in both Processing batch record & validation protocol.
Sampling according to validation protocol & providing QC with samples.
Collecting data from the various departments, analyzing information provided & preparing report to include results & conclusion of validation.
Performing of Cleaning Validation:
Studying the design of the machines &determine the critical points for cleaning.
Initiating the protocols & follow up distribution to concerned department after approval of concerned managers.
Following up of sampling process.
Revising data.
Preparing of the report showing the results of cleaning validation.
Performing of Media Fill Test:
Reviewing of media fill protocol.
Monitoring & checking of the various activities during media fill & ensuring that they are carried out as mentioned in the media fill protocol.
Collecting data from the various departments, analyzing information provided & preparing media fill repot to include results & conclusion of the media fill.
Reviewing & Updating of GMP documents:
Updating of Master BMRs SOPs, etc… & Ensuring the HSE approval if required.
Updating our GMP documents according to the last updated |GQDs directives & guidelines.
HSE:
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
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 PPEs for his/her area.
Define the list of CMR and its operational control for Quality labs and production areas. o 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 of Pharmaceutical Sciences
Related Experience: 4 – 6 years` experience in related quality assurance function.
Special Knowledge/Skills:
Good Communication skills with ability to co-ordinate several inter-departmental activities.
Presentation skills
Computer skills (Good command of MS office)
Sense of urgency
Follow up skills
Time management skills
Good Command of English Language
Attention to Details
Team Worker
Problem solving skills
Report writing skills
Validation theories, methodologies & sampling techniques
Good Manufacturing Practices (GMP) & Good Documentation Practices (GDP)
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