Quality Regulatory Compliance Officer
- Sanofi
- Cairo, Cairo Governorate, Egypt
وصف الوظيفة
Job title: Quality Regulatory Compliance Officer
- Location: Cairo Site
- Grade: L1
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.
JOB PURPOSE:
- Co-ordinate between Industrial Affairs department and DRA department in regulatory aspects of chemistry, manufacturing, and control for pharmaceutical products.
- Manage the regulatory activities with the Ministry of Health Inspection Department
- Preparing the registration files in coordination with DRA department during new registration or re-registration:
- Preparation of IA part of regulatory files (Products Renewal)
- Reviewing of IA part of regulatory files (New Products)
- Regulatory compliance checking (Gap analysis)
- Review & Approval of updated method of analysis from QC
- Revising stability data, gathering raw material specifications, printed packaging materials.
- Send updated data to DRA with samples of finished products, with their certificates.
- Managing of submission of variations to DRA to be submitted to MOH to close any identified regulatory GAPs found.
- Initiate the eCTD file for local and exported products.
- Managing regulatory activities with the MOH inspector Receiving of all the new MOH decisions & informing the concerned departments for implementation. Managing the release of certain products with the MOH inspector. Following Raw materials & finished products sampling with the MOH inspector on weekly basis
- Support in PQR preparation for regulatory chapter Prepare the regulatory chapter in PQRs.
- Management of Regulatory compliance activities: Perform regulatory compliance assessment for products dossiers. Put regulatory compliance action plan for the detected gaps. Follow-up for findings action plan execution.
- Final Authorization of Products specifications and Method of analysis
- Preparation of site master file, site management registration in MOH process.
- Ensures HSE approval on any SOP that requires certain HSE precautions.
- Ensures HSE approval on any change.
- 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.
- 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.
- HSE Responsibilities in case joining HSE Excellence team:
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.
Education: Bachelor of Pharmacy
Related Experience: minimum of 3 years' experience
Special Knowledge/Skills:
- Communication & Presentation skills
- Computer skills
- Sense of urgency & Follow up skills
- Time management skills, High organization & planning skills
- Good Command of English Language
- Attention to Details
- Hard Worker and Team Worker
- Knowledge of regulatory activity is a plus
- 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
Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
