Job title: QA products Senior Specialist - Shop floor
Location: Cairo Site
Hiring Manager: QA Section Head - Shop Floor
About the job
We deliver
- 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:
Maintain & Manage QA product shopfloor to ensure building of quality into the product to guarantee the conformance of the final product with its predetermined specifications and compliance to GMP regulations, Sanofi industrial quality and compliance directives & guidelines and Local national requirements.
Job Responsibilities:
Deviation Investigations:
All deviations in the process or specifications that can affect product quality are investigated to evaluate the root cause, corrective actions and preventive measures needed to prevent re-occurrence.
Ensure of non-recurrence of repeated deviations.
Shopfloor Activities:
Review of the batch records before release to the market.
Manage batch record archiving
Performing quality tours in each manufacturing GMP area.
Maintain compliance to local and Sanofi regulations in manufacturing areas.
Execution APR plan execution
Manage Quality culture program of the site.
Monitor Data integrity program of the site.
Monitor deviations impacted non-sterile areas.
Finished goods disposition. -
Collecting data daily from the various departments concerned i.e. production, packaging, & Q.C
Checking and reviewing the data to ensure its adherence to specified protocol & therefore, according to Sanofi Directives & Guidelines & current GMP, on daily basis.
Checking the finished goods retain samples.
Following up corrections with the concerned person in the respective department.
Summarizing data from protocols through documenting them in standard checklist& batch release.
Archiving of batch records with its concerned attachments up to 10 years.
Delegated by QA manager for finished products release/reject activities for non-sterile / sterile batches.
Quality tours
Perform routine Quality tours in the responsible areas.
Perform GEMBA & process observation within the responsible areas.HSE Responsibilities:
Ensures HSE approval on any SOP that requires certain HSE precautions.
Ensures HSE approval on any change.
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.
About You:
Bachelor's degree in pharmaceutical science
5 -7 years of related experience
Shop floor activities.
QA Documentation and compliance systems experience.
Expert in Pharmaceutical industry & raw materials API & Non-API
Decision making & problem solving.
Deviation management
Risk management & Root cause analysis tools.
Pursue Progress. Discover Extraordinary.
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.
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