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QA shopfloor Senior At Sanofi - Pharmacy Graduate Vacancy -5-7 years of experience

 QA shopfloor Senior At Sanofi - Pharmacy Graduate Vacancy -5-7 years of experience

QA shopfloor Senior At Sanofi - Pharmacy Graduate Vacancy -5-7 years of experience


Job Purpose:

- Reviewing Batch Records: Maintaining & controlling a firm system for revision of products manufacturing and packaging records to be ready for release.

- Performing quality assurance shop floor activities.

- Annual product review : Collecting and reviewing data from all related departments

- Responsible for finished products release activities for non-sterile / sterile batches. 

 


Responsibilities and Tasks:


1- Finished goods disposition.-


a) Collecting data daily from the various departments concerned i.e. production, packaging, &  Q.C


b) Checking and reviewing the data to ensure its adherence to specified protocol & therefore, according to Sanofi   Directives & Guidelines & current GMP, on daily basis.  


c) Checking the finished goods retain samples.


d) Following up corrections with the concerned person in the respective department.


e) Summarizing data from protocols through documenting them in standard checklist& batch release.


f) Archiving of batch records with its concerned attachments up to 10 years.          


g) Delegated by QA manager for finished products release/reject activities for non-sterile / sterile batches.


    


2- Annual Product Review:


a) Prepare APR plan and follow up the plan implementation.         


b) Collecting data from various departments concerned with APR.


c) Reviewing & checking the collected data.


d) Follow up all possible corrections if any with concerned responsible person.                              


e) Filing of finished report with its concerned attachments.


3- Production shop floor activities.


a) To follow GMP compliance of activities done in the area of responsibility.


b) Participating in investigation of relevant deviations and follow up of its CAPA.


Perform Process observations and internal inspections in the area of responsibility.


 d) To follow changes control system in the area of responsibility


4- HSE & Energy.


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.


5- Perform other duties as assigned.


Work Contacts


Internal:

• Production department.

• Quality control department 

• Quality Assurance department  

• Logistic department.

• Engineering department.

• Business development department.

External:

• MOH inspectors. 

 


Machines or Equipment Used:  Computer.


Job Holder Entry Requirements:


Education: Bachelor degree of pharmaceutical industries

Total quality management will be an asset


Related Experience: 5-7 years of experience within the same field


Special Knowledge/Skills:

•    Good communication skills  

•    Computer skills

•    Good Command of English Language 

•    Organization skills and high accuracy in documentation .

•    High sense of urgency

•    Time Management  

•    Problem solving skills

•    Presentation skills  Good 

•    Manufacturing practices (GMP) & Good documentation practice (GDP).

Apply Here

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