, pub-2091334367487754, DIRECT, f08c47fec0942fa0 Quality Assurance Specialist - Solid At Sanofi

Quality Assurance Specialist - Solid At Sanofi

 Quality Assurance Specialist - Solid At Sanofi

Quality Assurance Specialist - Solid At Sanofi

Job Purpose:

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

Performing quality assurance shop floor activities.

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

Assist  in onboarding of new QA professional colleagues

1- Reviewing Batch Records.-

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.          

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) Perform Process observations and internal inspections in the are of responsibility.

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

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

Job Holder Entry Requirements:

Education: The Bachelor degree of Pharmacy

Related Experience: 4-5 years of experience within the same field

Special Knowledge/Skills:

 Good communication skills   

 Problem solving skills

 Sense of urgency

 Good Command of Excel

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

Apply here