Evergreen - Quality Assurance Specialist

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 and tours.
• Annual product review: Collecting and reviewing data from all related departments
• Responsible for leading investigations for the area of responsibility.

Support in validation activities whenever needed.

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.

Annual Product Review:

• Prepare APR plan and follow up the plan implementation.         
• Collecting data from various departments concerned with APR.
• Reviewing & checking the collected data.
• Follow up all possible corrections if any with concerned responsible person.                              
• Filing of finished report with its concerned attachments.

Production shop floor activities.

• To follow GMP compliance of activities done in the area of responsibility.
• Participating in investigation of relevant deviations and follow up of its CAPA.
• To follow changes control system in the area of responsibility

Deviation Investigation:

Leading investigations in the area of responsibility. Perform root cause analysis for deviation in area of responsibility. Follow up of the outcomes from the deviations in the area. Support in the closure of CAPA for the area of responsibility.

HSE Requirements:

Commitment to the appropriate PPE use. Follow the approved HSE policy and energy law requirements. Following the statutory legislation concerning health, safety, energy & environmental policy & law.

Perform other duties as assigned.

Job Holder Entry Requirements:

• Education: Bachelor degree of pharmacy
• Related Experience: up to 7 years of experience within the same field