Quality Assurance Specialist - Shop floor

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.

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 year
• 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.

5HSE 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.