Quality Assurance Specialist - Shop floor

Sanofi - Cairo

96 people have clicked
Experience Needed:
4 to 5 years
Career Level:
Experienced (Non-Manager)
Job Type:
Full Time
1 open position
About the Job

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.
Job 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).
About this Company

Sanofi S.A. is a French multinational pharmaceutical company headquartered in Paris, France, as of 2013 the world's fifth-largest by prescription sales. The company was formed as Sanofi-Aventis in 2004 by the merger of Aventis and Sanofi-Synthélabo, which were each the product of several previous mergers.

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