- Experience Needed:
- 4 to 5 years
- Career Level:
- Experienced (Non-Manager)
- Job Type:
- Full Time
About the Job
- 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
- 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.
- 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.
4 to 5 years
Not Specified at least
Education: The Bachelor degree of pharmacy
Related Experience: 4-5 years of experience within the same field
- 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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