Professional QA Officer - Shop Floor

Job description

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

Responsibilities and Tasks:

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.

To follow GMP compliance of activities done in the area of responsibility. Perform Process observations and internal inspections in the area of responsibility. Leading investigations of relevant deviations and follow up of its CAPA. 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.

Work Contacts

Internal:

·    Production department.
·    Quality control department
·    Quality Assurance department 
·    Logistics department.
·    Maintenance department.
·    Business development department.

Machines or Equipment Used:    Computer & SAP system, Quality System.

Job Holder Entry Requirements:

Education: Bachelor degree of pharmaceutical industries

Related Experience: 6 months - 3 years of experience within the same field

Special Knowledge/Skills:

·  Good communication skills  
·  Computer skills
·  Good Command of English Language
·  High sense of urgency
·  Time Management 
·  Problem solving skills
·  Good Manufacturing practices (GMP) & Good documentation practice (GDP).

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.