Offers “Sanofi”

Expires soon Sanofi

Quality Assurance Officer

  • ITALY
  • Infra / Networks / Telecom

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
·  Investigating deviations in partnership with all stakeholders for the relevant production unit for identifying the actual root causes and defining efficient CAPA plans.

Responsibilities and Tasks:

1- Batch Records & GMP Documentation Review. -

a) Collecting data daily from the various departments concerned i.e. production, packaging, & Quality Control

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.

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 & analysing the collected data.

3- Production shop floor activities.

a) To follow GMP compliance of activities done in the area of responsibility.

b) To follow changes control system in the area of responsibility.

c) Perform quality tours for monitoring of the establishment of the system in the area of responsibility.

d) Perform process observations for the manufactuirng processes & other GMP steps to identify areas for improvement in these processes during day and night shifts.

4- Deviations Investigations

Leading Investigations with the relevant production unit stakeholders to identify the impact of these deviations.

Identifying the actual root causes for these deviations.

Defining effective CAPA plan to prevent its re-currence.

5- HSE & Energy.

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.

Key “MUST HAVE” competencies, skills & experiences

QA Experience not less than 5 years

Successful performance records

Sense of urgency

Problem solving and Decision making capabilities.

Conflicts resolution.

Good knowledge of GMP and GDP

Good command of English

“Desirable” / compromise experience

Previous experience in Process validation / cleaning validation / Qualification activities

Total Quality Management Diploma is a plus

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.

Make every future a success.
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