Quality Assurance Specialist - Solid At Sanofi
Reviewing Batch Records: Maintaining & controlling a firm system for revision of products manufacturing and packaging records to be ready for release for Solid manufacturing process.
Performing quality assurance shop floor activities.
Annual product review : Collecting and reviewing data from all related departments
Assist in onboarding of new QA professional colleagues
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.
a) To follow GMP compliance of activities done in the area of responsibility.
b) Perform Process observations and internal inspections in the are of responsibility.
c) Participating in investigation of relevant deviations and follow up of its CAPA.
d) 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
Job Holder Entry Requirements:
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)