Quality Assurance Officer

JOB PURPOSE:
* Maintain & Manage QA product shopfloor to ensure building of quality into the product in order to guarantee the conformance of the final product with its predetermined specifications and compliance to GMP regulations, Sanofi industrial quality and compliance directives & guidelines and Local national requirements
KEY RESPONSIBILITIES AND DUTIES:
* Deviation Investigations:
* All deviations in the process or specifications that can affect product quality are investigated to evaluate the root cause, corrective actions and preventive measures needed to prevent re-occurrence.
* Ensure of non-recurrence of repeated deviations.
* Shopfloor Activities:
* Review of the batch records before release to the market.
* Manage batch record archiving
* Performing quality tours in each manufacturing GMP area.
* Maintain compliance to local and Sanofi regulations in manufacturing areas.
* Execution APR plan execution
* Monitor deviations impacted non-sterile areas.
* 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 years.
* Quality tours
* Perform routine Quality tours in the responsible areas.
* Perform GEMBA & process observation within the responsible areas.
* HSE Responsibilities:
* Ensures HSE approval on any SOP that requires certain HSE precautions.
* Ensures HSE approval on any change.
* Commitment to the appropriate PPE use.
* Follow the approved HSE policy and requirements.
* Following the statutory legislation concerning Health, Safety and environmental law.
* Hydrocarbons/ hazardous substance & waste segregation in accordance with approved waste management system.
* HSE Responsibilities in case joining HSE Excellence team:
* Facilitate and guide the employees to implement the HSE&En. Policies.
* Implement all applicable standards and guides of Sanofi-Aventis in his/her area.
* Ensure from complying with all legal and Sanofi-Aventis requirements.
* Lead his/her team to implement the HSE & EnMS PASS.
* Train his/her team on HSE & EnMS procedures, SOP's and MSDS.
* Report any accidents/incidents in his/her area to the HSE department.
* Lead his/her team for investigate accidents/incidents to define the root cause.
* Support the area manager for takes the corrective and preventive actions to eliminate reoccurrence of any Environmental or Energy nonconformance.
* Support the area manager for takes the corrective and preventive actions to eliminate reoccurrence of any accident/incident.
* Sharing for HSE / EnMS inspection program, take the corrective actions for any violations in his/her area.
* Lead the team of his/her area for doing full risk assessment and Environmental aspects studies.
* Define and control the required PPE's for his/her area.
* Define the list of CMR and it's operational control for Quality labs and production areas.
* Control the first aid kits in his/her area.
* Leading his/her team for control the significant hazards /aspects and Energy use.
JOB-HOLDER's ENTRY REQUIREMENTS :
Education:
* Bachelor 's degree in pharmaceutical science
Related Experience:
* ‎2 - ‎5 years related experience
Special Knowledge/Skills:
* Shop floor activities.
* QA Documentation and compliance systems experience.
* Expert in Pharmaceutical industry & raw materials "API & Non-API"
* Decision making & problem solving.
* Deviation management
* Risk management & Root cause analysis tools.
Competencies:
* Stretch to go beyond the level we have operated at up until now
* Take rapid actions to meet the targeted and planned dates for each task.
* Act in the interest of our patients and customers
* Put the interests of the organization ahead of my own or those of our team
* Act for Change, strive for results, Cooperate Transversally, Commit to Customer
* Think Strategically, Lead Teams, Develop People, Make Decisions
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.