REPORTS TO: / QA Manager
BAND: / 10
AIP LEVEL: / 6%
BUSINESS AREA: / Quality Assurance
DATE AMENDED: / Oct 2015
JOB PURPOSE
To ensure that the quality systems under his/her responsibility will be in adherence with the plans and expectations from the local and corporate quality teams.
KEY RESULTS/ACCOUNTABILITIES
To ensure that Change Control and Deviation Investigation Systems are under control performing the needed follow up and updating and presenting KPIs linked to these two topics
To support the areas (Production, Quality Control and/or Warehouse) under his/her responsibility about GMP topics. The areas under his/her responsibility will be defined by the manager in agreement with the QA Specialist and it can change to provide the opportunity to know as many areas as possible
To perform internal audits in productive, control laboratories and warehouse according to the annual audit plan
To support her/his areas (Production, Quality Control and/or Warehouse) about:
- deviation investigation
- revising procedures and batch records before issuing them
- implementing CAPAs
- identifying gaps and proactively suggesting training, improvements and changes
To support projects defined to his/her acting areas related to GMP aspects
To support his/her QA colleagues when needed in order to keep an efficient team, delivering the key results on time
To ensure that the actions presented in the QA road map under his/her responsibility will be implemented on time
To ensure that actions generated from regulatory inspection and from GQA (Global Quality Audit – Sanofi Group) will be implemented on time
To ensure that all deviations linked to his/her areas (Production, Quality Control and/or Warehouse) that can impact on the batch release will be closed on time to avoid delays and negative impacts on the IO KPI (Customer Service)
KEY WORKING RELATIONSHIPS
INTERNAL
Regular, close contact with:
Supervisors, Managers and Operators/Technicians from the areas under her/his responsibility
QA Team
EXTERNAL
Possible contact with:
VMD, Merial Corporate, Sanofi GQA, Third part contractors
SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS
Experience in QA systems such as change control procedures, deviation and CAPA management;
Good communication skills and able to work with staff and external GMP inspectorates and auditors at all levels;
Good Leadership and management skills to embed a culture of QA throughout the site;
Excellent knowledge of the principles of EU Good Manufacturing Practice (GMP) and Quality Assurance;
Good knowledge of scientific principles for the production of veterinary or human vaccines and application of EU Pharmacopoeia standards and guidelines. Good communication skills and able to form constructive relationships with staff, Corporate Representatives and inspectorates at all levels.
Experience in manufacture of veterinary biological and/or pharmaceuticals desirable
COMPETENCY REQUIREMENTS / LEVEL
Think strategically = Translates agreed strategies into clear, tangible and actionable plans and initiatives.
Develop people = Takes time to listen and provide regular, fact based feedback for development.
Act for change = Creatively challenges the status quo to find new ways of working.
Cooperate transversally = Share information openly and seeks appropriate input from others outside of direct team.
Strive for results = Sets ambitious, tangible and measurable targets.
Commit to customers = Strives to build mutually beneficial solutions and partnerships.
Approved
Date: / 15 Oct 2015Job holder: / Jennifer Pagano
Manager: / Fernanda Abujamra
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