Qualification and Validation Manager

  • Nom de l'entrprise Le Groupe Sanofi
  • Secteur d'activité Industries
  • Lieu de travail Alger, Algérie
  • Date d'expiration 07 Janvier 2017
  • Nombre de postes 01 poste ouvert
  • Niveau de poste Manager / Responsable département
  • Niveau d'étude (diplome) Master 2, Ingéniorat, Bac + 5

Qualification and Validation  Manager

 

We are looking for Qualification and Validation Manager

The positon is based in Sidi Abdellah 

Duties and Responsibilities

  •  Management of a cross-functional team of QV engineers; Manage and successfully execute complex and multiple projects/activities independently.
    •    Lead and execute start-up activities including finalization of QV scope and gap analysis as needed; Estimate and manage start-up materials/resources.
    •    Interactive planning as part of development of fully integrated project schedules; Accountable for ensuring activities are scheduled, tracked and reported appropriately, and achieving project deadlines.
    •    Ability to lead risk assessments and mitigation, conduct root cause analysis and investigations.
    •    Draft, review & approve QV test documentation ( IQ/ OQ & PQ), VMP, protocols, reports, project change controls and deviations as required for assigned projects. Input into the core aspects of Operations SOP’s.
    •    Development of training packages for the QV team in line with current trends.
    •    Budgeting and cost control – estimate development and hours tracking for CQV activities.
    •    Resource management regarding allocation of personnel to projects and site secondments.
    •    Identifying training needs and ensuring that training records are kept for all staff
    •    Provide training, mentoring and guidance to department personnel to assist them in achieving project, client and departmental objectives.
    •    Ensuring the department complies with international engineering safety standards and regulations; Planning and execution of all Qualification & Validation activities in adherence to site safety procedures.

Experience

  • 3-5 years supervisory/management experience
  •  Previous Liquid & Solid Dosage experience
  • Good knowledge of Facility Qualification (HVAC / Water Systems)
  • Equipment qualification including computerized systems validation requirements.
  • Good Knowledge of Validation requirements ( process, packaging & Cleaning Validation)
  • Strong customer service background essential
  • Strong technical writing and communication skills essential
  • Ability to work with people with diverse backgrounds from all levels
  • Experience in GMP / FDA Regulated environment preferred
  • Strong knowledge of safety and documentation requirements
  • Ability and experience presenting functional work to external agencies where necessary e.g. Regulatory agencies
  • Proficiency with MS Office

Education

  •  Engineer's degree  / pharmacist or equivalent
  • 5 years’ experience in a similar position.

 


  

  • Nom de l'entrprise Le Groupe Sanofi
  • Secteur d'activité Industries
  • Lieu de travail Alger, Algérie
  • Date d'expiration 07 Janvier 2017
  • Nombre de postes 01 poste ouvert
  • Niveau de poste Manager / Responsable département
  • Niveau d'étude (diplome) Master 2, Ingéniorat, Bac + 5