Qualification and Validation Manager
Vous ne pouvez pas postuler à une offre expirée
- 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.
Vous ne pouvez pas postuler à une offre expirée
- 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