Qualification and Validation Manager

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.