Sr. Consultant & Engineer (CP15)
Casablanca, Morocco
il y a 6j
source : Tanqeeb

Notre offre

Altran is looking for a Consultant PQR / CPV for its Pharmaceutical Department.

Vos responsabilités

Purpose Of The Position

Preparation and delivery of PQR / CPV reports.

Expected Results

  • Data collection for PQR / CPV from client’s systems
  • Data reporting in client’s templates
  • Data analyses and evaluation
  • Coordination of review, comment resolution and approval of deliverables
  • Advanced level consultant : peer-review of deliverables (KPI FTQ)

  • Requesting additional information pursuant receipt of client’s data and internal information (assignment)
  • Pro-actively contacting stakeholders (Pilot Team) to discuss progress or delays (flagging alerts and obstacles, comment resolution)
  • Make proposals to stakeholders (Pilot Team) to improve delivery process and quality (e.g. SOPs, communication, alerts)
  • Advanced level consultant : Single Point of Contact (SPOC) for one or more client sites

  • Following international developments and guidelines in the field of QA, QS, GMP and general pharmaceutical knowledge, especially related to PQR and CPV
  • Providing support to other team members (knowledge sharing)
  • Contribute to continuous improvement (individual and team)

  • Tracking and reporting of own planning, delivery progress, comment resolution responses and approval time
  • Quality Systems, statistical and document management tools (e.g. Trackwise, Documentum, Minitab)
  • Analytical skills
  • Data management
  • Technical writing and template use

    Votre profil

    Level Of Working And Thinking

  • University (completed)
  • Education / experience

  • Academic, pharmaceutical or comparable life sciences area (e.g. chemistry, biotechnology, medical biology)
  • 5 years of experience for technical expertise in pharmaceutical industry or health authority, preferably in an international operating US / EU-based company
  • 5 years of experience in a QA / QS / GMP environment with focus on PQR / CPV, CAPA, Change Control, Validation
  • Languages

    English (verbally and writing) intermediate level and for SPOC an advanced level

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