Quality control compliance/ipc specialist

20/09/2023 Bayt.com
Description du poste

Missions:


  • Working in compliance with good manufacturing practices and data lntegrity
  • Apply safety, health and environmental rules applicable to the laboratory and staff.
  •  Participate in the  various projects of the Data  lntegrity emanating from  Quality Control in particular the monitoring of the smooth  running of the  start-ups  of the operations at the  level of production and packaging.
  • Ensure the  collection of samples for  analysis at  the laboratory level quality control and for   Classification in the sample library.
  • Samples of finished products from the store are taken in the event of an investigation.
  • Sampling and visual role of products.
  • Ensure the monitoring, control and sampling of products related to the validation process holding time;  cleaning validation  ...)
  • Control   and  monitor the primary and secondary packaging process (inspection, visual  control ...) .
  • Participate in the monitoring of quality metrics at the QC laboratory level
  • Actively participate in the investigations of the QC and Microbiology Laboratory.

Specific field of activity:


  • Ensure compliance with Data lntegrity during in process control (IPC) checks during the  start of production-level operations   .
  • Perform the collection of  bulk samples and  semi-finished and finished product manufactured for analysis.
  • Participate in  investigations of the quality of manufactured  products .
  • Carry out the collection of bulk samples, products manufactured for classification at  the sample library at the  climatic chambers (stability).
  • Carry out the collection of bulk samples, for  Holding-time   validation .
  •   Carry out the  sampling (  rinse water )   related to the  cleaning  check .
  • Notify the hierarchy of any actual and/or potential non-conformities at the production level.
  • Realize and Participate in the   continuous improvement  project of QC.
  • Participate in the review  of  logbooks used for traceability of analyses carried out at QC level .
  • Actively participate in QC laboratory investigations.
  • Participate in the annual preparation  of   trend analysis of laboratory investigations.
  • Participate in the preparation of risk assessment reports at the level of the quality department.
  • Creation and updating of documents under the responsibility of the  Quality Control Department
  • Participate in the follow-up of quality metrics and the update of the Visual management board
  • Comply with all  applicable procedures applicable to his/her position.

RESPONSIBILITIES EHS :


  • Report Near Miss for each situation that presents a risk.
  • Comply with Pfizer, regulatory and other requirements (EHS policy, instructions, etc.)
  • Comply with requirements for managing EHS aspects
  • Actively participate in the hazard identification and risk control program by proposing EHS ideas, reporting of "NEAR MISS INCIDENT", by respecting the SOPs in force and by the strict application of actions / means (communicated / implemented) of risk prevention / control
  • Conservation of natural resources (paper, water, energy...)
  • Prevent and notify the hierarchy of any actual and/or potential non-conformities (active reporting)

Experience & Knowledge:


  • University graduate with science background.
  • Relevant experience +2 years in pharmaceutical industry.
  • cGMP & cGLP knowledge.
  • Highly motivated towards achievement.
  • Good Negotiation skills
  • Good command of English both written and spoken.
  • Logic way of thinking.
  • High analytical skills.
  • Communication & high interpersonal skills.
  • High observation skills.
  • Problem solving skills.
  • Good planning skills.
  • Time Management skills.

 
Work Location Assignment: On Premise


Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


Quality Assurance and Control#LI-PFE Détails du poste Lieu de travail Maroc Domaine de la société Autres Services de Soutien aux Entreprises Type de société Non spécifié Type demploi Non spécifié Salaire mensuel Non spécifié Nombre de postes à pourvoir Non spécifié