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وظائف شاغرة لدى شركة حكمة للادوية

 


تعلن شركة حكمة للادوية عن حاجتها الى :

1- Sr. R&D Specialist - Process Development


Job Description:


Seeking a highly motivated and scientifically rigorous individual to join the Product Development (PD) team as a ‘Senior R&D Specialist -Process Development’. This role includes but is not limited to leading process development activities to support project team goals and will be responsible for: The successful scale-up and optimization of manufacturing processes from lab through production scale and the technical aspects related to troubleshooting of new products:

 

  • Supervision/support of validation and launch activities. Technology transfer between sites Pre/post submission product support.
  •    Partners closely with development teams to ensure successful transfer of process knowledge during technical transfers.
  •     Supervises scale-up and process validation activities by ensuring smooth and on time technology transfer (TT) and launch activities.
  •    Effectively identifies critical process parameters (CPPs) with appropriate ranges to ensure robust and capable manufacturing processes.
  •    Resolves technical problems while meeting quality and schedule objectives.
  •    Provides timely investigations, protocols, data analyses, and conclusions by writing and reviewing scientifically valid technical evaluations and ensuring project initiatives will achieve successful outcomes.
  •    Assesses product impact. Prepares regulatory submission documents.
  •    Supports internal/external audits or inspections.


Skills:


  • A strong pharmaceutical and technical background about problem solving and process/product improvements in support of manufacturing operations.
  •    Knowledge and awareness on regulatory and submission/filing approaches Thorough understanding of the change control (CC) procedures in the pharmaceutical industry and any impact on product quality.
  •    A strong background in pharmacokinetics and bioequivalence sciences. 
  •    Understanding of cGMPs, SOP, and up to date knowledge on regulatory guidance’s and systems for drug products.
  •     The ability to manage and meaningfully advance multiple tasks and projects with a high degree of initiative and self-motivation.
  •    Well understanding and knowledge of process development/support in a cGMP environment and awareness of regulatory expectations.
  •    Experience solving ambiguous problems, compile and statistically analyze data, draw appropriate conclusions, and make presentations to cross-functional audiences.
  •    Detailed understanding of all stages of process validation in pharmaceuticals.
  •    Knowledge of analytical techniques for characterization of drug products.
  •    A hard-working, passionate about science, team player that can effectively collaborate in a dynamic, cross-functional matrix environment.


Education:

BSc Pharmacy or Pharmaceutical Technology

MSc is a plus



للتقديم من خلال الرابط التالي :

https://careers.hikma.com/en/jordan/jobs/sr-r-d-specialist-process-development-4265776/


2- Pharmacovigilance Officer

Job Description

  • Assist in the preparation/revision of company core data sheets (CCDSs) and reference safety information (RSI) for MENA products.
  • Assist in the preparation/review of product information and safety variations in MENA.
  • Assist in literature screening and signal detection for MENA products.
  • Assist in the preparation of health risk assessment reports in MENA.
  • Assist in the preparation of risk management plans and implementation of risk minimization measures in MENA.
  • Assist in safety planning and review of Hikma-sponsored clinical studies and patient support programs in MENA.
  • Assist in the preparation and submission of periodic safety update reports in MENA.
  • Assist in the preparation/review of safety data exchange agreements for MENA products.

Skills

Medicine or Pharm D or MPharm

Education

Medicine or pharmacy or pharm.D

لتقديم من خلال الرابط التالي :

https://careers.hikma.com/en/jordan/jobs/pharmacovigilance-officer-4266440/

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