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/