Quality Control Vacancy At Rameda Pharmaceuticals
Stability Section Head at Rameda Pharmaceuticals
Job Requirements:
10- 14 Years of experience in pharmaceuticals QC
Bachelor degree pharmacy or science
Analytical thinking, problem solving and communication skills.
– Good communications and computer skills.
– Fluent in English language (reading, speaking and writing)
– High accuracy level to guarantee the reliability of results.
– Leadership skills
– Strong knowledge about GMP, GLP & ISO standards
Job Description
Fulfil all Rameda stability and bio waiver studies requirements according to global ICH,FDA,EMA guidelines & Supervise all the processes in his section
Daily tasks assigning for analysts, follow up and handling technical troubleshooting with analysts.
Fulfill all Rameda stability studies for EDA and Export requirements according to ICH guidelines.
Fulfill all Rameda Bio-waiver studies requirements according to FDA guidelines
Review and approve stability protocol and stability table for each study.
Reporting stability studies for both internal aim or for registration.
Handling on EDA local and Export stability and bio-waiver comments.
Handle OOS investigation for stability study.
Ensures that all activities in stability section are done according the relevant cGMP and ISO standards (ISO 9001, ISO 14001/2004, and OHSAS 18001/2007).
Continues coaching, training and development for all Quality control stability team to achieve the
Ensure Rameda data integrity , security and confidentiality .
Pass all internal & external audits without critical points.