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Methodology Supervisor (In-vitro...

Zeta Pharma
Alsadat City, Monufya

Methodology Supervisor (In-vitro)

Alsadat City, MonufyaPosted 2 months ago
12Applicants for1 open position
  • 0Viewed
  • 0In Consideration
  • 0Not Selected

Job Details

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Job Description

  • Responsible for receipt, analysis and management of innovator samples.
  • Responsible for Method development of finished product according to the regulations of pharmaceutical industry.
  • Responsible for Method validation according to the regulations of pharmaceutical industry from preparing the protocol to the final report that summarizing the data.
  • Responsible for Cleaning method development preparation and validation
  • Responsible for follow up application of good laboratory practices covering activities performed in Quality control department.
  • Prepare test method of analysis for new products (R&D trials). 
  • Perform invitro comparative Dissolution Protocols and Reports for different types of products "Tablet, Capsules and Suspension. 
  • Troubleshoot and resolve operations issues. 
  • Conduct training to fresh analyst. 
  • Prepare SOP related to methodology department. 
  • Contribute with other departments (QC, QA & RA). 
  • Responsible for fulfilling all regulatory requirements related to methodology department. 
  • Participate in out-of-specification and failure investigations. 
  • Responsible for preparation of NODCAR files for submission for regulatory aspects
  • Responsible for preparation of CTD files for submission for regulatory aspects
  • Responsible for preparation of Export files for submission for regulatory aspects.

Job Requirements

  • Bachelor of Pharmacy or Science.
  • 6-8 years of experience (at least one-year experience as Methodology Supervisor).
  • Excellent verbal, written and interpersonal communication skills.
  • English fluency is essential
  • Professional computer and MS-Office skills
  • Professional analytical skills
  • Strong organizational and multitasking skills
  • Attention to details

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JobsMedical/HealthcareMethodology Supervisor (In-vitro)