Electrical facilities engineer - Yanbu, المملكة العربية السعودية - Alfanar

وصف

Overview

TheCMC Document Specialist is responsible for developing, reviewing,and managing technical documentation related to chemistry,manufacturing, and control (CMC) activities within thepharmaceutical industry. This includes preparation and submissionof regulatory documents, development of quality systems, andmanagement of documentation related to process development,manufacturing, analytical testing, and qualitycontrol.

Responsibilities

• Developand maintain CMC documentation for pharmaceutical products inaccordance with applicable regulatory requirements and guidelines,including IND, NDA, and ANDAsubmissions.
  
• Managedocument preparation, specially technical writing, editing,formatting, indexing, to enable consistency in document writing andsharing of documents with regulatory affairs as well as externalparties, includingpartners.
  
• Workclosely with cross-functional teams, including process development,manufacturing, analytical development, and quality control, toensure that all CMC documentation is accurate, complete, andtimely.
  
• Maintainknowledge of current regulatory requirements and industry trendsrelated to CMC documentation, and provide guidance andrecommendations to internal stakeholders on regulatory complianceand bestpractices.
  
• Reviewdocuments for completion and accuracy, maintain a MasterDocumentation list, and provide notification that documents arerevised, effective orobsolete.
  

Requirements

Qualifications

• Directexperience authoring and reviewing technical documents to supportdrug productfilings.
  
• Mustbe capable of working in a fast-paced changing team environment,prioritizing multiple tasks to meet filing deadlines and ensuringthe most efficient regulatoryprocess.
  

JobDescription

• Bachelors degree in a scientific or technical field, such as chemistry,biochemistry, or pharmaceuticalsciences.
  
• Minimumof 3 years direct related experience supporting CMC filingdocumentation development and review forANDAs.
  
• Experiencein a cGMP regulated pharmaceutical sterile manufacturingenvironment(Preferred)
  
• Experiencewith cGMP Documentatione-Systems
  
• Goodverbal and written communicationskills
  
• Experiencewith Microsoftapplications
  

PhysicalRequirements:

• Employeemay be required to lift or handle objects not more than 25 lbs toperform certain duties essential to the jobfunction.
  
• Performanceof tasks essential to the job function may require the employee towork directly with, handle, or otherwise come into contact withchemicals or pharmaceuticalagents.
  

The QA/RA CMC DocumentationSpecialist plays a critical role in ensuring compliance withregulatory requirements and internal quality standards, and is anessential member of the cross-functional team responsible fordeveloping and manufacturing pharmaceutical products. If you have apassion for documentation and a strong understanding of regulatoryrequirements in the pharmaceutical industry, we encourage you toapply for this excitingopportunity.

Education and Experience Bachelor s degree in Chemistry,Biochemistry. Minimum of 5 years experience in an Analytical QCrole supporting a sterile pharmaceutical manufacturing operation.Minimum of 2 years supervision Knowledge of current USP standardsKnowledge of microbiological and analytical laboratory techniquesKnowledge of sterile technique Experience with microbiological andanalytical instrumentation Knowledge of FDA/USP guidelinesExcellent verbal and written communication skills Analyticalreasoning, root cause analysis and problem solving Technicalwriting: write, read, understand, and interpret technical writingand instructions MS Office skills; particularly Word and Excel Mathand calculation skills Multitask and coordinate with operations andquality assurance simultaneously Work with a wide range of peopleto solve problems and resolve issues Work in a fast-pacedenvironment Ability to maintain flexible task schedule and workflowHighly detail oriented with good record keeping skills Excellentpeople skills, with experience collaborating in amulti-disciplinary, diverse, and dynamic team