Quality Control Manager

GMS - Bourj Alarab, Alexandria

79
Applicants for
1 open position
50
Viewed
19
In Consideration
46
Not Selected
Experience Needed:
7 to 10 years
Career Level:
Manager
Job Type:
Full Time
Salary:
Confidential
Vacancies:
1 open position
Gender:
Males Preferred
About the Job
  • Manage and control all quality control activities associated with physical, mechanical, chemical and microbiological tests in accordance with the applicable standards, company procedures, client specifications and contract requirements.
  • Generation/update of procedures, instructions and technical documentation based on the regulatory requirements.
  • Checking and approving all reports of applicable physical, mechanical, chemical and microbiological tests required for materials, products and clean areas.
  • Communication with external labs.
  • Review batch control records for compliance, completion and correctness of all contents and attachment if any, then, sign, date and send all records to QA department for batch records review and final approval of batch release.
  • Share in generation of quality agreement of external labs and supplier.
  • Sharing in determination of purchased material specifications.
  • Support the development of quality objectives as part of the organization’s strategic plan.
  • Participate in management review meetings.
  • Share in evaluation, selection and auditing of suppliers and outsourced testing laboratories.
  • Packaging validation.
  • Share in EO sterilization validation.
  • Share in review of protocol and report of cleaning validation and routine monitoring.
  • Generation of stability study protocol and report.
  • Share in internal audits on other departments.
  • Represent QC in all external audits to ensure that all relevant data and documents “required for applicable certifications e.g. CE, ISO, FDA” are available.
Job Requirements
  • Experience:
  • 3 years' QC experience in Medical Devices industry or
  • 7 years' QC experience in Pharmaceutical, Plastic or Petrochemical industry.
  • Company Industry: Medical Devices
  • Location: preferably based Alexandria
  • Education: graduate from faculty of Sciences or Pharmacy.
  • Knowledge: good knowledge of good laboratory practices, Pharmacopeia, ISO 17025 and technical standards related to testing and specifications of medical devices.  
  • good knowledge of ISO 13485, ISO 9001 
  • Skills: 
  • Very good computer skills (Word, Excel, Search Engine, E-mail, PowerPoint) and language (Arabic and English "written & spoken").
  • Very good communication/presentation skills.
  • Details orientation.
  • Abilities:
  • Ability for domestic travel.
  • Ability for accepting new ideas and adapting to new assignments.
  • Problem solving skills.
  • Able to work effectively and efficiently with others.
About this Company

Since 1978, GMS Manufactures Medical Disposables, Surgical Suture, Sterilization Packaging, Hospital Furniture
and O.R Equipment.
We are ISO 9001:2000, ISO 13485: 2001 Certified & our products carry the CE Mark, and we export our products to different
countries all over the world.

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