Quality Assurance Supervisor
EGMED -
10th of Ramadan City, CairoPosted 6 years ago123Applicants for1 open position
- 62Viewed
- 0In Consideration
- 9Not Selected
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Job Description
- Establish QMS ( SOP, policies, work instruction and records ) to be comply with the company's internal requirements , ISO 9001, ISO 14001, OHSAS 18001, ISO 13485:2003 and Adhere with applicable standards of CE Marking
- Develop technical files for products to be comply with applicable standards and directives of CE Marking.
- Communicate the SOP's of different procedures with all concerned staff to facilitate the documentation cycle and ensure compliance.
- Develop training and awareness session for staff related to applicable standards ( ISO, OHSAS and CE Mark requirements)
- Monitor the internal Quality Management System and ensure compliance with the applicable international standards.
- Handle all documentation control process through collecting, modifying, creating, and updating all forms, letters, documents requested by certification body to avoid any discrepancies
- Prepare the annual internal audit plan this includes composing a virtual team from different departments and supervise them to perform the internal audit as well as interpreting the audit results to Management in order to take right actions.
- Supervise the certification procedures through ensuring fulfilling documentation requirements, handling any problem that may arise and counseling department's heads to ensure successful departmental involvement.
- Perform gap analysis activities through studying list of requirements delivered by the certification body and the actual status of operating systems and set gap closure tasks as to be implemented.
- Prepare for the external audit conducted once a year by the certification body and ensure compliance of all documentation, manuals, and processes to ensure accreditation and compliance with international standards.
- Communicate with European Authorized Representative (E.A.R), service provider, certification body and notified bodies to schedule appropriate date for external audit dates with all concerned department to facilitate the Audit cycle and ensure compliance.
- Perform sampling and product quality control for EG Med, and carry out investigation for critical deviations and making sure that all Non-conformities are reported, evaluated, resolved and the conclusions are recorded.
- Perform duties related to product quality control for EG Med plant using SPC (statistical process control), to ensure that comply with international standards, company's system and GMP.
- Prepare all tests whether a raw material , in process or finished products according to applicable standards as (biological media, Bioburden, sterility, and End toxin, Environmental control, hygiene tests of clean area and microbiological control on sterilization process )
Job Requirements
- B Sc in science or Pharmacy
- Diploma in Quality Management System is a plus.
- Certified internal auditor.
- Excellent command in English Language.
- Full awareness of ISO, HSE and CE mark systems and requirements
