Sterile Area Q.A. Specialist
- SEDICO Pharmaceutical
- 6th of October City, Giza Governorate, Egypt
- Full-time
وصف الوظيفة
2024-11-24
Shift Work type
Sterile area Q.A. Specialist
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Job Description:
- Ensure line clearance & cleaning checks of the batch manufacturing process.
- Reviews documentation associated manufacture of products on the manufacturing area during production.
- Work closely with manufacturing to address any production issues on shifts and ensure appropriate documentation.
- Coordinates and assembly of batch record documentation to assist with disposition.
- Reviews and approves completed manufacturing related documents for batch record disposition.
- Performs in process control sampling, testing and inspection (as AQL) for all SEDICO and Toll Products.
- Coordinates activities associated with deviation report and CAPAs to facilitate investigations and assure timely closure.
- Ensures adherence of appropriate cGMP regulations and quality standards.
- Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance, as needed.
- Ensures that all activities in his unit or section are done according the relevant cGMP, EDA and ISO standards (ISO 9001, ISO 14001, OHSAS 45001)..
- Bachelor's degree in science or Pharmacy.
- 1-3 years of experience within the area of Pharmaceutical Sterile area QA department.
- Excellent problem-solving and analytical abilities.
- Strong communication and interpersonal skills.
- Bachelor's degree in science or Pharmacy.
- 5:7 years of relevant experience in sterile manufacturing in the pharmaceutical industry.
- No less than 1 years in a similar position.
- Up to date knowledge of current GMP, EDA Regulatory requirements, WHO & ICH guidelines
- Excellent investigation and report writing skills.
- Excellent problem-solving and analytical abilities.
- Strong communication and interpersonal skills.
- Job Location: 6th of October City.
- Shift work is required.
- Social Insurance.
- Medical Insurance
- Profit Share
- Transportation is provided.
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