- Batch records documents receiving, auditing and corrections.
- Review the batch record and identify any incomplete data and calculations, ensure that its content is completed and all process complies with the approved procedures.
- Check that any OOS, NCMR / Deviation, Change request related to the batch are recorded, investigated and disposed properly.
- Check for the batch yield & accountability.
- Write all comments and findings on the audit form and attached on the batch record for correction.
- Communicate to the different concern departments any findings observed during batch record audit.
- Report for any deviation observed during batch record audit.
- Ensure compliance of related SOP s and keep updated.
- Managing all activities related to controlled drugs as per SFDA guidelines including new manufacturing requests, new transfer requests and destruction requests.
- Follow the safety and hygiene system as per the company s policy.
- To follow Quality Policy and maintain GMP.
- Registration of released finished goods batches in the IBRCS (Importing, Batch Release and Clearance System) as per Saudi Food and Drug requirements.
- Registration of released finished goods batches in SFDA RSD system.
- Submit the batch record to Document Control for archiving after reviewing and releasing are completed.
- Minimum A minimum of 03 years experience in same operation of pharmaceutical / nutraceutical products.
- Master s degree / Bachelor degree in Pharmacy.
- Professional Classification & Registration from SCFHS
- Knowledge of manufacturing instruments, equipment. PK and analytical studies are required.
- Excellent interpersonal, communication skills and team playing capability and ability to meet challenges and deadlines.
- Fluency in Arabic & English languages.
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Quality Assurance Sr. Executive - Jeddah, المملكة العربية السعودية - Jamjoom Pharma
وصف
Role Summary:
Quality Assurance person is responsible for providing evidence that all information necessary to determine that the product fit for the intended use is gathered evaluated and approved.
Responsibilities:
Qualifications:
Desired Candidate Profile
Education:
Bachelor of Pharmacy(Pharmacy), Master of Pharmacy(Pharmacy)
Gender:
nm
Nationality:
Any Nationality