Process Lead - QA/RA | Julphar Jobs in UAE 2021
Process Lead – QA/RA
Job: Full Time
Ras Al Khaimah, UAE
Julphar is a pharmaceutical manufacturer in the Middle East. Headquartered in Ras Al Khaimah, United Arab Emirates, the company employs more than 5,000 people and distributes its pharmaceutical products internationally
Process Lead – the role holder will support onsite regulatory related review files (New registration, Variation, Renewal, Inquiry response as per updated guideline), including review of all quality related documents, including but not limited to (MFM, FPD, CCF, ECT.). The role holder will review &ensure compliance with current regulatory obligations &Requirements, manage HA circulars’ assessment, maintenance of Vendor per country list execution, support in PV oversight & Regulatory document vendor communication. Quality Technical file preparation as per approved quality standards
- Support global RA functions in RAK, in all regulatory activities, in applying standards for regulatory relevant information
- Review RA files (New registration, Variation, Renewal, Inquiry response as per updated guideline
- Perform review of all quality related documents, including but not limited to (MFM, FPD, CCF, ECT
- Coordinate and respectively prepare timely letters to support registration activities & license maintenance consistent with the agreed HA letters strategy
- Vendor per Country list: Maintain timely manner update of Vendor per country list as per HAs approval for registration or variation, etc
- 4 years Bachelor degree in Pharmacy/ Life Sciences /any discipline in same field
- Master degree in Quality Management is a plus
- Total 6 – 8 years of experience pharmaceutical industry preferably in Quality Management systems. And proven experience in Regulatory or pharmacovigilance and distributor management as well
- Should have handled similar role for better fitment
- Excellent command in English (Communicating, writing and speaking
For more details, please scroll down & see the details.
|Title||Process Lead – QA/RA | Julphar Jobs in UAE 2021|
|Job Location||Ras Al Khaimah, UAE|
|Employment Type||Full Time|
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*This Jobs was Originally Posted on Julphar Jobs Site..