Job Ref. ID:
Officer / Assistant Officer
UNITED ARAB EMIRATES
UAE (RAK head office)
Full Time Employment (Un-limited Contract)
The Officer will be responsible to adhere and ensure the cGMP principles and maintain them in an effective manner. The position will play a key role to ensure the data integrity issues for all Batch Documents of all dosage forms related. The role will be responsible to perform Batch Document Audit of all dosage form related to all Plants and to ensure timely completion of document review activity. He will maintain the QMS System with properly handling Deviations and Change Control system.
Key responsibilities & Accountability:
Responsible for Receiving the Batch Documents and make entry in the Log Book and Tracker (Excel Sheet).
Reviews the Batch Documents as per the SOP TCS-003.
Check the accuracy of calculation of all the entries made in the batch record.
Critical process parameters, specific to each process stage, should be reviewed to ensure that time, temperature, pressure and RH etc. are within specification.
Ensure all printing requirement met with the sales order.
Ensure the availability of all related documents and raw data generated during batch manufacture, packaging.
Verify that all the analytical result met the specified limit and attach with the Batch documents.
Confirm good documentation practices followed during documentation of the batch.
Take printout from SAP (Refer SOP TCS-005) and attached the vendor information of the API used in the Batch. Verify the information with the approved Vendor list for the specified consignee.
Responsible to perform investigation in case of any deviation raised.
Responsible to ensure completeness and correctness of complete batch documents (Manufacturing, Packaging and QC compiled documents) and make result entry in SAP prior to release to the market.
Sign and attach the checklist according to the doses form refer SOP TCS-003.
Prepares the Batch auditing report for individual batch document after reviewing.
Responsible to report to Group Leader about the work status of the Batch Documents Review.
Performs any other work assigned by the Group Leader / QA Compliance Department Manager.
Bachelor's degree in Pharmacy or Medical Science or equivalent.
At least 5-6 years of experience in Quality Systems / Manufacturing Operations in Pharmaceutical Industries.
Having practical experience of deviation and change control handling.
Excellent communication and reporting skills.
Excellent computer skills.
Adequate knowledge about GxP and Data Integrity.
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