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Sr. Quality Compliance Officer
Job Description
Chemistry ,Chemical engineering, Industrial engineering, Pharmacy
- Reviewing and approving QC investigation reports (Variance, OOS, OOT and AR deviations).
- Performing QC trend reports (semi-annually and annually) of (OOS, variance).
- Performing Quarterly Corporate Analytical data for Chemicals API. Performing Quarterly Corporate GRC system through SAP.
- Reviewing/Approving QA deviation /Complaint reports. Performing all tasks requested by his manager.
- Following and performing all corporate policies to be complied with chemicals-API system. Solving SAP problems for all dep in chemical plant.
- Performing the dedicated SAP movements, which are related to compliance work.
- Performing and following NTM report. Reviewing/approving all change controls and SOPs related to QC, AR, QA and system.
- Reviewing Annual Product Review exhibits received from all departments and performing summary.
- Performing and approving Elemental Impurity Risk assessment.
- Approving change controls related to TM, COA and stability protocol through RIMS. Approving stability data sheets.
- Performing presentations for GMP trends training sessions to be sure that no GAP analysis found.
- Reviewing/ approving all documents generated through compliance department (Site master file, SOPs).
- Contacting and respond to all regulatory authorities for any requirements and Coordinate with Regulatory affairs in preparation submission. Understanding regulatory guidelines and latest requirements for USP, EP and BP. Electronic data check for HPLC, GC, IR and Mastersizer in QC and AR labs.
- Performing Monthly Audit in QC, QA and AR and other facilities whenever needed,
- Performing six system internal audit. Following up the external audit observations (FDA, JFDA … etc.
- Contacting the outside for HC issues (Hikma corporate, Quality Compliance GF, other sites).
- Approving any audit report respond /performed in Hikma chemicals.
- Excellent Arabic and English (Technical writing and Conversation).
- Excellent for computer skills (Excel, word, and power point).
- Excellent for communication skills.
- Excellent knowledge in SAP and RIMS technique
- Ability to achieve all tasks within timeline.
- Minimum 4 years experience in Compliance or QC or QA or validation.
Chemistry ,Chemical engineering, Industrial engineering, Pharmacy
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