Job Summary
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We are currently recruiting for a challenging opportunity with a leading Pharmaceutical organization. This is an excellent position for individuals seeking to join a multinational company that sets high standards in their industry.
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Duties
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* As a document system expert, you will be responsible for reviewing, approving, and expediting document workflow. This includes formatting, writing, delivering, and reviewing necessary documentation according to standard approval processes, as well as facilitating others to do so. Documents will include SOPs, SWIs, training documents, and change controls.
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* You will support operational activities through documentation generation, filing, tracking, auditing, and maintaining associated databases, including the maintenance, auditing, and archiving of the process documentation system.
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* Support batch release by completing Quality Notifications on time, generating Interim/summary reports, and meeting batch release requirements.
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* Raise CAPAs and conduct investigations using standard tools and methods, such as FMEA, Fishbone diagrams, and 5 Whys, to resolve system issues and implement corrective action through the change management system.
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* Complete customer complaint investigations and change controls to ensure timely closure and support production activities in conjunction with the SCM team.
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* You must comply with Merck Global Policies, Procedures, and Guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP) in performing daily activities and job functions.
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Requirements
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* Bachelor's Degree or higher preferred, ideally in a Science, Engineering, or Technical discipline.
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* SAP knowledge and experience required.
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* Report, standards, policy writing skills required.
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* Equipment and process validation.
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* Sterile filling processes and equipment.
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* Lean Six Sigma Methodology experience desired.
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