Assistant Manager-Middle East Region

Role Overview/Purpose ROW QA is responsible for monitor quality management systems at as per cGMP and Glenmark Quality policies to ensure the quality of drug products. ROW QA shall handle regulatory compliance for Drug products manufactured by External Manufacturing sites at and for ME region. ROW QA is responsible to ensure registration, Renewal and maintenance of product dossiers & regulatory status of drug products. This position reports to ROW lead at Glenmark HO India. Overall Job Responsibilities Key Responsibilities GMP audits •Develop audit plan for CMOs. •Serve as the primary point of contact for the CMO during the audit, facilitating communication and ensuring clear understanding of audit objectives and findings. •Plan and perform on-site audits of manufacturing facilities and quality systems. Quality agreement (QAg): •Review Quality agreement between Glenmark and CMO’s: Facilitate negotiations and update whenever there is a change in relevant sections of QAg. Quality management system: •Review, approve and maintain QMS documents such as change management, product quality review. •Investigate quality events within timeline defined by ensuring regulatory, quality compliance and put CAPA in place Oversight of the CMOs: •Product Quality review and action based on review outcome. •Perform risk ranking for CMO’s as per the Glenmark procedure. •Escalate any Quality issues as per the Global procedures. Batch release Controls: •Review and approval of commercial batches in compliance with specifications. Distributor oversight & agreements •Quality oversight of distributors in the region and facilitate agreements. Regulatory Compliance: •Respond to regulatory queries for local requirements in a timely manner. Artwork Management •Review of artwork and the general requirements as per SOP Desired Experience and Knowledge Educational Knowledge •Master in science /Pharmacy. Experience •10 to 15 years’ total experience in the Pharmaceutical Industry out of which at least 3 to 5 years should be in Quality Function in quality oversight. Knowledge and Skills (Functional and Technical) •Sound Knowledge on Current GMP requirements of local and various international regulatory agencies, Pharmacopoeias, and ICH guidelines. •Exposure to regulated, semi regulated markets. •Exposure to various formulations like sterile, ophthalmic, Tablets, Capsules, Aerosols, creams, Ointment, Oral liquids. •Communication Skills: Excellent verbal and written communication skills are necessary to effectively convey findings and recommendations to diverse audiences. •Analytical and Problem-Solving Skills: Strong analytical skills are required to assess complex data and identify root causes. Key Attributes •Conversant with Arabic and English language.