Quality Assurance Manager
1 day ago
Job DescriptionDesignation: Quality Assurance Manager/Deputy ManagerQualification: M.Pharma/ B.Pharma /M.sc (in Chemistry/Biochemistry/Industrial etc)Desired Experience: 8 to 12 years experience in API/Pharmaceutical industryEmployee Type: Full Time, PermanentLocation: Tumkur FactoryJob Responsibilities:- To develop and implement a comprehensive quality assurance strategy and quality management system to ensure compliance with regulatory requirements, industry standards, and company policies - Ensure that all manufacturing processes, documentation, and testing procedures comply with relevant regulatory standards such as WHO GMP, ICH guideline. - Develop and maintain SOPs for quality assurance, and quality management activities. Ensure that these procedures are followed consistently throughout the plant - Coordinate and conduct internal and external audits to assess compliance with regulatory requirements and identify areas for improvement. Prepare for and manage regulatory inspections by health authorities or customers. - Handling of market complaints, returns/recall, deviations, OOS, validation report review .Manage the deviation and Corrective and Preventive Action (CAPA) system, including investigating deviations, identifying root causes, and implementing corrective actions to prevent recurrence. - Provide training and support to personnel on quality systems, regulatory requirements, and quality-related procedures. - Ensure accurate and timely documentation of all quality-related activities, including batch records, test reports, and validation protocols. Maintain a systematic record-keeping system for easy retrieval and compliance. - Collaborate with the procurement and supply chain teams to establish and maintain a supplier qualification program, ensuring that all raw material suppliers meet quality standards and specifications - Identify and assess quality risks within the manufacturing processes, implement risk mitigation strategies, and drive continuous improvement initiatives - Define and track key quality performance indicators (KPIs) to measure the effectiveness of quality systems and report on quality trends to senior management - Drive a culture of continuous improvement by initiating and leading quality improvement projects, conducting root cause analyses, and implementing best practices - Maintain detailed documentation for audit trails and regulatory submissions. - Timely reply to customer queries. - To co-ordinate with head of manufacturing, stores, production and maintenance to document any change control requirement for any changes carried out. - To release or reject all raw materials , intermediates, packing materials, labelling materials and finished products. - Drug Master files (DMF), validation master plan updation, and quality manual updation. - Vendor on site audits, handling and managing of audits to meet regulatory requirements. - Performing on site audits of vendors. - To review and approve all specifications, STPs, BMR, MFR. - Review and approve the all the procedures impacting the quality raw materials, intermediates or APIs . - To review and approve of all validation protocols and reports. - To review and approve annual product quality reviews(APQR)
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