Quality Assurance Manager

4 days ago

Tumkur, India Alp Consulting Ltd. Full time

Job Description Designation: 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 policiesEnsure 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 plantCoordinate 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 specificationsIdentify and assess quality risks within the manufacturing processes, implement risk mitigation strategies, and drive continuous improvement initiativesDefine and track key quality performance indicators (KPIs) to measure the effectiveness of quality systems and report on quality trends to senior managementDrive a culture of continuous improvement by initiating and leading quality improvement projects, conducting root cause analyses, and implementing best practicesMaintain 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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