Assistant Manager, IPQA Amneal Pharmaceuticals

8.0 - 12.0 years

0 Lacs

gujarat

On-site

As an IPQA Specialist in an API manufacturing environment, your primary responsibility will be to monitor production activities and ensure cGMP compliance on the shop floor. You will be required to review and approve Batch Manufacturing Records (BMR), Batch Cleaning Records (BCR), and related analytical records before releasing API. Preparation and revision of SOPs, BMRs, BCRs, and other QA-related documents will also be part of your duties, aligning them with regulatory and internal requirements. Sampling of APIs, maintaining related records, overseeing proper cleaning and maintenance of sampling tools, and managing storage of control samples of API will be crucial tasks to uphold quality standards. Line clearance at each product changeover stage, coordinating dispatch processes, and supporting investigations of deviations and incidents with the QA Head/Designee are essential aspects of your role. Your involvement in Product Quality Reviews (PQR) for all APIs will require compiling relevant data and identifying areas for improvement. Monitoring process and cleaning validation activities on the shop floor to ensure compliance, supporting data integrity, documentation practices, and preparing for audits are integral to maintaining quality standards. Your collaboration with production, QC, engineering, and warehouse teams will be vital for addressing day-to-day IPQA requirements. Additionally, participation in risk assessments, change controls, CAPA implementation, and training QA executives and production personnel in cGMP, documentation, and in-process control requirements are part of your responsibilities. Handling quality events such as market complaints, recalls, and audit observations, contributing to continuous improvement initiatives, ensuring readiness and compliance for inspections and audits, and leading QMS enhancements and harmonization of documentation practices are key aspects of your role. Maintaining logs, registers, and master data related to IPQA activities, monitoring and reporting compliance KPIs to QA management, and representing QA in daily production meetings and batch release discussions are also part of your duties. **Qualifications:** **Education:** - Required: B.Sc in Organic Chemistry - Preferred: M.Sc in Organic Chemistry, B.Pharm / M.Pharm **Experience:** - 8 to 10 years of relevant experience in IPQA within an API manufacturing environment **Skills:** - Advanced knowledge in IPQA & Line Clearance Activities - Advanced expertise in Batch Documentation Review (BMR, BCR, BPR) - Intermediate to Advanced proficiency in Process & Cleaning Validation Oversight - Intermediate skills in Deviation/Incident Investigation - Intermediate understanding of Control Sample & Sampling Procedures - Advanced knowledge of cGMP & Data Integrity Compliance - Intermediate skills in QMS Documentation & SOP Preparation - Intermediate proficiency in Product Quality Review (PQR) - Advanced competence in Shop Floor Quality Monitoring - Intermediate to Advanced abilities in Cross-functional Communication & Coordination,

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