8 Anvisa Jobs

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary Responsible for auditing Apotex Enterprise sites, Apotex and Apotex Pharmachem...

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com. Job Summary Responsible for auditing Apotex Enterprise sites, Apotex and Apotex Pharmachem ...

Key Responsibilities: Warehouse Operations Leadership: Direct and supervise daily warehouse activities, including receiving, storage, material handling, dispatch, and documentation. Ensure that all operations align with company policies, cGMP (current Good Manufacturing Practices), and regulatory standards. Inventory Management: Oversee inventory control systems to maintain accurate stock levels, prevent shortages or overstock situations, and facilitate timely replenishment and movement of materials. Implement cycle counts, reconciliation, and develop strategies to minimize inventory discrepancies. Compliance and Documentation: Ensure all warehouse processes adhere to regulatory guidelines, ...

Role & responsibilities Coordination with different departments vise (QC, Manufacturing & QA) for material testing. Issuance and release as per the plan. Planning and reviewing of work force availability for material receipts, movements, sampling, Labeling, relocation & dispensing activities. Reviewing online documentation from all the areas. Initiating the material write- offs for the rejected as well as non-moving slow moving & expired materials with proper management approval and customs approvals and disposal as per SOPs. Coordinating with production Head and production planning department to execute daily production schedule requirements. Monitoring systems / team to follow as per the G...

JOB Description: Sound on Material (RM /PM / SPM) Receipt / Storage / Issue & Return Procedural Compliance (In Regard to GMP & SOP) Sound on GMP / GDP Guidelines GMP Operational Documentation Compliance (i.e GRN / AR No. track / Issuance / Temperature Record Maintenance / Intimation / Discard Compliance etc.) Worker Management (3 Shifts) Warehouse Management Technical / System compliance (i.e Walk In Cooler Monitoring / Equipments Handling / System Savy (JDE / DC Link)) Able to handle Regulatory Audits independently (i.e USFDA / MHRA / ANVISA / INVIMA etc.) QMS Elements Compliance and Closure on time (if any) QMS Investigation / CAPA / Impact Assessment report Drafting skills Zero” NCR Appro...

This is a full-time on-site role for a Manager / Deputy Manager Regulatory Affairs located in Vadodara. As the Manager / Deputy Manager, your responsibilities will include developing and implementing regulatory strategies, ensuring compliance with regulatory requirements, preparing and submitting regulatory documents, and maintaining regulatory files. Your role will involve interacting with regulatory agencies, managing timelines, and ensuring that all products meet regulatory standards. Your key responsibilities will be to develop and direct global regulatory strategies for clinical, non-clinical, and CMC aspects. You will lead the preparation, review, and approval of submission documents f...

Role & responsibilities Develop and implement regulatory strategies to support research projects and product development initiatives. Monitor and interpret regulatory requirements and guidelines related to scientific research, including USFDA, Europe (EMA), UKMHRA, Canada (Health Canada), Brazil (ANVISA), China (NMPA), Australia (TGA), New Zealand (MMDSA) Japan (PMDA) and other relevant international standards. Prepare and submit regulatory filing agency queries with gap analysis, including API DMFs, eCTD details, and other relevant documents, ensuring accuracy and compliance with regulatory requirements. Collaborate with cross-functional teams to integrate regulatory considerations into pro...

Job Description 1 Knowledge of operation & maintenance of Utility equipments like Chiller, Air Compressor, DG set, Boiler, Water pretreatment plant, UPS & ETP. 2 Should have adequate knowledge of Electrical maintenance of HT & LT Electrical Panels, Breaker and Transformer. 3 Hands on experience of qualification/validation of equipments, SOP preparation, PM, calibration of equipments, 21-CFR compliances. Should have knowledge of regulatory guidelines related to Engineering i.e. Water system, HVAC & compressed air. 4 Work Experience in USFDA / MHRA approved plants is must. 5 SAP Knowledge, Auto cad, Exposure to online documentation like SAP PM, eLog Books, QAMS. Work Experience 8-15 Years Educ...