6 Anvisa Jobs

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, such as FDA, WHO, and local drug authorities. Maintain comprehensive documentation for all transactionsgoods receipt, issue, transfer, and disposalsupporting traceability and audit-readiness. Material Handling and Storage: Guarantee that APIs, excipients, packaging materials, and hazardous substances are stored under prescribed environmental conditions. Oversee temperature and humidity controls, segregation of materials, labeling, and security to prevent cross-contamination or deterioration. Team Management: Recruit, train, and manage warehouse staff, fostering a culture of safety, accountability, and continuous improvement. Conduct regular performance reviews, set objectives, and provide feedback to ensure high levels of team engagement and productivity. Safety and Security: Implement and monitor safety protocols to protect personnel and materials. Oversee compliance with EHS (Environment, Health, and Safety) regulations, conduct safety drills, and ensure the availability and proper use of PPE (Personal Protective Equipment). Coordination with Other Departments: Collaborate closely with procurement, production, quality assurance, and logistics teams to ensure timely availability of materials, resolve discrepancies, and support production schedules. Continuous Improvement: Identify opportunities for process optimization, cost reduction, and technology adoption. Lead initiatives to automate warehouse operations, adopt barcoding or RFID systems, and implement Lean or Six Sigma methodologies. Dispatch and Distribution: Supervise outbound logistics, ensuring that finished APIs and materials are dispatched in accordance with client specifications, regulatory guidelines, and quality standards. Manage transport arrangements and documentation for domestic and international shipments. Audit and Inspection Management: Prepare for and support internal and external auditsregulatory, client, or quality. Address observations, implement corrective actions, and maintain audit readiness at all times. Please share relevant CVs to ramya_n@hikal.com Preferred candidate profile MSc / MBA with 12 to 15 years of relevant experience in API industry only .(Male candidates )

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 GMP guidelines; Monitoring unauthorized movement of people / materials and oversee cleanliness of warehouse. Monitoring control on rejected and expired materials. Creating internal dispensing plan and allocating the work in each dispensing area. Review and approving Change controls, Deviations, Investigations and CAPAs. Responses to regulatory audits like USFDA , PMDA, ISO ,FSSC , ANVISA internal compliance audits. Please share relevant CVs to ramya_n@hikal.com Preferred candidate profile MSc / MBA with 15 to 20 years of relevant experience in API industry only .(Male candidates )

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 Approach Team Management (3 Shifts) & Team Building.

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 for US FDA, EMA, Health Canada, Australia, and ANVISA. Providing strategic guidance on the impact of CMC changes on regulatory submissions and developing appropriate regulatory pathways will be crucial aspects of your role. Additionally, you will review and evaluate CMC documents, including specifications, batch records, stability data, and change controls. Collaboration with cross-functional teams to ensure regulatory compliance and timely submission will be essential. You will also participate in client discussions, training, and development activities as needed. Experience in handling teams and a total experience of 12 to 15 years is required for this role. Qualifications for this position include experience in regulatory strategy development and implementation, proficiency in preparing and submitting regulatory documents, a strong understanding of regulatory compliance, excellent organizational and timeline management skills, strong written and verbal communication skills, and the ability to interact effectively with regulatory agencies. Experience in the pharmaceutical industry is a plus, and a Bachelor's degree in Pharmacy, Chemistry, or a related field is required.,

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 project timelines and deliverables. Conduct regulatory reviews of research protocols, study reports, and other scientific documents to ensure compliance with regulatory requirements. Communicate with regulatory agencies as necessary to facilitate approvals, responses to inquiries, and other regulatory interactions. Maintain current knowledge of regulatory landscape changes and provide updates and training to internal stakeholders as needed. Participate in internal and external audits and inspections related to regulatory compliance. Demonstrated understanding of regulatory requirements and guidelines relevant to scientific research, including experience with reference listed product confirmation Qualifications Bachelors degree in a science, pharmacy, or a related field; advanced degree (e.g., Masters, PhD) preferred. Minimum of 8- 12 years of experience in regulatory affairs within a research environment, preferably in a Pharmaceutical, Biotechnology industry. Skills Strong organizational skills and attention to detail with the ability to manage multiple priorities in a fast-paced environment. Excellent communication and interpersonal skills, with the ability to collaborate effectively across multidisciplinary teams. Ability to independently solve problems and make decisions, exercising good judgment in ambiguous situations.

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 Education Diploma in Electrical B.Tech in Electrical Competencies