86 Deviations Jobs

As a Manager at Sun Pharma Laboratories Ltd in Guwahati - Operations OSD, your role will involve the following responsibilities: Role Overview: You will be responsible for monitoring and maintaining documentation related to QMS activities, including SOPs, change controls, deviations, and CAPAs. Additionally, you will handle market complaints by conducting root cause analysis and implementing corrective actions. Your role will also require ensuring implementation and compliance with Quality Management System (QMS) guidelines and facilitating training programs for personnel on QMS procedures, regulatory requirements, and best practices. Compliance with Good Manufacturing Practices (GMP) and co...

As a Scientist at Novartis, you will be responsible for planning and performing scientific experiments for the preparation and timely delivery of drug substances, drug products, processes, and procedures. You will collaborate within a multifunctional project team coordinated by a Project Leader and contribute to the maintenance of lab instruments and infrastructure. Your responsibilities will include: - Meeting quality, quantity, and timelines in all assigned projects - Performing and documenting scientific experiments - Planning and organizing scientific experiments under minimal guidance - Providing documentation of raw data and evaluating results - Proposing design for next experiments an...

As a member of the Process Engineering (Instrumentation) team at Knovea Pharmaceutical Pvt. Ltd. in Indore, MP, you will be responsible for the following key responsibilities: - Reviewing equipment design qualification documents such as PI&D, FS, DQ, SDS, HDS, IQ, OQ & drawings, and approving them if necessary. - Verifying process equipment instruments according to PI&D and electrical drawings, and commissioning instruments if needed. - Conducting FAT for process equipment when required. - Providing support for installation and commissioning activities. - Assisting in qualification activities for equipment like IQ, OQ & PQ. - Identifying all process equipment and utilities equipment field in...

Role Overview: As a member of the team, you will be responsible for performing line clearance activities before commencing operations, ensuring a clean and sanitized visual inspection and Packing area, and following the preventive maintenance schedule of machines. Operating the machines efficiently and filling the log of general areas as per SOP and work execution will also be part of your responsibilities. It is essential to adhere to cGMP, GDP, and maintain discipline in the department while ensuring that all employees comply with the same standards. Key Responsibilities: - Ensure that all equipment and production lines are in validated and calibrated status - Prepare daily production repo...

As a Microbiologist in our company, your role will involve performing microbiological testing of raw materials, in-process samples, and finished products including bandages, surgical dressings, and related medical devices. You will be responsible for conducting sterility, endotoxin, bioburden, and environmental monitoring tests in accordance with pharmacopeia and regulatory standards. Additionally, you will be required to ensure routine monitoring of cleanroom and controlled environments to maintain a sterile working environment. Key Responsibilities: - Support validation and calibration of microbiology laboratory equipment such as autoclaves, incubators, particle counters, etc. - Maintain a...

Role Overview: You will be responsible for various activities including line clearance before operations, maintenance of machines as per schedule, cleaning and sanitizing the inspection and packing area, operating machines, and maintaining logs as per SOP. Your role will also involve ensuring compliance with cGMP, GDP, and enforcing discipline within the department to uphold standards. Key Responsibilities: - Conduct line clearance activities before commencing operations - Follow preventive maintenance schedule of machines - Clean and sanitize visual inspection and packing area - Operate machines and maintain logs according to SOP - Ensure all employees adhere to cGMP and GDP standards - Val...

As the Quality Management Systems Specialist, your role will involve initiating, reviewing, and approving various quality management systems such as Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints. Additionally, you will handle Return Goods and ensure the proper functioning of the quality system by performing risk assessments as needed. Conducting regular internal audits will also be part of your responsibilities. Key Responsibilities: - Initiate, review, and approve quality management systems including Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints - Handle Return Goods and perform risk assessments to ensure the proper functioning of the qualit...

Role Overview: As a Supply Chain Master Data Specialist at Astellas, your primary responsibility will be to conduct supply chain impact assessments for master data in global systems such as SAP S/4 and IBP. You will represent the master data team in various projects, create and maintain global data rules, and possess the capability to train other Supply Chain Management (SCM) colleagues. Key Responsibilities: - Perform the roles of Technical Data Steward (TDS) as per Astellas master data governance policies and process designs. - Evaluate incoming Impact Assessments (IA) and communicate relevant impacts to the SCM Master Data Management (MDM) team, collaborating with stakeholders to find sol...

As a QA Docscell at our company, your role involves ensuring compliance with cGMP, ICH guidelines, and regulatory requirements. You will be responsible for reviewing and maintaining batch manufacturing records (BMRs), batch packaging records (BPRs), and quality documentation. Additionally, you will conduct in-process checks and line clearance during manufacturing and packaging activities. Your responsibilities will also include participating in internal audits, self-inspections, and external regulatory audits. You will review and assist in the preparation of SOPs, protocols, and reports. In case of deviations, CAPA, change controls, and OOS/OOT results, you will investigate and document them...

Job Description The role will have the following responsibilities: Responsible for planning stability studies, writing and/or review of stability protocols, reports, and preparation of technical documents in CTD format. Co-ordinate and follow up stability studies at contract research organizations (CROs)/ Chemical Quality Control lab of Orion (CQC). Co-ordinate and follow up validation and method transfer at CROs. Write/check/review analytical and pharmaceutical documents as per regulatory requirements (method and validation documents/ variations/ additional question responses) Evaluate/ review method validation protocols / reports / analytical methods prepared by CROs. Reviewing and comment...

Minimum 20 years in Quality Assurance/Quality Systems in API/pharmaceutical manufacturing, with significant exposure to regulated markets To provide strategic and operational leadership to the Quality function, ensuring robust implementation of quality systems, compliance with global regulatory requirements, and continuous improvement in all quality-related processes for API manufacturing. Key Responsibilities Quality Systems & Compliance Implement, maintain, and continuously improve Quality Systems in line with ICH Q7, EU GMP, 21 CFR Parts 11, 210, 211, Annex 11, and other applicable global regulations for APIs. Ensure site-wide compliance with internal quality policies, SOPs, and regulator...

As a Management Consultant in the Life Sciences Strategy & Consulting team, you will be responsible for supporting clients in Quality transformation initiatives. Your expertise in the Quality domain, with exposure to QMS systems, will be invaluable in this role. Key Responsibilities: - Lead or support Quality projects, including process improvement, compliance, and system-related transformations. - Perform functional and technical business analysis by gathering requirements, mapping processes, and documenting workflows. - Analyze and optimize quality processes such as Audits, deviations, CAPAs, root cause analyses, periodic reviews, and audit trail monitoring. - Collaborate with cross-functi...

As a Quality Control Analyst at Piramal Critical Care (PCC), your primary responsibility is to complete assigned tasks and ensure training on activities as instructed by the supervisor or Head of Quality Control (HOD-QC) before execution. Your duties include reviewing data related to packing materials, raw materials, stability samples, in-process and finished products. Additionally, you will be responsible for reviewing Qualification, Validation, Calibration data, Procedures, and Audit Trails in a timely manner. If you identify any unsafe conditions or acts within the laboratory, you must report them to the supervisor or HOD-QC and ensure their resolution. Key Responsibilities: - Receive and...

Who We Are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with. Th...

Job Description: As a member of the team, you will be responsible for the following key responsibilities: - Responsible for preparation & review of the master documents of sterile manufacturing for parenteral facility. - Responsible for preparation and review of protocols and reports based on the requirements. - Responsible for document management and preparation like BMRs, BPRs, master SOPs etc. - Responsible for the handling of change control, deviations, CAPA, investigation etc. - Responsible to give training to all the subordinates, technicians and operators of the department. - Responsible for Audit and compliance on manufacturing shopfloor. - Knowledge of kaizen and continuous improvem...

As a candidate, you will be responsible for maintaining self-hygiene and ensuring compliance with cGMP, GDP, and departmental discipline. Your key responsibilities will include: - Preparing and reviewing the master documents, protocols, and reports of production as per requirements. - Managing the Exhibit batch documents such as BMRs, BPRs, etc. - Handling change control, deviations, CAPA, investigation, etc. - Training all the subordinates, technicians, and operators of the department. - Performing other activities as per HOD's requirement and guidance. - Attending and ensuring training as per the training schedule and TNI. - Reviewing BMR, BPR, and other Exhibit batch related documents. Qu...

As an Engineering Compliance Specialist, your primary role will be to ensure all engineering activities are carried out in compliance with cGMP, GEP, and site SOPs. This includes handling quality documents such as Change Controls, Deviations, CAPA, and Quality Risk Management. You will review and update the planner to ensure activities are completed on time and prepare/revise SOPs for plant machinery, utilities, HVAC, and water systems. Additionally, you will support preventive maintenance execution, assist in equipment installation/commissioning, and ensure effective training through review and feedback. Your responsibilities as a Department Training Coordinator will involve updating traini...

As a member of the team at Biocon Biologics Limited, a subsidiary of Biocon Limited, you will be part of a fully integrated global biosimilars organization dedicated to leveraging cutting-edge science, innovative tech platforms, and advanced research & development capabilities to enhance healthcare outcomes while reducing treatment costs. With a strong research pipeline focusing on biosimilar molecules across various therapeutic areas such as diabetes, oncology, immunology, and other non-communicable diseases, Biocon Biologics has successfully brought six molecules from its portfolio to market in developed regions like the United States, EU, Australia, Canada, and Japan. With a workforce of ...

You will be responsible for: - Providing L1 & L2 support for Veeva Vault QMS, QualityDocs, and Training, resolving user issues and system errors. - Troubleshooting workflow automation, document control, access management, and security concerns. - Collaborating with IT teams to resolve integration, database, and system performance issues. - Liaising with Veeva Support for system updates, issue escalations, and troubleshooting. - Maintaining Veeva Vault applications ensuring system stability, performance, and compliance. - Managing user roles, permissions, and security policies to control data access. - Performing software updates, patches, and configurations in compliance with validation requ...

You will be responsible for testing and releasing raw material, packing material, and miscellaneous material samples. You must maintain reserve samples as per standard operating procedures (SOP). Your role will involve preparing specifications of raw materials, packing material, in-process and finished products, and stability protocols as required. You will also be responsible for preparing study protocols for the laboratory. Your key responsibilities will include: - Sampling raw material, packing material, and miscellaneous material samples and maintaining reserve samples as per SOP - Preparing volumetric solutions, reagent solutions, working standards, and maintaining records - Performing ...

As a Process Incharge for Injectable manufacturing projects, your role will involve reviewing equipment design qualification documents such as PI&D, FS, DQ, SDS, HDS, IQ, OQ, and drawings for approval. You will verify process equipment instruments according to PI&D and electrical drawings for commissioning. Additionally, you will conduct FAT for process equipment when necessary and provide support for installation and commissioning activities. Key Responsibilities: - Verify process equipment instruments based on PI&D and electrical drawings - Conduct FAT for process equipment when required - Provide support for installation & commissioning activities - Assist in qualification activities for ...

Role Overview: As a part of ACG Corporate, your role will involve preparing and carrying out tests such as MLT and Water analysis in the Micro Lab. You will be responsible for ensuring proper documentation, developing and establishing testing procedures, maintaining proper records, and work space. Your key responsibility will be to develop and sustain a quality culture across the plant and establish a review mechanism to constantly upgrade and standardize the process. Key Responsibilities: - Review customer quality complaints, including complaint investigation, root cause analysis, and identifying the Corrective and Preventive Actions (CAPA). - Ensure closure of complaints within defined tim...

Job Responsibilities To ensure Sit Ready for anytime Regulatory Inspection in Compliance to cGMP Norms of Various Regulatory Bodies. To train personnel on cGMP, regulatory expectations, and quality systems to enhance compliance and awareness. To ensure Vendor Qualification activities are conducted as per SOPs, and maintain an up-to-date Approved Vendor List and requalification of Vendor Schedule. To ensure Quality Assurance, Quality Control, Microbiology, Production, Warehouse, Engineering activities are performed in compliance as per current GMP requirement and their effective implementation. Responsible for ensuring QMS elements (Change Control, Deviations, CAPA, OOS, OOT, etc.) are implem...

As an Executive - QA (API - Pharma) at our manufacturing unit in Tumkuru, your responsibilities will include: - Handling QMS activities such as change control, deviations, CAPA, returned goods, and market complaints. - Preparation and review of all SOPs. - Monitoring online GMP activities in various departments. - Preparation of audit documents and active participation in audits. Qualifications required for this role: - 2-5 years of relevant experience in a similar position in the pharmaceutical industry.,

As an Executive/Senior Executive in the R&D Quality-CMC QA department at Gurugram location, your role involves the following responsibilities: - Review various R&D documents including stability data, analytical reports, method qualification reports, method verification reports, method validation protocols & reports, working standard / impurity standard profile, analytical data of pilot bio batches, and method transfers protocol & report. - Review lab events, deviations, change controls, CAPA, and associated investigation reports before Technology Transfer. - Support and actively participate in failure investigations, identifying root causes for issues related to systems and products develope...