39 Deviations Jobs

As a Quality Assurance Manager at Apotex Inc., you will be responsible for ensuring the effective review and approval of various quality control processes. Your key responsibilities will include: - Reviewing and approving lab investigation reports, deviations, questionable results, out of specification (OOS) and out of trend (OOT) investigations. - Preparing and reviewing standard operating procedures. - Coordinating with cross-functional teams for the closure of investigations in a timely manner. - Reviewing and approving change controls, lab events, and temporary changes. - Coordinating with the regulatory department for submissions and post-approval changes. - Identifying system improveme...

As a Scientist at Novartis, you will be responsible for planning and performing scientific experiments for the timely delivery of drug substances, drug products, processes, and procedures within a multifunctional project team. Your role will involve collaborating with a Project Leader and contributing to the maintenance of lab instruments and infrastructure. Key Responsibilities: - Meet quality, quantity, and timelines in all assigned projects - Perform and document scientific experiments - Plan and organize scientific experiments with minimal guidance - Provide documentation of raw data and evaluate results - Propose and provide input for the design of next experiments - Generate lab proced...

As a Microbiologist at our company, you will be responsible for performing microbiological testing on raw materials, in-process samples, and finished products such as bandages, surgical dressings, and related medical devices. Your key responsibilities will include: - Conducting sterility, endotoxin, bioburden, and environmental monitoring tests in adherence to pharmacopeia and regulatory standards. - Ensuring routine monitoring of cleanroom and controlled environments. - Supporting the validation and calibration of microbiology laboratory equipment like autoclaves, incubators, particle counters, etc. - Maintaining accurate test records, logbooks, and documentation following GMP/GLP guideline...

Role Overview: As a GLP-Quality Assurance Personnel at Syngene International Limited, Bengaluru, you will play a crucial role in contributing to the GLP Quality Assurance Unit. Your primary responsibility will be to ensure compliance with OECD principles of Good Laboratory Practices (GLP), as well as ICH and WHO-GCLP guidelines. You will be tasked with handling inspections and audits, managing QMS activities such as change controls, deviations, and CAPA, and reviewing SOPs and study plans. Your core purpose in this role is to align laboratory practices with GLP guidelines to uphold the integrity and reliability of non-clinical safety and clinical studies. Furthermore, you will work in a regu...

Role Overview: You will be responsible for initiating, reviewing, and approving various quality management systems such as Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints. In addition, 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 duties. Key Responsibilities: - Review and approve all documents including SOPs, Spec & STPs, Forms, protocols, and reports to ensure compliance. - Review annual product quality review reports and provide training on cGMP topics to employees at the site. - Support customer audits/visits and regulatory a...

As a Manufacturing Supervisor, your role involves ensuring efficient line clearance activities, preventive maintenance of machines, cleaning and sanitizing visual inspection and packing areas, operating machines, and maintaining logs as per SOPs. You are also expected to uphold cGMP, GDP standards, and enforce discipline within the department to ensure uniform compliance among all employees. Key Responsibilities: - Perform line clearance activities before commencing operations - Follow the preventive maintenance schedule of machines - Clean and sanitize visual inspection and packing areas - Operate machines and maintain logs according to SOP - Ensure adherence to cGMP, GDP, and discipline st...

As a Manufacturing Specialist in our company, your responsibilities will include: - Performing line clearance activities before commencing operations to ensure a clean and sanitized visual inspection and Packing area - Following the preventive maintenance schedule of machines - Operating the machines efficiently and filling the log of general areas as per SOP and work execution - Adhering to cGMP, GDP, and maintaining discipline in the department - Ensuring that all employees comply with the same standards Your role will also involve: - Ensuring that all equipment and production lines are in validated and calibrated status - Preparing daily production reports based on achieved targets - Crea...

Role Overview: You will be responsible for ensuring the timely and compliant review of CMC documentation, Method Development/Validation Protocols & Reports, Stability Protocols & Reports, Instrument/Equipment Qualification records, and BMR. You will also be involved in compiling high-quality Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products manufactured at various sites, liaising with third party contract manufacturers, and recommending actions for continuous improvement in product quality. Additionally, you will participate in Quality Management Systems, Performance Management, Training, and provide miscellaneous support as needed. Key Responsibilities: - Review CM...

Role & responsibilities Support Quality management system (QMS)/compliance activities pertaining to manufacturing sciences department. Coordination with cross-functional team for implementation of QMS systems across the department. Facilitate/coordinate the internal audit and support the internal teams for timely closure of the CAPA. Facilitate the continuous improvement via quality management system to improve the health of quality systems in department. Ensure that Deviations, Customer complaints investigated, reviewed and CAPA implemented in accordance with QMS Requirements. Initiation and review of change controls in accordance with team requirement and closure of actions with in target ...

-- Handle QMS activities: Change Controls, Deviations, CAPAs, and Event Investigations (TrackWise) , - Review and prepare GMP documents (SOPs, BMRs, BPRs). -Conduct training programs on cGMP and SOPs as per TNI or schedule. Troubleshoot production issues to prevent downtime. -Ensure compliance with regulatory standards and internal SOPs. - Maintain accurate documentation: batch records, equipment logs, quality reports. Hands-on with equipment: autoclaves, DHS, PFS filling machines, mixing vessels, packing lines. -Familiar with utilities: DG sets, HT Panels, Transformers. - 8+years of experience in OSD/API manufacturing.

As a Tester and Inspector, you will be responsible for designing and executing test plans to verify product functionality, reliability, performance, and adherence to specifications. You will also conduct inspections and audits to detect defects, deviations, or non-compliance issues. Key Responsibilities: - Design and execute test plans - Conduct inspections and audits - Analyze production processes - Optimize production processes - Implement continuous improvement initiatives Qualifications Required: - Previous experience in testing and inspection - Strong analytical skills - Knowledge of quality control processes This job is full-time and offers a permanent work location.,

You will be joining Sun Pharmaceutical Industries Ltd as a QA Sterile Manager in the Quality Assurance department. Your role will involve managing the Quality Assurance functions of the Manufacturing Block P. As the Manager-I, you are required to hold an M.Sc. degree in Biotechnology, Microbiology, or Chemistry with over 10 years of experience in the field. Your responsibilities will include ensuring that manufacturing and packing processes are carried out per SOPs and cGMP regulations. You will be responsible for certifying batch production records, releasing/rejecting batches after thorough reviews, and tracking the QMS system. It will be your duty to investigate complaints, deviations, OO...

Who We Are Together, were on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. Its 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 worlds leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organizations Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but were always looking for new ways to continue making a difference, and new people to make a difference with. How You...

As a professional in the field of Quality Assurance, you will be responsible for various key tasks to ensure compliance with regulatory standards and the maintenance of high-quality systems. Your expertise in FDA GMP audits will be essential in guaranteeing adherence to regulatory requirements. Additionally, your experience in establishing and overseeing Quality Management Systems (QMS) will play a crucial role in maintaining compliance with GLP and cGMP standards. Your proficiency in creating, reviewing, and maintaining Standard Operating Procedures (SOPs) will be vital in ensuring consistency and efficiency in processes. You will also be tasked with managing and implementing change control...

We are looking for an innovative and experienced quality analyst to join our team. The quality analyst is responsible for developing and supporting the planning, design, and execution of test plans, test scripts, and process plans for projects. The successful candidate will work closely with various departments to perform and validate test cases based on quality requirements, and recommend changes to predetermined quality guidelines. You will be responsible for ensuring that the end product meets the minimum quality standards, is fully functional and user-friendly. To be successful as a quality analyst, you should demonstrate strong attention to detail and have analytical and problem-solving...

As a Document Management Specialist in the sterile manufacturing department, you will be responsible for various crucial tasks. Your primary duties will include managing documents such as BMRs, BPRs, and master SOPs. You will be in charge of preparing and reviewing master production documents and ensuring the Unit Area File (UAF) is functioning correctly in the designated area. Additionally, you will handle change control processes, deviations, investigations, and CAPA activities. Providing training to subordinates, technicians, and operators within the department will also be a key aspect of your role. It is essential to perform any activities assigned by the Head of Department (HOD) beyond...

The role involves ensuring CGMP compliance and supervising overall production activities of the manufacturing area of multiple assigned manufacturing lines. Additionally, the position requires reviewing and maintaining online documents. You will be responsible for the preparation, review, revision, control, and implementation of standard operating procedures. You will also handle the preparation and review of master production documents, protocols, reports, and various document management tasks such as BMRs and BPRs. Your duties will include managing Change Control, Deviations, CAPA, Investigations, and ensuring line clearance activities are conducted before operations like manufacturing, fi...

You will be part of the Documentation team in the Production Department at Sai Life Sciences located in Bidar. As a leading Contract Research, Development, and Manufacturing Organization (CRDMO), we partner with numerous global innovator pharma and biotech companies to support the advancement of their NCE programs. With a workforce of over 3000 professionals in India, the UK, and the USA, we are dedicated to fostering scientific excellence and ensuring customer success. Our organization is characterized by a culture of openness, mutual respect, and inclusivity, and we are committed to diversity and equal opportunity practices at all levels. Your primary responsibilities will include drafting...

You will be responsible for leading the deployment and optimization of Quality Management System (QMS) processes as a Subject Matter Expert (SME) for Veeva Vault QMS. Your main focus will be on ensuring compliance, efficiency, and user adoption by utilizing your deep domain expertise in QMS processes within the life sciences or pharmaceutical industry. Your key responsibilities will include serving as the SME for Veeva Vault QMS, leading deployment, configuration, and optimization efforts. You will need to understand existing QMS processes and workflows, identify areas for improvement, and work closely with stakeholders to gather requirements. Additionally, you will design, implement, and re...

As a member of the ACG Corporate team, your primary responsibilities will include preparing and conducting tests such as MLT and Water analysis in the Micro Lab. It is crucial to ensure proper documentation and to develop and establish testing procedures. Maintaining accurate records, keeping the work space organized, and fostering a quality culture across the plant are essential aspects of this role. Additionally, you will be responsible for establishing a review mechanism to continuously upgrade and standardize processes. In the functional core of your role, you will be required to review customer quality complaints, which involves investigating complaints, conducting root cause analysis, ...

As a team member 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 and innovative tech platforms to enhance healthcare outcomes. With a strong research pipeline focusing on biosimilar molecules for diabetes, oncology, immunology, and other non-communicable diseases, we are committed to making treatment more accessible and affordable for patients worldwide. Your responsibilities will include performing line clearance for various manufacturing activities such as formulation, washing, filling, sealing, and others in designated areas. You will also be responsible for rev...

As a member of the ACG Corporate team, your primary responsibilities will include preparing and conducting tests such as MLT and Water analysis in the Micro Lab. It is crucial to ensure proper documentation, develop and establish testing procedures, maintain accurate records, and uphold a clean work space. Your role will also involve fostering a culture of quality across the plant and implementing a review mechanism to consistently enhance and standardize processes. Within the functional core of your responsibilities, you will be expected to review customer quality complaints, conduct complaint investigations, perform root cause analysis, and identify Corrective and Preventive Actions (CAPA)...

As a Process Incharge - Injectable, you will be responsible for overseeing formulation manufacturing projects with an experience requirement of 12-15+ years, including 5-6 years specifically in formulation manufacturing projects. Your key responsibilities will include reviewing equipment design qualification documents such as PI&D, FS, DQ, SDS, HDS, IQ, OQ, and drawings for approval when necessary. You will be tasked with verifying process equipment instruments in alignment with PI&D and electrical drawings, ensuring commissioning of instruments as needed, and conducting Factory Acceptance Tests (FAT) for process equipment where necessary. Additionally, you will provide support for installat...

You will be responsible for testing and releasing raw material, packing material, and miscellaneous material samples in the QC department of a sterile manufacturing plant. Your duties will include maintaining reserve samples as per SOP, preparing specifications for raw materials, packing material, in-process and finished products, and stability protocols. You will also be involved in preparing study protocols, sampling materials, preparing volumetric and reagent solutions, and conducting water analysis as per specifications. Additionally, you will be required to keep the workplace neat and clean, follow good laboratory practices, test and release in-process, finished product, standards, and ...

As an Assistant Manager/Manager- Quality Assurance, your responsibilities will include: - Reviewing and approving Standard Operation Procedures (SOP's) for all departments, ensuring timely completion of reviews and revisions according to the specified revision date. - Evaluating and approving analytical method validation protocols and reports, process method validation protocols and reports, water system validation protocols and reports, as well as equipment/instrument qualification protocols and reports. - Reviewing and approving raw material, packing material, semi-finished product, and final product specifications and test methods for analysis. Approving artwork and shade cards for printe...