94 Change Controls Jobs - Page 3

Primary Job Function To lead and manage all regulatory affairs activities at the manufacturing site located at Mumbai and LL locations, ensuring timely regulatory submissions, compliance with regulations, and providing strategic support to institutional and international business operations. The role is critical to maintaining business continuity and regulatory compliance. Core Job Responsibilities Regulatory Submissions and compliance Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes e...

As a Senior Executive at Syngene International Ltd. in Bangalore, you will be responsible for the commissioning & qualification, and QMS activities for biopharmaceutical manufacturing facilities. Your key responsibilities will include: - Performing validation of computerized systems and Electronic Records and Electronic Signature (ERES) Validation. - Timely preparation, review, and approval of URS, DQ, IQ, OQ, and PQ protocols and reports. - Coordinating the Calibration Program, Preventive Maintenance Program, and Alarm Management for manufacturing facilities. - Conducting investigation for equipment failure, root cause identification, and implementation of appropriate CAPA. - Participating ...

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...

Role Overview: As a Formulations Scientist in Hyderabad, India, you will be responsible for the development of oral solid dosage forms of Non-DEA and DEA substances. Your key functions will include conducting Literature Search, Pre-Formulation, Formulation Design, and Development of stable, Bioequivalent, and Manufacturable generic solid oral formulations. Key Responsibilities: - Act as a mentor and motivator to the team. - Develop robust formulations and processes for immediate release and modified release tablet and capsule dosage forms. - Evaluate patents and develop non-infringement strategies, including the capability of developing Paragraph IV products. - Scale-up and optimize manufact...

As a Regulatory Affairs Manager, you will play a crucial role in monitoring the company's production activities to ensure compliance with all applicable regulations and standard operating procedures. Your responsibilities will include devising regulation compliance strategies, creating training and orientation programs for staff, conducting internal inspections and information drives, and staying updated with the latest rules and regulations. Key Responsibilities: - Possess in-depth technical knowledge of Chemistry, Manufacturing, and Controls (CMC) aspects, dossier compilation, review, evaluation, and compilation for new marketing authorizations. - Review and approve submission documents ac...

In this role at Piramal Agastya, your primary responsibility is to ensure compliance with regulatory and Pharmacopoeial standards through compendia assessments, Quality Management System (QMS) oversight, and documentation preparation. You will collaborate with global sites, vendors, and internal teams to develop quality agreements and provide support during audits and inspections. Additionally, you will be managing SOPs, monitoring QMS events, and preparing essential quality documentation and reports. As part of your responsibilities, you will: - Conduct compendia assessments for all materials used on-site to identify gaps against current Pharmacopoeial requirements and implement risk mitiga...

As a Specialist Product Analyst - Industrial DataOps/Data Engineer at our company, you will be at the forefront of leveraging cutting-edge Industry 4.0 technologies and industrial DataOps tools to enhance data aggregation, management, and contextualization capabilities in the manufacturing sector. **Key Responsibilities:** - **Technical Leadership:** - Assist in designing and implementing technical solutions to improve shop floor data aggregation and management using Industry 4.0 technologies. - Collaborate with senior architects and product leads to define technical standards and best practices. - **DataOps Implementation:** - Support the integration and deployment of industrial DataOps too...

As a Site Transfer and ANDA Specications Specialist at our company, you will play a critical role in creating, revising, and reviewing specifications and methods for site transfers and ANDAs. Your responsibilities will include: - Having knowledge of method validation protocols and being able to create, revise, and review validation reports for drug substance, excipients, and drug products. - Initiating change controls as necessary for various aspects including method and specification revisions, stability protocols, batch analysis, reference standards, characterization of impurities, justification of specifications, facility templates, stability summary reports, 5313 reports, QOS, and stabil...

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 Qualified Person within the Quality department at Piramal Critical Care (PCC) in Haarlem, Netherlands, your primary responsibility will be to certify batches of Medicinal Products before release for sale. This includes ensuring compliance with EU-GMP regulations, relevant EU-directives such as 2001/83/EC and 2011/62/EU, Dutch National Legislations, and overseeing that public service obligations are met. - Collaborate with key personnel like heads of production, quality control, quality assurance, and supply chain to supervise the company's activities and ensure continuous compliance with legal requirements. - Be regularly present at the facilities where the operations take place to fulf...

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 Overview: You will be responsible for the CMC review of technical documentation for regulatory filings across various markets including the US. This will involve conducting Gap Analysis and Remediation for Module 3 - CMC. Additionally, you will play a key role in the development and implementation of regulatory strategies, processes, and timelines for the grant of Marketing Authorization in regions such as Africa, GCC, LATAM, and ASEAN. Key Responsibilities: - Reviewing CTD dossiers, variations, change controls, renewals, and ensuring their alignment with applicable regulatory guidelines while maintaining the highest quality standards. - Critically reviewing documentation intended for s...

As a part of the Technology Transfer Team under the R&D vertical at Palli location, your primary responsibilities will include: - Preparing Master BMR and BPRs - Managing documents - Coordinating with various departments such as Regulatory Affairs, Manufacturing, Warehouse, Quality Assurance, Quality Control, and Engineering for the execution of Scale-up and Exhibit batches - Reviewing GMP related documents - Selecting equipment at the facility Your role will involve facilitating Change Controls for various reasons and initiating them due to revisions in BMR/BPRs and other PD related changes. You will also study critical parameters during scale-up batches to optimize the CPPs and CQAs, provi...

Position: Sr. Manager / AGM Regulatory Affairs Qualification: M.Sc. / Ph.D. (Life Sciences, Biotechnology, or related discipline) Experience: 1316 years in Regulatory Affairs (vaccines/biologicals) Role: The role is responsible for global product registrations (LatAm, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and regulatory compliance/audit support. The role ensures accurate and compliant representation in dossiers, while guiding strategy for regulatory filings, variations, and lifecycle management across multiple regions. Key Responsibilities Deep expertise in vaccine/biological regulatory affairs, dossier preparation, and lifecycle management. Strong track reco...

As an Engineering Stores - Executive at Teva Pharmaceuticals, you will play a crucial role in ensuring the smooth functioning of the engineering department. Your responsibilities will include the following: - Overall management of engineering activities, including monitoring and review of procedures and cGMP records in the engineering store to ensure compliance. - Preparation and review of Engineering store SOPs in Glorya Electronic Data Management System. - Ensuring readiness of the department for regulatory inspections and compliance with regulations. - Upkeeping of engineering store compliance and initiation/execution of Change Controls, Deviations, Investigations, CAPAs in Trackwise Syst...

Role Overview: You will be joining Syngene International Ltd. as a Senior Executive 9-II in the Quality Assurance department at the Mangaluru location. Your main responsibility will be to provide in-process Quality Assurance support for executing GMP manufacturing activities at the Mangalore manufacturing facilities. You will ensure that the Site Quality system is always in compliance and ready for Regulatory & Client inspections by following all necessary quality procedures. Additionally, you will handle change controls, deviations, CAPAs, and assure online documentation integrity. Key Responsibilities: - Provide In-process Quality Assurance support for GMP manufacturing activities - Ensure...

Designation- QA Executive Looking for QA Executives/Sr. Executives from Injectables and formulations background only. Roles and Responsibilities: 1.Responsible for all Quality Management System (QMS) and documentation activities in the plant. 2. Responsible for logging, review, follow-up and closure of Change controls, Deviations, Corrective and Preventive actions, OOS, OOT, Market complaints and Product recalls. 3. Responsible for investigations of different deviations, OOS, OOT, market complaints, product recalls and Risk assessments. 4. Responsible for preparation of internal audit schedules and coordination and organization of audit meetings and participation as Auditee / Auditor. 5. Res...

As a Material Management Specialist, your role involves planning and controlling inventories of raw materials and packaging materials to meet production requirements. You will coordinate with Purchase and Quality Control teams to ensure timely availability and release of materials. Additionally, you will oversee the receipt, storage, and dispensing of materials in compliance with SOPs, MSDS, and safety requirements. It will be your responsibility to manage the return, rejection, and destruction of non-conforming materials following established procedures. Your key responsibilities include: - Planning and controlling inventories of raw materials and packaging materials - Coordinating with Pur...

Review of all quality systems i.e Change controls, Deviations, Market complaints, OOT, OOS, CAPA etc., To monitor Batch manufacturing at CMOs and review and compliance of the documents as per the requirements. To conduct/participate internal quality audits & regulatory / customer audits. Communications with External Vendors/customers for relevant information/documents Co-ordination with cross-functional teams for meeting schedule timelines for commercial and development activities. Review of development and commercial batch documents

As a key member of the team at a leading manufacturer of active pharmaceutical ingredients (APIs) and an end-to-end solution provider for the pharmaceutical industry, your primary responsibilities will include leading R&D CRO projects for global customers. You will be tasked with developing non-infringing routes for APIs with sustainable processes, focusing on Impurity synthesis. Additionally, you will play a crucial role in developing robust, scaleable, operationally safe, and commercially viable processes. This includes synthesis route selection, lab feasibility, process optimization, technology transfer, and scale-up & commercialization for tonnage scale campaigns, always prioritizing saf...

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...

1. QA Executive Junior Level Experience Required: 24 years Salary Offered: 20,000 per month Job Summary: We are seeking motivated QA Executives with 24 years of experience to support daily quality assurance activities in a GMP-regulated pharmaceutical facility. The role will focus on documentation review, QA activities, and ensuring compliance with regulatory standards. Key Responsibilities: Review batch manufacturing and packing records Line clearance for production and packaging activities Support in handling deviations, change controls, CAPA, and incident reports Ensure compliance with cGMP and Revised Schedule M requirements Participate in in-process checks and quality monitoring Assist ...

You are a dedicated and detail-oriented Quality Management System (QMS) Executive responsible for supporting and enhancing the organization's quality framework. Your primary role includes implementing, maintaining, and continuously improving the QMS in line with ISO 9001:2015 and relevant regulatory standards. Your focus will be on ensuring quality compliance across departments and fostering a culture of continuous improvement. Your key responsibilities will involve implementing and maintaining the Quality Management System in alignment with ISO 9001:2015 standards. You will be tasked with developing, reviewing, and controlling quality documents such as SOPs, manuals, work instructions, and ...

As an experienced professional in the pharmaceutical industry, you will be responsible for authoring, writing, and reviewing CMC sections of dossiers. Your critical review skills will be essential in examining design stage documents such as specifications, controls, and protocols to ensure compliance with regulatory requirements. You will play a key role in assessing change controls to determine their regulatory impact and develop strategies for post-approval submissions. Coordinating the collection of post-execution data from different functions and reviewing them against design specifications will be part of your daily tasks. Collaboration with cross-functional team members will be crucial...