1120 Change Control Jobs - Page 16

Date: 2 Jul 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Essential Functions Job Description Job Title: QMS Project Reviewer Job Location: Syngene International Limited, Bengaluru About Syngene : Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation f...

The C&P Transformation Portfolio Management Office (PMO) Lead supports the Customer & Products (C&P) Leadership team in steering the delivery of business transformation towards an Integrated Energy Company. Reporting to the VP Cost Transformation, you bring clarity and execution to all transformation programs and cost initiatives across the C&P businesses. Collaborating with various stakeholders, you build coordinated timelines, reports, and risk overviews to advise on progress and support prioritization and risk management. Data-driven insights and challenge to the delivery of cost savings targets are key responsibilities. You will coordinate inputs from C&P business units and Enablers into...

The responsibilities for this role include reviewing raw and finished product specifications, ensuring good laboratory practices in the Quality Control department, reviewing audit trial records, analyzing analytical records, reviewing instrument calibration and equipment qualification documents related to QC, validating analytical methods, verifying samples, handling reserve sample room, ensuring analyst qualification, reviewing working standards, managing deviations, change control, OOT, OOS, laboratory incidents, investigations, and annual trends, coordinating CAPA implementation verification and closure, reviewing instrument and equipment preventive maintenance, monitoring and recording t...

The ideal candidate for this role should have 6-10 years of experience and possess the following competencies: - Punctual with a proven track record of dedication and reliability. - A team player who is equally capable of working alone. - Fluent in both written and spoken English. - Knowledge and experience in peptides Quality. - Reviewing the Batch Manufacturing Records. - Executing and Monitoring Process Performance Qualification (PPQ). - Preparing Cleaning Validation Protocol and Monitoring Cleaning Validation/Verification activities. - Reviewing the SOPs, Validation, and Qualification Record. - Handling Dispatch and Line clearance activities. - Preparing Annual Product Review. - Initiati...

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job Overview Reporting to a Portfolio Manager the position holder will have primary responsibility for delivery of a series of Product Development Projects within the Relays Product Group. The Senior Project Manager is a prominent Project Management role with TE and the position holder will drive the successful performance of multiple high profile/value projects following defined methods and processes to achieve commercial and efficiency targets set by the business Developing relationships and maintaining a high-level of communication wit...

Agivant Technologies is looking for Software Technical Writer (Lucknow) to join our dynamic team and embark on a rewarding career journeyWriting, editing, and proofreading technical documentation, including user manuals, product specifications, and process documentation.Collaborating with cross-functional teams, to gather information and ensure accuracy of technical documentation.Conducting research and gathering information from subject matter experts to develop technical documentation and other materials.Organizing and managing documentation, including updating and maintaining document libraries and version control systems.Creating and maintaining templates, style guides, and other documen...

Shaan Energy is looking for Testing & Commissioning Engineers to join our dynamic team and embark on a rewarding career journey Analyzing customer needs to determine appropriate solutions for complex technical issues Creating technical diagrams, flowcharts, formulas, and other written documentation to support projects Providing guidance to junior engineers on projects within their areas of expertise Conducting research on new technologies and products in order to recommend improvements to current processes Developing designs for new products or systems based on customer specifications Researching existing technologies to determine how they could be applied in new ways to solve problems Revie...

Must have minimum 4 years experience in QMS activity Issuance and management of QMS Forms (e.g., CC, CAPA, Deviation, etc.) Participate in the evaluation and investigation of quality-related issues Coordinate with cross-functional teams (CFT) and relevant stakeholders for issue resolution Review and compile supporting documents for QMS processes Maintain and update QMS log registers Ensure proper documentation and records management of QMS activities Perform artwork review to ensure compliance with quality standards Job Location: Kadi, Gujarat ( Bus facilities are available) Note: Immediate joiners will be preferred first

Seeking a CSV Consultant to work on a variety of validation projects including manufacturing systems, lab systems, risk assessments, etc. Some of the work may be done remotely, some at client sites and others at one of our offices. Immediate start date Job Responsibilities: Responsible for the Computer System Validation processes of the company Maintain expertise in current and emerging cGMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11) Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule Lead system qualification efforts and be the primary client contact for coordinating work, repo...

**Job Description:** As a CSV Lead in the Drug Safety domain, you will be responsible for overseeing the validation process of safety systems, including but not limited, or other drug safety databases. You will lead cross-functional teams and manage CSV lifecycle activities, including planning, executing, and documenting validation efforts for drug safety systems. **Key Responsibilities:** - Lead validation efforts for drug safety systems such other similar platforms, ensuring compliance with industry standards (21 CFR Part 11, GxP, and other relevant regulations). - Develop, review, and approve validation documentation, including Validation Plans, Protocols, Reports, and Traceability Matric...

Walk-In Drive for Development Quality Assurance - Formulation Department @ MSN R&D Center Pashamylaram on 02.08.2025 (Saturday ) Roles & Responsibilities 1. Issuing of Batch Manufacturing Records, Analytical Raw datas and maintaining the respective log books. 2. Issuing of registers and formats for all departments and maintaining of records for issuance and reconciliation. 3. Issuance approval, Issuance and Retrieval of the documents in eDMS. 4. Receiving, Issuing and reviewing the bio batches related executed Batch Manufacturing Records, Analytical raw datas and archiving. 5. Responsible for review of product development documents and analytical documents related to technology transfer. 6. ...

Our Senior Regulatory Affairs Specialist position is primarily focused on supporting regulatory sustaining activities within the SM organization, including providing support for change control activities and continued compliance with postmarket MDR and IVDR regulatory requirements. The ideal candidate will be energetic, possess strong regulatory technical knowledge (particularly in the area of change control), have experience supporting MDR and IVDR requirements, and perform well independently and as part of a team. Be part of something bigger! BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagno...

As the Head of Corporate Quality in the Global Supply Organization at our base location in Navi Mumbai, India, you will play a crucial role in leading the development and execution of quality assurance strategies that are in line with our company's long-term objectives. Working closely with the Chief Technology Officer and the GSO Leadership Team, you will be responsible for ensuring the implementation of robust quality management systems, regulatory compliance, and driving continuous improvement in operational performance. Your responsibilities will include establishing best-in-class quality goals, analyzing quality metrics trends, implementing problem-solving strategies and system enhancem...

As a Configuration Manager at our development and engineering project team, you will play a critical role in maintaining configuration control over software and system components. Your responsibilities will include developing and implementing configuration management processes, policies, and tools to ensure the integrity, security, and traceability of all configuration items (CIs) throughout the project lifecycle. You will be tasked with planning and maintaining a configuration management (CM) plan for the project, outlining procedures to control CIs. It will be your responsibility to oversee version control of all software artifacts, ensuring correct versions are used across different envir...

The AGM / DGM Technical Services position requires a candidate with a B.Pharma / M.Pharma qualification and 15 to 20 years of experience in tech transfer activities of solid oral dosage forms for regulated markets. The ideal candidate should have experience in managing a team of 15 to 20 scientists, documentation officers, and technicians. As an AGM / DGM Technical Services in Kandivali, Mumbai, your responsibilities will include planning and executing scale-up and Exhibit batches of solid oral dosage forms for regulated markets such as US, EU, ROW, and Canada. You will be accountable for ensuring the timely initiation of stability studies for exhibit batches and overseeing the technical ser...

About Us bp Technical Solutions India (TSI) centre in Pune aims to build on bp's existing engineering and technical strengths to deliver high-quality services to its hydrocarbons and new energy businesses worldwide. TSI brings together diverse engineering capability to provide technical services across a range of areas including engineering, maintenance, optimization, data processes, projects, and subsurface, to deliver safe, affordable, and lower emission energy, while continuously innovating how we work. About The Role As a Cost Engineer, you will provide cost engineering support to the project portfolio and be responsible for cost reports, delivery, identification, and mitigation of risks...

The Quality Engineer plays a crucial role within the Quality department, serving as a functional expert for the Change Management process. This position requires in-depth knowledge of CAPA, NC, and Investigations, as well as proficiency in the change control process. One of the key responsibilities is to address and resolve issues related to Change and Documentation Modules on SmartSolve. In addition, the Quality Engineer collaborates with the Master Data Team to resolve issues in SAP for the ECO notifications. It is essential to maintain procedures for Document Control and Change Control processes while ensuring compliance with the established Change Management process. Timely review of app...

The C&P Transformation Portfolio Management Office (PMO) Lead supports the Customer & Products (C&P) Leadership team in steering the delivery of business transformation towards a driven Integrated Energy Company. You will be responsible for bringing clarity and execution field to all transformation programs and cost initiatives across the C&P businesses, as well as interdependencies with planned changes in the wider organization. Working collaboratively with program PMOs, business transformation managers, and the Group Transformation office (GTO), you will build coordinated timelines, reports, and risk overviews to provide insights for progress, prioritization, risk management, and intervent...

13-15 years of experience with QMS Activity and all QA activities. Process validation cleaning validation Monitoring of IPQA Data Integrity

Qualification: B.Tech / M.Sc. in Life Sciences, Biomedical Sciences, or a related postgraduate degree Job Summary: We are seeking a highly skilled and experienced Quality Assurance (QA) professional to serve as Assistant Manager for QA operations supporting IVD manufacturing and compliance activities at Labsystems Diagnostics Oy . This role will lead Change Control processes , assist in ISO 13485 QMS audits , and support a range of quality system functions , including CAPA, document control, training, and cross-functional quality initiatives. The ideal candidate will have strong domain expertise in IVD and be confident in supporting both internal quality improvement and external regulatory e...

About The Role Job Title: Internal Audit Analyst Management Level: 11 Analyst Location: Bangalore Must have skills: Chartered Accountant with 2 - 3 years of post-qualification experience in external or internal auditing, preferably in Big 4 or a global organization. Good to have skills: Internal Audit experience with Big 4 or a global organization Job Summary : An agile, highly motivated, innovative thinker with a background in audit, risk, or compliance looking to join a fast-paced, global Internal Audit department that has embraced transformative capabilities including advanced analytics, dynamic risk assessment, and automation to retain its role as a trusted advisor to the business. You a...

Overview: The role is for an Active Directory Engineer in Core Infra IAM operations within Identity & Access Technology Services, responsible for the operation of the Active Directory environment and related technologies. Responsible for the delivery of tiered admin solution and other global solutions for both on premise and cloud identity solutions. The successful candidate must possess relevant experience of operating enterprise scale identity platforms. Role / Principal Accountabilities: The Core Infra IAM function is responsible for operating of all aspects of core infrastructure components relating to Identity and Access Management. The candidate must be highly self-motivated team playe...

Job Title : Assistant Manager Or Deputy Manager Job Location : Hyderabad Department : QA Reports to : HOD Job Objective : To perform the QA activities in view of system upgradation and improvement in the existing procedures. Job Role: 1. Execution & co-ordination for investigations, Identification of root cause along with assignment of adequate CAPAs for Returned material, Incidents, Deviation, OOS, OOT, complaints & other quality events. 2. Logging, Review & Closing of the change controls and CAPAs along with implementation of CAPA and its effectiveness verification as applicable. 3. Responsible as site representative during Regulatory Audits and customer inspections to co-ordinate with the...

As the Purchasing Manager at our company, you will be responsible for leading the day-to-day purchasing operations of various categories including raw materials, solvents, intermediates, packaging materials, engineering spares, and capex items. Your role will involve developing, qualifying, and managing a global supplier base, while negotiating contracts for cost, quality, and compliance. It is essential to maintain strong vendor relationships, monitor inventory levels, and coordinate capex projects, site expansions, and new machinery purchases to ensure uninterrupted production support. In this role, you will be expected to ensure that all materials suppliers meet the cGMP and ICH Q7 standa...

As a Senior Project Manager, you will be responsible for leading projects with a focus on Agile methodologies. Your role will require proficiency in Agile processes, including experience as a Scrum Master. Knowledge of using JIRA and experience as a Business Analyst are essential for this position. Ideally, you should have 8 to 15 years of experience, with a strong background in ERP/Finance projects. Your key competencies should include leadership skills, effective stakeholder management, schedule management, finance management, team management, as well as expertise in risk, opportunity, issue management, and change and quality control. If you meet these qualifications and are ready to take ...