1120 Change Control Jobs - Page 28

The Senior Executive QA (Vendor Management) will be responsible for managing vendor qualification processes, preparing periodic vendor audit schedules, and ensuring vendor compliance in line with cGMP and global regulatory expectations. The role also involves reviewing and maintaining Quality Agreements, monitoring vendor performance, supporting cross-functional risk assessments, and ensuring timely closure of audit observations. The position demands strong coordination with cross-functional teams, external vendors, and regulatory bodies. Key Responsibilities: Execution and oversight of vendor qualifications Planning and coordination of vendor audits Preparation and review of Quality Agreeme...

About the Role: Grade Level (for internal use): 08 S&P Global Mobility The Role: Software Engineer The Team Assembly Operations team is responsible for managing optimizing and enhancing daily production operations within the Data Factory, focusing on the development and implementation of data processes for Mobility data products. It thrives on collaboration, encouraging open communication and teamwork, which fosters a dynamic environment where innovative solutions are valued. The team is distinguished by its commitment to data integrity and operational excellence, ensuring that client needs are met with precision and efficiency. The Impact This role is crucial for maintaining the efficiency ...

Creation Plans effectively around delivery constraints and optimizes the plan to maximize benefits and minimize risk. Ensures the baselined scope, requirements, benefits, schedule and budget are managed as outlined in Business Transformation Frameworks Proactively monitors project execution to effectively identify risks/issues/dependencies as they arise throughout the project lifecycle. Collaborates and builds positive stakeholder relationships providing regular updates, obtains buy in from the project sponsor, Steering Committee and other stakeholders for all key project plans, commitments, and changes including requirements. Produce a well defined project plan, identifying the key mileston...

This role is responsible for leading a project team in delivering a solution to the client using the appropriate business measurements and terms and conditions for the project according to the project charter, project agreement or contract. They have overall performance responsibility for managing scope, cost, schedule, and contractual deliverables, which includes applying techniques for planning, tracking, change control, and risk management. They are responsible for managing all project resources, including subcontractors, and for establishing an effective communication plan with the project team and the client. They provide day to day direction to the project team and regular project stat...

Responsible for maintaining GDP and GLP in lab. Responsible for maintaining all laboratory testing documents according to GLP requirements and sustain all records in an accurate and legible manner Responsible for preparation of COA.

Job Description 1) Supervise compliance to all cGMP, GxP, or any other regulatory requirements, Including EH&S requirements. 2) Execute and supervise all tasks and activities as per the applicable SOPs. 3) Complete self-training and monitor training of team members on the relevant SOPs. 4) Report any quality concerns or suggestions for improvements to Managers. 5) Review of Master document such as Validation protocol and reports. 6) Review and monitoring of Quality system document such as deviation, change control, OOS, OOT, Vendor complaint, CAPA, Risk assessment, Non conformities, Internal Audit & Market Complaint. 7) Ensure preparation and periodic review / updation of APQR. 8) Preparatio...

Role & responsibilities 1. Work closely with the Quality Assurance (QA) team to promptly address and resolve any deviations, non-conformances, or regulatory issues to maintain high-quality standards. 2. Manage and handle key QMS tools such as Change Control, Deviation Investigations, OOS (Out of Specification), OOT (Out of Trend), CAPA (Corrective and Preventive Actions), ensuring their timely closure. 3. Conduct thorough investigations for deviations, incidents, and market complaints to determine root causes and implement corrective actions. 4. Develop, implement, and enforce standardized operating procedures (SOPs) across all production departments to maintain consistency and quality stand...

Role & responsibilities Responsible for managing and maintaining Quality Management System (QMS) activities within the Supply Chain Management (SCM) department, including Change Control, Deviation, and CAPA management. Ensures daily operations and documentation are in compliance with cGMP and regulatory standards. Supports audit readiness and continuous improvement initiatives within SCM.

Roles and Responsibilities Conduct quality audits, BMR reviews, CAPAs, deviation investigations, change controls, equipment qualifications, process validations, and vendor qualifications. Ensure compliance with USFDA regulations through IPQA activities Engineering Documentation ,Qualifications &Validations. Warehouse Documentation ,Qualifications &Validations. Cleaning Validation Perform analytical QA tasks such as OOS management and sterility testing. Participate in MHRA / USFDA inspections by providing necessary documentation and supporting audit findings. Collaborate with cross-functional teams to resolve quality issues. Regulatory Audit Exposer LIKE FDA, MHRA, TGA Audit Reponses and Audi...

Immediate Openings on CSV Analyst _Bangalore Experience : 5+ Skill:- CSV Analyst Location : Bangalore Notice Period :- Immediate . Employment Type: Contract . Job Description: Key Skills: - Application/Product development testing and experience in Computer Systems Validation (CSV) - Experience in QMS, Regulatory Requirements, GxP Compliance, and Good Documentation Practices - Strictly adhereing to Business SOPs, cost & coverage, requirement specifications & formulation of Test Cases in HP ALM for the Functional, Integration, end-to-end, Usability, and smoke testing. - Experience in the development of Qualification test scripts (IQ,OQ, PQ and VSR) for CSV projects - Good knowledge of CSV, GAM...

JD SAP PI/POCollaborates with cross functional IT business analyst team to review the integration requirements and recommend best integration solutionsDesign, build, support interfaces; develop and maintain data mappings, JAVA mappings, XSLT mappings, EDI and XML communications, PI Proxies, interface definitions, and XSDsDevelop and maintain Integration Repository (Interface Objects, Mapping objects and Adapter objects), Integration Directory (Communication channels, Sender and Receiver agreements, Receiver and Interface determination) and Integration Engine (Central Monitoring)Develop interfaces using adapters available in PI: File, FTP, SFTP, HTTP/HTTPs, PROXY, JDBC, SOAP, SQL, ALE and IDO...

- 6 to 8 years of experience in SAP Solution Manager with specialization in Application Lifecycle management in a medium or large size firm. - Strong experience of end-to-end implementation of CHARM in Solman 7.2. Should be able to independently handle configuration related to Solution Manager and CHARM. Having a good understanding and Deep knowledge of the best practices of SAP Solution Manager and ChaRM functionality - Experience on SAP Solution Manager in configuring ChaRM (Change Request Mgmt, Change Control Mgmt), Document Management, Service Desk, Business Process Monitoring, Project definition and blueprint nodes, Template Management. - Understanding of and capability to Plan, design ...

Role & responsibilities Preparation, Review and Execution of Process Validation Protocols and summary reports based on the Analytical results and Batch documents data.

Carry out manufacturing activities as per Batch Manufacturing Records (BMR) and SOPs. Monitor and control production parameters to meet quality and output targets. Ensure timely completion of batches to meet production schedules. Ensure adherence to current Good Manufacturing Practices (cGMP) and company policies. Report and document any deviations, incidents, or abnormalities during production. Operate, clean, and maintain manufacturing equipment (e.g., granulators, blenders, tablet compression machines, filling machines). Perform line clearance, changeovers, and cleaning as per SOPs. Maintain accurate and timely records of all production activities. Fill out logbooks, checklists, and BMRs/...

The Senior Executive QA (Engineering Assurance) will be responsible for executing and reviewing qualification lifecycle documents for GMP equipment, utilities, and facilities. The role includes oversight of URS, DQ, IQ, OQ, and PQ protocols, engineering change controls, risk assessments (FMEA), and periodic requalification activities. This position works closely with Engineering, Validation, Projects, and cross-functional QA teams to ensure timely qualification and regulatory readiness. Key Responsibilities: QA review and approval of qualification protocols and reports (URS, DQ, IQ, OQ, PQ) Oversight on facility, utility, and equipment qualification activities QA support for engineering chan...

Employment Type: Contract Working Mode : Hybrid 12+ years of experience working in electronic based Computer System Validation in a GxP environment Demonstrated ability to maintain a CSV and Computer and Instrument System Change Control process Experience in employing risk-based approaches to CSV Experience in qualification of GLP Instrument Systems Ability to provide Quality oversight during implementation of GxP Software as a Service tools and systems Experience in perform

Skills: Oracle Database, Postgres, Database design Secondary Skills: Data modelling, Performance Tuning, ETL processes, Automating Backup and Purging Processes Skill Justification Database Designing, Data Modelling, and Core Component Implementation: These are fundamental skills for a DBA. Database designing involves creating the structure of the database, data modelling is about defining how data is stored, accessed, and related, and core component implementation ensures that the database is set up correctly and efficiently. Data Integration and Relational Data Modelling: Data integration is crucial for combining data from different sources into a unified view, which is essential for accura...

Key Responsibilities. Working on being familiar with the underwriting criteria of our partner banks, which include SBI, BOB, ICICI, Axis Bank, HDFC, etc. Screening the education loan applications, advising students on the documentation, and coordinating with bank staff for smooth processing of the education loan. Working on solving students' queries. Managing the process from eligibility to the sanctioning of the loan. About CompanyWeMakeScholars is a Hyderabad-based fintech startup specializing in education loans and scholarships. Established seven years ago, we collaborate closely with major banks and NBFCs in India, including SBI, Axis Bank, and ICICI Bank, to simplify the education loan ...

Key Responsibilities. Work on being familiar with the underwriting criteria of our partner banks, which include SBI, BOB, ICICI, Axis Bank, HDFC, etc. Screen the education loan applications, advise students on the documentation, and coordinate with bank staff for smooth processing of the education loan. Work on solving student's queries. Manage the process starting from eligibility to the sanctioning of the loan. About CompanyWeMakeScholars is a Hyderabad-based fintech startup specializing in education loans and scholarships. Established seven years ago, we collaborate closely with major banks and NBFCs in India, including SBI, Axis Bank, and ICICI Bank, to simplify the education loan applic...

Key Responsibilities. Working on being familiar with the underwriting criteria of our partner banks, which include SBI, BOB, ICICI, Axis Bank, HDFC, etc. Screening the education loan applications, advising students on the documentation, and coordinating with bank staff for smooth processing of the education loan. Working on solving students' queries. Managing the process from eligibility to the sanctioning of the loan. About CompanyWeMakeScholars is a Hyderabad-based fintech startup specializing in education loans and scholarships. Established seven years ago, we collaborate closely with major banks and NBFCs in India, including SBI, Axis Bank, and ICICI Bank, to simplify the education loan ...

Key Responsibilities. Work on being familiar with the underwriting criteria of our partner banks, which include SBI, BOB, ICICI, Axis Bank, HDFC, etc. Screen the education loan applications, advise students on the documentation, and coordinate with bank staff for smooth processing of the education loan. Work on solving student's queries. Manage the process starting from eligibility to the sanctioning of the loan. About CompanyWeMakeScholars is a Hyderabad-based fintech startup specializing in education loans and scholarships. Established seven years ago, we collaborate closely with major banks and NBFCs in India, including SBI, Axis Bank, and ICICI Bank, to simplify the education loan applic...

Key Responsibilities. Work on being familiar with the underwriting criteria of our partner banks, which include SBI, BOB, ICICI, Axis Bank, HDFC, etc. Screen the education loan applications, advise students on the documentation, and coordinate with bank staff for smooth processing of the education loan. Work on solving student's queries. Manage the process starting from eligibility to the sanctioning of the loan. About CompanyWeMakeScholars is a Hyderabad-based fintech startup specializing in education loans and scholarships. Established seven years ago, we collaborate closely with major banks and NBFCs in India, including SBI, Axis Bank, and ICICI Bank, to simplify the education loan applic...

Key Responsibilities. Working on being familiar with the underwriting criteria of our partner banks, which include SBI, BOB, ICICI, Axis Bank, HDFC, etc. Screening the education loan applications, advising students on the documentation, and coordinating with bank staff for smooth processing of the education loan. Working on solving students' queries. Managing the process from eligibility to the sanctioning of the loan. About CompanyWeMakeScholars is a Hyderabad-based fintech startup specializing in education loans and scholarships. Established seven years ago, we collaborate closely with major banks and NBFCs in India, including SBI, Axis Bank, and ICICI Bank, to simplify the education loan ...

Key Responsibilities. Working on being familiar with the underwriting criteria of our partner banks, which include SBI, BOB, ICICI, Axis Bank, HDFC, etc. Screening the education loan applications, advising students on the documentation, and coordinating with bank staff for smooth processing of the education loan. Working on solving students' queries. Managing the process from eligibility to the sanctioning of the loan. About CompanyWeMakeScholars is a Hyderabad-based fintech startup specializing in education loans and scholarships. Established seven years ago, we collaborate closely with major banks and NBFCs in India, including SBI, Axis Bank, and ICICI Bank, to simplify the education loan ...

Key Responsibilities. Work on being familiar with the underwriting criteria of our partner banks, which include SBI, BOB, ICICI, Axis Bank, HDFC, etc. Screen the education loan applications, advise students on the documentation, and coordinate with bank staff for smooth processing of the education loan. Work on solving student's queries. Manage the process starting from eligibility to the sanctioning of the loan. About CompanyWeMakeScholars is a Hyderabad-based fintech startup specializing in education loans and scholarships. Established seven years ago, we collaborate closely with major banks and NBFCs in India, including SBI, Axis Bank, and ICICI Bank, to simplify the education loan applic...