1115 Change Control Jobs - Page 9

Assistant Manager / Sr. Executive based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 5 to 10 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improveme...

Micro Head based in Kathua, Jammu & Kashmir. The ideal candidate brings 12 - 15 yrs exp. and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Lead mi...

Chief Manager Training Centre (MP 25/14) based in Narmada, Gujarat. The ideal candidate brings 15-20 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lea...

The ideal candidate brings 2 yrs exp and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Strengthen QMS: author/review SOPs, BMR/BPR, oversee IPQA/AQA,...

The ideal candidate brings 5 to 10 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Additional info: Key Skills: DMF Compilation, QA Coordinat...

The ideal candidate brings 15-20 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Plan resources, ensure statutory compliance, drive traini...

The ideal candidate brings 8 to 10 year and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Additional info: Key Skills: QMS (Change Control, Deviation...

The ideal candidate brings 3- 8 Years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Own production execution and shift supervision; ensure lin...

The ideal candidate brings 15-20 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Plan resources, ensure statutory compliance, drive traini...

Utility Operator HVAC / Water / Electrical (01 Position) based in Vapi, Gujarat. The ideal candidate brings 5 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvemen...

Designation - Sr. Executive / Asst. Manager - Quality Assurance Company - Leading Pharma Raw Material Mfg. Company Job Location - Ahmedabad Qualification - B.Sc. / M.Sc. / B.E.- Chemical / B.Pharm Experience - Min. 6+yrs. and above Required Candidate profile Company coming up with Greenfield Project Responsible for handling QA / GMP Related documentation QMS, Audit Preparation, Vendor Questionnaire, Market Compliant & Customer Compliance

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...

Perform the release workflows and detailed steps to ensure on-time and effective delivery of high quality releases Create and maintain a process for documenting releases, bug-fixes, etc for mixed audiences (stakeholders technical team) Communicate and plan for high risk deployments including ensuring support team is ready to handle any issues Define and manage change control processes for development and release readiness criteria and ensure all changes meet criteria prior to deployment Assume ownership and continuous improvement of the release process by documenting release issues and developing plans to improve process or automation Ensure the SFDC scheduled updates are considered when dep...

Perform the release workflows and detailed steps to ensure on-time and effective delivery of high quality releases Create and maintain a process for documenting releases, bug-fixes, etc for mixed audiences (stakeholders technical team) Communicate and plan for high risk deployments including ensuring support team is ready to handle any issues Define and manage change control processes for development and release readiness criteria and ensure all changes meet criteria prior to deployment Assume ownership and continuous improvement of the release process by documenting release issues and developing plans to improve process or automation Ensure the SFDC scheduled updates are considered when dep...

Perform the release workflows and detailed steps to ensure on-time and effective delivery of high quality releases Create and maintain a process for documenting releases, bug-fixes, etc for mixed audiences (stakeholders technical team) Communicate and plan for high risk deployments including ensuring support team is ready to handle any issues Define and manage change control processes for development and release readiness criteria and ensure all changes meet criteria prior to deployment Assume ownership and continuous improvement of the release process by documenting release issues and developing plans to improve process or automation Ensure the SFDC scheduled updates are considered when dep...

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 job holder, based at the British High Commission in New Delhi, will play a crucial leadership role in establishing and managing a new team dedicated to Commercial Project Management activities for the UK's Foreign, Commonwealth and Development Office (FCDO). The team will function as a part of the FCDO's broader Commercial Directorate, reporting to the Digital, Data and Technology (DDaT) Commercial Team in the UK. The primary objective of the New Delhi DDaT Team is to serve as a Commercial Project Management Office (CPMO), focusing on commercial service delivery for key stakeholders within the FCDO's Diplomacy and Development sectors. As the Head of CPMO in New Delhi, the job holder will...

As an R&D Executive at PTC - MORAIYA, your primary responsibility will be characterizing materials and developing/qualifying packaging systems including primary, secondary, and tertiary packaging. You will be tasked with completing design control deliverables and ensuring compliance with relevant regulatory requirements for submission. Additionally, you will provide post-launch troubleshooting support for complex products and develop various drug delivery devices such as Pen Devices, Auto Injectors, DPI, and pMDI while maintaining a deep understanding of regulatory expectations. Your role will involve compiling essential documents such as User Requirement Specifications (URS) and design cont...

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...

Role & responsibilities Complete knowledge of Validation ( AHU / Autoclave / Dry Heat Sterilizer etc ) and Calibration -Capable of Compiling the Validation and calibration Activities -Good Computer Skill Preferred candidate profile CLEAN SHAVEN MALE CANDIDATE WITH MINIMUM 2-3 YEARS EXPERIENCE IN STERILE INJECTION SECTION

You will be responsible for providing support for issue resolution according to defined SLAs. This includes tasks such as investigation, identifying solutions, making recommendations, configuring, conducting unit testing, and documenting solutions. Additionally, you will be required to prepare functional specifications and change control requests. You will need to assess Support Pack configuration based on directed requirements and complete subsequent configuration and testing activities resulting from support pack application. Providing consulting services to clients when required is also part of your responsibilities. It is important to adhere to GlobalView configuration standards, convent...

More than 5 years of experience in Quality Management Systems (QMS), including handling of change control, deviations, OOS, and Audit readiness. Proficient in electronic systems such as Trackwise and SAP. Qualifications: - MSc in Chemistry or BTech in Chemical Engineering Piramal Group, with three decades of existence, has strategically grown through both organic and inorganic means. Committed to inclusive growth and ethical practices, the group values equal employment opportunities. Employment decisions are merit-based, considering qualifications, skills, performance, and achievements. The group ensures equal opportunities for all applicants and employees in recruitment, training, promotion...

The Full Stack Developer position at ClinRT Global Services in Pune requires a minimum of 2 years of experience in Angular and .NET core. ClinRT is committed to revolutionizing clinical trials through its Interactive Response Technology (IRT) platform, aimed at enhancing efficiency, accuracy, and compliance in drug development. As a trusted partner to pharmaceutical companies, researchers, and healthcare professionals, ClinRT streamlines patient interaction, randomization, drug supply management, and data management for a seamless clinical trial process. The Clinical QA Manager role involves overseeing the quality of activities related to the IRT platform used in clinical trials developed by...

As a Senior Manager in R&D Quality (Pharmacovigilance Quality Assurance) at Sun Pharmaceutical Industries Ltd in Gurgaon, your primary responsibility will be to implement a well-defined Quality Assurance program in compliance with regional and global regulatory requirements, SOPs, and company policies. You will play a key role in developing and executing global Pharmacovigilance auditing programs, ensuring adherence to established Quality Systems. Your duties will include conducting audits at Sun Pharma sites associated with Pharmacovigilance activities, as well as auditing outsourced parties, affiliates, and partners involved in Pharmacovigilance operations. You will manage the Internal Aud...

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...