1740 Change Control Jobs - Page 6

Role Overview: You will be based at the British High Commission in New Delhi and will play a crucial leadership role in establishing and managing a newly formed team focused on Commercial Project Management activities for the United Kingdoms (UK) Foreign, Commonwealth and Development Office (FCDO). Your team will operate as a Commercial Project Management Office (CPMO) within the FCDO's wider Commercial Directorate, reporting to the Digital, Data and Technology (DDaT) Commercial Team in the UK. Your primary responsibility will be to ensure the delivery of CPMO services, lead your team, and coordinate with stakeholders across Diplomacy and Development. Key Responsibilities: - Lead and manage ...

As a member of ACG Corporate, your primary responsibilities will include: - Prepare and carry out tests like MLT, Water analysis etc in Micro Lab - Ensure proper documentation - Develop and establish testing procedures - Maintain proper records - Maintain work space - Develop and sustain Quality culture across the plant - Establish a review mechanism to constantly upgrade and standardize the process In your functional core role, you will be responsible for: - Reviewing customer quality complaints (includes complaint investigation, root cause analysis and identifying the CAPA) - Ensuring closure of complaints in defined timelines with implementation of CAPA - Ensuring sustainability of QMS (D...

Role Overview: You will serve as a General Manager (Engineering) with a focus on overseeing various engineering operations in a regulated market and sterile background. Your responsibilities will include signing, reviewing, and verifying engineering GMP documents, maintenance reports, qualification documents, and QMS documents. Additionally, you will handle engineering operations related to HVAC, electrical systems, and facility management, ensuring continuous improvement and adherence to quality standards. Key Responsibilities: - Authorize and oversee the signing, reviewing, and verifying of various engineering documents such as GMP documents, maintenance reports, and qualification document...

Job title Quality Management System (QMS) Manager Reports to Operation Head Job purpose : Establishment, implementation, and continuous improvement of the company's. Quality Management System (QMS) to support its clinical-stage biopharmaceutical development programs while ensuring compliance with applicable regulatory requirements (e.g., FDA, EMA, ICH) and GxP standards (GMP, GDP, GCP, GLP). Cross-functional collaboration to embed a proactive quality culture, align GxP activities with corporate quality objectives, and drive operational excellence as the organization advances toward late-stage and commercial readiness. Duties and responsibilities QMS Development & Implementation Develop, impl...

Job Title: Senior Trainer Validation (CQV, Equipment, Injection Mold, HVAC) Location: Remote Job type: Part-time Job Summary: To design, develop, and deliver comprehensive training programs on Commissioning, Qualification & Validation (CQV), Equipment Qualification, Injection Molding Process Validation, and HVAC System Validation. The trainer will ensure technical competency development across engineering and quality teams in compliance with international regulatory standards (USFDA, EU GMP, ISO 13485, etc.). Key Responsibilities: Develop and deliver training modules on: Commissioning, Qualification, and Validation (CQV) lifecycle Equipment Qualification (IQ/OQ/PQ) Process Validation for Inj...

Job Title: Senior Trainer Computerized System Validation (CSV) & Data Integrity (ALCOA Principles) Location: Remote Job type: Part-time Job Summary: We are seeking a highly experienced CSV & Data Integrity Trainer with a strong background in regulatory compliance and hands-on experience in validating computerized systems used in GxP environments. The ideal candidate should have in-depth knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+ principles , and be capable of delivering engaging, practical training to QA, QC, Manufacturing, and IT professionals. Key Responsibilities: Develop, design, and deliver training programs on Computerized System Validation (CSV) and Data Integrity (A...

KGVK (NGO & CSR Arm of Usha Martin Limited) is looking for Quality Control/Assurance Professional to join our dynamic team and embark on a rewarding career journey. Develop and implement quality control systems to ensure products meet regulatory and customer standards. Conduct inspections, audits, and testing to identify deviations or defects. Collaborate with production and R&D teams to address quality issues and implement corrective actions. Maintain documentation and compliance with ISO and GMP standards for continuous improvement. Disclaimer : This job description has been sourced from a public domain and may have been modified by Naukri. com to improve clarity for our users. We encourag...

KGVK (NGO & CSR Arm of Usha Martin Limited) is looking for Quality Control/Assurance Professional to join our dynamic team and embark on a rewarding career journey. Develop and implement quality control systems to ensure products meet regulatory and customer standards. Conduct inspections, audits, and testing to identify deviations or defects. Collaborate with production and R&D teams to address quality issues and implement corrective actions. Maintain documentation and compliance with ISO and GMP standards for continuous improvement. Disclaimer : This job description has been sourced from a public domain and may have been modified by Naukri. com to improve clarity for our users. We encourag...

Manage day-to-day office operations, including administrative tasks and employee coordination. Handle communications, both internal and external, ensuring timely responses and follow-ups. Organize meetings, prepare agendas, and take minutes for effective documentation. Maintain office supplies and ensure all equipment is in working order. Assist with budgeting, invoicing, and other financial tasks as needed.

Manage day-to-day office operations, including administrative tasks and employee coordination. Handle communications, both internal and external, ensuring timely responses and follow-ups. Organize meetings, prepare agendas, and take minutes for effective documentation. Maintain office supplies and ensure all equipment is in working order. Assist with budgeting, invoicing, and other financial tasks as needed.

Job Description JOB Responsibilities: - Location: Ahmedabad 1. Ensuring the GMP compliance at CMO and Release of batch manufactured for US market at CMU. 2. Monitoring of process starting from dispensing to packing including witness analysis of Lupin products manufactured at CMO for US market and Domestic market. 3. Handling of market complaint with root cause identification and ensuring the CAPA implementation. 4. New product review to be carried out at manufacturing site after availability of all the documents. 5. Review and authorize Master Batch Records, stability protocol, process validation protocol, temperature cycling protocol, specification of in-process, intermediate and finished p...

Reviewing advertisements as per code of advertisement Coordinating with Exchanges and Internal Stakeholders for the purpose of advertisements Reviewing content ofcommunication Digital and non-digital posted on social media Submissions of variousregulatory reporting to Regulators.

Liaising with users/business teams for requirements gathering for new and ongoing projects Preparation of Business requirement Document. Identify changes/enhancements/issue fixes required in existing systems as per user requirements, evaluate impact, prepare change request specifications, and obtain business user sign-off. Preparation of Test Cases, User Acceptance Testing, Product and Process release of the project/fix, Preparation of User Guides and train users on newly developed Systems. Coordinate for all stages of software project development life cycle including system design, development, testing, training, roll out and post-implementation support Manage end-to-end execution of assign...

Manage and maintain daily, weekly and monthly MIS reports. Extract, clean, and analyze data from internal systems. Prepare dashboards and ppts for business review. Track campaign performance and prepare reports. Co-ordinate with internal team for data reconciliation and validation. Prepare ad-hoc reports as required by management.

Responsibilities Formulation and filling in-charge Planning of Formulation and Filling area Indenting of raw materials from store Availability of raw materials, consumables required for Formulation and Filling area Maintain Raw and PPM inventory as per the production schedule Product changeover in Formulation and Filling Media fill simulation activity Coordinate with other department for equipment qualification / requalification / revalidation and equipment calibration activity Supervision of online documentation Review of documentation Preparation of new SOPs, Annexures, BMRs and summary protocols Awareness about deviation, investigation, change control, CAPA cGMP practices Heath hygiene Qu...

Job Title: Senior QC + QA Trainer (Pharma / Biotech Laboratory) Location: Remote Job type: Part-time Job Summary: We are seeking a highly experienced and knowledgeable QC + QA Trainer to design, develop, and deliver technical training programs for quality control and quality assurance teams. The trainer will be responsible for building competence in analytical testing, documentation practices, GMP compliance, and QA/QC systems within a regulated laboratory environment. Key Responsibilities: Training & Development Develop and deliver structured training programs on QC laboratory techniques, QA systems, and GMP compliance . Conduct practical laboratory training (analytical instruments, wet che...

Tips: Provide a summary of the role, what success in the position looks like, and how this role fits into the organization overall. Responsibilities Participate in the implementation and maintenance of the management system compliance with relevant international quality standards and regulatory requirements (Such as ISO 13485, ISO 14971, MDR 2017/745, and 21 CFR part 820). Participate in development of Regulatory Strategy for upcoming products against GSPR requirements. Participate in the development of QA strategies, recommendations for Continual improvement, Quality planning in conjunction with the needs of the company, for each product range and Quality Management System. Sustain and acti...

As the Head Delivery & Client Onboarding at Locus, you will play a crucial role in building and leading the global delivery organization, overseeing end-to-end client onboarding, implementation, and go-live processes for enterprise customers, with a focus on Western markets such as North America & Europe. Your responsibilities will include: - Build & Lead the Delivery Function: - Establish the global delivery organization from scratch, including designing processes, governance models, and performance metrics. - Recruit, mentor, and expand a high-performing delivery team comprising regional leaders, project managers, solution architects, and onboarding specialists. - Foster collaboration betw...

Aeva's mission is to bring the next wave of perception to a broad range of applications from automated driving to industrial robotics, consumer electronics, consumer health, security, and beyond. Aeva is transforming autonomy with its groundbreaking sensing and perception technology that integrates all key LiDAR components onto a silicon photonics chip in a compact module. Aeva 4D LiDAR sensors uniquely detect instant velocity in addition to 3D position, allowing autonomous devices like vehicles and robots to make more intelligent and safe decisions. As an EC analyst with TeamCenter experience at Aeva, you will play a crucial role in managing EC workflows and approval processes to ensure the...

"QMS Knowledge of Regulatory standards CFR820 , ISO 13485 & 14971, 60601 Hands on experience on Risk Management Good understanding of Post Market Survey and complaint handling Design plan Medical Process DQC Deviation and CAPA preferred " " Be a part of core project team and support the quality engineering across the entire development cycle Lead product risk management, usability, reliability and design validation efforts for new product development and design change projects, Lead the development and implementation of design verification and validation plans with project design lead, Lead the development of Critical to Quality (CTQs), design input and output documents, Lead the fixture qua...

Candidate should be B.Pharm Candidate should have regulatory exposure/ in previous organisation Candidate should have well command on IPQA activities Candidate should have Command on packaging operations Candidate should be able to work in shift well aware with regulatory requirement

Handling of Manufacturing Compliance i.e. IPQA Activity Handling of QMS Documents like CAPA, and OOS and Change control Handling of APQR Handling of Batch release activity Good in communication skills Exposure of Regulatory audit

Bakingo ( A Brand of FA Gifts Pvt Ltd) is looking for Executive to join our dynamic team and embark on a rewarding career journey Assisting with the preparation of operating budgets, financial statements, and reports Processing requisition and other business forms, checking account balances, and approving purchases Advising other departments on best practices related to fiscal procedures Managing account records, issuing invoices, and handling payments Collaborating with internal departments to reconcile any accounting discrepancies Analyzing financial data and assisting with audits, reviews, and tax preparations Updating financial spreadsheets and reports with the latest available data Revi...

Bakingo ( A Brand of FA Gifts Pvt Ltd) is looking for Executive to join our dynamic team and embark on a rewarding career journey Assisting with the preparation of operating budgets, financial statements, and reports Processing requisition and other business forms, checking account balances, and approving purchases Advising other departments on best practices related to fiscal procedures Managing account records, issuing invoices, and handling payments Collaborating with internal departments to reconcile any accounting discrepancies Analyzing financial data and assisting with audits, reviews, and tax preparations Updating financial spreadsheets and reports with the latest available data Revi...

Bakingo ( A Brand of FA Gifts Pvt Ltd) is looking for Executive to join our dynamic team and embark on a rewarding career journey Assisting with the preparation of operating budgets, financial statements, and reports Processing requisition and other business forms, checking account balances, and approving purchases Advising other departments on best practices related to fiscal procedures Managing account records, issuing invoices, and handling payments Collaborating with internal departments to reconcile any accounting discrepancies Analyzing financial data and assisting with audits, reviews, and tax preparations Updating financial spreadsheets and reports with the latest available data Revi...