1753 Change Control Jobs - Page 33

Major accountabilities: Ensures the timely collection, monitoring, and reporting of Quality Key Performance Indicators (KPIs) for management reporting -Assists in Health Authority inspections and internal audits by supplying information and documentation in a timely manner -Support and track the implementation and maintenance of the local Quality system in in accordance with the Novartis Quality Manual -Manages processes and systems for all GxP Quality Assurance e.g. Change control, Training Management, Escalation Management, Risk Management. Ensures that processes are conducted in full compliance with the GxP and the Novartis Quality. Contributes to an improvement of current processes and/o...

Reviews change records to evaluate impact of the change with respect to reportability and product restrictions for any product in scope. Defines and documents the reporting and product distribution restriction requirements for the change within the change control management system. Liaise with other functions, including Process Development, Operations, Quality and Supply Chain to ensure alignment of regulatory strategies. Basic Qualifications: Master's degree Bachelor's degree and 2 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Associate's degree and 6 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Dip...

It's more than a job When you work in Freight Logistics and Operations at Kuehne+Nagel, you play a key role in optimising processes and ensuring that inventory and shipments move efficiently. But that is not all. Your work also helps ensure that vital medicines reach patients on time and supports other essential deliveries, from wind turbines to semiconductors. At Kuehne+Nagel, our contribution counts in more ways than we imagine. ? The Quality Auditor is a vital member of the Integrated Logistics Team, responsible for ensuring quality and compliance throughout the supply chain. Reporting to the Integrated Logistics Quality Manager, they collaborate closely with the Excellence, Operations, P...

Job Description Turner & Townsend are looking for Project Manager to join our award winning, for Mumbai cost centre, growing project management team working within Turner & Townsend's team. There are long term secured frameworks with national and regional organisations within the following sectors - Retail, Commercial, Industrial, Education, etc. The right candidate will have the opportunity to progress within our business and receive a competitive salary. There will also be the opportunity to support internal business initiatives and development, in order to offer our people an all-round exposure to the business. The successful candidate must be able to demonstrate consultancy experience. R...

Photon Interactive is looking for enthusiastic and detail-oriented Data Entry Operators (Freshers) to join our dynamic team on a 6-month contract . This role is ideal for candidates who are looking to start their career in the IT/Software industry and gain experience in a fast-paced, professional environment. Key Responsibilities: Accurately enter data into internal systems, spreadsheets, or databases Maintain and update records with high attention to detail Perform regular data backups and ensure data integrity Assist in verification, validation, and cleanup of data Coordinate with team members to ensure timely completion of tasks Maintain confidentiality and security of data Requirements: ...

Impetus Infotech ( India ) Pvt. Ltd. is looking for Java Engineer 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 R...

InRhythm is looking for Sr. Java Engineer 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 Reviewing existing produc...

Key Responsibilities: Conduct comprehensive Risk Assessments to ensure robust quality controls Lead Investigation Reviews & Approvals with cross-functional teams Manage Change Control & CAPA processes for continuous improvement Execute SAP BOM Updates with precision and accuracy Oversee LIMS & DMS Activities for data integrity and documentation compliance Drive QMS Trending & Reporting to support strategic decision-making Prepare and review SOPs in alignment with regulatory standards Benefits other than CTC: Insurance - (Health, Life & Accidental) Transportation (Air Conditioned) from nearby locations like Chandigarh, Panchkula etc Alternate Saturday Off

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. The goal is to deliver safe, affordable, and lower emission energy while continuously innovating how work is done. About Role The Project Management Excellence team supports the project management leadership team to ensure predictable delivery of high-value, competitive projects and sha...

You will be responsible for writing and proposing revisions to Standard Operating Procedures, Analytical Methods, Lab Reports, and related Forms. You will perform reviews to support Validation, Document Control, and Change Control systems. Additionally, coordination and maintenance of the stability program for new product development and existing products will be under your purview. Tracking and reporting on Quality System Metrics relevant to testing, OOS Investigations, and training to support Quality Systems Reporting is also a key aspect of this role. Furthermore, you will provide QA Support for Audits and Inspections. To be considered for this position, you must have an M.sc in Microbiol...

You should possess a B. Pharmacy/M. Pharmacy (Pharmaceutical Analysis and Quality Assurance) or M. Sc. in Chemistry or equivalent with 5 to 8 years of experience in formulation pharmaceutical industries in the quality control department. In this role, you will be responsible for handling day-to-day activities related to sampling, testing, and release of active ingredients, inactive ingredients, packaging materials, in-process and finished products, stability samples. Your primary responsibilities include ensuring that all activities within the quality control section meet current applicable cGMP guidelines and regulatory expectations. You will be accountable for ensuring timely sampling, ana...

This job role involves the documentation activities conducted at the Par Formulation Indore Sterile Facility. As a personnel in this role, your main responsibilities include managing documentation and training, as well as handling various software such as Doc pro, Veeva, and Compliance wire (LMS). Your tasks will include: - Issuing Records of Analysis - Issuing controlled and uncontrolled copies of standard operating procedures - Issuing protocols, reports, layouts, and forms - Issuing logbooks and drawings - Following cGMP practices according to defined procedures - Performing distribution, retrieval, and destruction of documents as per procedures - Maintaining employee training files - Ens...

Production GMP coordinator To initiate change control, preparation of draft documents (Existing and proposed) of change control. To discuss the changes with QA and to take approval. To initiate investigation and preparation of OOS, OOT and deviation investigation report of respective plant and ensure timely closer of documents. Preparation of new SOP and revised existing SOP as per requirement and initiation in documentum software and to take approval. To perform daily GMP round in respective plant and ensure compliance and online documentation. Monitor the Change control, CAPA and deviation in track wise system and its tracking and closures of respective plants and ensure timely closer of d...

*Retrieve the correct medical record of a patient, review & validate completeness of documentation along with signatures, orders for diagnostic tests etc. Review and validate and/or assign/modify, providers, Dates of service, CPT codes, Diagnoses and modifiers by following general coding guidelines, payer specifications and client specifications if any. *Adhere to the standard operating procedures and instructions related to the process in coding.

Engineering based in Waghodia, Vadodara The ideal candidate brings 4-7 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) Maintain utilities: HV...

We are looking for a meticulous Asst. Manager Production to lead production activities at Synnat Pharma Private Limited, ensuring seamless API manufacturing operations and adherence to the highest quality standards. As Asst. Manager Production, you will play a pivotal role in overseeing daily production activities, monitoring validation batches, and ensuring compliance with cGMP guidelines. Your responsibilities will include the preparation and review of production-related documents, coordination with cross-functional teams, and active participation in internal and external audits. You will also be responsible for identifying and resolving operational gaps, managing deviations and Out-of-Spe...

Role & responsibilities Contributing to maintain or improve quality performance and compliance of operational PV activities Ensuring Deviation and CAPA Management, Change Control, Document Control, and other Quality Management System activities Developing, managing, and executing quality management processes to ensure quality standards are maintained and compliant with regulatory requirements Coordinating PV audits and Inspections Preparation and management of Pharmacovigilance System Master File (PSMF) Generation, quality review, and distribution of compliance and quality metrics and trending activities. Coordinating compliance, quality, and process improvement initiatives while providing i...

The ideal candidate brings 1-7 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) Lead microbiology practices including EM, MLT, sterility assur...

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...

Sterile Manufacturing based in Waghodia, Vadodara. The ideal candidate brings 1- 7 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). Additio...

Chief Manager Township Administration (MP 25/13) 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...

QC Head 1 Pos 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). Mana...

Boiler Engineer (On Contract) (MP 25/19) 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...

Officer Production / Sr. Officer-Production based in Ankleshwar, Gujarat. The ideal candidate brings 5-8 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...

Foreman Injectables 1 Post based in Amritsar The ideal candidate brings 5-6 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) Operate and tro...