Search Results: 26 vacancies
...preventive actions. The ideal candidate will oversee the receipt, issuance, storage, and reconciliation of materials, ensuring compliance with GMP and SHE requirements, and acting as a liaison with government authorities. Additionally, responsibilities include team building, budget...
...preventive actions. The ideal candidate will oversee the receipt, issuance, storage, and reconciliation of materials, ensuring compliance with GMP and SHE requirements, and acting as a liaison with government authorities. Additionally, responsibilities include team building, budget...
...ensure no critical findings within the assigned projects.
Actively contribute to team goals.
Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISEC & Novartis Guidelines.
Key performance indicators:
Successful execution of assigned tasks within given timelines...
...smooth manufacturing operation, new product launches/transfer in a compliant/timely manner, drug substance batch review/release are in full gmp compliance to regulatory standards and ensures quality strategy/continuous improvement are executed in alignment to site objective...
...Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Key performance indicators:
Quality (GMP), quantity, and timelines for all assigned tasks/projects -Compliance with Novartis standards, in particular, ethics, health, safety,...
...launches/ changes/ transfers/divestment by coordination of involved partners from different functions. Ensures compliance with Regulatory and GMP, law, SOPs, HSE and Code of Conduct.
Key Responsibilities:
~ Align capacity & production plan with CMO up to 2y horizon Lead...
...such as FDA, MHRA, etc. on one or more of the following areas: CFR Title 21 (parts 11, 210, and 211), Annex 11, GAMP, V-Model, CAPA, GxP (GMP, GLP, GCP, GVP, etc.), ERES regulations and Computer Systems Validation (CSV) coupled with ability to apply the same.
• Familiar with...
...Job Description · Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution.
You should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and...
...Supply Chain Management (SCM), Incentive Program, Including Gdp, Integrated Business Planning (IBP), Inventory Management, Knowledge Of Gmp, Lean Manufacturing, Master Data, Operations, Order Fulfillment, Procurement, Product Distribution, Risk Management, Sales Operations,...
...include:
Responsibilities
To maintain consistent and documented compliance with all relevant Safety, Good Manufacturing Practice (GMP), Data Integrity (DI), quality and best practice requirements.
To identify and document computer systems which impact upon GxP and...
...comply with regulatory requirements and industry standards such as FDA regulations (e.g., 21 CFR Part 11) and Good Manufacturing Practices (GMP).Key Requirements:1. Proficiency in either of the programming languages used in the Discoverant platform (e.g., Java, JavaScript, SQL,...
...Supply continuous improvement projects to achieve operational excellence and enhance quality & productivity
• Ensure compliance with GMP, regulatory requirements, HSE (including record management).
• Hands on experience and in depth understanding and Knowledge of Supply...
...data across projects
• Manage quality and consistency of NBS CONEXTS data services delivery to all partners
• Ensure compliance with GMP and regulatory requirements and continuous improvement of quality relevant processes within area of responsibility
• Deliver on data...
...logistical, technical, or related business area
• Basic project management, good organization, and planning skills
• Good knowledge of HSE/GMP standards and processes
• Problem-solving and idea generation skills
• Good presentation skills along with Fundamental Leadership...
...Company Description
Stanex Drugs & Chemicals Pvt. Ltd. is a Sterile Injectable Manufacturing Facility with an approved "Russian GMP" & ‘WHO GMP’. We manufacture Liquid Injectables, Lyophilized Products & Pre-Filled Syringes. Our mission is to be a leading player in Pharmaceutical...
...representative of the patients and communities we serve.
Role Requirements
• Knowledge in quality principles driving drug development such as GMP; understanding of general regulatory and quality expectations.
• Strong communication skills, including presentation and scientific/...
...equivalent
~ Expertise and broad experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements
~ API experience (active pharmaceutical ingredients)
~ Excellent problem-solving skills, based on...
...logistical, technical or related business area
• Basic project management, good organization and planning skills
• Good knowledge of HSE/GMP standards and processes
• Problem-solving and idea generation skills
• Good presentation skills. Fundamental Leadership skills.
•...
...product lifecycle projects such launch, transfer, change, divestment and pruning etc. in compliance with Good Manufacturing Practices (GMP) & Regulatory requirements while creating value for the stakeholders across Novartis divisions across geographies.
Key Responsibilities...
...scientific literature, technology transfer and interpretation of the results to draw conclusions in reports.
• Author, review, approve GMP documents ( eg : Analytical methods, raw data, SOP’s, Qualification reports for analytical instruments.).
• Report and present...
