7 Oos Investigation Jobs

As a Quality Assurance Manager, you will play a crucial role in ensuring the quality standards for all products and manufacturing activities. Your responsibilities will include: - Ensuring GMP compliance throughout the facility. - Organizing, educating, and executing activities in line with Quality Assurance objectives. - Handling customer audits effectively. - Releasing or rejecting APIs and Intermediates based on quality standards. - Keeping the workforce motivated and aligned with Company objectives. - Conducting OOS investigations as required. - Ensuring compliance with QMS, GMP, and GLP. - Managing Regulatory audits and compliance with agencies like USFDA, EU, TGA, WHO, Cofepress, and K...

Job Title: Senior Officer to Senior Executive QMS (Production) Section: QMS - Production - API Mfg. Department: Production Qualification: M.Sc. (Chemistry) / B.E. (Chemical) Experience: 5 to10 years Location: Raks Pharma Pvt. Ltd. Dahej, Bharuch, Gujarat Job Description We are looking for an experienced QMS professional for our Production Department who will be responsible for ensuring compliance with cGMP, documentation practices, validations, and audit readiness. Key Responsibilities: Prepare new SOPs and revise existing SOPs as per requirements, periodic updates, and audit recommendations, including review and implementation for the Production department. Carry out process validation and ...

As a Quality Assurance Manager, your role will involve ensuring quality standards for all products and manufacturing activities. This includes maintaining GMP compliance throughout the facility and organizing activities in line with Quality Assurance objectives. Your responsibilities will also include handling customer audits, releasing or rejecting APIs and Intermediates, and ensuring the workforce is highly motivated and aligned with company objectives. You will be involved in OOS investigations, regulatory audits, and compliance with QMS/GMP/GLP standards. Key Responsibilities: - Ensure quality standards for all products and manufacturing activities - Maintain GMP compliance throughout th...

As a Quality Assurance Manager, your role involves ensuring quality standards for all products and manufacturing activities. Your key responsibilities will include: - Ensuring GMP compliance throughout the facility - Organizing, educating, and executing activities as per Quality Assurance objectives - Handling customer audits - Releasing or rejecting APIs and Intermediates - Ensuring workforce motivation and alignment with Company objectives - Handling OOS investigation - Ensuring compliance of QMS/GMP/GLP - Managing Regulatory audits and compliance (USFDA/EU/TGA/WHO/Cofepress/KFDA) - Knowledge and handling of Risk assessments, cleaning validation, Preparation of site master file, Quality Ma...

Role Overview: As a Site Processing Engineering Lead/Team Member, you will be responsible for utilizing your 10-15 years of experience in a Medium to large Generic API company to enhance solvent recovery, troubleshoot scale-up issues, and continuously improve running molecules in the plant. Your expertise will be crucial in reducing time cycles, improving process economics, reducing utility costs, facilitating technology transfer, and leading operational excellence programs. Key Responsibilities: - Enhancing solvent recovery - Troubleshooting scale-up issues - Continuous improvement of running molecules in the plant - Reducing time cycles - Improving process economics - Reducing utility cost...

As a Quality Assurance Specialist, your responsibilities will include reviewing all Master Production and Control Record (MPCR) and Batch Packing Records (BPR), as well as Standard Operating Procedures (SOPs). You will need to meticulously review specifications and testing procedures for starting materials, packaging materials, in-process products, finished products, working standards, and stability (Shelf life). Additionally, you will be tasked with reviewing Out-of-Specification (OOS) investigation reports and participating in investigations related to complaints, vendor audits, external testing laboratories audits, and the subsequent Corrective and Preventive Actions (CAPA). You will also...

You will be responsible for leading the Site Processing Engineering team in a Medium to large Generic API company. With a minimum of 10-15 years of experience, you should have a strong background in solvent recovery enhancement, troubleshooting scale-up issues, and continuous improvement of running molecules in the plant. Your expertise should include time cycle reduction, improving process economics, utility cost reduction, technology transfer, and a proven track record of leading operational excellence programs. As a Process Chemist, you will join our team with a focus on Plant based Process Development. With a minimum of 5-8 years of experience, you will work on Process Development, Yield...