532 Cgmp Jobs - Page 13

Role & responsibilities Incharge for QMS activities, Preferred candidate profile Should have good knoledge about QMS, Validation, calibration , qualification, re-qualification, change control. CAPA, OOS, OOT & Investigation. Mainly for all Process equipments and Utility ( HVAC System, Purified System, Refrigerator System, Air Compressor System & Boiler ) Exposure with Regulatory Aduits.

Review SOP Support quality system Familiar with process/cleaning validation Assist internal & external audits Assist specification settings, OOS investigation, change controls, regulatory submission/update, annual product reviews, other investigation Required Candidate profile Must have min. 2 yrs experience & must be familiar with cGMP requirements. Candidate should have good knowledge of computer & ability to effectively interact with individuals at all levels.

We are seeking a dedicated & skilled Production Officer to join our team. The ideal candidate should have experience in a regulatory-approved manufacturing plant with experience in handling critical production equipment & knowledge of cGMP standards.

Position Overview: We are looking for a Sr. Manager will be responsible for leading and managing end-to-end multiple API production blocks. The role requires ensuring optimal productivity, quality, cost control and regulatory compliance in alignment with cGMP standards. This position plays a critical role in driving continuous improvement, cross-functional coordination, and operational excellence within the production unit.. Key Responsibilities: Oversee daily production activities to ensure efficiency, quality, and cost-effective management of resources. Develop and implement production schedules based on inventory / market requirements / capacity constraints and provide feedback accordingl...

Role & responsibilities 1)Strategic Process Optimization: Diagnose performance gap across core value chain (Manufacturing, supply chain , Quality , regulatory)and identify value leakages Liaison with site Business excellence team and setup monitoring mechanisms for key project /Initiatives Partner with functional leaders to drive cost, quality and service level improvement Digitization and automation enablement: Collaborate with IT / Tech teams to identify use cases of digital intervention in manufacturing R&D and supply chain digitization 2)Performance Management system: Design and Implement KPI dashboards with real time visibility into key operational metrics Establish structured performan...

Role & responsibilities Should have knowledge of SLD drawing Should be able to read the Electrical and Mechanical Drawing. Should be able to understand of P&ID and isometric Drawing. Basic knowledge of AutoCAD Hands on experience of Budget preparation of project work. Hands on experience on Project planning, handling and management. Should have able to manage material stock and record for consumption sheet preparation. Understand Companys Health & Safety Policy and follow all company HSE procedures. Should able to deliver the assigned task on time. Finalization of technical specification of machine Hands on experience on documentation like OQ,IQ,URS etc. Hands on experience of execution and ...

The Chemist role involves performing standard chemical and physical analysis of inner and outer nutritional products in the quality control lab using wet chemistry techniques and instrumental analyses. As a Chemist, you will contribute by conducting laboratory testing, preparing standards and reagents, calibrating and operating sophisticated laboratory instrumentation, reviewing product certificates of analysis, maintaining Certificates of Analysis (C of A) files, and providing input on Standard Operating Procedures (SOPs), Test Methods, and laboratory documents. You will also participate in investigations, address Out of Specifications (OOS), resolve deviations, and implement CAPA with gene...

Responsibility for conducting Chemical and Instrumental testing on samples of raw materials. Ensuring the quality of products manufactured by Sun Pharmaceutical Industries Ltd for both domestic and emerging markets. Implementing system upgrades in alignment with CQ and regulatory guidelines. Analyzing and reporting stability and finished goods samples when necessary. Monitoring gowning and sanitation practices within the operational area. Ensuring compliance with standard operating procedures for analytical instrument operation. Operating analytical equipment in quality control as per assigned shifts. Adhering to good documentation procedures and recording results as per SOP on GDP and labor...

You will be responsible for initiating, reviewing, and approving various quality management systems such as Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints. In addition, you will handle Return Goods and ensure the proper functioning of the quality system by performing risk assessments as needed. Conducting regular internal audits will also be part of your duties. Reviewing and approving all documents including SOPs, Spec & STPs, Forms, protocols, and reports will be crucial to ensure compliance. You will also review annual product quality review reports and provide training on cGMP topics to employees at the site. Additionally, you will support customer audits/visits a...

The machine operator role requires 1 to 2 years of experience in relevant machine operations within the pharmaceutical manufacturing industry. The ideal candidate should possess a strong understanding of cGMP and quality control principles. Additionally, the candidate must be able to work effectively in a fast-paced environment, meeting production targets efficiently. Excellent communication and teamwork skills are essential for this role. The primary responsibilities of the machine operator include operating Blister and Alu Alu machines. Candidates with an educational background from ITI Mechanical are preferred for the position. If you are an experienced and skilled operator looking to joi...

You are an experienced mechanical maintenance engineer with API Pharma experience. You hold a BE/B.TECH degree in Mechanical engineering and possess a minimum of 3 to 8 years of shift maintenance experience with API process equipment. Your role involves ensuring overall adherence to safe practices and procedures, contributing to the development of procedures that ensure safe operations, and compliance with integrity and quality standards. You are responsible for driving a corporate culture that promotes environment, health, and safety (EHS) mindset, and operational discipline at the workplace. It is essential for you to ensure safety by adhering to safety protocols and following environment,...

You will be responsible for performing line clearance activities before commencing operations, ensuring a clean and sanitized visual inspection and Packing area, and following the preventive maintenance schedule of machines. Operating the machines efficiently and filling the log of general areas as per SOP and work execution will also be part of your responsibilities. It is essential to adhere to cGMP, GDP, and maintain discipline in the department while ensuring that all employees comply with the same standards. Your role will involve ensuring that all equipment and production lines are in validated and calibrated status, preparing daily production reports based on achieved targets, and cre...

You are being hired for the position of QC Head at our company based in Ankleshwar, Gujarat. As the QC Head, you will be responsible for ensuring the quality of all batches manufactured, overseeing the Quality Control department functions, and managing activities related to quality assurance. Your main duties will include sampling, inspection, and testing of raw materials, packaging materials, in-process products, and finished products as per specifications for release or rejection. You will also be in charge of stability chamber handling, stability testing, and evaluation of shelf-life of products, as well as preparing stability testing protocols and reports. In addition, you will conduct m...

Role & responsibilities Execute and review Equipment Qualification protocols (IQ, OQ, PQ) in compliance with regulatory requirements. Prepare, execute, and review Cleaning Validation protocols and reports . Participate in the design, execution, and documentation of Computer System Validation (CSV) as per GAMP 5 guidelines. Coordinate and support Process Validation activities, including preparation and review of protocols, execution, and final reporting. Ensure that all validation activities are compliant with cGMP, regulatory guidelines , and internal SOPs. Perform gap assessments, risk assessments , and deviation handling related to validation. Collaborate with cross-functional teams includ...

Background Industry: Pharmaceutical Formulations (Injectables) or Medical Devices (EU Class 2b or higher) manufacturing company with turnover higher than 300 Cr Required Skills: Experience in QA management across multiple projects involving the implementation of the Company's QA processes and strategies. The projects include IPQA, QMS, cGMP, validation and Compliance related assignments Ensure that the norms and laws, set by regulatory authorities, are met. Preferentially an audit experience for FDA, EU MDR, PMDA, SFDA, TGA and KFDA requirements Excellent knowledge of QA processes including of risk management, clinical data management and electronic data management systems. Ability to handle...

Oversee all QA activities related to API manufacturing in line with cGMP and regulatory standards. Review and approve manufacturing and analytical documents including MBMRs, BPRs, validation protocols and reports. Required Candidate profile Lead handling of Quality Management System (QMS) activities: deviations, change controls, CAPAs, OOS/OOT, and risk assessments. Immediate to 30 days preferred

The ideal candidate should have a good understanding of cGMP. You should be capable of independently managing the Receipt, Issue & Dispatch activities related to Raw Materials (RM), Packaging Materials (PM), and Finished Goods (FG). Additionally, familiarity with Quality Management Systems (QMS) and Safety protocols is essential for this role.,

Oversee all QA activities related to API manufacturing in line with cGMP and regulatory standards. Review and approve manufacturing and analytical documents including MBMRs, BPRs, validation protocols and reports.

Ensure compliance with cGMP, ICH, and regulatory guidelines in API manufacturing Review and approval of master batch manufacturing records (MBMR) and batch packing records (BPR).

You will be responsible for ensuring compliance and further development, support, maintenance, and constant review of the Quality Systems, as well as supporting projects and reporting necessary performance indicators (KPIs) and quality indicators (KQIs). Your role will involve supporting the implementation of effective and efficient processes that meet regulatory requirements and expectations for the global Novartis product portfolio. As the Global QMS Manager based in Hyderabad Hybrid, you will be accountable for developing, implementing, and continuously improving processes within the Third-Party Management Global Quality System. This includes ensuring compliance with cGMP/ICH, Regulatory ...

You will be responsible for strictly following cGMP, Safety, and Environmental Practices in the manufacturing facility. Your duties will include filling Batch Manufacturing records and equipment cleaning records, as well as following Good Manufacturing practices during operations. It will be important to ensure Good Housekeeping in the plant area and equipment, and to use proper personal protective equipment as required. You will be in charge of planning and ensuring the availability of raw materials for daily production according to the production plan. Additionally, you will need to maintain documents such as Issue and dispensing register, and carry out processes as per Batch Manufacturing...

Role & responsibilities Preferred candidate profile Perks and benefits

Chemical and Instrumental analysis and review of in process/ intermediate/finished API sample as per the specification and STP. Quality Control, Quality compliance, method Validation, Analytical Technology Transfer, Vendor Analytical method verification/ validation, Faced internal audits and regulatory audit (USFDA, EUGMP, ROW MARKET, WHO-Geneva). HPLC, GC, Optimization of analytical methods for qualification and release testing of raw materials, In-process materials, Intermediates, Finished products, etc.

COMPUTER OPERTOR WITH FULLY KNOWLEDGE OF TALLY MAKING ENQUIRY , QUOTATION, INVOICE Operate and monitor computer systems and equipment. Perform routine maintenance and troubleshooting of computer hardware and software. Ensure the security and integrity of data and systems. Collaborate with IT staff to resolve technical issues. Maintain accurate records of computer operations and activities. Provide technical support and assistance to users. Stay updated with the latest advancements in computer technology.

Role & responsibilities Job Description: 1. Preparing and implementing of standard operating Procedures, Batch records, Protocols, cleaning procedures and relevant log sheets. 2. Maintaining documents as per regulatory and cGMP norms. 3. Handling of QMS activities, Change controls, Deviations, Incidents and risk assessments. 4. Responsible for ensuring the department employees for training as per training plan schedule in the TRIMS. 5. Responsible to attend all training programs, SOPs and cGMP trainings relevant to area and equipments. 6. Responsible for monitoring of periodic review of SOP’s related to FP Departments and ensuring the completion with in due date. 7. Performing DQ, IQ, OQ, an...