304 Cgmp Jobs - Page 5

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 accordingly. Deployment of manpower & supervisor as per production requirement. Monitor and adjust production processes as necessary to meet production targets and quality standards. Ensure all production batch records are completed and signed off on time. Responsible or keeping production facilities clean and appropriately disinfected. Responsible for the validation protocols and reports are completed and signed. Responsible for qualification of new and modied facilities, when appropriate and equipment. Responsible for maintaining and updating the documents related to the Production activities. Ensure smooth production under EHS & cGMP compliance. Ensure for reporting of all production deviations and evaluation of the same. Ensure process problems /deviations are solved and rectified within a set of time frame, co-ordination/follow up with all the departments like R&D, MSTG, QC, QA, Engineering & Stores. Institute operational controls, monitor the key characteristics, carry out root cause analysis for the non-conformity and take CAPA. Responsible for self-inspection of the area w.r.t EHS and production systems. Responsible for training all the employees of production. Responsible for preventive maintenance is executed as per the planned schedule. Responsible for analyzing the time cycle of each batch and taking corrective actions if any deviations are observed. Responsible for any optimization initiative across the production blocks. Ensure that the yield, % solvent recovery and quality of APIs and Intermediate products are as per the standard norms. Analyze production costs and recommend strategies to reduce costs and improve Profitability. Responsible for monthly RM requirement and weekly RM schedule. Responsible for performing of Internal audit. Responsible for water consumption, effluent generation as per the set norms. Responsible for controlling hazardous waste generation. Identification of Risks & Hazards, Environmental aspects & evaluation and review the same. Responsible for any other work assigned by senior management in the absence of Site Head/ Unit Head. Qualifications and Experience: Analytical Skills and Communication Basic understanding of pharmaceutical or chemical industry Strong organizational, multitasking abilities, time management skills Company Website :- www.scllifesciences.com

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 performance review mechanism (Daily tier reviews, monthly ops scorecards, etc) 3)Cross Functional Execution: Align improvement initiatives with corporate strategy and ensure cross functional engagement. Lead or co-lead high -impact special project, such as plant productivity programs, cost rationalization or new tech transfer readiness Provide structured problem-solving support to senior leadership on complex operational issues 4)Success Metrics: Net saving from OpEx initiatives (Direct and Indirect) Validate through finance % of strategic operational initiatives delivered on time and within scope 9Linked to transformation road mad) Improvement in service ability at the enterprise level(Supply chain + Production + customer service ) Adoption rate of new digital tools / platforms %Of core business process digitized /standardized Interested candidate can drop their resume on renuka.u@encubeethicals.com

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 commissioning of pharma machineries and utility Equipments Should have knowledge of HVAC system and clean room applications Should have knowledge of CGMP and revised schedule M Hand on experience of solid oral facility (Nutraceutical experience also be considered)Hands on Experience of WTP/utilities (Boiler, Chiller, WTP, Compressor, ETP, STP) piping, installation and commissioning. Hands on experience of vendor co ordination Should be able to present Project status/ reports and Daily work status/report. Manpower handling Hands on experience on Facility qualification, HVAC and Compressed Air Validation Provide technical input as required to ensure projects progress in line with their scope requirements. Support the development and completion of documentation in relation to purchasing, planning, implementation, commissioning and validation activities in relation to the above. Be responsible for Supervision of 3rd party contractors and internal service providers Be responsible for tracking and reporting project delivery, ensuring projects are delivered on time and within budget. Ensure training has been Given before undertaking specific duties and that all training is recorded in training records. Preferred candidate profile 5-7 years of hands-on experience in project engineering or project management roles within OSD pharmaceutical manufacturing . In-depth knowledge of OSD manufacturing processes , equipment, utilities, and facility layouts. Hands on Experience of HVAC system, cleanroom classification, and GMP /cGMP requirements. Hands-on experience with equipment installation, commissioning, and qualification (IQ/OQ/PQ).

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 general supervision while strictly adhering to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP). Key responsibilities include interpreting test results, maintaining a safe, clean, and efficient laboratory environment, and ensuring routine calibration and performance verification of lab equipment and instrumentation. Although there are no supervisory responsibilities, you should possess the ability to adapt as the external environment and organization evolve. Successful candidates will demonstrate the ability to complete testing according to established methods, proficiency in lab instrumentation and multiple test methods, problem-solving skills, and the capacity to coordinate workload effectively. The ideal candidate will hold a Bachelor/Master of Science in Chemistry, Biochemistry, or related scientific fields, or equivalent experience. Additionally, knowledge of LC/MS and GC/MS, previous cGMP regulation and compliance knowledge, nutraceutical or pharmaceutical laboratory work experience, and familiarity with ISO17025 Lab Management are preferred. Join us in this exceptional opportunity to contribute to world-class research and shape the future of nutritional science.,

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 laboratory practices. Supporting internal audits, regulatory inspections, and FDA audits with best practices. Adhering to cGMP regulations as per schedule M. Maintaining safety protocols for handling analytical equipment and potential hazards. Completing assigned training as per identified training needs through organized sessions or self-study. Calibrating analytical equipment as per calibration procedures for assigned responsibilities. Keeping analytical equipment and laboratories in good operational condition. Managing stock levels of working standards, columns, reagents, chemicals, glassware, etc. Following procedures for non-conforming results as outlined in SOPs for OOT, Lab Incidents, and OOS. Complying with administrative procedures related to attendance, leave, and other benefits.,

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 and regulatory audits, as well as provide necessary documentation for amendments, annual updates, regulatory filings, and CMC supporting documentation. Your role will also involve filling out questionnaires, declarations, and quality agreements. Finally, you will execute any additional responsibilities assigned by the Head of Department.,

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 join a dynamic pharmaceutical manufacturing team, we encourage you to apply for this exciting opportunity.,

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, health, and safety (EHS) requirements in the workplace. Your responsibilities include full compliance with cGMP regulations, audit readiness of the site, and achieving quality metrics. You contribute to the development of procedures that ensure quality operations and compliance with the company's quality standards. As the Mechanical In-charge and Shift In-charge, you lead the operations of the designated section. Your duties involve breakdown and preventive maintenance of various process-related equipment, operation and maintenance of utility-related equipment, maintenance of air handling units, cleanrooms, and infrastructure facilities. You are also involved in maintenance, projects, and modification-related activities in the Mangalore unit. You are responsible for qualification activities of equipment, preparation of SOPs, ensuring house-keeping standards, following up on Supply Chain Management for required materials, and preparing/updating training matrix for employees. Additionally, you ensure that training needs are completed for all employees in the department and update training records accordingly. Your behavioral skills include adhering to the company's systems and policies with dedication, a result-oriented approach, and self-drive. Team coordination is also essential in your role. You are a part of an Equal Opportunity Employer and play a crucial role in ensuring safe, compliant, and efficient operations within the organization.,

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 creating production plans on a monthly and daily basis according to material availability. Handling tasks such as change control, deviations, CAPA, investigations, and document management including BMRs, BPRs, and master SOPs will be part of your duties. You will also be involved in the preparation, review, revision, control, and implementation of standard operating procedures within the sterile manufacturing department. Conducting line clearance activities before commencing various operations such as manufacturing, sterilization, and filling, as well as checking and maintaining records and logbooks related to manufacturing processes, garment washing, drying, and equipment sterilization are key aspects of your role. Additionally, you will be required to perform any activities as instructed by the HOD, provide training to subordinates, technicians, and operators, and stay updated on self-hygiene practices. Attending training sessions as per the schedule and ensuring compliance with the Training Need Identification (TNI) will also be part of your responsibilities. Qualifications required for this role include M.Sc., B.Pharm, or M.Pharm degree.,

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 microbiological analysis of raw materials, finished products, water, and environmental bio-burden monitoring. You will review monthly trend reports for physicochemical and microbiological data and ensure compliance with predefined specifications. Analytical investigations for complaints, product recalls, out of specification results, and deviations will also fall under your purview. Furthermore, you will be responsible for internal Quality System audits, quality review, analysis of non-conforming products, reference standards, working standards, and solution preparations. You will plan and manage all activities of the Quality Control Department to assure the quality of all products manufactured by the company. Coordinating with the manufacturing department to control processes and products at every stage of manufacturing will also be part of your role. Moreover, you will work on the development of specifications and analytical procedures in coordination with the Quality Assurance Department and R&D. You will review the adequacy and relevance of specifications and analytical procedures, ensure instrument qualification, implement audit trail systems for data integrity and security, and coordinate technical audits of the Quality Control Laboratory. Your responsibilities will also include maintaining Quality Control records, control samples, release records, routine Good Laboratory Practices auditing, organizing training programs, establishing guidelines and procedures on cGMP and Good Laboratory Practice, and evaluating Change Control suggestions for overall reviews and validations. As the QC Head, you will play a key role in upholding quality standards, ensuring compliance with regulations, and contributing to the continuous improvement of quality control processes within the company.,

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 including production, engineering, QC, and IT for validation planning and execution. Assist in internal audits, regulatory inspections , and prepare responses to audit observations. Maintain and update validation master plans and SOPs regularly. Skills & Competencies B. Pharm / M. Pharm / M.Sc. in relevant field. Minimum 4 years of hands-on experience in QA validation functions in a regulated pharmaceutical manufacturing environment. Strong understanding of equipment and utility qualification, cleaning validation, CSV, and process validation . Familiar with guidelines such as GAMP 5, 21 CFR Part 11, ICH Q8-Q10 , and applicable regulatory standards. Good documentation and analytical skills. Proficient in MS Office , knowledge of QMS software is an advantage. Strong communication and coordination skills.

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 adverse events and rectify non conformities reported in inspections

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 Authority, and Novartis Group Quality Manual requirements and policies. You will need to stay updated with industry trends and Health Authority expectations to incorporate them into Novartis QMS. Your key responsibilities will include being the Process Owner for Supplier Lifecycle Management and Quality Agreements, supporting the execution of the Quality System strategy, driving simplification and optimization of processes, reviewing and updating process-related documentation, assessing technology needs, ensuring compliance with regulations, participating in benchmarking activities, authoring QMS documentation, acting as a subject matter expert for relevant IT systems, interacting with stakeholders, and supporting quality-related initiatives. To be successful in this role, you must have fluent spoken and written English, thorough knowledge of cGMP requirements, at least 10 years of experience in pharmaceutical industrial Quality and Compliance activities, strong analytical and risk management skills, good interpersonal and communication skills, experience in a matrix organization, and familiarity with supplier management and quality agreement processes. Novartis aims to improve and extend people's lives by reimagining medicine and becoming the most valued and trusted medicines company globally. Joining Novartis means being part of a mission-driven organization where associates are empowered to reach ambitious goals. If you are looking to contribute to a brighter future in healthcare, consider joining our network to stay connected and explore career opportunities with Novartis.,

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 Record without any deviation. It will be crucial to adhere to data integrity in online documentation and handle hazardous operations safely. Part of your role will involve effectively utilizing resources such as utilities, personnel, and machinery to support efficient production processes.,

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, and PQ for the equipment’s. 8. Writing of relevant Batch documents and log books. 9. Execution of production plan for formulation and filling. 10. Achieving planned FP targets with strict adherence to cGMP. 11. Execution of planned activities of Aseptic Processing Areas like media fills simulation trials, Formulation and filling activities. 12. Execution of preventive maintenance plan for equipment’s in coordination with Engineering and QA departments. 13. Performing day to day activities as per requirements. 14. Reporting all the activities, deviations and issues to Reporting officer. Preferred candidate profile ITI/ DIPLOMA/ B. TECH/ Pharmacy With Relevant experience