284 Cgmp Jobs - Page 3

You have an exciting opportunity to join as a Deputy Manager in Stores within the pharmaceutical sector located in Surendranagar, Gujarat, India. With over 10 years of experience in pharmaceutical warehouse operations, you will play a vital role in ensuring efficient and compliant warehouse management. Your main responsibilities will include overseeing warehouse operations, such as the receipt, verification, storage, and dispatch of raw materials, packaging materials, and finished goods while adhering to cGMP and GDP standards. You will be responsible for maintaining accurate inventory records through physical stock counts and reconciliation with SAP/ERP systems to minimize waste and identify non-moving or expired materials. In addition, you will develop, review, and implement Standard Operating Procedures (SOPs) aligned with cGMP, GDP, and regulatory requirements, ensuring proper labelling, segregation, and documentation of materials for traceability and prevention of cross-contamination. Leading and mentoring warehouse staff to enhance compliance and continuous improvement will also be a key aspect of your role. Collaborating with various departments such as Quality Assurance, Quality Control, Procurement, Production Planning and Inventory Control, and Finance will be essential to streamline operations and resolve any discrepancies. Your expertise in SAP/ERP systems, knowledge of cGMP, GDP, and pharmaceutical warehousing regulations, along with strong leadership and communication skills, will be crucial for success in this role. Furthermore, you will be responsible for maintaining a safe and hygienic warehouse environment through monitoring cleaning, sanitization, and pest control measures, while ensuring compliance with Environmental, Health, and Safety (EHS) standards. Managing dispatch of finished goods, accurate preparation of dispatch-related documents, and handling rejected materials as per PPIC instructions will also fall under your purview. To qualify for this role, a Bachelor's degree in Pharmacy, Science, or a related field is required, with a Master's degree or MBA in Supply Chain Management being preferred. Proficiency in SAP/ERP systems for inventory and warehouse management, along with a deep understanding of cGMP, GDP, and pharmaceutical warehousing regulations will be necessary. Your strong leadership, communication, and interpersonal skills will be key assets in successfully fulfilling the responsibilities of this position.,

Roles and Responsibilities: You will be assisting seniors in drafting Concept & Basic Engineering drawings (PFD, P&ID, layouts, 3D plans), Revit modeling of civil/structural drawings, and coordinate with the Detailed Engineering team. Required Candidate profile 5–10 yrs exp in pharma consultancy/design-build, Certified in AutoCAD/Revit (on-job cert accepted). Knowledge of cGMP. Concept/basic engineering for API/chemical plants. Skilled in MS Word/Excel.

Responsible for reviewing all QC lab documents (reports, chromatograms, test records) to ensure accuracy, compliance, and completeness as per cGMP, SOPs, and regulatory guidelines. Check HPLC/GC/UV data, assay results, and dissolution profiles.

1)Compliance and Documentation Management 2) Quality Control Performance Metrics 3)Stability study & Documentation Oversight 4)Quality Management System (QMS) Management 5 to 10 years of relevant experience Should be familiar with cGMP practices.

1.Perform and monitor In-process Quality Assurance activities during the manufacturing process. 2.Responsible to perform line clearance activities in different stages of manufacturing and Monitoring of cleanroom behavior, aseptic activities. 3.Responsible to verify the In-process samples for quality testing and ensure the test results of products at various stages of manufacturing. 4.Review and verify documentation related to manufacturing processes i.e., BMR, BPR and GMP documents, ensuring accuracy and completeness. 5.Regularly inspect and assess manufacturing operations to ensure compliance with quality standards and procedures. 6.Responsible to Preparation Review of standard operating procedures. 7.Responsible to ensure cGMP and GDP during document preparation and review. 8.Ensure that all in-process activities align with Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP). 9.Responsible to review of Plasma inward, sampling procedures, Issuance and Reconciliation. 10.Responsible to Review and compliance of Down stream activities and Filling activities as per established procedures. 11.Responsible to involve in Change controls, Deviations, CAPA and other QMS activities. 12.To get involved in Process validation, cleaning validation and APQR activities. 13.To Involve in Risk assessment procedures with the coordination of SMEs. 14.Responsible to perform additional activities assigned by the superiors/ Head of the department.

Shall have good knowledge on operation of Purified water system. 2. Shall have good knowledge on operation of Pure steam generator system. 3. Shall have good knowledge on operation of WFI system. 4. Shall have good knowledge on GMP and GDP.

1. Shall have good knowledge on operation of Purified water system. 2. Shall have good knowledge on operation of Pure steam generator system. 3. Shall have good knowledge on operation of WFI system. 4. Shall have good knowledge on GMP and GDP.

1. To perform the equipment sanitization and cleaning. 2. To perform and ensure area cleaning and sanitizationactivities. 3. To prepare and filter disinfectant solutions. 4. To perform the CIP, PHT and SIP of the process vessels. 5. To operate the machines and equipments like autoclave,lyophilizer, vial washing, vial filling and vial capping machine, vialpasteurizer and manufacturing vessels. 6. To perform the vial washing, filling and sealing machinechange parts assembling and dismantling according to different vial sizes. 7. To perform activities like machine parts cleaning, loadpreparation, load wrapping and garments washing. 8. Adhere to cGMP practices during batch processing andoperation of equipment and GDP practices. 9. All the GMP documents e.g., BMR and logbooks to be filledon time and revise periodically. 10. Adhere to aseptic batch processing and gowning practicesduring performing aseptic activities in DPM area. 11. To plan and ensure availability of machine and material asper the batch requirement. 12. To participate in Media fill, Trial batch and Validationbatch activities. 13. To involve in batch execution. 14. To support the batch manufacturing activities. 15. To perform and coordinate in site acceptance test,Installation qualification, Operational qualification and Performance qualificationsfor new equipments. 16. To maintain the Inventory consumable required for dailyactivities. 17. To coordinate with other cross functional team for smoothfunctioning of departmental activitie s.

1. Shall have good knowledge on operation of Purified water system. 2. Shall have good knowledge on operation of Pure steam generator system. 3. Shall have good knowledge on operation of WFI system. 4. Shall have good knowledge on GMP and GDP.

1. To perform Equipment operation and cleaning. 2. To supervise the Visual inspection and batch packing execution as per plan. 3. To perform the documentation as per Batch record and SOP. 4. To perform the equipment qualification as per protocols and SOP. 5. Responsible to maintain documents as per cGMP norms. 6. Co-ordinate to cross functional team as per day-to-day activities. 7. Responsible for SOP, MPR and BPR preparation and revision. 8. Co-ordination with team to execute daily packing and visual inspection plan. 9. Ensure the training completion before doing activity. 10. To raise batch record request as per plan. 11. Responsible for QMS related activity(Change control, Deviations, Batch record) in packing and visual inspection activity. 12. Monitor day to day activities. 13. Reporting all the activities, incidents and problems to Reporting officer

Responsible for production (downstream) activities Monitoring of area drains cleaning and documents updation. Updation of room / equipment status labels. Verification of material required for production activities. Preparation of area, equipments before batch activities. Execution of production activities. Monitoring of batch parameters. Updation of batch parameters. Samples handling (Sampling and labelling). Intimation of incidents to Shift in-charge. Assisting in column packing, unpacking and evaluation activity. Chromatography column and resin monitoring. Handling of documents Checking practical feasibility of new / revised SOPs, protocols. Updation of log books. Updation of BMRs and attaching annexures online. Responsible for operation of following production equipments (but not limited to): AKTA Process Purification system Conductivity meter AKTA Pilot Purification system Peristaltic pumps TFF System Mixing Systems LAFU Filter integrity tester pH meter Heat exchanger Walk in cold room Freezer room Training: Attending training on SOP's / GMP as per schedule.

Responsible for production activities 1. Monitoring of area drains cleaning and documents updation. Updation of room / equipment status labels. Verification of material required for production activities. Preparation of area, equipments before batch activities. Execution of production activities. Monitoring of batch parameters. Updation of batch parameters. Samples handling (Sampling and labelling). Intimation of incidents to Shift in-charge. Assisting in column packing, unpacking and evaluation activity. 2. Chromatography column and resin monitoring. 3. Handling of documents Checking practical feasibility of new / revised SOPs, protocols. Updation of log books. Updation of BMRs and attaching annexures online. 4. Responsible for operation of following production equipments (but not limited to): AKTA Process Purification system Conductivity meter AKTA Pilot Purification system Peristaltic pumps TFF System Mixing Systems LAFU Filter integrity tester pH meter Heat exchanger Walk in cold room Freezer room 5. Training: Attending training on SOP's / GMP as per schedule. 6. Responsible for Quality Management Systems Initiation of breakdown request. Initiation of CRN's. Initiation of incidents, Investigations and CAPA.Please enter job description

1. Execution of production plan for formulation and filling. 2. Achieving planned FP targets with strict adherence to cGMP. 3. Execution of planned activities of Aseptic Processing Areas like media fills simulation trails, Formulation and filling activities. 4. Ensuring of sterilizing loads, cleanliness of filling room, entry and exit change rooms of aseptic areas. 5. Preparing and implementation of standard operating Procedures, Protocols, cleaning procedures and relevant log sheets. 6. On-line execution of Batch documents and related logbooks. 7. Execution of preventive maintenance plan for equipments in coordination with Engineering and QA departments. 8. Maintaining documents as per regulatory and cGMP norms. 9. Performing day to day activities in manufacturing areas. 10. Reporting all the activities, incidents and issues to Reporting Manager. 11. Responsible to attend all training programs, SOPs and cGMP trainings relevant to area and equipments. 12. Handling of SAP and DMS as per the requirement.

1. Following GMP, safety practices in production facilities and work place. 2. Responsible for production activities: Monitoring of area drains cleaning and documents updation. Updation of area / equipment status labels. Samples handling (Sampling and labelling). Arrangement of material required for activities. Assisting in Execution of production activities. Updation of BMR's. Receiving material (RM miscellaneous). Returning miscellaneous materials to warehouse. Planning and Execution of FDS thawing and dispensing activities. Assisting in product changeover activities before batch execution. Assisting column packing and execution of equipment specific protocols. Assisting in Equipment (Purification TFF system) cleaning.

We are looking for a skilled MySQL DBA Professional with 5-10 years of experience to join our team in IDESLABS PRIVATE LIMITED. The ideal candidate will have a strong background in database administration and management. Roles and Responsibility Design, implement, and manage database architectures to support business requirements. Develop and maintain databases to ensure high performance, security, and availability. Collaborate with cross-functional teams to identify and prioritize database needs. Troubleshoot and resolve complex database issues efficiently. Ensure compliance with organizational standards and best practices. Optimize database queries for improved performance and efficiency. Job Requirements Strong knowledge of MySQL database administration and management. Experience with database design, development, and implementation. Excellent problem-solving skills and attention to detail. Ability to work collaboratively in a team environment. Strong communication and interpersonal skills. Familiarity with database security and access control measures. Proficiency in managing large-scale databases and ensuring data integrity.

3-5 yrs of experience as CRC JD: Preparation of SOP's for operation, establishment of work/trial conduct systems/ training to new joiners/ training to trainers internal trainings, QC Visit of current project remotes, Checking weekly logs, equipment management, market Research

As the QA Oversight Specialist for R&D third parties involved in GMP Manufacturing processes at GSK, your primary role is to ensure the adequate Quality Assurance of services provided by external third-party providers. You will be responsible for managing the Third Party Quality Process to guarantee compliance with GSK quality requirements, cGMP, and regulatory standards. Your duties will include overseeing the release of batches and data in accordance with GMPs and regulatory requirements. Key responsibilities include developing effective processes and procedures in R&D Third Party Quality, contributing to business processes, and providing guidance on quality and compliance policies. You will act as the primary quality contact for assigned third parties or projects, ensuring they operate in alignment with GSK standards. Additionally, you will manage quality governance meetings, handle quality contracts, and oversee deviations, change controls, and validations related to third parties. You will actively participate in the selection and approval of third parties, manage approval statuses, identify and mitigate risks, review documentation for batch release processes, and ensure proper documentation management according to GSK requirements. Collaboration in third-party audit organization, preparation, and execution may also be required, along with participation in product/process transfer teams. In terms of Health and Safety, you will ensure that housekeeping and safety standards are maintained at high levels and that all activities adhere to relevant legislation, GSK safety documents, and local procedures. Qualifications/Requirements: Basic Qualifications: - Bachelor's Degree in Pharmacy, Science, or an engineering discipline, OR equivalent knowledge and experience in Good Manufacturing Practices in the pharmaceutical industry - 5 years of Manufacturing/Quality experience in the Pharmaceutical sector - Familiarity with Quality Systems application in manufacturing, warehousing, and distribution Preferred Qualifications: - Experience working with multi-functional teams - Ability to work independently and prioritize tasks effectively - Strong communication skills, both oral and written - Excellent interpersonal skills to facilitate change and drive initiatives - Proficiency in problem identification and resolution If you possess the required skills and experience and are looking to contribute to a dynamic team focused on ensuring quality and compliance in GMP Manufacturing processes, we encourage you to apply for this role.,

Job Summary As a qualified candidate, you will be leading the Quality Assurance, QC Chemistry and Microbiology Laboratories for the site. Your role will involve developing Standard Operating Procedures (SOPs), ensuring compliance with current Good Manufacturing Practices (cGMP) and regulatory guidelines, and monitoring day-to-day department activities. Responsibilities include reviewing and approving documents, executing in-process controls, participating in investigations, vendor qualification, stability management, and ensuring safety practices. Roles & Responsibilities You will be responsible for organizing the recruitment and training of QA (Quality Assurance) and laboratory personnel for chemistry and microbiology laboratories. You will ensure adherence to systems and procedures by all QA and laboratory personnel. You will be responsible for organizing contract laboratory audits and certification. You will formulate systems and procedures for the effective implementation of cGMP, GLP (Good Laboratory Practices), and other industry practices and regulations for the manufacture, storage, and distribution of drug products. You will plan and monitor the daily activities of different sections of the department, ensuring the availability of required facilities and materials for daily functions. You will ensure timely review and approval of all Master documents, such as SOPs, guidelines, production records, specifications, validation protocols, and other necessary reports/documents. You will be responsible for proper sampling of in-process and finished products, management of reserve and stability samples, and collection of finished products. You will oversee the execution of in-process controls and checks during manufacturing and packing. Your role includes reviewing and releasing/rejecting finished drug product batches, evaluating product recalls, monitoring quantity and disposition of recalled/returned material. You will participate in investigations, providing suitable Corrective and Preventive Actions (CAPA) to prevent recurrence. You will review, approve, and implement CAPA for incidents, change controls, Out of Specifications (OOS) and Out of Trends (OOT) observations. You will manage vendor qualification, material management, vendor audits, stability management, and field alerts as required. As a qualified trainer, you will implement training programs, ensure compliance, and provide training on cGMP and SOPs. You will ensure compliance with CAPA for deficiencies noted in self-inspections, internal audits, and external audits. Your responsibilities include preparing and approving Annual Product Quality Reviews, reporting Adverse Drug Reactions, and ensuring departmental adherence to safety practices. You will also be responsible for ensuring the safety, strength, purity, and efficacy of the product, along with any other assignments from higher management. Qualifications Educational qualification: An M. Pharm/M.Sc. with experience in Sterile products. Minimum work experience: 15 to 20 years. Skills & Attributes Technical Skills Experience in recruitment and training of QA and laboratory personnel in Chemistry and Microbiology laboratories. Experience in establishing systems and procedures for cGMP, GLP, and other industry practices. Experience in handling investigations, audits, and implementing resulting CAPAs. Skills in vendor qualification, audits, and material management. Behavioural Skills Effective leadership and organizational skills for managing laboratory personnel and operations. Detail-oriented mindset for thorough review and approval processes. Strong communication and collaboration skills for audits, investigations, and compliance activities. Commitment to safety practices and reporting Adverse Drug Reactions. Additional Information About the Department Global Manufacturing Organisation (GMO) Dr. Reddy's Laboratories is dedicated to making an impact on global healthcare through precision manufacturing and innovation. With 19 state-of-the-art manufacturing plants across multiple locations, we are a leading force in the pharmaceutical industry. Our capability to deliver quality medicines to patients in 66 countries is driven by benchmarking manufacturing processes and operational excellence. Benefits Offered At Dr. Reddy's, we prioritize your career growth and professional development through personalized learning programs. Our benefits are designed to meet industry standards, including joining & relocation support, family benefits, learning opportunities, medical coverage, and life coverage. Our Work Culture At Dr. Reddy's, our employees are guided by the principle of "Good Health Can't Wait." We see healthcare solutions as a means to help patients lead healthier lives. Our work culture fosters empathy, dynamism, and teamwork, empowering individuals to make a meaningful impact on global healthcare. Visit our career website at [Dr. Reddy's Careers](https://careers.drreddys.com/#!/) for more details.,

You will be working at Jubilant Pharma Limited, a global integrated pharmaceutical company that offers a wide range of products and services across different geographies. The business is organized into two segments: Specialty Pharmaceuticals and Generics & APIs. Jubilant Generics (JGL) is a wholly-owned subsidiary of Jubilant Pharma with Research & Development units in Noida and Mysore, India. JGL operates manufacturing facilities in Mysore, Karnataka, and Roorkee, Uttarakhand, focusing on APIs and Dosage manufacturing. The Mysore manufacturing site, spread over 69 acres, is USFDA approved and manufactures APIs targeting Lifestyle driven Therapeutic Areas such as CVS and CNS. The Roorkee facility is a state-of-the-art site approved by multiple regulatory bodies including USFDA, Japan PMDA, UK MHRA, TGA, WHO, and Brazil ANVISA, primarily focusing on a B2B model for EU, Canada, and emerging markets. Both manufacturing units are supported by around 500 research and development professionals in Noida and Mysore, working on developing new products in API, Solid Dosage Formulations, Sterile Injectable, Semi-Solids Ointments, Creams, and Liquids. The R&D facility also conducts BA/BE studies in-house and has global regulatory accreditations. JGL's Regulatory Affairs & IPR professionals focus on maintaining a unique portfolio of patents and product filings in regulatory and non-regulatory markets. Jubilant Pharma's revenue has been consistently increasing, reaching INR 53,240 Million during the Financial Year 2018-19 compared to INR 39,950 Million in the Financial Year 2017-18. Your responsibilities will include managing Stability Chambers, handling Stability Samples, loading & withdrawing Stability samples, storage, and destruction of samples after testing, compiling Stability reports, timely analysis of stability samples, investigation of deviations, incidents, OOS & OOT results, recording analytical data, preparation & review of SOPs, self-auditing, adherence to SOPs, STPs, GTPS, and cGMP/GLP compliance. For more information about the organization, please visit www.jubilantpharma.com.,

You will be responsible for strictly following cGMP, Safety, and Environmental Practices in the manufacturing facility. This includes filling out Batch Manufacturing records and equipment cleaning records. It is crucial to adhere to Good Manufacturing practices during all operations and ensure Good Housekeeping in the plant area and its equipment. You must use the proper personnel protective equipment as required for each task. Planning and ensuring the availability of Raw Materials for daily production as per the production plan is essential. Keeping track of documents such as Issue and dispensing register is part of the responsibilities. Carrying out the manufacturing process according to the Batch Manufacturing Record without any deviation is a key aspect of the role. Ensuring adherence to data integrity in online documentation is of utmost importance. Handling hazardous operations in a safe manner is critical for the safety of yourself and others. Effective utilization of resources such as Utility, Manpower, and Machinery is required to meet production targets. It is essential to be detail-oriented, safety-conscious, and proactive in ensuring the smooth and compliant operation of the manufacturing processes.,

You will be responsible for initiating, reviewing, and approving various quality management systems such as Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints. You will also handle Return Goods and ensure the smooth functioning of the quality system by performing risk assessments as required. Conducting regular internal audits and reviewing/approving all documents including SOPs, Spec & STPs, Forms, protocols, and reports will be part of your duties. Additionally, you will review annual product quality review reports, provide training on cGMP topics to employees, and support customer audits/visits as well as regulatory audits. You will assist in providing necessary documents for amendments, annual updates, regulatory filings, and CMC supporting documentation. Other tasks may include filling out questionnaires, declarations, quality agreements, and executing any additional responsibilities assigned by the Head of Department.,

You will be responsible for attending training sessions as per schedule to ensure alignment with the Training Needs Identification (TNI). Your duties will include performing and monitoring activities in both general and controlled areas, and filling logs, Batch Manufacturing Records (BMRs), and area documents according to Standard Operating Procedures (SOP) and work instructions. Additionally, you will be accountable for area cleaning, sanitization, and equipment preparation as per SOP, as well as adhering to preventive maintenance schedules for machines, instruments, and equipment. Line clearance activities before commencing operations, operation of Steam Sterilizer and Terminal Sterilizer, and immediate reporting of any observations or disturbances in the aseptic area to the supervisor are also part of your role. You should stay updated on self-hygiene practices, cleaning and sanitization protocols, SOP compliance, and documentation requirements for the area. Ensuring the Unidirectional Airflow (UAF) system works effectively, following cGMP (current Good Manufacturing Practices), Good Documentation Practices, and maintaining discipline in the department are crucial responsibilities. Furthermore, you will be required to follow preventive maintenance schedules for machinery, manage cleaning and sanitization of general and controlled areas in line with SOPs, and operate machines in the control area for Manufacturing of Injectable Products. The ideal candidate should possess an ITI/ Diploma in Mechanical Engineering with 3-6 years of experience, specifically as a skilled operator for Machine Operation of Steam Sterilizer (Component Preparation & Terminal Products) in a manufacturing environment for Injectable Products.,

Prepare Validation Master Plan(VMP, PVMP, CVMP, QMP).,Handling and storage of all quality document like BMR, BPR, log book, Protocol, Report and SOP throughout life cycle. prepare and review SOP. Monitoring of PPQ and cleaning validation activities.

Summary Job Functions: Handling, supporting and executing all activities including training to subordinates for manufacturing process support and any late stage developmental work for process improvement related to Downstream process in MSAT. Key Responsibilities: - Execution of process scale up experiments, documentation and process improvements to support manufacturing. - Process transfer and execution of tech. transfer with help of BBM. - Planning and executing experiments of DSP for process improvement, demonstrating and recording the same in proper format / report. - Designing and execution of scale down experiments to support manufacturing for scale up. (Bag evaluation/Filter sizing/Alternate vendor evaluation etc.) - Drafting the process related reports, protocols and IOC as a part of documentation - Support of process transfers- Evaluation and support for implementation of new processes focusing on direct transfers - Preparation of Qualification /verification documents (Protocols and reports) of equipment Responsible for conducting experiments to support the manufacturing team in need for any issues or improvement in the process. Both for microbial and mammalian process - Responsible for providing shop floor support during scale up activities for engineering, CT and PPQ batches - Ensures corporate cGMP and GLP compliance of all activities performed. - To follow Good Documentation Practices and Data Integrity’ requirements during any GxP Operation and recording at site. - To take responsibility that application of Data Integrity requirements and potential consequences for not following it are understood and followed. - To review in the perspective of compliance to Data Integrity requirements while reviewing any GxP data (Records, Reports) specific to Job description.

Hi, Greetings Walk in Invitation: We are having face to face interview on 19th July 2025 Saturday in Mysore Single Round Face to face Company : A leading Pharma API Unit - in Mysore Position - Production Department Associate Work Experience Min 3 yrs in API in current Hike would be appreciable on Current CTC Note: No Charges If interested drop your CV to Priyanka Palit [ 7780363938|| jyotsna@avaniconsulting.com ] Thanks & Regards Priyanka Palit