1027 Cgmp Jobs - Page 16

To work as per cGMP and ensure its compliance as per current guideline and SOPs. Responsible to align with organization goal and other responsibilities assigned by reporting authority. Responsible to perform the calibration of instrument and to maintain instrument/equipment as per SOPs. Responsible to follow safety precaution as per laboratory procedure. Responsible for method development studies of Drug Substance, Drug Product & In process Materials related to Peptides. Responsible for method Validation studies of Drug Substance, Drug Product & In process Materials related to Peptides. Responsible for analysis of routine samples and stability studies of Drug Product & In process Material Dr...

Job Description: Technician Compression Job Purpose To operate and maintain tablet compression equipment in compliance with cGMP, SOPs, and safety standards, ensuring consistent production of high-quality tablets. Key Responsibilities Set up and operate tablet compression machines and ancillary equipment (e.g., metal detectors, dedusters, friability testers, scales). Perform in-process checks such as tablet weight, thickness, hardness, and visual inspection as per Master Batch Records (MBR). Clean and sanitize equipment and manufacturing areas according to SOPs. Accurately complete equipment logs and batch documentation. Ensure proper execution of MBRs, SOPs, and validation protocols. Coordi...

Job Title Sr.Manager Warehouse Business Unit Sun Global Operations Job Grade G9B Location : Guwahati At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world, you'll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other's journeys. Key Responsibilities Ensure compliance to regulatory requirements like cGMP,...

To maintain facility and equipment. To procure engineering consumables, proprietary spares and to maintain inventory of the same. To perform and to approve Qualification studies for equipment (Plant and Utility) and Facility. To schedule and to execute preventive maintenance program for plant equipment and utility equipment. To review and to participate in process validation program. To maintain and to update drawing like plant layout, equipment layout, P & ID for equipment (Plant and Utility), HVAC system etc. To schedule and to execute Annual Maintenance Program for Utility and material handling equipment. To arrange instruments for plant equipment and accessories. To review, authorize and...

Division Department Sub Department 1 Job Purpose Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines Key Accountabilities (1/6) Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner Collect data from all SPOCs with respect to received work plan for review Escalate any delays in receiving response from unit with respect to work plan Review of collected data for work plan fulfilment Send data to HO for compilation of deficiency response Take follow up with HO to receive updated dossier...

Job Summary Experienced Quality Assurance professional with a strong background in the Active Pharmaceutical Ingredient (API) industry. Responsible for implementing and maintaining GMP-compliant Quality Management Systems to ensure product quality, regulatory compliance, and operational excellence. Key responsibilities include managing documentation, handling audits (regulatory and customer), overseeing batch release, deviation investigations, and ensuring adherence to global regulatory standards (cGMP, ICH, FDA, etc.). The role demands expertise in validation, change control, and continuous quality improvement within a highly regulated API manufacturing environment. Quality Planning and Sch...

Company Name: Global calcium Pvt Ltd Location: Hosur Knowledge of ISO 9001, 14001, FSSC 22000, HACCP, Halal and cGMP standards requirement relevant to the function assigned and food & feed safety activities and ensure to comply the statutory and regulatory requirements Responsible for preparation & implementation of related SOPs and OCP (Operational Control Procedures) of the department. Reviewing PRPs (Pre-Request Program) & CCPs (Critical Control Points) as per relevant procedures under certification audits. Determination for right manpower strength for the assigned responsibilities and involving in the recruitment process for both new and replacement positions. Training the subordinates o...

Job Purpose To ensure the accuracy, completeness, and compliance of all Quality Control documentation and test results as per current Good Laboratory Practices (cGLP), regulatory guidelines, and internal SOPs before final release or submission. Key Responsibilities Review analytical raw data, calculations, and reports for accuracy, completeness, and compliance with approved specifications and methods. Ensure all laboratory documentation meets regulatory and internal quality standards (e.g., USFDA, EU-GMP, ICH, WHO, etc.). Review chromatographic data (HPLC, GC), wet chemistry reports, and other analytical test results. Verify results for routine analysis, stability studies, and validation rep...

Job Summary Roles & Responsibilities Review and approval of all analytical test data of Quality control. Review and usage decision of analytical reports in LIMS, Empower and SAP. Electronic signatures level-2 for chromatography data station (CDS) and standalone instruments. Review the Analytical test report in LIMS. Review the reported results against specification and trends. Review the method validation and method transfer documents. Review the instrument calibrations and working standard qualification records. Handling the Incidents/ Deviations, Out of Trends, Out of Specification including investigations, Corrective and Preventive actions follow up and closure. Monitoring of analytical a...

You become a part of a quality-driven, fast-paced pharmaceutical manufacturing team focused on the production of solid oral dosage forms. The role contributes directly to delivering high-quality, compliant, and timely products while ensuring continuous improvement and team development. - Supervise and manage end-to-end Tablet production activities as per cGMP and company guidelines. - Lead a team of operators and supervisors to ensure daily targets and quality standards are met. - Monitor and maintain all production documentation, including BMRs and logbooks. - Coordinate with cross-functional teams like QA, maintenance, planning, and stores. - Ensure readiness for audits and adherence to al...

As a Quality Assurance Specialist at our pharmaceutical manufacturing facility, your role is crucial in ensuring the compliance of operating state with cGMP (current Good Manufacturing Practices) in Solution/Emulsion preparation, vial/ampoule washing, Depyrogenation, Filling, Capping, and Collection operations. Your responsibilities include: - Maintaining regulatory compliance according to cGMP standards. - Ensuring that manufacturing policies and procedures align with Pfizer standards. - Reviewing eBR (Electronic Batch Record) and assessing AMPS (Agile Manufacturing Production System) exceptions with technical support from your supervisor. - Reviewing batch reports and equipment audit trail...

Job Title: Calibration & Validation Trainer Pharma Industry Location: Remote Job type: Part-time Job Summary: We are seeking an experienced Calibration & Validation Trainer with 10+ years of expertise in pharmaceutical quality systems, equipment calibration, and validation practices . The role involves delivering high-impact training programs to professionals and fresh graduates, focusing on regulatory compliance, instrumentation, validation protocols, and audit readiness . The trainer will act as both a technical instructor and career enabler , ensuring participants gain hands-on knowledge aligned with industry standards (FDA, cGMP, ISO, ICH, GAMP5, 21 CFR Part 11). Key Responsibilities: De...

Role & responsibilities 1. Prepare detailed project timelines using tools such as Gantt charts and milestone trackers to monitor the end-to-end progress of API and intermediate projects. 2. Define critical path activities that determine the project delivery date and monitor them closely to ensure adherence to schedules. 3. Escalate risks or delays to senior management and stakeholders, and implement recovery plans to bring projects back on track. 4. Rebaseline timelines with proper approvals when there are changes in scope, resources, or regulatory requirements. 5. Coordinate with cross-functional teams including Process R&D, Production, Engineering, QA/QC, SCM, RA, and EHS to ensure timely ...

Production : • To receive crude solvents from plants and issue recovered solvents to plants. • To check the labels of raw material, packing materials and solvents before usage. • Perform column distillation as per SDR. • To maintain process conditions for batch as per SDRs. • To maintain storage conditions of raw material/solvents in plant. • To take instruction from superior for batch charging / monitoring & follow up. • To report any deviation / discrepancy in plant / process to seniors. • To complete given task within stipulated time. • To maintain environment conditions in Plant as per SOP. • To perform safe operations of plant equipments and utilities. • To store solvents in proper cond...

Role & responsibilities To maintain warehouse operation in accordance with cGMP procedures & ensure smooth operation in warehouse department. Responsible for raw material Issues and document up-dating of on-line log book activity and GMP pro. Monitoring the day-to-day activities related to warehouse. Responsible for recording the daily usage log books. To ensure that the warehouse related SOPs are being followed. To ensure that avoid the cross contamination and proper storage of the material. To responsible to check the issuance of the material to production as per FIFO/FEFO. To responsible to monitor the materials due for re-testing and intimation to QC for sampling and testing purpose. To ...

Role & responsibilities: Ensure training management and compliance on the shop floor. Preparation of training materials including presentation for the effective training at shop floor. Coordination with the cross functional team for the execution of training as per the plan. Updating of employees, courses, modules and other amendments in the training system. Follow-up the reconciliation of training materials with cross functional teams on shop floor. To ensure 100% training execution of every employee working on the shopfloor. To ensure the training of new employees with respect to job description within the timelines to ensure smooth transition of employees in company roll shall ensure re-t...

Handling Batch process and process equipment, manpower handling, following safety rule. Responsible for consumption of Raw material, yield and quality of intermediate, semi-finished, finished product. Online BMR, BPR and ECR, Daily Records checking.

Job Summary We are seeking an individual to oversee batch manufacturing, ensuring adherence to cGMP (Current Good Manufacturing Practices), providing training, and coordinating day-to-day activities. Responsibilities include minimizing machine downtime, managing subordinate staff, assuring compliance with standards and SOPs (Standard Operating Procedure), leading regulatory audits, compiling reports, ensuring safety norms, and budget management. Roles & Responsibilities • You will be responsible for enforcing cGMP for batch manufacturing in order to obtain high-quality products and achieve targeted production within a span of control. • You will be responsible for imparting general and cGMP ...

Responsibilities: Operate and maintain ointment filling machines. Ensure accurate filling, sealing, and labeling of products. Monitor production line for quality and efficiency. Follow safety and hygiene standards in a cleanroom environment. Requirements: Prior experience in pharmaceutical or cosmetic manufacturing preferred. Basic understanding of machine operations. Attention to detail and ability to work in a fast-paced setting. ** Immediate Joiners are preferred. **

Role Overview: As the Head of Engineering & Maintenance at a large-scale API pharmaceutical plant in Digwal, Hyderabad, you will be leading all engineering and maintenance operations. Your primary responsibility will be to ensure the optimal performance, reliability, and compliance of plant equipment, systems, and facilities. Your extensive experience in API manufacturing, expertise in CGMP, FDA regulations, and managing regulatory audits will be crucial in developing and executing maintenance strategies, driving continuous improvement, managing OPEX budgets, and leading a high-performing team to ensure safe, efficient, and compliant plant operations. Key Responsibilities: - Lead, manage, an...

As an Assistant Manager - Quality Control at Bharuch SEZ, you will play a crucial role in ensuring compliance with global regulatory requirements such as 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP, ISO9001, FSSC, and HACCP. Your responsibilities will involve regularizing QC activities as per cGMP requirements, ensuring lab compliance with regulatory and Pharmacopeia requirements, reviewing hybrid and electronic data for IPQC & FG analysis, conducting analytical method validation, OOS & OOT, and demonstrating knowledge of IMS system standards. Key Responsibilities: - Regularize the QC activities as per cGMP requirements. - Ensure compliance with regulatory and Pharmacopeia requirements for lab. - R...

As the leader of the DQA department, your role is to ensure the implementation of CGMP rules and regulations in Research & Development. Your responsibilities include: - Reviewing the Lab validation Protocol and Report of CRD. - Reviewing the Process Development report for DMF filing. - Reviewing the Specification and STP of Key Raw Material, In-Process, Intermediate stage, and Finished Product. - Reviewing the Method Development Report, Method Validation Protocol/Report, Method Transfer Protocol of ADL. - Reviewing the stability protocol and Report. - Preparing SOP, Formats / Annexures, Log books, and ensuring RA and GLP Compliance. - Interacting and communicating with R&D, ARD, QA, and Regu...

You will become a part of a quality-driven and compliance-focused production team responsible for manufacturing high-quality pharmaceutical products. Your role will contribute directly to ensuring uninterrupted production, regulatory compliance, and delivery of safe, effective medicines to patients. You will work in a GMP-regulated facility and collaborate closely with cross-functional teams like QA, Engineering, and Planning. Key Responsibilities: - Execute daily production activities (granulation, compression, coating, or packaging) as per approved batch manufacturing records (BMRs). - Ensure compliance with cGMP, safety, and regulatory guidelines during all production operations. - Superv...

In this role as an Officer, your main responsibility will be to supervise the manufacturing, processing, packaging, and holding of drug products according to defined and approved procedures for stability batches and commercial batches. You will need to ensure that the area and equipment are maintained in an orderly manner as per cGMP requirements, in a good state of repair, and in a sanitized condition. It is essential for you to perform online documentation in adherence to departmental procedures and maintain good documentation practices. Additionally, you will be responsible for providing training on operation and cleaning-related SOPs to all subordinates and operators. Coordinating IQ / O...

As an Upstream Manufacturing Documentation at Syngene, your role will involve leading the upstream process group to design and develop cell culture processes for monoclonal antibody and fusion protein production. You will provide expert leadership overseeing strategic and day-to-day activities in upstream process development of complex novel biologics. Your responsibilities will include overseeing technology transfer to support scale-up and GMP manufacturing, building strong relationships with CMOs, designing and executing risk-based process characterization studies, scaling up processes, preparing technology transfer protocols, collaborating with other teams, liaising with regulatory affair...