41 Cgmp Compliance Jobs

Role Summary Manufacturing Quality Downstream Associate is responsible for primary contact of quality on the floor, particularly in the Terminal sterilization, Visual Inspection and Packing areas of production and monitor processes for compliance to cGMP standards. Responsibilities Responsible for ensuring operating state of cGMP compliance in Terminal Sterilization, Visual Inspection and Packaging operations. Maintain regulatory compliance in accordance with cGMP practices Ensure manufacturing policies and procedures conform to Pfizer standards Knowledge and hands on experience in reviewing eBR and assessing the impact of AMPs exceptions with technical support/inputs from Sr. Associate or S...

As a motivated individual, you will play a crucial role in supporting cGMP compliance within procurement operations at Regeneron. Your responsibilities will include investigating deviations, supporting CAPAs, coordinating supplier audits, handling change controls, and contributing to the development and implementation of the Supplier Corrective Action Report (SCAR) process. **Role Overview:** You will be essential in ensuring successful audit closures by proactively addressing issues with suppliers and maintaining clear communication to achieve satisfactory outcomes. Additionally, you will manage SCARs, follow up with suppliers and internal team members, and ensure timely reporting and closu...

Job Title Senior Officer Process Engineering Business Unit Sun Global Operation Job Grade G12B Location : Gangtok 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 Execution of Breakdown maintenance of Proc...

As the Head of Manufacturing API, your role is crucial in leading all API production activities to ensure safe, compliant, and efficient manufacturing operations. You will be responsible for achieving production targets, maintaining cGMP compliance, and driving continuous improvement across the API manufacturing units. Key Responsibilities: - Production Management - Plan and execute API manufacturing as per production schedules. - Ensure adherence to batch production records (BMRs) and standard operating procedures (SOPs). - Optimize process yields and reduce production cycle time. - Review and approve production documentation. - Compliance & Quality Assurance - Ensure full compliance with c...

Core Purpose of the Role: Experience - 8 to 10 years Line Clearance process overview, Product change over. Timely area readiness (Cleaning, EMS, OOS status) and ensures availability of documents and material status. Monitoring of process through process step verification. Reviewal of Batch Manufacturing Record to check compliance from stepwise process execution till written instructions. Equipment / utility Qualifications, Calibrations, PM verification. Utility / Computer system validation Process validation and cleaning validation. Target Monitoring for batch related process activities. cGMP compliance and verification overview of BMP facility & Utilities. SOP preparation and review. Traini...

To perform Area cleaning. To perform Equipment operation and cleaning. To perform the visual inspection and packing activities. To perform the documentation as per Batch record and SOP. Responsible to maintain documents as per cGMP norms. Ensure the training completion before doing activity. Maintain personal hygiene.

We are looking for a dedicated and detail-oriented individual to support sterile injectable production operations. The role involves handling equipment, cleaning, sterilization processes, documentation, and adherence to cGMP standards within the pharmaceutical manufacturing unit. Key Responsibilities: Operate and clean HPHV steam sterilizers as per SOP. Handle and maintain vial washing machines and depyrogenation tunnels. Clean, assemble, and prepare machine parts and load patterns. Wash and prepare sterile garments for manufacturing zones. Prepare and filter disinfectants, IPA, and other cleaning solutions. Perform cleaning of equipment and rooms in the sterile processing areas. Execute bat...

To perform area cleaning. To perform equipment operation and cleaning. To perform the visual inspection and packing activities. To perform the documentation as per batch record and SOP. Responsible to maintain documents as per cGMP norms. Ensure the training completion before doing activity. Maintain personal hygiene. Reporting all the activities, incidents and problems to reporting officer.

To perform area cleaning. To perform equipment operation and cleaning. To perform the visual inspection and packing activities. To perform the documentation as per batch record and SOP. Responsible to maintain documents as per cGMP norms. Ensure the training completion before doing activity. Maintain personal hygiene. Reporting all the activities, incidents and problems to reporting officer.

Role Overview: As a Production Supervisor in the manufacturing area of multiple assigned manufacturing lines, your primary responsibility will be to ensure CGMP compliance and supervise overall production activities. You will also be required to review and maintain online documents. Key Responsibilities: - Prepare, review, revise, control, and implement standard operating procedures. - Review and prepare master documents of production. - Prepare and review protocols and reports according to requirements. - Manage documents like BMRs, BPRs, Master SOPs, etc. - Handle Change Control, Deviations, CAPA, Investigations, etc. - Conduct line clearance activities before manufacturing, filling, cappi...

We are looking for a meticulous Chemist Production to manage production documentation preparation and batch record review at Synnat Pharma Private Limited. As a key member of our API Manufacturing Unit, you will play a crucial role in ensuring seamless production processes and adherence to the highest quality standards. Your responsibilities will include verifying daily logbooks, reviewing online Batch Manufacturing Records, and managing all production-related documents, including Process Deviation Control Orders (PDCOs). You will also be responsible for raw material indenting, updating activities in our ERP system, and participating in preventive maintenance programs. This role requires clo...

This is where your work makes a difference. At Baxter, we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. He...

What You Will Achieve In this role, you will: Provides Quality oversight for warehouse activities-Dispensing, Sampling, Material management, and cGMP compliance etc. Also involves in review and release of incoming material, In process reports P1, P2 and P3 reports. Maintain inspection readiness, support regulatory and customer inspections, and improve quality assurance systems. Responsible to ensure adherence to all quality procedures and material management procedures. Review logbooks/electronic log as per the procedures and ensure compliance. Ensures that analytical report compliance to relevant specification, standards, and site/global procedure. Usage decision (Acceptance/ Rejection) of ...

Job Description Summary Compression Technician Job Description Safety: To follow and ensure 100% safe operation in manufacturing area. Ensure all the necessary PPEs are available in production facility and were the proper PPEs during manufacturing. Reporting the near miss and ensure their compliances. Follow ISO 14001 & 45001 practices. To follow and maintain 5s in workplace. Quality and Compliance: cGMP Compliance in entire manufacturing area and SOP compliance on all aspects. To ensure zero overdue on trainings. Follow ALCOA++ and ready for any time inspection. Responsible to face regulatory and customer audits. Ensure to follow quality culture in organization. Delivery: To achieve the wee...

Qualification : Diploma or B.E. in Mechanical Engineering Experience : Minimum 2 years in pharma packaging machinery industries Expected Joining : Immediate Job Responsibilities : Hands-on experience with pharma packaging machines: tablet counting, liquid filling, cartoning, labeling, capping, induction sealing, etc. Ability to read GA, layout, pneumatic, and electrical drawings. Basic understanding of cGMP compliance, GEP standards, and 21 CFR Part 11. Skilled in preparing IQ, OQ, DQ, PQ, FS documents, service manuals, and QA checklists. Coordination with purchase for test and MOC certificates. Familiarity with interlocks and logical testing procedures. Conducting IFAT and CFAT, reporting o...

Job Title DGM Production - API Business Unit Global API Business Job Grade G8 Location : Ahmednagar / Ahilyanagar 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 Responsible for Manufacturing Blocks which...

Job Description Roles and Responsibilities Operate as part of the QC team according to Company safety policies and cGMP to drive compliance with our company's Global policies, procedures, guidelines and regulatory requirements in the performance of all applicable job functions. Complete all documentation in compliance with cGMP and GxP standards. Perform receipt and release of all materials ensuring QC Right First Time and turnaround time KPIs are achieved. Review of all vendor and external laboratory documentation associated with receipt and release of materials to ensure compliance with internal specifications and Pharmacopeia. Maintain clear, accurate records associated with all day to da...

Job Title Junior Technician Coating Business Unit Sun Global Operation Job Grade 303 Location : Gangtok 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 Responsible to operate the coating activities machin...

As a Functional Engineer in the Engineering Maintenance & Reliability Team at the Active Pharmaceutical Ingredient department of the Manufacturing Division, your primary responsibility is to ensure the efficient maintenance activities in the plant while adhering to safety and GMP standards. You will support the Senior Engineer in planning, scheduling, and executing maintenance tasks to ensure plant and equipment availability, capacity, integrity, and reliability in compliance with Cipla Policies. Your role also involves collaborating with maintenance personnel in the Manufacturing, Packing, and utility areas. Key Responsibilities: - Execute maintenance activities in a shift by managing avail...

As a Pharmaceutical Machine Operator with 12 years of experience, your role will involve operating Blister and Alu Alu machines in compliance with cGMP and quality standards. You will be responsible for monitoring production, adjusting machine settings, troubleshooting, and maintaining production records to meet targets effectively. Key Responsibilities: - Operate Blister and Alu Alu machines efficiently. - Ensure compliance with cGMP and quality standards. - Monitor production, adjust machine settings, and troubleshoot as needed. - Maintain production records and collaborate with teams to meet targets. Qualifications: - ITI Mechanical or equivalent qualification. - 12 years of experience in...

As a Maintenance Engineer I in the IT Maintenance department at Teva Pharmaceuticals, your role involves carrying out preventive maintenance of all computer systems of ICS, troubleshooting hardware and software problems, and installing/configuring standalone instruments/equipment/output devices. You will also be responsible for managing vendor coordination for resolving QC/QA laboratories instrument software issues, ensuring electronic records and signatory system data maintenance, and conducting system validations for new installations. Key Responsibilities: - Perform preventive maintenance of PLC, HMI, IPC, and SCADA systems - Troubleshoot hardware and software issues for servers, desktops...

As a Material Management Specialist, your role involves planning and controlling inventories of raw materials and packaging materials to meet production requirements. You will coordinate with Purchase and Quality Control teams to ensure timely availability and release of materials. Additionally, you will oversee the receipt, storage, and dispensing of materials in compliance with SOPs, MSDS, and safety requirements. It will be your responsibility to manage the return, rejection, and destruction of non-conforming materials following established procedures. Your key responsibilities include: - Planning and controlling inventories of raw materials and packaging materials - Coordinating with Pur...

As a responsible team member in the pharmaceutical manufacturing process, your role involves the following key responsibilities: - Conduct line clearance activities before starting various operations such as dispensing, manufacturing, filling, inspection, sealing, labeling, and packing. - Perform process validation, cleaning validation/verification, hold time study, media fill, and routine batch sampling according to protocol/SOP. - Review executed Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs). - Perform in-process tests at different stages as per batch documents/SOP. - Review environmental monitoring and water trends. - Review different types of calibration certifica...

Execute day-to-day production activities as per production plan. Operate and monitor production equipment (Granulation, Compression, Coating, Packing, etc. based on plant). Ensure adherence to cGMP, SOPs, and regulatory guidelines during all production activities. Maintain batch manufacturing records (BMRs), logbooks, and online documentation. Coordinate with QA, QC, Maintenance, and Warehouse for smooth operations. Implement safety, quality, and housekeeping standards within the production area. Support investigations (deviations, OOS, incidents) and assist in CAPA implementation. Train new operators / apprentices on processes and equipment. Participate in qualification/validation activitie...

We are looking for a meticulous Chemist Production to manage production documentation preparation and batch record review at Synnat Pharma Private Limited. As a key member of our API Manufacturing Unit, you will play a crucial role in ensuring seamless production processes and adherence to the highest quality standards. Your responsibilities will include verifying daily logbooks, reviewing online Batch Manufacturing Records, and managing all production-related documents, including Process Deviation Control Orders (PDCOs). You will also be responsible for raw material indenting, updating activities in our ERP system, and participating in preventive maintenance programs. This role requires clo...