532 Cgmp Jobs - Page 21

Department: Pharma Standard - AD Required Qualification & Experience: M.Sc. in any Life science(s)/Analytical/M-Pharmacy, with 0 - 5 Years of experience in the field of pharmaceutical industry/CRO setup. For Preparative: Experience on instruments like Preparative HPLC and SFC Expertise in Purification of peptides, impurity isolation. For Analytical: Expertise Analytical Method Development of peptides and oligoes. Regular sample analysis for supporting to synthesis team. Handling experience on DAC column packer and media packing will be advantageous. ************************************************************************************************** Department: Pharma Standard - Quality Control...

Key Responsibilities: Operate, monitor, and maintain Lyophilizers, HVAC systems, chillers, and AHUs to ensure efficient functioning. Perform routine and emergency maintenance tasks, ensuring minimal downtime and optimal performance of equipment. Maintain accurate operational records and detailed maintenance logs for all equipment. Ensure adherence to cGMP (current Good Manufacturing Practices) and cleanroom standards in daily operations. Follow Quality Management System (QMS) protocols, including SOPs (Standard Operating Procedures), change control, and Corrective and Preventive Actions (CAPA). Troubleshoot equipment issues and implement effective solutions to prevent recurrence. Conduct equ...

Manage the technology transfer process for established products, ensuring robust and compliant manufacturing processes e.g. implementation of new API sources. Write, review, and maintain regulatory response documents, justification reports, and risk assessments related to technology transfer activities. Oversee the preparation and review of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) for smooth transfer and manufacturing. Review process validation protocols and reports. Coordinate with R&D, production, quality assurance, and regulatory teams to ensure alignment on project deliverables and timelines. Troubleshoot and optimize manufacturing processes addressing deviatio...

Job summary We are seeking an individual to perform the Preventive Maintenance and Break Down Maintenance of Analytical Equipment's present in Quality Control . Roles & Responsibilities To perform the preventive and breakdown maintenance of analytical equipment's or Instruments like HPLC, UPLC, GC-HSS, Dissolution Test Appratus, Titrators, FTIR, UV-VIS Spectrophotometer,.... To update the preventive maintenance plan whenever addition of instruments or match the calibration schedule. To prepare the task lists for all analytical equipment's and update them in SAP. To perform the preventive maintenance as per the PM schedule. To make sure of closing the generated PM orders in SAP after performi...

Hii, Greetings from Avani consulting ! We are hiring for Production Officer/associate for a leading Pharma API Manufacturing company Position- officer/Associate Work Experience Min 3-10 yrs in API Location - Mysore Gender - Any Qualification- B.Tech in Chemical Engineering /Msc Chemistry/Diploma Chemical/BSC Chemistry Roles & Responsibility 1. Responsible for appropriate production planning & execution of batches in line with targeted commitments complying cGMP& Safety requirements. 2. To ensure gowning practices, entry / exit procedures, usage of PPEs are followed by team while in the department. 3. To ensure adherence of process instructions as per Batch Manufacturing Record and respective...

Role & responsibilities To lead a team of Process Engineers, Electrical Engineers, Mechanical Engineers, Instrumentation Engineers and Architects/Civil Engineers Project Manager for major Projects and coordination with the Clients Team Experience in designing chemical intermediates, specialty chemicals and/or bulk drugs, manufacturing facilities. Knowledge of cGMP norms for Bulk Drug Manufacturing Plants is an added advantage Preferred candidate profile : 1. Preparation of Design Philosophy 2. Scaling up the process based on laboratory/pilot plant trials. 3. Material Balance and Energy Balance. 4. Sizing of all equipment including pumps & Heat Exchangers. 5. Finalization of MOC. 6. Utilities...

Role & responsibilities RESPONSIBILITIES: - To follow the cGMP Rules and regulation. Documentation Control: maintenance, updation and issuance of documents in compliance with regulatory requirements and implementation of Good Documentation Practices. Review and approval of all Master documents like SOP, Batch Manufacturing record, Batch packing record, Calibration schedule, Preventive maintenance Schedule and other quality related documents Responsible for preparation and review of protocol and report for Process validation, Cleaning validation as per the schedule and validation master plan. Handling of documents like SOPs, formats / Annexures, Log Books, BMR / BPR & all other GMP Documents ...

experience in Vaccine or Biosimilar manufacturing Strong exposure to In-Process Quality Assurance & Quality Management Systems Knowledge of GMP guidelines and documentation practices Ability to work in a fast-paced, regulated environment

Review & approval of laboratory analytical data, test reports, and chromatographic data HPLC/GC/UV. Ensure GLP & cGMP standards, Participate in investigations of Out of Specification & Out of Trend, deviations, & lab incidents. SOP Review, CAPA.

Must have demonstrated experience and a track record of success as Cutover Manager / Lead on ERP transformations. Demonstrated through At least five years prior experience in having led SAP cutovers. Must have enterprise scale experience Develop and own the overall Deployment workplan. This should contain a list of deliverables and activities that will be executed by the Deployment workstream. Liaise with project teams to develop a detailed integrated cutover which include both technical and functional steps to be executed during the deployment phase. Identify risks, cross application dependencies and downstream impacts for each release. Manges risks and issues associated with the cutover an...

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. ...

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. ...

1. Quality Management Systems: Implementing, monitoring, and maintaining Quality Management Systems to ensure compliance with CGMP/regulatory guidelines. 2. Documentation: Reviewing and approving technical and quality documents. Required Candidate profile Should be minimum Post Graduation in Science having the work experience of about 10 Yrs in Chemical .

Candidates should have good hands on Experience on HPLC, GC, Stability, Wet Lab, RM Sampling & Analysis, Documentation, Standardization of Karl fisher Titrator. Responsible for Calibration of Instruments. Can handle QMS & AMV activities Required Candidate profile Preferred immediate Joiners. USFDA preferable. Interested candidate can share CV on sachin.kapte@enaltec.com Mob.8976826875

Role & responsibilities Master degree in chemistry preferably Analytical Chemistry from reputed university. Min. 20 years of experience in quality control, preferably in the pharmaceutical or chemical industry. Strong knowledge of regulatory requirements , including cGMP, ISO and other relevant standards. Excellent leadership, communication and strong analytical problem solving skills. Well versed with quality management systems such as SAP QM or similar. Coordinate with cross - functional teams to ensure readiness for audits and inspections. Also maintain knowledge of regulatory requirements and industry trends

Position: Production Chemist Job Location: Jammu (Samba) Industry Preference: Candidates with API Plant Interview Mode: Face-to-Face (Walk-in Interview) Interview Location: Chandigarh interested candidate share resume on 9815675900

1. Carry out all operation as per SOP, BMR. 2. Carry out all processes as per BMR, ECR & daily logs. 3. Complete the BMR, ECR, log books, daily records and ensure that are completed & signed. 4. Keep production facility clean and appropriate disinfected. 5. Maintain all equipment and surrounding area cleaned while batch processing to avoid Contamination. 6. Carry out daily weight verification of Weighing Balances as per SOP. 7. Cleaning of all Equipments as per the ECRs and SOP’s. 8. Execute all production activities as per instruction of superiors viz, Drum handling, Material handling, Raw material charging, Loading & Unloading the material, Milling, Sifting activity, etc. 9. Follow EHS nor...

Preferred candidate profile Qualification : B Pharma/M Pharma Year of Experience : 3 - 5 Yrs in shop floor management. Must have hands on experience in Compression/Coating Section. Having exposure of Audit facing internal and external party. Interested candidates may share profile at hr.plant@zuventus.com Job Location : Sikkim

- Sterile Injectable Manufacturing (Core) - Liquid ampoules, vials, lyophilized products - BMR/BPR Documentation - cGMP - Production Line Operation - Pharmaceutical Equipment Handling - Cleaning/Sterilization - Internal Audit/Validation - Maintenance

- 8+ yrs in Sterile Injectable Manufacturing - 3+ yrs as Production Manager in Injectable Plant - Handling Liquid Ampoule, Vial, and Lyophilized Vial Lines, BMR/BPR Documentation - Leadership & People Management - cGMP; WHO-GMP; FDA Guidelines, SOP

Preventive Maintenance: Perform preventive maintenance of instruments and equipment as per SOP/checklists and Section In-Charge instructions. Prepare and update preventive maintenance schedules and checklists for the entire plant. Monitor and calibrate IMTE (Instrument Measuring & Testing Equipment) periodically. Breakdown Maintenance: Minimize downtime by attending to breakdowns promptly. Troubleshoot and rectify issues in field instruments, PLC/SCADA systems, sensors, and transmitters . Identify root causes and implement corrective actions. Coordinate safety permits and maintain post-maintenance cleanliness and documentation. Calibration & Validation: Responsible for routine and scheduled ...

i. Experienced in independent instrumental analysis of raw material, in process samples, finished product and stability samples of pharmaceutical products. ii. Well versed in analysis of Tablets, capsules, liquids samples, for common test as Assay, Related substances, Dissolution and preservative content analysis as per controlled specification and method of analysis. iii. Should able to operate, calibrate and maintain instruments like HPLC, GC, Dissolution apparatus, UV and FTIR etc. iv. Experience of Empower, Lab solution software shall be recommended. v. Exposure to perform AMV or development shall be preferred. vi. Aware about on line & good documentation practices. vii. Should have know...

The Apex Group was established in Bermuda in 2003 and is now one of the worlds largest fund administration and middle office solutions providers. Our business is unique in its ability to reach globally, service locally and provide cross-jurisdictional services. With our clients at the heart of everything we do, our hard-working team has successfully delivered on an unprecedented growth and transformation journey, and we are now represented by over circa 13,000 employees across 112 offices worldwide.Your career with us should reflect your energy and passion. Thats why, at Apex Group, we will do more than simply empower you. We will work to supercharge your unique skills and experience. Take t...

Role & responsibilities Should have Knowledge about IMS system (ISO 9001:2015, ISO 14001:2015 OHSAS 18001:2007, and cGMP, USFDA, FSSC 22000, NABL. Analytical skill for QC instrument, i.e. GLC, HPLC, UV-Visible, FTIR, ICP, K/F, Melting point etc. Regularize the QC activities as per cGMP requirements. RM, PKG, In-process and FG sampling & Analysis. Co-ordination with QC staff, R&D, Commercial and production for quality & dispatch related activities for on time dispatches. Day to day monitoring and execution online all IPQC and FG analysis activities. Resolve the trouble shooting related to QC activities. Knowledge about 21 CFR Part 211, 111 with data integrity (Part-11) Awareness about respons...

Role & responsibilities The position is responsible for Moisture and Thiomersal estimation and ensuring GMP practices Physical observation of vaccines and diluents Formulation Verification Record maintenance Maintenance of Live and Inactivated FG samples and register Maintenance of Pullet ND samples at R&D in coordination with production Moisture estimation of Live vaccines, stability & record keeping and R&D testing To Fill records & BTR Regarding Moisture Determination RM - pH, viscosity, density, specific gravity, refractive index, LOD, water Egg sampling and record maintenance Maintenance of retain samples of RM Preferred candidate profile Should have technical knowledge in GMP, GLP, ISO...