532 Cgmp Jobs - Page 19

Well known Denmark based pharma co Hiring QA Pharmacist Excellent communication skills 5 days working Pl share updated CV to careers5.righthire@gmail.com

About Amgen Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning cultur...

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collabo...

Specialist Quality Assurance - Global Supply Quality What you will do Let’s do this. Let’s change the world. In this vital role you will be serving patients through internal collaboration with Amgen’s global quality teams, manufacturing sites and external engagement with suppliers of raw materials and devices. You will make key contributions to ensure high quality and right first time materials are received at the Amgen, build a resilient supply network and conclude with a positive patient experience. In this role you will be part of Amgen’s Global Supply Quality team supporting oversight and maintenance of external suppliers and contract manufacturers. Roles & Responsibilities: Periodic rev...

Responsibilities Reporting review of microbiology results of Raw Materials, Packing Materials, In-process Materials and Finished Products as required. Review and approval of Microbiological analysis reports [Water, Microbial monitoring of clean rooms, MLT and BET]. Preparation of SOPs related to QC Microbiology. Maintenance of media stock and related GPT records. Implementation of Good Microbiological Laboratory Practices at work. Review of microbial test results of water samples as required. Maintenance of reference standard cultures subcultures; preparation and maintenance of working cultures as applicable for microbiological testing. Adherence to cGMP, ISO 9001, ISO 14001 and HACCP norms ...

To Maintain the machine and work place clean in all respect. Carry out all activities in area with required status labelling procedure as per SOP. To maintain overall cGMP and GDP in department. To impart training and evaluation of company employees. Preparation of SOP, BPR and Validation Protocol. Handling of deviation, incident, change control and CAPA. Responsible for all activities carried out in shift. To ensure availability of secondary packing material for packing activities. Responsible to ensure dispensing, equipment cleaning, visual inspection, vial labelling, cartonator machine,online Responsible for in process Packing activities and Finished good activities as per SOP. Planning a...

Establish / maintain compliance with FDA QSRs (GMP) Working with Production teams to develop validation protocols for production processes, and generating the final report covering the validation results and a recommendation for approval or disapproval for the release of the process to manufacturing. Export compliance system, Compliance of labeling, quality control and a quality system for excipients Documentation Control Process and Documentation Change Control Process Good Documentation Good Communication

Quality Control Dept, ensuring Timely testing & quality check of Raw Materials and Finished Products. Analysis on equipment like HPLC, FTIR, GC etc, all other Q.C. related matters Required Candidate profile Experience in handling HPLC, FTIR, GC etc, for 3 to 7 yrs, Experience in Quality Control dept. of Pharma Company. FDA Approval Required. Perks and benefits Apply with Salary Drawn & Expected Salary

Role & responsibilities In process / Intermediate / Raw Material test limits preparation as per MPR • Receive and safeguard Batch Production Record (BPR) from QA • Follow the appropriate Good Manufacturing Practices • Ensure that entire operations are being carried out in a prescribed manner • Handle the Non-Confirming product as per the Shift-In charge • Follow the transfers of intermediates/ Final Product/ finished product to appropriate storage area • Record any deviation or abnormality in the batch production records during the process and inform the same to Shift-In charge • Prepare the deviation report for standard time deviations and deviation of BPR operations during the process • Re...

Role & responsibilities: Work with the European Lead I&C Engineer(s) to: Develop, own and finalize User Requirements Specifications (URS), Functional Requirement Specifications (FRS), System Architecture and Network Architecture of the I&C systems for clients Oversee development of I/O Schedule, Alarm schedule, Lists, Hook Up Drawings, Loop Drawings Develop Routing and Cable Containment layouts Provide design calculations for the system and Fieldbus / Profibus design Develop schematic drawings and single line diagrams Design and develop specifications for DCS, PLC, and SCADA-based process control systems Select, size and specify the right instrumentation and controls based on the requirement...

Role & responsibilities: Killed Vaccine production as per planning. Operate and clean production equipment (CIP/SIP) and maintain logs as per cGMP guidelines. Coordinate with QC department regarding results Prepare and maintain Batch Manufacturing Records (BMRs) and deviation reports Collaborate with QA/QC, Engineering, and Validation teams during audits and batch reviews Support scale-up and technology transfer activities for killed vaccine processes. Job Location: Kadi,Gujarat (Bus transport facility available from Ahmedabad, Kalol & Kadi)

Role & responsibilities: Killed Vaccine production as per planning. Operate and clean production equipment (CIP/SIP) and maintain logs as per cGMP guidelines. Coordinate with QC department regarding results Prepare and maintain Batch Manufacturing Records (BMRs) and deviation reports Collaborate with QA/QC, Engineering, and Validation teams during audits and batch reviews Support scale-up and technology transfer activities for killed vaccine processes. Job Location: Kadi,Gujarat (Bus transport facility available from Ahmedabad, Kalol & Kadi)

Company Profile: Our Clients Company provides tailored intelligent healthcare solutions based on the latest professional insights. Every year, they supply high volumes of healthcare products via pharmaceutical supply programmes across the continent. Job profile: - 1. Perform Desktop evaluation of Manufacturers 2. Verification of ISO and other Certificate for its Authenticity with certified issuing body. 3. Collect and assess documents needed for product approval including but not limited to product questionnaire, product specification, release criteria, stability studies etc. 4. Review and approval of product documentation in share point. Desired Candidates: Bachelor / Masters degree of Phar...

This senior leader will be responsible for strategic planning, operational excellence, compliance, and P&L accountability, reporting directly to the VP/Head of Operations. end-to-end product development, manufacturing, and quality assurance.

Business Unit / Function Department - Quality Control Location Bharuch; SEZ;;; Reports to Lab In charge-QC Summary of Job (Purpose/ objective of the job Department Organogram to be enclosed) candidate is required having complete experience in API/Bulk/ Intermediates industries as per global regulatory requirements and responsible for implementation and compliances of ICH-Q7A, cGMP, WHO-GMP, ISO9001, FSSC, HACCP / global QMS requirements at SEZ site. Key Responsibilities (Performance Indicators) 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, Meltin...

Role & responsibilities Maintain site Annual validation Plan & track activities as per Validation Plan. Tracking & follow-up on Validation & Change Control records at site. Coordinate for eQMS records (Investigation, CAPA, effectiveness checks) closure at site. Monthly trending of Non-Conformance records at site. Data update for Daily & Monthly Quality meetings. Govern Global SOPs compliance at site. Manage periodic review of documents (SOPs, attachments, forms etc) at site. Vendor complaints: Handle vendor complaints at site for getting actions closed at site & with suppliers for on time closure. Training: Ensuring completion of site trainings as per training calendar at site. Work with Sit...

Role & responsibilities The individual should be documenting Annual Product Quality Review (APQR): Collection of process and quality data for all products. The individual is capable for management of Retain Samples: Storage, maintain, visual inspection & destruction of Retain samples of all FG samples. Management of central document room/Documents: Issuance, Retrieval, Destruction & Control of all the GMP documents (eg: facility documents, Batch records, Protocols, Reports, etc.) Key competencies Skill Required/ Tools/ Software: The individual is responsible to work in compliant with Good Documentation Practice (GDP) and current Good Manufacturing Practice (cGMP). Interpersonal Skill: The in...

Key Roles & Responsibilities : The individual is responsible to work in compliant with Good Documentation Practice (GDP) and current Good Manufacturing Practice (cGMP). Interpersonal Skill: The individual must have good communication skill with team, team-work capabilities, patience to work under pressure. Digital Skills: Effectively use MS tools, i.e., Word, Excel, PowerPoint, in day-to-day operations. If required, need to operate company software. Maintain site Annual validation Plan & track activities as per Validation Plan. Tracking & follow-up on Validation & Change Control records at site. Coordinate for eQMS records (Investigation, CAPA, effectiveness checks) closure at site. Monthly ...

A. Job Objective Monitor and review In Process quality control checks to meet the required quality compliance as per specifications. Strategic and planning Functional Core:- Review and provide decision based on the IQC sheet Online feedback to production for correction Daily plant round for ensuring compliance of SOPs, GDP, GMP guidelines etc. on the shop floor Refer ZMIC for special instruction during color change/ product change and guide the IQC operator for the same. Review the implementation of the same. Monitoring CAPA during shifts. Investigation of internal stranger/failure to identify the Root cause analysis and take corrective/preventive action for the same. Track instance of repea...

To follow safety rules in the premises according to the company norms. Responsible for Dispensing, checking and receiving of PPM from warehouse on need basis. Responsible for operation Maintenance and cleaning of External washing and Vial washing & Depyrogenation tunnel areas. Operation and cleaning of glove integrity and filter integrity testers. Responsible to perform the in process checks during operation. Responsible for Decartoning activity. Responsible for monthly frequency activity. Responsible for line clearance before start of the Activity. Preparation and periodic revision of SOPs related to respective area. Monitoring of DP, RH and temperature area in their respective area. To mai...

Role & responsibilities Responsible for all process operation / activities during the shift as per CGMP. To maintain BMR/BPR/BCR etc. for record the batches. To co-ordinate with engineering department for the shift break down jobs. To handle manpower during the shift as per process operations. To work in safe work environment and ensure the sub ordinate are working in safe To maintain good housekeeping in respective area. To co-ordinate for the raw material from warehouse for issuing the raw materials. To co-ordinate to QC dept. for In- process and Intermediate testing. To fill the entire document legible. To record and maintain all the documents online as per CGMP.. Preferred candidate prof...

Roles and Responsibilities Develop project plans, schedules, and budgets; track progress against targets using MS Project software. Manage engineering projects from concept to delivery, ensuring timely completion within budget and quality standards. Ensure compliance with CGMP regulations during manufacturing processes through effective documentation and risk mitigation strategies. Collaborate with cross-functional teams to identify potential risks and develop contingency plans for successful project execution. Provide technical guidance on SOPs (Standard Operating Procedures) development and implementation. Desired Candidate Profile B.Tech/B.E. degree in Any Specialization or M.Tech degree ...

Job Title: FDA & International Pharma Compliance Consultant (Excipients, API & Ingredients & Formulations) Location: Kutch, Gujarat (Remote advisory with periodic on-site presence) Experience: 2025 years in pharmaceutical manufacturing and regulatory compliance Salary: Competitive Education: Bachelors or Master’s in Pharmacy, Pharmaceutical Sciences, Chemistry or related discipline Kindly get in touch for career advancement opportunities with us at rupsha.saha@antal.com Roles & Responsibilities Guide the upgrade and development of plant infrastructure and systems to achieve compliance with: WHO-GMP Regulatory requirements of Russia, Australia/New Zealand, African authorities Ultimate readine...

Preferred candidate profile Year of experience : 4 - 6 yrs Must have exposure on Review of documents MFR, BMR, BPR, QC specification, process validation data, stability summary report. Having exposure in licensing, Knowledge of GMP & GDP. Candidate must have exposure in regulatory market. Interested candidate may share resume at hr.plant@zuventus.com

Develop and implement QA strategies and systems. Lead and mentor the QA team. Ensure compliance with regulations and standards like ISO. Drive process improvements, manage audits, collaborate with teams, maintain documentation.