137 Cgmp Jobs - Page 2

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 culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Sr Validation Engineer What you will do Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. In this role you will be serving patients through internal collaboration with Amgen’s global quality teams, manufacturing sites and external engagement with contract manufacturing organizations. You will make key contributions to fulfill Amgen’s missions of serving patients by ensuring supply of high-quality product produced at contract manufacturers to patients. The Senior Validation Engineer will oversee strategies and documents related to DS/DP Process Performance Qualification, Cleaning Validation, and Packaging Qualification at contract manufacturing organizations (CMOs) located across North America, Europe and JAPAC regions. The candidate should have prior experience with qualification of the following modalities, primarilysynthetic API/DS and DP manufacturing, FDP and packaging qualification, and aseptic DP. Be an integral quality member of Amgen cross-functional contract manufacturing teams that includes but is not limited to operations, analytical science, process development, supply chain, etc. Project teams will includetech transfers, new product introductions, and ongoing validation maintenance activities. Roles & Responsibilities: Translate Amgen requirements into the language of the CMO Identify and assess validation/quality risks to enable risk-based decisions Validation document author/approver Determine appropriate sample plans and acceptance criteria for primary and secondary packaging processes. Aseptic processing system oversight (media fill, autoclave validation, EM) Prepare materials/documents (playbooks) for topics to be presented during audits/inspections Perform validation change control assessments Review/approve validation deviations Review/approve Master Batch Records Perform Person in Plant activities as required Escalate issues to Validation/Quality management, as needed Author Validation sections of Marketing Applications Write/review responses to regulatory questions (RTQs) Drive Operational Excellence and Champion Change Authority: Determine outcome of validation activities Decision to approve or reject validation documentation Provide input on Validation position on related topics and strategy for the site Decision to approve Master batch Records This role may require working in shifts or extended hours within the same shift to support global time zones. What we expect of you Basic Qualifications and Experience: Doctorate degree OR Master’s degree with 4 to 6 years of experience in process validation or a related field OR Bachelor’s degree with 6 to 8 years of experience in process validation or a related field OR Diploma with 10 to 12 years of experience in process validation or a related field. Functional Skills: Must-Have Skills: Prior experience serving as Validation lead for NPI or tech transfer of manufacturing processes. Relevant experience in qualification of finished drug product and packaging processes. Minimum of 6 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations. Ability to have a positive impact on others; the ability to affect the behaviors of others by connecting with and inspiring them Good-to-Have Skills: Working foundation in cleaning validation and aseptic process simulation.Experience in resolving complex deviations associated with validation studies. Understanding of the applicable manufacturing/testing processes (i.e. Synthetic API, Drug Substance, Drug Product, Packaging, Device manufacturing processes). Proven experience in designing and/or improving processes at conceptual level Desire to partner with internal and external stakeholders across teams Understanding of industry requirements/expectations that comprise a robust Validation package. Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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 collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. QA Manager What you will do Role Description: In this role you will be serving patients through internal collaboration with Amgen’s global quality teams, manufacturing sites and external engagement with contract manufacturing organizations. You will make key contributions to fulfill Amgen’s missions of serving patients by ensuring supply of high-quality product produced at contract manufacturers to patients. The QA Manager will support implementation and management of quality assurance activities at the Amgen Technology and Innovation Center, supporting oversight and maintenance of external suppliers and contract manufacturers. You will be responsible for leading a team of quality professionals who will be maintaining and approving various quality documents including but not limited tosupplier documentation, analytical results investigations, CAPA and audit records. This role will involve collaboration with various Amgen teams to ensure seamless handoffs between teams Roles & Responsibilities: Oversee a team of approx. 6 staff, ensuring their activities and priorities are managed in a compliant and structured manner. Ensure team members are appropriately qualified and trained to perform needed activities per company procedures. Conduct goal setting, performance reviews, and compensation planning to align with organizational goals. Develop, implement, and maintain quality records in compliance with industry standards, GMP practices, and regulatory requirements. Continuously improve processes to enhance efficiency and quality, by applying lean principles and automation. Develop, monitor and report metrics to senior management to assess the health of the team’s performance. Develop solutions that are thorough, practical, and consistent with functional objectives. Work cross functionally with various Amgen teams and stakeholders to ensure seamless transition of tasks and continuity across groups. Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations. This role may require working in shifts or extended hours within the same shift to support global time zones. What we expect of you Basic Qualifications and Experience: Doctorate degree OR Master’s degree with 4 to 6 years of experience in quality management systems or a related field OR Bachelor’s degree with 6 to 8 years of experience in quality management systems or a related field OR Diploma with 10 to 12 years of experience in quality management systems or a related field. Experience managing staff in a GXP environment Functional Skills: Must-Have Skills: Working foundation in quality assurance roles and proven team leader. Minimum of 6 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations. Ability to have a positive impact on others; the ability to affect the behaviors of others by connecting with and inspiring them Good-to-Have Skills: Experience in investigations, project management and trending and analysis Relevant experience in Supplier Management, raw materials, packaging components, and/or device manufacturing. Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes). Proven experience in designing and/or improving processes at conceptual level Desire to partner with internal and external stakeholders across teams Understanding of industry requirements/expectations of a robust Quality Management System and documentation. Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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 review and updates to quality agreements to ensure alignment to Amgen expectations and to address needs depending on material type. Documentation review and approval includingsupplier records, investigation reports, Amgen quality records, and validation records. Evaluation and documentation of raw materials and devices for changes to incoming inspection profiles Oversight and completion of supplier assessments and documentation to support product complaints. Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships. Review and approval of change control records for supplier changes. Management of supplier audit records, ensuring on time completion and CAPA closeout activities are documented with appropriate closeout evidence. Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations. Take part in operational and quality improvement initiatives, programs, and projects. Develop solutions that are thorough, practical, and consistent with functional objectives This role may require working in shifts or extended hours within the same shift to support global time zones. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree OR Master’s degree with 4+ of experience in quality management systems or a related field OR Bachelor’s degree with 6+ years of experience in quality management systems or a related field OR Diploma with 8+ years of experience in quality management systems or a related field. Preferred Qualifications: Must-Have Skills: Minimum of 2 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations. Good-to-Have Skills: Experience in creating digital solutions and working within computerized systems Experience in investigations, project management and trending and analysis Relevant experience in Supplier Management, raw materials, packaging components, and/or device manufacturing. Understanding of the applicable manufacturing/testing processes and regulatory requirements (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes, and combination products). Desire to partner with internal and external stakeholders across teams Understanding of industry requirements/expectations of a robust Quality Management System and documentation. Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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 and guidelines as required. Preparation of miscellaneous validation protocols reports as required. Preparation of MLT & BET method validation protocols reports as required. Executing bacterial endotoxin testing review of analytical data and related documentation. Imparting technical training whenever required to the microbiologists. Maintenance of laboratory area and related monitoring records as applicable. Skills: testing,bacterial endotoxin testing,validation,microbiology,cgmp,haccp,technical training,good microbiological laboratory practices,iso 14001,iso 9001,microbial analysis, validation protocols,sop preparation.

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 and participation in validation of equipment. Report to Department head regarding any process or operation related problem. Manpower planning and allocation of work according to their skill.

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 • Responsible for calibration of equipment and cleaning activities • Participate in performance qualification of the equipment • Responsible for checking the intermediate analytical reports status during the process • Responsible for filling the reduce/skip testing format • Check yield calculations in CPR • Prepare protocol request from and fill the data in protocol forms • Involved in storage tanks periodical inspections • Prepare the Finished product transfer note Preferred candidate profile 1-3 years experience in API Manufacturing

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 Support DQ/IQ/OQ for the project lifecycle Assist in preparing proposals, estimates, presentations, and other activities. Collaborate and coordinate with other department design teams (mechanical, electrical, process, building services, etc Ensure that all automation documentation prepared meets the IPS Quality Standards (QMS) Preferred candidate profile: Bachelors degree in engineering or equivalent degree from an accredited university 10+ years of experience within the Oil, Natural Gas industry, Life sciences industry a plus Experience with the development of cGMP and GAMP automation lifecycle documents (URS, FRS, I/O List, etc Experience with specifying field instrumentation, process analysers, DCS/PLC hardware and wiring design Experience in leading small to medium sized projects with minimal supervision.

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 Pharmacy or science with suitable stream 1-2 years on hands experience in pharmaceutical industry preferred including prequalification experience based on WHO cGMP guidelines. Should have basic understanding of overall quality management system (QMS) and shall be able to handle various documents of QMS Contact Person: Neha Sharma/ Chhavi Kankariya Unitedmkt@uhr.co.in

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, Melting point etc. Regularize the QC activities as per cGMP requirements. RM, PKG, In-process and FG sampling and Analysis. Co-ordination with QC staff, R and D, Commercial and production for quality and 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 responsible care (Environment, Health, Safety and Security) No. of Reportees Qualification and Experience M.Sc. (Chemistry) with 2 - 6 yrs. Key Competencies (Technical, Functional and Behavioral) Handling, Calibration and Hand-on experience of all QC instruments. Compliance of 21 CFR Part-11. Troubleshooting related to QC analytical instrument

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 Site "Education & Training Lead" to improve site training program (e-Learning). 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 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

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 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.

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 trending of Non-Conformance records at site. Data update for Daily & Monthly Quality meetings. Govern P&G Global SOPs compliance at site. Manage periodic review of documents (SOPs, attachments, forms etc) at site.

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 repeat failure from operators and take measures/set processes to avoid re-occurrence of the same and to ensure FTR. Line clearance of camera inspections, HCM, ATS, printing machines and Final Inspection System Ensuring document verification generated during shift on daily basis against defined standards Internal process Preparation of various reports Maintenance and verification of gauges to ensure proper calibration of these equipments on a regular basis in each shift Ensure verification of shade against master and Macbeth report Verification of daily profiles and online graphs Periodically conduct process, product and systems Audit. To provide data for annual product quality review & Participate in APQR and finalise the recommender's People development Ensure proper manning and shift handling, shift activities. Effective training to the operators with evaluation for compliance. Effective manning to utilization of available sources.

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 maintain the BMRs and other log books in respective area as per cGMP and SOP. Responsible for timely completion of calibrations and validations in coordination with Eng. and QA related to respective areas. Responsible for the Operation and cleaning of Automatic visual inspection. Responsible to perform visual inspection of the products /media filled vials as per the sop. Operation and cleaning lux mater, visual inspection table. Operation and cleaning of glove integrity and filter integrity testers Preparation, filtration and issuance of disinfectant and deactivation solutions to all the sections in the production area. Responsible for cleaning and storage of all the filling machine accessories and change parts Operation and cleaning of table mounted LAF and Ceiling mounted LAF Operation and cleaning of steam sterilizer and HPHV steam sterilizer. Preparation of loads meant for Autoclaving like garments, disinfectant, filling, filtration, rubber stopper and seals for sterilization as per the validated load pattern. Responsible for ensuring garments washing, drying and folding activities Timely completion of SOPs Training and On the job trainings related to respective area. Responsible for Maintenance of cleaning in in External washing and vial washing area & Depyrogenation tunnel areas and f Component preparation and sterilization area. Cleaning and sanitization of drain points in External washing and Vial washing & Depyrogenation tunnel areas and f Component preparation and sterilization area Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HODs instructions and guidance.

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 profile Education : B.sc Chemistry Suitable Candidates please share the cvs below mail id Ramesh.sanaboni@amneal.com 9550545943

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 in Any Specialization required. Strong understanding of project planning, scheduling, cost optimization, regulatory compliance, risk mitigation, and budget management principles.

Job Description Candidate should the exposure for handling the Bottle packing line. Should have the work experience in Regulatory plant. Faced the USFDA, MHRA,TGA inspection. Good Communication skill. Having the SAP knowledge. Work Experience 3 to 05 years' Experience. Education Graduation in Pharmacy Competencies

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 readiness for UK MHRA and US FDA audits Provide expert support on: WHO-GMP and GLP compliance for excipients, APIs, and formulation ingredients Equipment qualification (DQ/IQ/OQ/PQ) and cleanroom classification Process and cleaning validation Quality Management Systems (QMS), documentation (SOPs, BMRs, BPRs) and change control protocols Advise on regulatory documentation strategy for DMF and CTD/ACTD filings, including supplier qualification Assist in product selection and formulation pipeline development, identifying high-potential excipients and formulations for domestic and export markets Train and mentor QA, QC, production, and R&D teams on global pharmaceutical standards and best practices Desired Profile 20–25 years’ experience in excipients, API or formulations manufacturing, with a top-tier pharmaceutical company Proven track record of preparing and leading facilities through US FDA, MHRA or TGA audits Deep working knowledge of: ICH Q7/Q8/Q9/Q10 WHO GMP and EU GMP Annexes Indian D&C Act & Schedule M Hands-on experience supporting DMF submissions and familiarity with USP, EP, BP and IP Prior consulting or leadership roles serving regulated export markets Strong grasp of product lifecycle management, export documentation and quality risk management for emerging markets Tech-savvy, with exposure to digital QMS or e-BMR systems (desirable) Awareness of sustainability and EHS standards for global audit readiness Excellent cross-functional collaboration skills spanning production, QA/QC, R&D and supply-chain teams About Antal Antal International is a 30-year-old global executive search and placement firm with a network of over 800 people across 35+ countries, originally based out of the UK.

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