291 Cgmp Jobs - Page 10

For Production Incharge : @ Post Graduate Profile only considered (MSC Chem) @ Shift handling @Shift planning @Documents review during shift. Production Operator/ Chemist. @Should follow Gmp @ Should follow documents.

Role & responsibilities 01 Quality Control Functions: 1.1 To ensure that the laboratory carrying out its testing, calibration, validation and all other technical activities in such a way to meet GLP requirements. 1.2 To carry out all technical activities and implementation of documented quality system. 1.3 To plan, schedule and monitor analysis of Raw Materials, Premix, Packing Materials, In-process materials, Finished products, Microbiological analysis, Water analysis and ensure that they meet defined relevant quality standards. 1.4 Periodically review logbooks, reports and test protocols related to Raw Materials, Premix, Packing Materials, Microbiological analysis, In-process and Finished products for proper entries, accuracy and completeness and ensure that they meet defined relevant quality standards. 1.5 To handle Quality management events according to SOP and complete its documentation with corrective and preventive actions. 1.6 To ensure that updated Specifications, Standard Testing Procedure, Test protocol and documents are available for use. 1.7 To review the resources of Manpower, Instruments, Equipment, Material and advise Management on the provision with justification. 1.8 To train the personnel in the department regarding Chemical Testing, Instrument qualification & current regulatory guidelines. 1.9 To establish effective communication systems with other departments including Commercial departments to achieve effective and efficient service from Quality Control Department. 1.10 To ensure implementation of cGMP in laboratory. 1.11 To ensure Qualification, Annual Maintenance and Calibration of QC instruments. 1.12 To ensure Management of Standards, Chemicals, Reagents and Glasswares. 1.13 To Review and approval of new or revised SOPs. 1.14 To handle instrument troubleshooting and interact with service Engineer in case of instrument breakdown. 1.15 To ensure compliance of Laboratory safety practices and firefighting devices. 2.0 General function 2.1 To provide compliance of Audit observations. 2.2 To take adequate measures to ensure updating of information and knowledge of the key people in the Quality control. 2.3 To provide support to planning, production, finish product for timely release of the goods for dispatch. 2.4 To monitor the microbiological analysis and ensure that all testing is carried out. 2.5 To create SOP awareness by continuous training. 2.6 To ensure good housekeeping of laboratory and up-keep of laboratory. 2.7 Self-updation of current regulatory guidelines. 2.8 Self inspection of other departments, as and when scheduled. . 2.9 Take necessary measures to prevent accident/incident and help in accident/incident Investigation. 3.0 Adherence and compliance to cGMP requirements. 3.1 Undertaking any other work, either for this department or any other department which the organization, which may be requested by the Plant Manager, for which training and/or an explanation has been provided and understood.

QA Specialist What you will do 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 organisations. 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 contract manufacturers. Perform tactical batch disposition activities in support of lot release Enter and approve analytical data in LIMS Manage and drive Quality records to closure including deviation records, investigation reports Initiate Quality records for supplier related changes. Collaborate with Complaints team to request assessments, reviews complaint report and have comments addressed Provide data to the networks to support Quality Management Processes) 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. Communicate effectively with partners, ensuring alignment on quality objectives and compliance needs. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: 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. Must-Have Skills: Working foundation in quality assurance roles. Minimum of 4 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 collaborators 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 and make a lasting impact with the Amgen team. 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.

Position Overview: We are looking for a Sr. Manager will be responsible for leading and managing end-to-end multiple API production blocks. The role requires ensuring optimal productivity, quality, cost control and regulatory compliance in alignment with cGMP standards. This position plays a critical role in driving continuous improvement, cross-functional coordination, and operational excellence within the production unit.. Key Responsibilities: Oversee daily production activities to ensure efficiency, quality, and cost-effective management of resources. Develop and implement production schedules based on inventory / market requirements / capacity constraints and provide feedback accordingly. Deployment of manpower & supervisor as per production requirement. Monitor and adjust production processes as necessary to meet production targets and quality standards. Ensure all production batch records are completed and signed off on time. Responsible or keeping production facilities clean and appropriately disinfected. Responsible for the validation protocols and reports are completed and signed. Responsible for qualification of new and modied facilities, when appropriate and equipment. Responsible for maintaining and updating the documents related to the Production activities. Ensure smooth production under EHS & cGMP compliance. Ensure for reporting of all production deviations and evaluation of the same. Ensure process problems /deviations are solved and rectified within a set of time frame, co-ordination/follow up with all the departments like R&D, MSTG, QC, QA, Engineering & Stores. Institute operational controls, monitor the key characteristics, carry out root cause analysis for the non-conformity and take CAPA. Responsible for self-inspection of the area w.r.t EHS and production systems. Responsible for training all the employees of production. Responsible for preventive maintenance is executed as per the planned schedule. Responsible for analyzing the time cycle of each batch and taking corrective actions if any deviations are observed. Responsible for any optimization initiative across the production blocks. Ensure that the yield, % solvent recovery and quality of APIs and Intermediate products are as per the standard norms. Analyze production costs and recommend strategies to reduce costs and improve Profitability. Responsible for monthly RM requirement and weekly RM schedule. Responsible for performing of Internal audit. Responsible for water consumption, effluent generation as per the set norms. Responsible for controlling hazardous waste generation. Identification of Risks & Hazards, Environmental aspects & evaluation and review the same. Responsible for any other work assigned by senior management in the absence of Site Head/ Unit Head. Qualifications and Experience: Analytical Skills and Communication Basic understanding of pharmaceutical or chemical industry Strong organizational, multitasking abilities, time management skills Company Website :- www.scllifesciences.com

Responsible to monitor operations in granulation, blending area, compression, coating and tablet inspection area. Responsible to manufacture and ensure quality of the product at respective processing area. Responsible to follow all regulatory/cGMP/Statutory/Company policies are followed in manufacturing area. Responsible for online documentation with real time data. Responsible to participate in equipment qualification and process validation activities Preferred skills : Granulation, Compression, coating and packing of & Exposure in OSDs

Review SOP Support quality system Familiar with process/cleaning validation Assist internal & external audits Assist specification settings, OOS investigation, change controls, regulatory submission/update, annual product reviews, other investigation Required Candidate profile Must have min. 2 yrs experience & must be familiar with cGMP requirements. Candidate should have good knowledge of computer & ability to effectively interact with individuals at all levels.

Preferred candidate profile Qualification : B Pharma/M Pharma Year of Experience : 5 - 6 Yrs in shop floor management. Must have hands on experience in Granulation Section. Having exposure of Audit facing internal and external party. Interested candidates may share profile at hr.plant@zuventus.com Job Location : Sikkim

Roles and Responsibilities Conduct quality control activities such as BMR reviews, stability studies, process validation, and equipment qualification. Ensure compliance with cGMP guidelines and regulatory requirements through IPQA activities. Investigate deviations and CAPAs to maintain product quality and prevent recurrence of issues. Collaborate with cross-functional teams for change control processes and batch manufacturing record (BMR) review. Perform analytical testing using HPLC/GC/UV methods to ensure product purity. Desired Candidate Profile 2-7 years of experience in API manufacturing or bulk drug industry only male candidate. MS/M.Sc(Science) degree in Chemistry or related field; . Strong understanding of Good Manufacturing Practices (cGMP), Current Good Laboratory Practice (cGLP), and International Organization for Standardization (ISO). Proficiency in handling chemicals safely according to OSHA regulations.

Dear Applicants, Greeting from Biophore India pharmaceutical Pvt Ltd, We have opening for Formulation DQA- Department . Position :Executive or Sr Executive Experience : 2 - 8 Yrs Job Description: 1) Handling of QMS documents like Incident, change control and LER. 2) Review of Formulation Analytical Development & Method Validation and Transfer Protocols and Reports. 3) Review of Product development with QbD approach. 4) Review of FRD Documents (LNBs, BDRs, PDRs, MFRs and MPR) 5) Preparation and Review and Approval of SOPs ,Guidelines. Responsible for conducting Internal Audits/External Audits for Cross functional Departments.Responsible for Review and Approval of Vendor Qualification Please Share me Update Resume :Careers@biophore.com Total Exp: Current CTC: Exp CTC: Notice Period: Designation:

Strong Online Testing & Analysis knowledge Strong Sampling & Methodology knowledge Instrument Calibration & Validation Documentation & Label Method Development & Validation Strong SOP & QMS Compliance Candidates from Herbal/Phyto industry is required

Job summary We are seeking an individual to test samples and release results within Turnaround Time (TAT) for commercial and stability batches, adhering to GMP (Good Manufacturing Practices). This role involves calibrating and maintaining assigned equipment within departmental and organizational guidelines, processes, and procedures. The primary objective is to ensure accuracy in results provided within timelines. Roles & Responsibilities • Your responsibilities encompass testing assigned samples and releasing data within defined timelines, ensuring absence of executional errors against established procedures. You will be responsible for preparing required reagents and buffers in alignment with the testing plan and ensuring the availability of equipment for analysis. • Your role involves documenting activities contemporaneously, adhering to Good Documentation Practices and compliance expectations, and conducting self-checks post-analysis to ensure accuracy. • You will promptly inform the supervisor about risk actions, providing necessary data and analysis to support the investigation process. You will adhere to QMS (Quality Management systems) and closure timelines, actively participate in laboratory investigations and discrepancy closures, fulfilling defined roles in audits. • Your responsibilities also include ensuring lab cleanliness, proper sample storage, chemical labeling, removal of expired material, usage of calibrated equipment, equipment calibration, maintenance, and qualification. • You will address instrument-related issues and conduct root cause analyses (RCAs) for unknown problems, and play a crucial role in training new team members on analytical techniques. Qualification Educational qualification: An M.Sc., M.Tech. or B.Tech. in Microbiology, Biochemistry, or Biotechnology Minimum work experience : 2 years Skills & attributes: Technical Skills • Basic understanding of the Biologics/Biosimilar industry, including processes, regulations, and trends. • Hands-on experience in High-Performance Liquid Chromatography (HPLC) techniques, including Size Exclusion, Reverse Phase, Ion Exchange chromatography, and Peptide mapping analysis, especially within the context of Analytics. • Hands-on experience in Biochemical analysis techniques, specifically Electrophoresis, Enzyme-Linked Immunosorbent Assay (ELISA), and Polymerase Chain Reaction (PCR), with a focus on Analytics. • Working experience in a cGMP (Current Good Manufacturing Practice) environment, with a special emphasis on Good Documentation Practices (GDP). • Basic knowledge in protein chemistry, including an understanding of protein structure, function, and relevant analytical techniques. • Basic knowledge and hands-on exposure to Microbiology techniques, particularly relevant for individuals working in Microbiology Labs. • Basic knowledge and hands-on exposure to cell culture techniques, specifically for working in Bioanalytics (BA) Labs. Behavioural skills • Prioritizes effective communication and demonstrates a performance-oriented mind-set. • Effective verbal and written communication skills. • Performance-oriented approach, consistently striving for high standards. • Demonstrates flexibility in working shifts and a clear understanding of team dynamics. Additional Information About the Department Biologics Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon. With a robust portfolio of biosimilar products across key therapeutic areas, covering ~US$80+ Bn in innovator sales – future business pipeline covers a variety of product classes and therapy areas, and new modalities. Fully integrated organization with over two decades of experience in developing, manufacturing and commercializing multiple biosimilar products. With a Product Development engine that has end-to-end capabilities – in-house clone development, upstream and downstream process development, bioanalytical development and proprietary formulation. Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs. We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure Rich experience of commercializing high-quality biosimilars in multiple markets with over 900,000 patients having benefited from our products till date. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

Walk-In Drive Hyderabad | June 1, 2025 Join our growing team at OneSource The new way to CDMO We're hiring for multiple roles across our R&D and Manufacturing facilities in Bengaluru. Walk-In Interview Details: Date: Sunday, June 1, 2025 Time: 9:00 AM 4:00 PM Venue: Oakwood Residence, 115/1, Road No. 2, Financial District, Gachibowli, Hyderabad, Telangana 500032 Open Positions: Process Development Lab (Unit 1, Bommasandra) Research Associate | Sr. Research Associate | Scientist Qualification: B.Tech / M.Tech (Biotechnology) Experience: 2 – 12 years Drug Substance Manufacturing (Unit 2, Doddaballapura) Executive | Sr. Executive Qualification: MSc / B.Tech / M.Tech (Biotech, Microbiology) Experience: 2 – 8 years Drug Product Manufacturing (Unit 2, Doddaballapura) Executive | Sr. Executive | Team Leader Qualification: B.Sc / M.Sc / B.Pharm / M.Pharm Experience: 2 – 12 years in sterile injectables

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