60 Pq Jobs - Page 2

Job Summary We are looking for a detail-oriented engineering team member to coordinate preventive maintenance schedules, manage breakdown records, and ensure adherence to SOPs, critical for maintaining operational efficiency and equipment reliability. This role plays a pivotal part in inventory control, and CAPA closure, contributing to seamless production operations, compliance with regulatory standards, and effective resource utilization. Roles & Responsibilities • To maintain the facility as per cGMP, and GMP requirements of country where product is being exported and strict adherence of Good Engineering practices during task execution. Can handle Water system operation and maintenance. Can handle HVAC system operation and maintenance. Must have knowledge of RO membranes & EDI replacement and its troubleshooting. Must Have knowledge of SCADA system and cGMP documentation. Spare management, Vendor management, MIS reports etc. Do the planned work on time. e.g. PM, PR, PO's etc. To carry out upkeep round as per schedule and updating of the records. To follow the instructions relating to engineering operations and to ensure their strict implementation. Ensuring continuous improvements and engineering excellence. To follow good documentation practices. To ensure EHS procedures and practices are followed at site to achieve zero lost time accident and compliance. Responsible for documentation related to upkeep of water system and HVAC. Must have knowledge of RCA, FMEA, Change Control, deviation and other GxP documentation. You will be accountable for ensuring implementation of Good Engineering Practices (GEP) at Site. Qualification Educational qualification : A Diploma or a B.Tech in Mechanical or Electrical Engineering Minimum work experience : 5 to 8 years Skills & attributes: Technical Skills Responsible for documentation related to upkeep of water system and HVAC. Responsible of Operation oif water system and HVAC Managing contractors at site. Their Work permits etc. Water system Maintenance and upkeep of HVAC in proper manner. Spare management for water system and HVAC Spares Experience in managing RO Mem. and EDI maintenance plans. Ability to manage maintenance budget of an area/unit. Knowledge of GMP and GEP. Behavioural skills • Communication and collaboration skills to coordinate with cross functional teams, external contractors and agencies. • Attention to detail to ensure preventive maintenance, documentation, and inventory control. • Commitment to quality and compliance. Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. 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/#!/

Job Description Must Have: Experience in handling Clients and Stakeholder interactions. Well versed with CSV and GxP process and ability to adopt to client Process, systems and documentation needs like Test Protocol, Test Plan, Test Strategy, IQ/OQ/PQ scripts, RTM, Test Summary Report etc., Understanding of various SDLC methodologies(Agile, Waterfall, V) Flexibility to Work as per Customer timings Generate Automation Test Strategy for applications deployed on Cloud. ( Public and Private cloud) Automate scripts using a given Selenium-based framework, Serenity based BDD framework or any open-source tools. Working experience in testing Restful Webservices and APIs using frameworks or tools like POSTMAN, Rest API, etc. Analyze requirements, perform impact analysis, and regression analysis, and communicate with stakeholders on the need for changes in requirements. Perform Risk Analysis of Project & automation deliverables and work towards mitigation plans. Good experience with various testing types like Functional, Regression, UI/ Usability, Integration testing, etc., Hands-on experience using ADO or any test management tools. Good to Have: Experience in Programming or scripting languages (Java/JS etc.,). Experience in designing automation frameworks (POM, Cucumber BDD, etc.,.). Experience working on CAPAS, Incident Management, FMEA Risk Assessment, Functional Risk Assessment etc., Experience with Vulnerability testing (VAPT). Knowledge of Performance testing using Jmeter or any open-source tools. Idea on Generative AI for testing. An idea of estimation techniques for Automation testing efforts (Design and Execution). Experience in testing and test planning of CI/CD-based solutions through tools like Azure DevOps. Role & responsibilities Preferred candidate profile

Candidates experience with ISO 15378/GMP, ISO 13485, and IQ, OQ, and PQ, particularly in relation to the pharmaceutical industry. Position :- Quality Assurance- Engineer- No of positions:- 1 Location:- Isnapur- Hyderabad Preferred candidate profile

Qualification : Bachelor's degree in a related field or equivalent work experience. Years of experience : 1 to 4 Years relevant experience Required skills : Proven experience in technical document control or a related field. Strong knowledge of document management software and tools. Attention to detail and the ability to work with complex technical documents. Familiarity with project management Familiarity with industry standards and regulations related to documentation. Roles & Responsibilities Manage and control all technical documents, including engineering drawings, manuals, specifications, and procedures Ensure that all technical documentation adheres to regulatory and quality standards. Facilitate the retrieval of technical documentation Collaborate with subject matter experts to review and validate technical documents Ensure that all technical documentation adheres to regulatory and quality standards.

What you will do Role Description: The Sr. Validation Engineer – Clinical Computation Platform will support the validation and operational management of clinical computation platforms at Amgen, ensuring the integrity and compliance of critical systems and data. This role involves collaboration with various Amgen teams to enhance and secure clinical operations This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with Product Managers and developers to maintain an efficient and consistent process, ensuring quality deliverables from the team. Roles & Responsibilities: Develop detailed test plans and strategies based on project requirements and specifications Perform manual and automated testing of software applications, including functional, regression, and performance testing Document and report defects and issues identified during testing, and work with development teams to resolve them Maintain detailed documentation of test/validation plans, test cases, and test results Validate that test scenarios meet feature acceptance criteria and customer expectations Maintain and ensure the quality of documented user stories/requirements in tools such as Jira Provide experienced technical support in validation to meet objectives of quality, output and cost in developing, trouble shooting, standardizing and improving new and existing equipment Prepare, execute, document, and report validation protocols in line with GxP’s and other regulatory requirements and standards Assure that all validation test procedures are in line with current technology, corporate, and governmental regulations Perform IQ, OQ, and PQ validation on processes, equipment, and systems in conjunction with suppliers as appropriate What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree with 4 - 6 years of experience in Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelor’s degree with 6 - 8 years of experience in Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma with 10 - 12 years of experience in Life Science/Biotechnology/Pharmacology/Information Systems experience Functional Skills: Must-Have Skills: Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology Experience with Agile software development methodologies (Scrum) Excellent communication skills and the ability to interface with senior leadership with confidence and clarity Experience with validation solutions, including compliance and data integrity. Good-to-Have Skills: Familiarity with cloud validation (AWS / Azure / GCP). Experience with validation solutions, including compliance and data integrity. Able to communicate technical or complex subject matters in business terms Jira Align experience Professional Certifications SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision 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 Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. 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. Equal opportunity statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with 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 an accommodation. 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.

ABOUT AMGEN 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. ABOUT THE ROLE Role Description We are looking for a skilled Validation Associate Analyst to ensure our Master Data Management solutions are of good quality , compliant and GxP validated . As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data mastering solutions and pipelines follow the required validation processes, documentation, and comply with Amgen’s standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant. Roles & Responsibilities Plan, coordinate, and execute validation activities, including qualification and validation of data products and software applications. ? Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports and get reviewed and approved Ensure validation strategies meet regulatory requirements and company standards Write Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents and get reviewed, and approved Stay updated on relevant changes to Amgen’s SOPs and ensure validation practices are aligned with evolving standards. ? Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps , engineering, and data engineering teams to drive validation activities and meet project deadlines. ? Track the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. ? Ensure timely and effective completion of all validation activities in line with project objectives and schedules. ? Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management. ? Identify opportunities for process improvements in validation activities. ? Stay current on new technologies , validation trends, and industry best practices to improve validation efficiencies. ? Collaborate and communicate effectively with the product teams. ? Basic Qualifications and Experience Master’s degree with 1 - 3 years of experience in Business, Engineering, IT or related field OR Bachelor’s degree with 2 - 5 years of experience in Business, Engineering, IT or related field OR Diploma with 6 - 8 years of experience in Business, Engineering, IT or related field Functional Skills: Must-Have Skills: 2 + years of experience in validation in a G x P -regulated environment (pharmaceutical, biotech, medical devices, etc.) Experience of working in software validation projects Strong experience on tools like ALM , JIRA etc Must have worked in Agile or SAFe projects Experience with automated and computer-controlled systems validation (21 CFR Part 11) Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation Candidate must be able to write validation scripts in ALM and execute them independently Experience with computer system validation and software validation is a plus Strong problem-solving and analytical skills Excellent communication and teamwork skills Good-to-Have Skills: Understanding of compliance and regulatory considerations in master data. In depth knowledge of GDPR and HIPPA guidelines . Good to have prior work experience in MDM domain Hand son experience on JIRA, Confluence Professional Certifications CSV Certified Agile or SAFe certified Soft Skills: Strong analytical abilities to assess and improve master data processes and solutions. Excellent verbal and written communication skills, with the ability to convey complex data concepts clearly to technical and non-technical stakeholders. Effective problem-solving skills to address data-related issues and implement scalable solutions. Ability to work effectively with global, virtual teams EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with 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.

About ValGenesis ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelligence across their product lifecycle. Learn more about working for ValGenesis, the de facto standard for paperless validation in Life Sciences: https://www.youtube.com/watch?v=tASq7Ld0JsQ About the Role: ValGenesis is the market leader in end-to-end digital validation and we are looking for a Lead Validation Engineer to join our team in Chennai. In this role you will drive the validation processes of our cutting-edge products, ensuring they meet the highest quality standards. Responsibilities Collaborating with Product, Engineering, and Testing teams to gain a comprehensive understanding of product functionalities. Reviewing Product Requirements including Epics, User Stories, and Software Requirements. Developing thorough test cases in Operational Qualification (OQ) and Performance Qualification (PQ) protocols aligned with guidelines. Creating realistic test cases and datasets based on real-world customer scenarios. Executing test cases, logging defects, documenting deviations, and reporting test outcomes. Peer reviewing test documentation to ensure quality and adherence to standards. Working collaboratively in a dynamic team environment with open communication. Understanding and adhering to Quality Management System (QMS) standards. Leading a team of engineers, providing guidance, overseeing workload, and conducting reviews. Managing product validation timelines and ensuring quality deliverables. Requirements Bachelor's or higher degree in Computer Science, Biology, Biomedical Engineering, or a related field. At least 8 years of experience in Computer System Validation and Product Software Validation in a regulated environment. Deep knowledge of the product development life cycle. Understanding of GMP, FDA, and ISO regulations. Proficiency with testing tools and Microsoft Office suite. Self-motivated with a willingness to quickly learn new technologies and products. Excellent interpersonal, writing, communication, and troubleshooting skills. Passionate about testing, validation, and product quality. Able to mentor colleagues and lead small projects efficiently. We’re on a Mission In 2005, we disrupted the life sciences industry by introducing the world’s first digital validation lifecycle management system. ValGenesis VLMS® revolutionized compliance-based corporate validation activities and has remained the industry standard. Today, we continue to push the boundaries of innovation enhancing and expanding our portfolio beyond validation with an end-to-end digital transformation platform. We combine our purpose-built systems with world-class consulting services to help every facet of GxP meet evolving regulations and quality expectations. The Team You’ll Join Our customers’ success is our success. We keep the customer experience centered in our decisions, from product to marketing to sales to services to support. Life sciences companies exist to improve humanity’s quality of life, and we honor that mission. We work together. We communicate openly, support each other without reservation, and never hesitate to wear multiple hats to get the job done. We think big. Innovation is the heart of ValGenesis. That spirit drives product development as well as personal growth. We never stop aiming upward. We’re in it to win it. We’re on a path to becoming the number one intelligent validation platform in the market, and we won’t settle for anything less than being a market leader. How We Work Our Chennai, Hyderabad and Bangalore offices are onsite, 5 days per week. We believe that in-person interaction and collaboration fosters creativity, and a sense of community, and is critical to our future success as a company. ValGenesis is an equal-opportunity employer that makes employment decisions on the basis of merit. Our goal is to have the best-qualified people in every job. All qualified applicants will receive consideration for employment without regard to race, religion, sex, sexual orientation, gender identity, national origin, disability, or any other characteristics protected by local law.

Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves to go further in our efforts to build a more equitable, inclusive world for our employees, our customers and our communities. The Role Are you passionate about delivering exceptional service and revolutionizing the world of technology? We have an incredible opportunity for a talented individual to join our dynamic team as a Plant IT Operations Lead. In this customer-centric role, you will play a pivotal role in ensuring our customers receive top-notch service within a contractual framework. As a visionary leader, you will inspire and guide our team of experts to deliver high-quality and reliable information technology services. Working closely with the latest systems, software products, and networked devices, you will align our solutions perfectly with our customers' evolving business needs. Your deep knowledge of the services we provide paired with your understanding of customer businesses, will enable you to propose and implement tailored solutions that exceed their expectations. You will be an integrated part of our customer account structure, fostering strong relationships with our customers and collaborating closely with our Delivery Partner & Customer Partner. Together, you will create an environment that promotes innovation, collaboration, and customer success. By owning the technical and managerial support for our plant IT team, field engineers, technicians, system administrators, subject matter experts, and product support personnel, you will empower them to deliver, manage, maintain, and deploy IT services effectively. When troubleshooting incidents, problems, changes, and escalations, you will be at the forefront, providing swift support to fix any issues that may arise in malfunctioning services, operations, software, or equipment. Your expertise will ensure that our systems run smoothly, offering our customers a seamless experience. As a plant operations Lead, you will have the unique opportunity to collaborate with an exceptional team of Delivery Partners, Architects, and SREs (Site Reliability Engineers). You will co-create, design, deploy, and maintain reliable, available, and future-proof systems and services. Your innovative ideas and leadership skills will play a vital role in shaping the technological landscape of our organization and the industry as a whole. If you are ready to make an impact, drive customer success, and be at the forefront of technological advancements, this is the role for you. Join our team and be part of an exhilarating journey as we reshape the IT services landscape with creativity, passion, and excellence. Your Future at Kyndryl Kyndryl has a global footprint, which means that as a Delivery Management Lead at Kyndryl you will have opportunities to work on projects and collaborate with colleagues from around the world. This role is dynamic and influential – offering a wide range of professional and personal growth opportunities that you won’t find anywhere else. Who You Are You’re good at what you do and possess the required experience to prove it. However, equally as important – you have a growth mindset; keen to drive your own personal and professional development. You are customer-focused – someone who prioritizes customer success in their work. And finally, you’re open and borderless – naturally inclusive in how you work with others. Required Skills and Experience Over 12 years of experience leading delivery teams and providing quality services to customers. Pervious experience in working with Pharma will be advantageous Strong understanding of Kyndryl competencies, managed platforms, IT services, and technology vendors. Strong understanding and knowledge of Pharam Plant IT Operations Oversee the day-to-day operations of IT infrastructure, network, applications, and support services. Ensure high availability and performance of critical systems including MES, LIMS, ERP, and SCADA. Ensure compliance with regulatory standards (e.g., FDA 21 CFR Part 11, GAMP 5, GxP). Collaborate with QA/Compliance teams to support audits and inspections. Maintain cybersecurity posture in line with corporate standards and industry best practices. Lead and mentor a team of IT professionals and support staff. Manage IT budgets, contracts, and vendor relationships. Work closely with cross-functional teams including manufacturing, QA/QC, engineering, and supply chain. Experienced in leading teams through incident, problem, and change management, as well as root cause analysis. Capable of partnering with Delivery Partners and collaborating with SREs to achieve positive customer outcomes. Hands-on knowledge of AIOps with an automation and innovation-focused mindset. Proficient in maintaining direct and ongoing interaction with customers. • Compassionate and empowering delivery resource manager, promoting growth Knowledge of IT/OT systems, industrial networking, and cybersecurity in manufacturing. Preferred Skills and Experience •Bachelor's degree •Six Sigma, PMP, and/or ITIL certifications Being You Diversity is a whole lot more than what we look like or where we come from, it’s how we think and who we are. We welcome people of all cultures, backgrounds, and experiences. But we’re not doing it single-handily: Our Kyndryl Inclusion Networks are only one of many ways we create a workplace where all Kyndryls can find and provide support and advice. This dedication to welcoming everyone into our company means that Kyndryl gives you – and everyone next to you – the ability to bring your whole self to work, individually and collectively, and support the activation of our equitable culture. That’s the Kyndryl Way. What You Can Expect With state-of-the-art resources and Fortune 100 clients, every day is an opportunity to innovate, build new capabilities, new relationships, new processes, and new value. Kyndryl cares about your well-being and prides itself on offering benefits that give you choice, reflect the diversity of our employees and support you and your family through the moments that matter – wherever you are in your life journey. Our employee learning programs give you access to the best learning in the industry to receive certifications, including Microsoft, Google, Amazon, Skillsoft, and many more. Through our company-wide volunteering and giving platform, you can donate, start fundraisers, volunteer, and search over 2 million non-profit organizations. At Kyndryl, we invest heavily in you, we want you to succeed so that together, we will all succeed. Get Referred! If you know someone that works at Kyndryl, when asked ‘How Did You Hear About Us’ during the application process, select ‘Employee Referral’ and enter your contact's Kyndryl email address.

Computer System Validation Role Currently, we are urgently looking for junior/ mid-senior Labs System CSV / Validation professional for an opportunity in our consulting organization. Desired Skills and Experience A CSV consultant will use his/her knowledge of FDA cGMP and related regulations and guidelines, and specific knowledge of computer validation methodologies and principles to perform CSV on a variety of systems and programs. Experience of QA in a FDA regulated environment is preferred. At least 2 years of Computer System Validation or any validation experience required. Experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report). Experience in any other validations (cleaning, process, etc.), temperature mapping etc. would be a plus: Excellent communication skills. Ability to work as a team player in a consulting environment. Proficiency with MS Office tools. Documentation management Strong Project Management experience (preferred but not required)

Job Description The scope of work for this role is to provide QA Validation support to validation activities associated with of Laboratory instruments and Manufacturing equipment in pharmaceutical industry. The responsibility includes review and approval of Qualification/Validation documentation DQ,IQ,OQ,PQ including Risk assessment, specifications, executed protocols, summary reports, deviations, periodic reviews, procedures, and change controls. In addition, this role may provide support to the sites data integrity initiative. Successful candidate requires a strong working knowledge of global cGMP with an emphasis on validation lifecycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures Candidate requires strong interpersonal, oral and written communication skills as there is a high degree of collaboration required between members of QA Validation/Qualification personnel. Candidate must be detail oriented as the main job responsibility is review and approval of validation documentation Should also have some experience in Mechanical Qualification Job Requirements Skills: Strong working knowledge of global GMPs with emphasis on validation, including computer validation Strong interpersonal, oral and written skills Detail oriented Education: Candidate must have at a minimum a BE or equivalent, engineering or related sciences with pharmaceutical or biopharmaceutical experience in a quality assurance and/or validation/Qualification role. Past experience working with Equipment Qualification, Quality Management system, Document, Document Management System, Track wise, and etc. Experience working with process manufacturing equipments (RMG, Sifter, Blender, compression m/c, Capsule filling m/c & etc), Utility (Water system, HVAC & etc) and other lab instruments is a plus.

Role & responsibilities Knowledge on Design, develop, and improve manufacturing processes for medical devices. Support and implement lean manufacturing and Six Sigma methodologies to enhance efficiency and reduce waste. Ensure manufacturing processes comply with FDA (21 CFR 820), ISO 13485, and other relevant medical device regulations Develop and maintain process validation (IQ, OQ, PQ) and documentation. Support root cause analysis (RCA) and corrective/preventive actions (CAPA) Provide technical support for new product introductions (NPI) and process transfers Knowledge on lean tools and techniques EXPERTISE AND QUALIFICATION S VSM, process improvement, layout design

Academic: 1. Should have minimum qualification of M.Sc preferably in chemistry. 2. Minimum 10+ years experience 3. Academic career should be good (preferably first class and above) 4. Candidate will be preferred having good communication skill and writing Job Profile: Equipment Qualification protocol / report review DQ, IQ, OQ, PQ, FAT & SAT Should have knowledge of API process equipment like reactor, centrifuge etc. Equipment URS review, Layout, P & ID review Handling of QMS documents Like Change control, Deviations, Incidences, Performing the Investigation using different investigation tools. Performing the Risk Assessment like nitrosamine Risk Assessment, Quality risk Assessment. HVAC Qualification, PP area Qualification. Handling of temperature mapping activities. Facility Qualification

1) To prepare the Standard operating procedure for Engineering Department. 2) Operation & Maintenance of Purified Water System, UF, CSRO, HSRO, EDI & Distribution loop system 3) Operation & Maintenance of HVAC/AHU system in API Industry, Pressure balancing, Filter cleaning & area validation activity at site. 4) To prepare qualification documents DQ/IQ/OQ for the equipment to be install at site. 5) To prepare preventive maintenance schedule for the newly installed equipment. 6) To comply the Engineering related points as per cGMP & GDP practices. 7) To Orient the Engineering Team towards Updated Knowledge for cGMP and Regulatory Norms. 8) To maintain discipline with co-employees & workers. 9) To initiate & implementation ideas with respect to energy conservation. 10) To allocate manpower as per work priority. 11) To ensure the critical equipment spares as availability and Co Ordinate with engineering store. 12) To maintain engineering related documents. 13) To act as training coordinator.

Designation: Quality Assurance Chemist Location :Medchal, Hyderabad Qualification: B.sc/B.pharma Experience: Min.3 relevant exp as Qa chemist Package: 4-5LPA Shifts: General shifts If interested Contact: 8247381453 Share Cv laxmi@hireiton.com Required Candidate profile • Qualification of utilities like Purified Water systems • Reviewing BMR/BPR & issuing analytical worksheets, logbooks • Must have worked in a pharmaceutical company in the past

1. To review URS, DQ of new equipment, system & utilities like HVAC, Water system, Compressed air, Nitrogen system etc. 2. To prepare, monitor and review of qualification documents i.e. FAT, SAT, IQ, OQ & PQ protocol and reports. 3. To review all types of area layouts. 4. To execute the facility qualification for release facility in routine use. 5. To review calibration certificate of instruments. 6. To review preventive maintenance report. 7. To prepare, monitor and review temperature mapping protocol and report of equipment and area. 8. To tracking of periodic qualification of equipment, area and inform to responsible person. 9. Prepare & review of Standard Operating Procedure. 10. Preparation & review of Quality risk assessments report. 11. Preparation of Product Quality Review Report. 12. Preparation & review of Trend report of Deviation, Market Complaint, Out of Specification, Out of trend, Return Goods. 13. Release of RM/PM/FP & Intermediates in SAP system. 14. Perform internal audits of different departments. 15. Knowledge about GEMBA walk / Walk through audit in respective department and ensure the compliance of identified observations. 16. Initiation, review, evaluation & closure of change controls as initiator or QA coordinator role. 17. Issuance, archival and control of all documents likes SOPs, MPCR, format and logbook. 18. Withdrawal of raw material, intermediate/ finished product, stability, hold time and equipment cleaning (swab) samples.

Job description Job Title: Desktop Support Engineer | Pharma Industry | Bangalore /Hyderabad Location Company: Instrumentation and Control Solutions (ICS) Website: www.ics-india.co.in Location: Bangalore/Hyderabad Experience: 2-8 years (Pharma Industry experience mandatory) Qualification: BE/B.Tech/ Any Graduation Key Responsibilities: Maintain inventory of manufacturing automated systems, including PLCs and SCADA systems. Install and maintain computer hardware and peripherals. Install and upgrade operating systems and computer software. Troubleshoot networking and connection issues. Provide recommendations for software or hardware upgrades. Assist in 21 CFR Part 11 compliance assessments during computerized system selection. Prepare and maintain IT-related SOPs for Manufacturing Automated Systems. Participate in the qualification and validation of automated systems from an IT perspective. Prepare daily reports and manage manual backups (weekly/monthly/yearly). Manage service and incident requests via the help desk dashboard. Skills Required: Strong technical knowledge. Basic understanding of computer systems and networks. Eagerness to learn new technologies and processes. Why Join Us? Work with a reputed MNC Pharmaceutical Client. Be part of a dynamic team focused on cutting-edge technology in manufacturing automation. Enjoy a collaborative and growth-oriented work environment. Application Process: Interested candidates can share their updated resumes at hr@ics-india.co.in or contact us at 9109102346 for further details. Note: This is a full-time position requiring candidates with prior experience in the pharmaceutical industry. Connect me on LinkedIn- www.linkedin.com/in/nikita-sen-2a9565114

Works with engineers to develop sampling, quality tools, and PFMEA. Leads PPAP, ensures supplier qualification via IQ, OQ, PQ. Manages supplier list compliance with strong Supplier Quality experience in medical devices.

1) To prepare the Standard operating procedure for Engineering Department. 2) Operation & Maintenance of Purified Water System, UF, CSRO, HSRO, EDI & Distribution loop system 3) Operation & Maintenance of HVAC/AHU system in API Industry, Pressure balancing, Filter cleaning & area validation activity at site. 4) To prepare qualification documents DQ/IQ/OQ for the equipment to be install at site. 5) To prepare preventive maintenance schedule for the newly installed equipment. 6) To comply the Engineering related points as per cGMP & GDP practices. 7) To Orient the Engineering Team towards Updated Knowledge for cGMP and Regulatory Norms. 8) To maintain discipline with co-employees & workers. 9) To initiate & implementation ideas with respect to energy conservation. 10) To allocate manpower as per work priority. 11) To ensure the critical equipment spares as availability and Co Ordinate with engineering store. 12) To maintain engineering related documents. 13) To act as training coordinator.

Position Overview: We are seeking a knowledgeable and results-driven CSV Engineer to join our team, specializing in providing expert validation services to our clients. In this role, you will work closely with a diverse range of companies, ensuring the compliance, reliability, and quality of their computerized systems while adhering to industry regulations and best practices. Key Responsibilities: Validation Strategy and Planning: - Collaborate with clients to develop tailored validation strategies and plans based on their specific needs and regulatory requirements. - Assess project scope, goals, and timelines to design efficient validation approaches. Validation Execution: - Design, develop, and execute validation protocols, including IQ, OQ and PQ to verify system functionality and compliance. - Provide on-site or remote assistance during testing and data collection phases. Documentation and Reporting: - Generate comprehensive validation documentation, such as validation master plans, Risk assessment/GxP Assessment, FS, CS, FRA, test scripts, 21 CFR PART 11 Assessment and validation reports. - Create clear and organized documentation that demonstrates compliance and traceability. Change Control and Risk Management: - Collaborate with clients to assess and manage risks associated with changes to computerized systems, ensuring proper change control procedures are followed. - Advise on the impact of changes and recommend appropriate validation strategies. Regulatory Compliance: - Stay up-to-date with relevant regulations, guidelines (e.g.,21 CFR PART 11, EU Annexure 11, cGMP, GAMP5, Data Integrity etc.), and industry trends related to computer system validation. - Apply your expertise to guide clients in meeting regulatory requirements during the validation process. Client Collaboration: - Build strong working relationships with clients, acting as a trusted advisor and validation expert. - Provide guidance, recommendations, and regular updates to ensure successful validation outcomes. Training and Support: - Provide training to Perfect Utilities engineers involved in the validation process, empowering them to understand and implement validation principles. Continuous Improvement: - Offer insights and suggestions for process improvement and optimization within the validation lifecycle. Required Qualifications and Candidate Profile: Diploma, Bachelors Degree or equivalent in technical area preferred 1-5 years of hands-on experience in computer system validation of PLC based complex system preferably across different industries and systems. Knowledge of BMS, DCS, Lab Software Validation, Vision Software Validation. Being familiar with validation principles, regulatory requirements (e.g., 21 CFR PART 11, EU Annexure 11, cGMP, GAMP5, Data Integrity etc.) Proven track record of delivering successful validation projects and ensuring compliance. Excellent communication and interpersonal skills to collaborate effectively with diverse clients. Candidate should be ready for travelling across India. Benefits: As a valued member of our team, you will enjoy the opportunity to work with a range of clients, contribute to their success, and expand your professional network. We offer competitive compensation, a dynamic and supportive work environment, and the chance to make a meaningful impact in the industry by delivering exceptional validation services. If you are a skilled CSV Engineer with a passion for assisting companies in achieving compliance and reliability in their computerized systems, we invite you to join us. Help us provide top-notch validation expertise and contribute to our clients' growth and success.

CSV Overall, 10 + Yrs. of experience in SAP CSV Validation Services. Developing validation strategies and plans for SAP implementations, upgrades, and modifications to ensure compliance with regulatory requirements. Conducting System GMP impact assessment, GAMP category assessment, ERES applicability assessment, Requirement/ Functional risk assessment after establishing communication with relevant stakeholders. Conducting change assessments and impact analyses to identify mandatory validation deliverables. Collaborating with cross functional teams, including IT, Business Process, CSV and Quality Assurance to ensure alignment on validation deliverables. Creation, execution, documentation, and review of validation plan, including FDS, BDS, TDS, test plan/ scripts, IQ/OQ/PQ Protocols, Traceability Matrix, validation reports and Release notification (Go Live). Support in defect management/ discrepancy investigation if any as part of the validation deliverables. Providing guidance and support to project teams on validation best practices and compliance requirements. Submit the complete Change/Incident/Project documentation with evidences for review and approvals by the business/quality teams. Upon acquiring all approvals, shall communicate to the development/transport/Basis teams to deploy the change/incident/project in Production environment. Ensure the change/incident/project in Production environment is deployed without any deviations. Participating in validation related meetings, training sessions. Participate in Governance reviews, status reporting and handling of escalations Keeping abreast of industry trends, regulatory changes, and best practices related to CSV in SAP. Contributing to the continuous improvement of validation processes and procedures within the organization. Support during Client Visit and Regulatory inspections.

Description 1. Ensure Review and Approval of planning, execution and documentation of Change Management Activities (at Asses / Review states); along with associated lifecycle documents and test documents for Change Lifecycle by maintaining the IT Compliance standards. 2. Responsible for the review and approval of Test Scripts and executed test cases to assure compliance with good documentation practices. 3. Individual contributor for Quality, Compliance, and Good Documentation Practices 4. Experienced in authoring review of validation documentation such as URS, FRS, and SDS, Validation Plan, Issues Log, Design Review, IQ Protocol/Report, OQ Protocol/Report, Test Cases, Test executions, Trace Matrix, and Validation report, etc. 5. Working on Defect Management, CAPA and Deviation documentation, review and approval. working on testing and validation management tools like ServiceNow, HP ALM, Document Management (GDRS/ EDMS), or equivalent tools, etc. 6. Research in supporting systems (e.g., GDRS, ServiceNow, EDMS, etc.) that store the records to be reviewed 7. Sign Approve request forms for HPQC as IT Compliance approver. Named Job Posting? (if Yes - needs to be approved by SCSC) Additional Details Global Grade C Level To Be Defined Named Job Posting? (if Yes - needs to be approved by SCSC) No Remote work possibility No Global Role Family To be defined Local Role Name To be defined Local Skills validation Languages RequiredENGLISH Role Rarity To Be Defined

Project Role : Tech Delivery Subject Matter Expert Project Role Description : Drive innovative practices into delivery, bring depth of expertise to a delivery engagement. Sought out as experts, enhance Accentures marketplace reputation. Bring emerging ideas to life by shaping Accenture and client strategy. Use deep technical expertise, business acumen and fluid communication skills, work directly with a client in a trusted advisor relationship to gather requirements to analyze, design and/or implement technology best practice business changes. Must have skills : Computer System Validation (CSV) Good to have skills : Life Sciences Minimum 2 year(s) of experience is required Educational Qualification : BE Summary :As a Tech Delivery Subject Matter Expert in Business Process Architecture, you will be responsible for driving innovative practices into delivery, bringing depth of expertise to a delivery engagement. Your typical day will involve using your expertise in Computer System Validation (CSV) to analyze, design and/or implement technology best practice business changes, while working directly with clients in a trusted advisor relationship to gather requirements. Roles & Responsibilities: Lead the analysis, design and/or implementation of technology best practice business changes using your expertise in Computer System Validation (CSV). Collaborate with cross-functional teams to ensure successful delivery of projects. Provide subject matter expertise to clients and internal teams on Computer System Validation (CSV) and related topics. Stay updated with the latest advancements in Life Sciences and related technologies, integrating innovative approaches for sustained competitive advantage. Professional & Technical Skills: Must To Have Skills:Expertise in Computer System Validation (CSV). Good To Have Skills:Knowledge of Life Sciences. Strong understanding of business process architecture and related technologies. Experience in collaborating with cross-functional teams. Excellent communication and interpersonal skills. Additional Information: The candidate should have a minimum of 2 years of experience in Computer System Validation (CSV). Qualification BE

Description Talent with Lifesciences domain experience with Manual testing and GxP testing skills Named Job Posting? (if Yes - needs to be approved by SCSC) Additional Details Global Grade B Level To Be Defined Named Job Posting? (if Yes - needs to be approved by SCSC) No Remote work possibility No Global Role Family To be defined Local Role Name To be defined Local Skills Manual tester with GXP life science Languages RequiredENGLISH Role Rarity To Be Defined

Documentation Management: Lead the creation, review, and approval of qualification documents (DQ, IQ, OQ, PQ). Revision Control: Maintain effective revision control to ensure all documents are current and compliant. Quality Assurance: Collaborate with QA teams to meet regulatory and quality standards. Training and Support: Provide training on documentation practices and regulatory compliance. Cross-Functional Collaboration: Work with engineering and validation teams for comprehensive documentation. Audit Readiness: Ensure documentation is complete and accessible for audits. Process Improvement: Identify and implement best practices to enhance documentation workflows. Regulatory Compliance: Stay updated on industry regulations and align documentation practices accordingly. Risk Management: Assess documentation-related risks and implement corrective actions. Reporting: Generate reports on documentation status and compliance metrics for senior management.

Responsibilities: Will be responsible for handling HVAC, water treatment plant, compressed air, handling of boiler / chiller / air compressor & ETP and pharmaceutical machinery, repairs and maintenance. Will be responsible for AMC and preventive maintainance Schedule and will be responsible for plant maintenance. The candidate must have knowledge of BMS systems, handling PLCs and also have knowledge of DQ, IQ, OQ and PQ. Keeping equipment operational by coordinating maintenance and repair services, following manufacturer's instructions and established procedures, requesting special services will all be part of the job responsibilities Will be involved in handling all pharmaceutical machinery. Will be responsible for confirming system and product capabilities by designing feasibility and testing methods, testing finished product and system capabilities; confirming fabrication, assembly, and installation processes. Responsible for keeping equipment operational by coordinating maintenance and repair services; Maintain product and company reputation by complying with government regulations Develop processes by designing and modifying equipment as per the requirement and making sure the project is completed by training and guiding technicians. Prepare reports by collecting, analyzing, and summarizing information and trends. Provide engineering information by answering questions and requests. Maintain system and process data base by writing computer programs and entering data. Experience with computer software, AutoCAD, Microsoft Word, Powerpoint & Excel Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies. Needs to be self-motivated, cooperative, work well with others Ability to trust Team members and support Team Decisions Roadmap would be heading the engineering department. Should be able to contribute to team effort by accomplishing related results as needed. Should have managed a team/teams.