16 Empower Jobs

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/#!/

What you will do As Senior Manager Information Systems, you will lead a dynamic team of Validation Engineers, Software Developers, and and Scrum masters responsible for the ongoing maintenance and management of Amgen Operations Digital Lab Infrastructure. You will also be the reporting manager for this team and will be responsible for the coaching and development of these resources. Maintain strategic relationships and strong communication with the leadership team to ensure all collaborators feel informed and engaged Oversee the software, hardware, and firmware development lifecycle, ensuring standard methodologies in development, testing, and deployment across the product teams Lead and handle large, teams with varied strengths within a matrixed organization, collaborating with geographically dispersed teams, including those in the US and international locations Develop and implement strategic plans for technology and workforce growth, including recruiting top talent and building a robust team in India Developing talent, motivating the team, delegating effectively, championing diversity within the team, and acting as a role model of servant leadership Ensuring global ways of working are embedded in the local organization Develop a culture of collaboration, innovation, and continuous improvement, driving talent development, motivation, and effective delegation Fostering standard methodology sharing and alignment with business goals Collaborate with Platform Owners, Product Owners, Service Owners, and delivery teams to ensure delivery matches commitments, acting as a critical issue point and facilitating communication when service commitments are unmet Participate in team member and leadership meetings, working with other parts of the organization and functional groups to ensure successful delivery and alignment with strategy, compliance, and regulatory requirements Remain accountable for ensuring overall organizational compliance with quality and GxP in technology services Monitor emerging technologies and trends to find opportunities for platform growth and expansion Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The ideal candidate will have a consistent track record of leadership in technology-driven environments with a passion for fostering innovation and excellence in the biotechnology industry. The role requires strong expertise in handling the security and compliance of Lab Instrument Controllers at the Global Enterprise Level as well as enhancing the digital experience for Lab Scientists in streamlining and accelerating their business process workflows. They should also have experience leading and effectively working with large, diverse and globally dispersed teams within a matrixed organization. Extensive collaboration with global cross functional teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a strong background in the end-to-end software development lifecycle, technical product ownership, business analysis, be a Scaled Agile practitioner, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational critical initiatives, develop a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Basic Qualifications: Doctorate Degree and 2 years of experience in Engineering, IT or related field OR Masters degree with 8 - 10 years of experience in Engineering, IT or related field OR Bachelors degree with 10 - 14 years of experience in Engineering, IT or related field OR Diploma with 14 - 18 years of experience in Engineering, IT or related field Strong knowledge of COTS (Commercial-off-the-shelf) Validations on HPLCs, UPLCs, CEs, GCs, standalone systems like Titrators, Cary60, Cell Counters, Solo VPE etc. and other Lab Instrument Controllers Demonstrated experience of IT support in a Life Sciences, Pharmaceutical, Biotech company or equivalent industry or knowledge of the pharmaceutical industry GxP system qualification and validation processes for computer related systems Proven knowledge of Microsoft Windows system administration. Knowledge of Linux systems will be a plus. Experience with scientific data acquisition systems like SDMS, Empower, Chromeleon, and Electronic Lab Notebooks Integration Proven leadership skills with the ability to lead large matrixed teams. In addition, demonstrated experience in leading and developing a hard-working team of technology professionals, building a culture of innovation and continuous improvement within the team to deliver powerful solutions and platform improvements. Strong skills in collaborating and communicating with cross-functional teams, business collaborators, and executives to ensure alignment of platform initiatives with business outcomes, handling expectations, and ensuring successful delivery of projects. Experience with Advancing Capabilities and Delivering Innovative Technology Solutions in a Pharma/Biotech environment Degree in Computer Science, Information Systems, Engineering, or Life Sciences. Preferred Qualifications: At least 5 - 8 years of domain knowledge in health and/or life sciences combined with Information Technology Understanding and applied experience in Lab Informatics and cross functional data harmonization Leadership experience within a highly regulated pharmaceutical or technology organization, with the ability to ensure compliance with industry regulations and standard methodologies for GxP software validation. Strong analytic/critical-thinking and decision-making abilities. Demonstrated ability to work effectively in a fast-paced, dynamic environment. Extensive experience in the software development lifecycle. Experience using and adoption of Scaled Agile Framework (SAFe) Understanding of ITIL processes and implementation. Established business partnerships and IS governance practices involving senior business partners Experience handling vendor relationships and working with external partners or consultants to ensure optimal performance, support, and development of digital products. Soft Skills: Excellent leadership and team management skills. Strong transformation and change management experience. Ability to work effectively with global, virtual teams. Excellent analytical and troubleshooting skills. Ability to handle multiple priorities successfully. Strong presentation and public speaking skills. Strong verbal and written communication skills. High degree of initiative and self-motivation. Work Hours: 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.

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/#!/

Hi, We are having an opening for Executive/Sr. Executive- R&D IT at our Gurgaon location Job Summary : R&D-IT Executive/Sr. Executive will be responsible for supporting IT applications, managing QMS across R&D Gurgaon functions. The person should have a strong understanding of CSV. The role requires a good understanding and experience in R&D/Lab policies and procedures to ensure applications/QMS are comply as per the applicable regulation. Job Description : Role and Responsibilities Application support for R&D applications (PMS, NuGenesis, Empower, Amplexor etc.) Managing and closure of assigned QMS within the timelines Application implementation support, testing and documentation of ongoing assigned projects Helping and providing IT support to business users during Performance Qualification phase Perform miscellaneous job-related duties as assigned Qualifications Bachelor's degree in Information Technology, or Computer Science or related field. Minimum of 3-5 years of experience in application support, preferably Pharma/ life sciences domain Strong understanding of CSV Software Development Life Cycle Preferred Qualifications Experience in NuGenesis and Empower is preferred Good documentation skills to create and manage GxP documents

Job description OpenText Exstream Developer - IMMEDIATE requirement. Please respond with your updated resume if you can immediately, within 2 weeks. Responsibilities Work with business partners and development teams to create letter/document applications based on requirements. Translate technical and/or design specifications into code for new or enhancement projects. Support of OpenText infrastructure. Provides technical support and troubleshooting for system related issues. Required Qualifications Bachelor's degree in computer science, Engineering or equivalent. 3 to 5 years development experience in OpenText Exstream Knowledge or work experience in Communication Server, CAS, OTDS and Empower Experience designing email templates using Containers 3 to 5 years of experience with Exstream output format handling AFP, PDF, HTML Experience supporting Opentext infrastructure.

Experience: 8 to 12Years Location Bangalore, Hyderabad, Pune Notice period : Immediate to 30days Mandatory Skill - Labware LIMS, Caliber LIMS, Empower Job Description 8-12 years of experience in Labware LIMS ( Development, support, upgrade implementations) Experience in management of stakeholders/vendors/teams of IT engineers. Experience in troubleshooting and resolving performance issues, System and Application Log analysis experience required. Proficient in LabWare ELN and Method Execution (v7) modules. Experience in SQL, PLSQL and Good knowledge of SDLC / ITIL processes, change management, ticket management, SNOW reports customization, creating Pharma domain specific SOPs, WI, process and policies to meet 21CFR Part 11 compliance requirement. Proficient in LIMS Basic coding, debugging and crystal reports configurations and enhancements. Well versed with all the Labware (v6,v7,v8) modules (EM, Stability, Labstation, Inventory, sample management etc) Should have Familiarity with applications like Caliber LIMS, Lonza MODA, CDS (Empower, Nugenesis, chromeleon) Handling escalations and addressing them as per business requirements, Sound knowledge of key Pharma QC and R&D laboratory processes, products and services. Must have knowledge in Trackwise (CAPA, Investigation), any document maintenance tool like Documentum, HP ALM Testing tool. Good verbal and mail communication skills, flexibility in working on global time zones.

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

Preferred profile : Bachelors / Masters (electronics and instrumentation / Computer science / IT) with 3 5 years experience. Roles & Responsibilities: Ensuring smoot GxP IT operations at site. Ensuring that IT operations in the facility are running smoothly. Effective management of system administration and operations. IT activities are managed in the plant with respect to procedures and policies. Providing necessary support to the plan for the business contunity and maintaining procedures in the facility to achieve 100% uptime GxP IT function. Ensure the periodic review and governance of IT systems to validate their ongoing compliance and effectiveness. Instrument software troubleshooting EMPOWER/FTIR/ICDAS/SCIEX Analyst / Agilent CDS / SEPAX-C PRO / BD FACSUITE / LOVO / DENOVIX / Osmometer / Nucleon cell etc., Knowledge of GXP windows server and active directory and GPO design & management. Participate and support all cGMP / GLP / GCP audits conducted at the site. Manage desktop/laptop support/PC Hardware, L1 AD Maintaining networking LAN/WAN, Printer support. Windows 7/8/10 installation and troubleshooting. Work on MS office, Outlook, Exchange knowledge, AV installation/update, and maintenance. Computer system validation executions To follow good documentation practices Performing any other activity delegated by reporting manager or designated authority. Qualification of servers Preparation of operating procedures Quality management system document handling Privileges executed based on GXP requirements. Audit trail and Event Logs verification

Job Summary: We are seeking an experienced Labware LIMS Developer with 3 to 7 years of hands-on experience to join our team. The ideal candidate will possess a deep understanding of Labware LIMS software and its integration into laboratory processes. The candidate will be responsible for the design, development, customization, and support of the LIMS system. Key Responsibilities: Labware LIMS System Development and Customization: Design, develop, and implement Labware LIMS configurations, enhancements, and customizations. Develop and maintain Labware LIMS workflows, interfaces, and modules. Create custom reports, dashboards, and data visualizations within the Labware LIMS platform. Integrate Labware LIMS with other laboratory systems and enterprise systems (e.g., ERP, CDS and Empower). System Support and Maintenance: Provide ongoing support for Labware LIMS by troubleshooting issues, identifying bugs, and implementing solutions. Perform system upgrades and patch management for Labware LIMS. Monitor system performance, address issues, and ensure data integrity and reliability. Collaboration and Requirement Gathering: Work closely with laboratory and business teams to understand system requirements and ensure LIMS meets operational needs. Prepare and maintain technical documentation, including requirements, system configurations, and testing procedures. Required Qualifications: Experience: 3 to 7 years of hands-on experience in Labware LIMS development, customization, and support. Technical Skills: Strong experience with Labware LIMS software, including configuration, customization, and implementation. Proficiency in programming languages such as JavaScript, C#, or Java, and experience with Labware LIMS scripting. Experience with SQL and database management (e.g., MS SQL Server, Oracle). Familiarity with Labware LIMS integration technologies (e.g., web services, APIs, XML). Experience with LIMS testing, validation, and documentation for regulatory compliance. Education: Bachelor’s degree in Computer Science, Information Technology, or related field (or equivalent experience). Knowledge of Regulatory Standards: Understanding of regulatory guidelines such as 21 CFR Part 11, GxP, and other industry-specific standards. Problem-Solving Skills: Strong analytical skills with the ability to troubleshoot and resolve technical issues effectively. Communication Skills: Excellent verbal and written communication skills, with the ability to collaborate effectively with both technical and non-technical teams. Team Player: Ability to work effectively within a team and independently in a fast-paced environment.

Department - Quality Analyst Position : Executive / Senior Executive Experience : 3 to 6 Years Qualification : MSc/Bsc/Bpharma/Mpharma Location : Jaipur Experience in Tablet/Capsule/Liquid Oral Formulation. Immediate Joiner Preferred

Job Role: Mandatory area: Knowledge on 21 CFR Part 11 / EU Annexure 11, GMP, GAMP5 guidelines Adequate knowledge in CDS (preferably in Empower) and non-CDS applications. Knowledge in backup and restoration such as Veritas, Veeam, and Symantec. Knowledge of Computer System Validation Hands-on experience working in managing Active Directory, DNS, and DHCP Knowledge on Antivirus, Windows Patching activity including functionality & ease of using it. Daily Helpdesk troubleshooting and analytical approach while resolving various user calls. Adequate networking knowledge, including troubleshooting knowledge on LAN, WAN, and IP addressing. Hands-on experience in troubleshooting client end O365 Apps i.e., MS Outlook, Teams, One Drive, Excel, Word & PowerPoint Desirable Area Maintaining escalation matrix and understanding its requirement. Experience in documentation activities such as SOP preparation, change controls, and deviation handling. Knowledge of IP phone and EPABX management. Experience in CCTV camera systems and DVR/NVR management. Familiar with OS installation, configuration, and managing. Strong skills in laptop/desktop hardware troubleshooting.

Role: Informatics Account Manager || Location: Bangalore, Hyderabad, Ahmedabad Exp - 6-12 yrs Key skills: Should have relevant experience handling laboratory software sales - Informatics Software - Empower / NuGenesis along with good knowledge of Waters Instruments like LC/MS / LC-MS / HPLC. JD: As Product Specialist Informatics: you are an ambassador of Waters and will bring to the market Waters products and services. You will demonstrate a clear grasp of understanding the customers business and its growth plans, as well as be able to take the knowledge and convert that into a solution and offering from Waters, with a primary aim of bringing customer success. This position brings you a great degree of flexibility working in the field. Your role will be designated to either a territory and/or markets. 1.Addressing new and existing customers in diverse markets (All Market: Informatics solutions) 2. Maintaining and developing existing customer and identifying and developing new accounts; 3. Regularly visiting customers within the assigned territory; 4. Organizing, delivering and following up seminars and workshops at customer sites; 5. Providing customers with high quality technical advice whilst maintaining a focus on maximizing the sales potential; 6. Collaborating, liaising and providing guidance and support across departments to ensure customer success. You will be working closely with all other groups at Waters (e.g. Instrument Sales, Chemistry Operation and Service dept etc.); 7. Formulating and successfully implementing business plans; 8. Planning and prioritizing personal time and sales activities; 9. Adhering to Waters and customers relevant Health, Safety and Environment requirements when on site and as an individual employee; 10. Using related systems, e.g., Sales Force, Quotation system, with a keen mind on improvements and upgrades. Education: University Degree in Chemistry or Engineering or equivalent Experience: 6-10 years of experience in IT solution or similar sales or service. Knowledge of Chromatography, Pharmaceutical Lab Compliance and its application Nice to have technical and practical solution Selling Experience, particularly in selling High end Technology products will be an added advantage Competencies: Highly passionate individual with charisma, perseverance and determination, plus the ability to work effectively in competitive sales situations. Customer focused with good level of listening skills. Ability to understand and communicate technical & commercial values. Good interpersonal skills with a positive sense of humors and is able to contributing as part of an integrated sales/service organization; Good priority setting and organizational skills. Proficient English and regional Language Skills. Travel: A clean driving license and a valid passport will be required. This is a territory-based position with travelling within your designated territory, and occasional travels to other countries for activities such as governance of department, local business support, meetings and training. A disclosure of any criminal convictions may be required as some of our customers work in sensitive and confidential government areas.

Product Validation ~Documentation Control ~Equipment Validation & Qualification ~Product Lifecycle Management ~Defect Management ~Project Handling Expertise Knowledge of FDA regulations, EU guidelines, CSV, GAMP guidelines and product development process. Ensuring the quality compliance with respective areas and GxP guidelines. Significant exposure in maintaining & ensuring stringent adherence to quality, identifying gaps, norms & practices. Abilities to understand their requirement related to product they need and deliverables. Abilities in implementing quality plans with focus on identifying gaps. Key result Areas: Execution and compliation of CSV Qualifications for all the GxP applications in Manufacturing area. Execution of Qualification activities IQ, OQ, PQ for all GxP systems in the manufacturing process equipments. Administration and User Management of all the laboratory applications, Instruments, Manufacturing process Equipments as per SOP. Vendor co-ordination for all the IT related news projects and requirements. Co-ordination with CFT's for qualification document approvals. Performing the User ID Role Matrix, Manual Backup periodic activity as per SOP. Ensuring that validation activities align with relevant regulations such as FDA 21 CFR Part 11, EU Annex 11, and other applicable guidelines. Ensuring all documentation aligns with regulatory expectations and internal quality standards. Responsible for curation and review of quality and validation documents with assurance of GxP compliance, adherence to safety polices. Responsible for knowledge sharing to new joiners on projects and standard operating procedure. Responsible for putting ideas and suggestions to teams with respect to process & projects.

Job Summary We are seeking an associate for the Quality team responsible for conducting sampling and analysis of packaging and raw material samples. The role involves ensuring accuracy in documentation, adherence to safety procedures, reporting discrepancies, and maintaining lab safety. Roles & Responsibilities • You will be responsible for conducting sampling and analysis of raw material samples as allotted by the group leader. • You will also be responsible for the proper use and care of instruments or equipment as instructed in relevant SOPs (Standard Operating Procedure), including cleaning before and after analysis. • You will adhere to safety precautions and procedures during analysis. • Your responsibilities include placing SOP/STP/reference standards at their designated locations after analysis, and reporting discrepancies or incidents promptly to the Group Leader. • Lab safety, following JSA (Job Safety Analysis), and using proper PPE (Personal Protection Equipment) at the workplace are emphasized. • You will oversee the handling and upkeep of the chemical and solvent store, preparation of Spec-check, catalog, and result entries, as well as maintaining volumetric solutions and reagents. • Your role also includes preparation of out lab testing samples (as required), timely destruction of samples as per SOP and any additional responsibilities assigned by the Group Leader. Qualification Educational qualification: A Bachelor’s degree in Chemistry, Analytical Chemistry, or a related field Minimum work experience : 2 to 5 years of experience in a laboratory setting, preferably in the pharmaceutical or related industry Skills & attributes: Technical Skills • Proficient in various analytical techniques, including sampling and analysis of raw material samples. • Experience with the operation and maintenance of analytical instruments like HPLC, GC, Potentiometer, Particle Size Analyzer, XRD, ensuring proper use and care as per SOPs. • Competent in LIMS activities related to sample tracking, documentation, and data entry. • Knowledgeable about cGMP, SOPs, and STPs, ensuring accurate documentation and adherence to specifications. • Adheres to safety precautions and procedures during analysis, emphasizing the importance of lab safety, JSA (Job Safety Analysis), and proper use of PPE (Personal Protective Equipment). • Expertise in handling and upkeep of the chemical and solvent store, including the preparation and maintenance of volumetric solutions and reagents. Behavioural Skills • Keen attention to detail in analysis and documentation, ensuring accuracy in all tasks. • Effective communication and collaboration skills for communicating with the Group Leader, reporting discrepancies, incidents, and providing timely updates. • Takes initiative in ensuring the proper use and care of instruments, timely destruction of samples, and other assigned responsibilities. • Demonstrates problem-solving skills in addressing discrepancies, incidents, and ensuring smooth laboratory operations. • Upholds ethical standards, compliance with SOPs, and follows regulatory requirements in all activities. 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/#!/

Roles and Responsibilities To participate and prepare/ review Computer System Validation and IT-QMS documentation To implement automation at site in coordination with IT, CSV, and user departments To implement software at site i.e. Labware LIMS, SAP, e-QMS, e-DMS, e-LMS, Minitab, e-BMR, Lab-solution, Empower etc. To perform / participate in qualification / periodic qualifications of software at site To prepare compliance documents preparation against observations related to computer systems To participate / perform self-inspections / internal audits at site To prepare SOPs in Quality Assurance Department To involve in Regulatory audits/customer audits for the compliance of Software & IT systems at site. To participate in qualifications of IPC/ SCADA, PLC, HMI system based equipment. To participate in qualifications/calibration of system connected / standalone instruments in laboratory. To perform GAP assessment of computerized system with respect to regulatory and current requirements in GMP To perform and review Data Backup, Verification and Restoration in GxP systems. To perform / review Preventive Maintenance of GxP system software. Skills & Knowledge Required in Candidate Sound knowledge in automation / Software implementation in the pharmaceutical industry Management of GxP automation activities and compliance at site. Good communication and interpersonal skills EU/ TGA/ ANVISA regulatory audit exposure is an advantage Good knowledge of European agency guidelines & GAMP guidelines Well-versed with EU Annex 11 / 21 CFT Part 11 guidelines Sound knowledge of ALCOA+ concepts and able to identify gaps w.r.t. ALCOA+ principles if any in software implemented at site Preference if any The candidate is required to be present at the site by JULY 2025.

** VEDIO CALL INTERVIEW ** Roles and Responsibilities Perform CSV (Computer System Validation) tasks for new systems implementation. Ensure compliance with GMP regulations during software validation processes. Conduct software validation activities according to GAMP guidelines. Key Skills : Good Exposure on CSV,PLC, Software Validation in pharmaceutical industry, SAP,LIMS Qualification, TRIMS,NICHELONS,HVACMS/BIMS,EMPOWER,ELMS. ** Preferred male candidate only. Interested candidate can share their resumes below mail id: sonali.n@hetero.com/9100408534. Job Location : Unit V, Hetero Labs limited, Jadcherla, Hyderabad.