44 Empower Jobs - Page 2

The role of Executive - QC (Stability) at Piramal Pharma Solutions involves conducting stability studies, analyzing samples, preparing reports, and ensuring compliance with regulatory guidelines to maintain product quality throughout its shelf life. You will be working closely with Operations, R & D, QA, and Regulatory affairs teams under the supervision of the QC Supervisor. With a minimum of 3 years of experience in the stability section, you should be a quick learner with excellent communication skills. Punctuality, dedication, and reliability are essential qualities for this role, as well as the ability to work both independently and as part of a team. Proficiency in written and spoken English is required, along with knowledge or experience in peptides. Your responsibilities will include working in the stability section, handling instruments such as HPLC, UV, Culometer, KF-titrator, LCMS, conducting stability sample analysis, managing stability chamber, and utilizing software like Lab solutions, Empower, DMS, and Ensur. The ideal candidate for this position should hold an MSc in Chemistry and be committed to inclusive growth and ethical practices. Piramal Group values equal employment opportunities and makes decisions based on merit, ensuring that all applicants and employees are treated fairly and have equal access to recruitment, training, promotion, compensation, and working conditions. Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) providing end-to-end solutions across the drug life cycle. As part of a global network with facilities in North America, Europe, and Asia, PPS offers a wide range of services including drug discovery, process development, clinical trial supplies, commercial supply of APIs, and finished dosage forms. Specialized services such as highly potent APIs, antibody-drug conjugations, and biologics are also offered, making PPS a trusted partner for innovators and generic companies worldwide. This full-time position is based in Piramal, Thane, Maharashtra, 400703, IN and requires a Master's Degree qualification. If you are passionate about maintaining product quality through stability studies and analysis while upholding ethical standards and values, we invite you to join our team at Piramal Pharma Solutions.,

The Senior Underwriter (Residential) position requires you to relocate to Pune, Mumbai, or Bangalore and work from the office during US timings night shift (EST). As a Senior Underwriter, your primary responsibilities include reviewing and verifying loan applications, analysing loan risk, ensuring compliance with regulatory standards and company policies, and documenting loan conditions. You will also need to communicate loan decisions effectively and identify portfolio risks from client business practices. Additionally, you may be assigned other tasks by your manager. To excel in this role, you must have a deep understanding of mortgage guidelines for various types of loans such as VA, FHA, FNMA, FHLMC, and USDA. You should be adept at analysing income from tax documents, credit reports, and bank statements. Experience with automated underwriting systems (AUS) and manual underwriting methods is essential, along with knowledge of industry-standard loan origination systems like Encompass, BytePro, Calyx, Empower, or Lending QB. The ideal candidate should have at least 5 years of recent US mortgage underwriting experience and be well-versed in compliance review, disclosures preparation, and closing procedures in the residential mortgage industry. Knowledge of current mortgage policies, compliance laws, and regulations, including TRID, is crucial. Strong attention to detail, time management skills, and commitment to customer service are essential for success in this role. You should be proficient in Microsoft Office, possess strong communication skills, and be able to work independently under pressure while meeting deadlines. Maintaining a positive attitude, punctuality, dependability, and adherence to company policies and procedures are also key aspects of this position. This is a work-from-office role requiring you to work during US hours (India Night Shift).,

Role & responsibilities/ Preferred candidate profile Knowledge on LIMS, chromotogarphy and MES. Experience in supporting LIMS and Empower application in Pharma/Process industry L2 debugging skills in (SQL, .Net, Server, network (basic)) Experience in coorindating issues with L1,L2 ,and other support vendor teams Knowledge of incident, change and problem management - ITIL processes Good verbal and written communication Pharma Knowledge/Validation Process/Quality processes Other Lab and quality system knowledge Lab application implementation/testing experience ALM, Veeva Vault and LIMS Basic Programming language JAVA and SQL.

Preferably Master’s or Bachelor's degree in Gender Studies, Social Work, Community Development, or a related field. Knowledge of gender equality and women empowerment programs. Work with self-help groups (SHGs) and community development initiatives.

To involve from start and investigate level 2 & 3 incidents, by working closely with site CFT and operating people to arrive at proper Root cause, CA and PA and in report writing. To Involve in valid OOS and other cases as relevant, by working closely with site CFT and operating people to arrive at proper Root cause, CA and PA and in report writing. To review level 1B incidents and give feedback for improvement. To periodically trend level 1A incidents and highlight/escalate key observations. To review any other referred reports associated with incidents/events in association with sites. To possess high level of integrity to have unbiased, independent and objective closure of incidents and maintain high level of confidentiality and have the tenacity to get to the root cause. To use Rubrics template for investigation report writing. To provide appropriate support to site in preparing for or during regulatory inspection for investigations. Qualification looking someone with strong QC investigation background, QC Compliance, Analytical development Education :B.Pharm, M.Sc, M.Pharm Exp : 8-10 Years Industry : OSD preferred/ Injectable, API also work 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/#!/

Greetings from Sri Krishna Pharma We are hiring Quality Control for our API , Formulation (OSD ) and Nutra .Biotech Units Roles and Responsibilities Conduct quality control tests on OSD (Oral Solid Dose) and API (Active Pharmaceutical Ingredient) products using various instruments such as HPLC, GC, UV-Vis Spectrophotometer, Polarimeter, Karl Fischer Titrator, pH Meter, Finished Products Analyzer, Melting Point apparatus, Auto titrator, IR Spectrometer, Potentiometer. Ensure compliance with cGMP guidelines during testing procedures. Maintain accurate records of test results and reports. Collaborate with cross-functional teams to resolve any issues related to product quality or manufacturing processes. Participate in continuous improvement initiatives to enhance laboratory operations. if interested please share your resumes to jayakishore.gollapalli@srikrishnapharma.com

We are looking for a passionate and skilled M.Sc. Chemistry graduate (Organic/Analytical) to join our R&D or Quality Control team. The candidate will assist in routine chemical and instrumental testing, synthesis, method development.

QC Reviewer / Sr. Research Associate: Role & responsibilities Review analytical raw data, calculations, and reports for accuracy, completeness, and compliance with approved specifications and methods. Ensure all laboratory documentation meets regulatory and internal quality standards (e.g., USFDA, EU-GMP, ICH, WHO, etc.). Review chromatographic data (HPLC, GC), wet chemistry reports, and other analytical test results. Verify results for routine analysis, stability studies, and validation reports. Check instrument calibration records and ensure compliance before reviewing analytical results. Identify and report any data discrepancies, deviations, or non-conformities. Review and verify entries in logbooks, worksheets, and other controlled documents. Assist in investigations related to out-of-specification (OOS), deviations, and laboratory incidents. Coordinate with analysts and the QA team to ensure timely corrections or clarifications. Ensure timely completion and archival of reviewed documents. Provide support during internal and external audits (regulatory and customer). Participate in continuous improvement initiatives within the QC function. Preferred candidate profile Education: B.Sc / M.Sc in Chemistry / Pharmaceutical Sciences or related field. Experience: 4 -8 years of experience in Quality Control, preferably in API manufacturing. At least 2 years in a QC Reviewer role. Technical Skills: Hands-on experience and data interpretation of analytical instruments like HPLC, GC, FTIR, UV, KF, etc. Thorough understanding of cGMP, GLP, and regulatory requirements. Good documentation and analytical skills. Key Competencies: Attention to detail. Strong analytical and problem-solving skills Good communication and interpersonal skills Ability to manage priorities and meet deadlines High integrity and compliance mindset

Mode of Work : Hybrid Location : Pune, Bangalore, Hyderabad, Pune, Noida, Gurgaon, Chennai, Kolkata, Skill Set : LIMS, GMP, cGMP, Starlims, Labware Lims, Labvantage. The opportunity Were looking for Senior with expertise in LIMS Implementations & Configurations for Life Sciences industries to join our Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your key responsibilities Work closely with business stakeholders, laboratory personnel, and IT teams to gather and document LIMS requirements. Gather and analyse business requirements related to LIMS functionality and enhancements. Analyse laboratory workflows and processes to recommend and implement LIMS solutions. Translate business needs into functional specifications and system configurations. Configure, test, and validate LIMS functionalities to meet business needs. Conduct impact analysis and risk assessments for LIMS changes and enhancements. Serve as a liaison between business users and technical teams to ensure effective communication and system alignment. Participate in business process mapping and workflow optimization to enhance LIMS utilization. Provide input on LIMS enhancements and new feature development to improve system performance. Assist in troubleshooting, identifying, and resolving LIMS-related issues. Conduct user training sessions and provide end-user support. Work with laboratory teams to ensure LIMS supports laboratory practices, procedures, and workflows effectively. Identify opportunities for automation and process improvement within laboratory operations using LIMS. Master Data Design Configuration Analyse the Technical documents such as SOP/STP/Monograms/Pharmacopeial references and convert them into LIMS compatible data sets. Configure master data elements such as test methods, sample types, specifications, workflows, and stability studies within LIMS. Maintain data integrity, consistency, and version control across the system. Implement changes and updates to LIMS master data in alignment with business and regulatory needs. Collaborate with cross-functional teams to ensure accurate data migration and system integration. Troubleshoot and resolve issues related to master data configuration and system functionality. Work on optimizing data structures and database management within LIMS. Configurations & Customizations Develop, customize, and implement LIMS applications to meet laboratory and business requirements. Configure, extend, and support LabWare LIMS, LabVantage LIMS, and other LIMS platforms. Integrate LIMS with other enterprise systems such as ERP, ELN, CDS, MES, and laboratory instrumentation software. Design and optimize databases for efficient storage and retrieval of laboratory data. Develop and maintain system interfaces, workflows, and automation scripts to streamline laboratory processes. Provide technical support, troubleshooting, and bug fixes for LIMS applications, ensuring minimal downtime. Collaborate with laboratory personnel, IT teams, and stakeholders to enhance system functionality and usability. Create and maintain system documentation, including user guides, SOPs, validation protocols, and technical specifications. Ensure compliance with industry standards such as CGxP, PICS, FDA 21 CFR Part 11, EU GMP Annex 11 etc. Stay up to date with new LIMS technologies, trends, and best practices. Ensure system security, access control, and compliance with IT policies. Provide ongoing support and maintenance for LIMS applications. Engage in change management processes and drive adoption of new system functionalities. Work with vendors and third-party providers to Configure, implement upgrades and enhancements. Demonstrate teamwork by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills and attributes for success Strong understanding of laboratory workflows, sample lifecycle management, and data integrity principles. Familiarity with analytical techniques, laboratory instrumentation, and regulatory standards. Exposure to Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and ISO 17025 compliance. Experience in working with scientific and analytical teams to align LIMS functionality with laboratory operations. Understanding of quality control, stability studies, environmental monitoring, and batch release processes within laboratories. Proficiency in LIMS software (e.g., LabWare, LabVantage, STARLIMS, SampleManager, or similar platforms). Knowledge of system integration with ERP, MES, or other enterprise applications. Previous experience as a Business Analyst or System Administrator or Master Data Manager working with LIMS. Hands-on experience in master data configuration within LIMS platforms. Experience in system validation, testing, and documentation. Exposure to Enterprise IT applications like ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, etc. in Pharmaceutical organization Understanding of relational databases and SQL queries. Experience with scripting or automation tools for LIMS is a plus. Understanding of API integrations, web services, and middleware solutions for LIMS. Ability to troubleshoot system and data issues efficiently. Strong problem-solving and analytical skills. Excellent communication and stakeholder management abilities. Ability to work independently and as part of a cross-functional team. Strong attention to detail and commitment to data integrity. Adaptability to dynamic business and regulatory environments. Demonstrated track record in project management, governance, and reporting Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management. Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Comp. Science/ Life Sciences/Chemistry/Information Technology or a related field)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 4-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies or Leading Life sciences / Pharmaceutical Industries. Good interpersonal skills; Good written, oral and presentation skills. Interested Candidates can send their Cv's to frichardson@allegisglobalsolutions.com. Regards, Franklin.A

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 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.

Job Description Position Title : Lab systems Run Lead Function : GIDC Location : GC Bangalore About Viatris VIATRIS , is a new kind of healthcare Company, committed to providing access to medicines, advancing sustainable operations developing innovative solutions, and leveraging our collective expertise to improve patient outcomes. Formed in 2020, through the combination of Mylan and Up-John-Pfizer, Viatris bring together best in class scientific, Manufacturing and distribution expertise with proven regulatory, Medical, and commercial capabilities to deliver quality medicines to patients when and where they need it. Fast Facts Headquartered in the US with global centers in Pittsburgh (USA), Hyderabad (India) and Shanghai (China) Our global workforce of ~45000, includes expertise across scientific, manufacturing, regulatory and Commercial Operations Have ~ 50 Manufacturing Facilities across Oral Solid Doses, Injectables, Complex dosage forms and APIs Total 1400+ Molecules, have portfolio that treats nine out of ten WHO causes of death. Our 200+ medicines are on WHO essential medicines List. We have commercial reach to 165+ Countries and territories. Role Purpose Subject matter expert and handle run operations for Lab system applications (Labware LIMS v6/v7, Empower/Chromeleon CDS, NuGenesis SDMS and MODA). Define procedures or standards, since he/she has the knowledge of what the right or best way to execute a task would be. Define performance objectives and determine acceptable performance levels. Provide recommendations for procedural improvements. Understand the language/terms/jargon in his/her area of expertise. Understand requisite knowledge that underlies effective decision-making and is able to describe where anomalies or flaws may occur in the decision-making for his/her area of expertise. Act as the go to person within a department or function for questions and problems within his/her area of expertise. Explain his/her area of expertise clearly to others. Not only answer how things are done, but why. Key Responsibilities The responsibilities of the SME are to ensure the facts and details are correct so that the project's/program's deliverable(s) will meet the needs of the stakeholders, legislation, policies, standards, and best practices. To achieve this, SMEs will: Responsible for day to day run support of lab systems and should be able to manage the team. Experience in configuration, administration, and support of scientific applications like Labware LIMS v6/v7, Empower/Chromeleon CDS, NuGenesis SDMS and Lonza Moda. Experience in SQL. PLSQL, Crystal reports and good knowledge of SDLS process. Knowledge of incident, problem, change management and service requests. Experience in handling escalations and addressing them as per business requirements. Assist the team with technical and functional knowledge as needed, and prioritize work based on importance and urgency. Research and resolve the issues related to system operations and performance. Ability to handle multiple responsibilities at any given time, set priorities, schedules, and meet deadlines. Provide technical solutions for the Labware LIMS and Empower requirements. Experience on compliance activities like periodic review, BAR, DR and UAR. Strong analytical and problem-solving skills. Ensure that all the Lab system application servers are patched during monthly cycle. Address all incidents and service request within SLA and to meet MTTR. Extend the run scope and service to new sites. Co-ordinate with the project team during the phases of new implementation, migration, and retirement. Perform impact assessment for all the infrastructure related activities like (OS upgrade, VDA Components upgrade & Patch) and test application functionalities. Identify inefficiencies in the existing processes, develop and implement new process to eliminate these efficiencies. Assist with development of new process to support the efficient, effective, and compliant use of lab systems applications. What we are looking for : A passion for working in customer facing roles and have great interpersonal communication, facilitation, and presentation skills. 6 to 9 years of experience in a technical support role with bachelors degree in computer science. However, a combination of experience and/or education will be taken into consideration. Experience in configuration, administration, and support of scientific applications like Labware LIMS v6/v7, Empower/Chromeleon CDS, NuGenesis SDMS and Lonza Moda. Experience in SQL/PLSQL, Crystal reports and good knowledge of SDLC process. Pharma template understanding (relationship between item code, sample plan, Analysis, Analysis variation and product). Should have knowledge of Labware sample life cycle, integrations with CDS and SAP systems. Knowledgeable on CDS applications with instrument configurations, connectivity issues, sample set acquisition, processing, and reporting. Should have knowledge of current regulatory & guidelines like 21 CFR part 11. Should be familiar with GCP, GLP, GMP guidelines/SOPs and ITIL support model. Pharma/Life science domain knowledge and proficiency in English. Flexibility to work in non-business hours based on business need/ urgent requests. Proficient in the use of Microsoft Excel / PowerPoint for analysis and presentation. Excellent communication, presentation, facilitation, time & team management, and customer relationship skills Very good experience in conducting Impact Analysis of issues and preparing RCAs. Able to follow and participate in technical discussions reviews.

Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.

We are looking a skilled and motivated Executive IT (GMP Operations) with 3 to 5 years of experience for our Manufacturing Unit (Karakhadi Plant) The candidate will handling IT systems within GMP-regulated environments and support QC and Manufacturing IT operations with a strong focus on compliance, data security, and system integration. Key Responsibilities: Oversee IT GMP operations for QC and Manufacturing systems. Manage user access , data security , domain controllers , and backups . Integrate manufacturing equipment with IT systems and ensure GxP system compliance. Administer QC and Manufacturing applications like Chromeleon, Empower , etc. Operate and support SCADA, HMI , and other manufacturing systems. Ensure IT infrastructure qualification and regulatory compliance . Implement and configure Manufacturing/QC GxP systems . Maintain IT SOPs and ensure compliance during regulatory audits (USFDA, etc.). Communicate effectively and demonstrate leadership in cross-functional Candidate Profile: Bachelor's in IT, Computer Science, or related field. 35 years in pharma IT within a GMP environment . Strong understanding of 21 CFR Part 11, GAMP 5, Annex 11 , etc. Experience with regulatory audits and IT compliance. Good problem-solving, communication, and leadership skills . Interested candidates can share their updated resume at "I tcv@alembic.co.in" with the subject line "Executive IT (GMP Operations)"