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3.0 - 7.0 years

0 Lacs

telangana

On-site

As a member of our team, your primary responsibilities will include ensuring smooth GxP IT operations and maintaining all-time GxP IT compliance at the site. You will be involved in vendor management, implementing solutions with a focus on project execution and delivery, as well as supporting various business initiatives. Additionally, you will provide application support to meet the needs of the organization. To excel in this role, you should have knowledge of Pharma IT compliance, plant IT operations, IT infrastructure and networking management, computer system validation, data historian, LIMS, cloud computing, MES, and Empower. Your expertise in these areas will contribute to the success of our IT operations and compliance efforts.,

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20.0 - 30.0 years

500 - 1000 Lacs

Hyderabad

Work from Office

Conduct final inspection and testing of finished products to ensure compliance with quality standards and customer specifications. Hands-on experience in testing of Finished products Instruments must be handled like HPLC, GC, KF, IR, DT, and Dissolution. Hands-on experience like software like Empower and LIMS. Qualification M.SC/B.Pharma 3 to 6 years Additional Information

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5.0 - 10.0 years

0 Lacs

hyderabad, telangana

On-site

You will be responsible for configuring and maintaining Sample Manager LIMS v123 for battery testing workflows, which includes managing job sample test hierarchies. Additionally, you will need to implement and support DBDS features for sample build mapping and data archiving. Your role will also involve managing and optimizing Integration Manager interfaces, agent, and transformation logic. As a Sample Manager LIMS Manager, you will perform lifecycle management of sample tests and jobs within the LIMS system. It will be your responsibility to develop and maintain test plans, workflow, and reporting structures. Troubleshooting and resolving performance issues, including database indexing and service configuration, will also be part of your duties. Collaboration with QA engineering and IT teams is essential to ensure data accuracy and compliance. You will be required to document Standard Operating Procedures (SOPs), Knowledge Transfer (KT) plans, and training materials for onboarding and support processes. The role requires strong experience with Thermo Fisher Sample Manager LIMS v123 and above, as well as proficiency in Integration Manager configuration and troubleshooting. Familiarity with DBDS workflows and Oracle SQL Developer is necessary, along with knowledge of C Net Net WCF for customization and service integration. Experience with ServiceNow for ticketing and support workflows is also preferred. An understanding of lab operations in analytical, physical, and chemical domains is crucial for this position. A Bachelor's degree in Computer Science, Life Sciences, or a related field is preferred. Experience in battery testing environments, specifically Lead Acid LithiumIon, is an advantage. Prior exposure to global manufacturing systems and multisite deployments will also be beneficial. Key Skills: - Strong experience with Thermo Fisher Sample Manager LIMS v123 and above - Proficiency in Integration Manager configuration and troubleshooting - Familiarity with DBDS workflows and Oracle SQL Developer - Knowledge of C Net Net WCF for customization and service integration - Experience with ServiceNow for ticketing and support workflows - Understanding of lab operations in analytical, physical, and chemical domains Preferred Qualifications: - Bachelor's degree in Computer Science, Life Sciences, or related field - Experience in battery testing environments, Lead Acid LithiumIon - Prior exposure to global manufacturing systems and multisite deployments Mandatory Skills: Labvantage, LabWare, SampleManager, StarLIMS, Empower, Lab Management Systems, Caliber LIMS, AR_VR_MR,

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5.0 - 9.0 years

0 Lacs

karnataka

On-site

As a Senior Underwriter in the Residential Mortgage industry, you will be part of the Shared Services function that aims to deliver operational support to Business Units within the organization. Your role will involve reviewing and verifying loan applications, analyzing loan risks, ensuring compliance with regulatory standards and company policies, and communicating loan conditions to stakeholders. Additionally, you will be responsible for identifying portfolio risks, documenting loan decisions, and performing other tasks as assigned by your manager. To excel in this role, you should possess a strong understanding of mortgage guidelines and policies for various loan types such as VA, FHA, Client, FHLMC & USDA. Your expertise should include analyzing qualifying income from tax documents, credit reports, and bank statements, as well as experience in both automated underwriting systems (AUS) and manual underwriting methods. Familiarity with fraud detection tools and industry-standard loan origination systems like Encompass, BytePro, Calyx, Empower, or Lending QB is preferred. The ideal candidate will have at least 5 years of recent US Mortgage underwriting experience, with a background in compliance review, disclosures preparation, closing, and due diligence within the residential mortgage sector. You should stay updated on mortgage policies, compliance laws, and regulatory changes, including TRID, to ensure accurate and efficient underwriting processes. Your commitment to quality, excellent time management skills, and ability to work independently while meeting deadlines will be crucial for success in this role. As a Senior Underwriter, you must demonstrate professionalism, attention to detail, superior communication skills, and proficiency in Microsoft Office applications. This role requires you to work under pressure, adhere to company policies, and maintain a positive attitude while delivering exceptional customer service. This position is based in the office, with working hours aligned with the US time zone (India Night Shift). If you are seeking a challenging opportunity to leverage your underwriting skills in the residential mortgage industry, this role offers a dynamic environment where you can contribute to the success of the organization while ensuring compliance and quality in loan processing.,

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2.0 - 7.0 years

3 - 7 Lacs

Pimpri-Chinchwad, Kurkumbh

Work from Office

Walk-in Drive for API-Quality roles!!! Walk-in Dates: Friday July 25 & Saturday July 26, 2025 Time: 1000 hrs. to 1600 hrs. Address: Emcure Pharmaceuticals Ltd. D-24, M.I.D.C., Kurkumbh, Tal- Daund, Dist.- Pune, PIN- 413 802, Maharashtra, India. API-Quality Control M.Sc. (Analytical / Organic Chemistry) with 2-5 years of experience in Expertise in handling RM, intermediates & Finished products in API manufacturing. Handling HPLC, GC, LCMS, GCMS, ICPMS, Particle Size analyzer, and hands-on experience on Empower 3 & Chromeleon software preferred. API Quality Assurance- QMS & IPQA M.Sc. (Organic Chemistry, BE/ B. Tech- Chemical Engineering) with 2-8 years of experience in Must have experience in API in-process QA, QMS, Equipment Cleaning, QA Certification, APQR etc. Experience in Process & Cleaning validations will be desirable. Experience in both API production and QA will be preferred API Analytical QA / Lab QA M.Sc. (Analytical / Organic Chemistry) with 5-7 years of experience in QC instrumentation, QC data review and LAB QA

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5.0 - 9.0 years

0 Lacs

karnataka

On-site

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, you will be responsible for reviewing and verifying loan applications, analyzing loan risks, ensuring compliance with regulatory standards and company policies, and determining loan conditions. Your duties will include identifying portfolio risks, documenting loan decisions, and communicating requirements to clients. You should have a strong understanding of mortgage guidelines for various loan types, such as VA, FHA, FNMA, FHLMC, and USDA. Additionally, you should be able to analyze income from tax documents, credit reports, and bank statements, and have experience with underwriting methods and industry-standard LOS systems. To qualify for this role, you need at least 5 years of US mortgage underwriting experience, compliance review knowledge, and familiarity with current mortgage policies and regulations. You should be detail-oriented, customer service-oriented, and possess excellent time management and communication skills. Working under pressure, meeting deadlines, and adhering to company policies and procedures are essential requirements for this position. This work from office role requires you to work during US hours (India Night Shift) and exhibit professional behavior, including a positive attitude, punctuality, dependability, and adherence to company standards.,

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10.0 - 14.0 years

0 Lacs

ankleshwar, gujarat

On-site

As a Quality Control Manager at our company, your primary responsibilities will include overseeing the quality control department in Panoli, Gujarat. With over 10 years of experience and an educational background of M.Sc. in Chemistry, you will be leading the GC section and working standard section. Your duties will involve planning, distributing, and monitoring work in the GC section and working standard section. You will be responsible for tasks such as LIMS template preview, instrument method preparation, and updating in Empower software. Additionally, you will initiate laboratory events, out of specification instances, out of trend observations, deviations, and change controls in Track Wise, following standard operating procedures for investigations. It will be your duty to ensure the qualification of working standards, manage procurement activities for reference standards, impurity standards, GC standards, and GC columns. You will also oversee the cleanliness of instruments, workplaces, and laboratories, ensuring a safe environment by providing necessary personal protective equipment as per work requirements. Furthermore, you will be responsible for providing training to subordinates and adhering to safety protocols in the laboratory. You are expected to carry out any other activities as instructed from time to time to maintain the quality and efficiency of the quality control department.,

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3.0 - 7.0 years

0 Lacs

maharashtra

On-site

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.,

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5.0 - 9.0 years

0 Lacs

karnataka

On-site

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).,

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5.0 - 10.0 years

7 - 17 Lacs

Noida, Gurugram, Delhi / NCR

Work from Office

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.

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0.0 - 2.0 years

3 - 4 Lacs

Ranchi, Khunti

Work from Office

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.

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3.0 - 6.0 years

10 - 20 Lacs

Hyderabad

Work from Office

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/#!/

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5.0 - 10.0 years

5 - 10 Lacs

Hyderabad/ Secunderabad

Work from Office

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

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0.0 - 1.0 years

1 - 2 Lacs

Dholka, Bavla, Ahmedabad

Work from Office

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.

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4.0 - 9.0 years

3 - 5 Lacs

Hyderabad

Work from Office

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

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3.0 - 8.0 years

8 - 12 Lacs

Hyderabad, Chennai, Bengaluru

Hybrid

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

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20.0 - 30.0 years

4 - 6 Lacs

Visakhapatnam

Work from Office

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/#!/

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2.0 - 7.0 years

4 - 9 Lacs

Hyderabad

Work from Office

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.

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20.0 - 30.0 years

500 - 1000 Lacs

Baddi

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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/#!/

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3.0 - 5.0 years

7 - 11 Lacs

Gurugram

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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

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1 - 3 years

5 - 10 Lacs

Hyderabad

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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/#!/

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7 - 12 years

7 - 14 Lacs

Mysuru

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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.

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2 - 7 years

3 - 5 Lacs

Jadcherla

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** 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.

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