362 Method Validation Jobs - Page 12

Literature survey for assigned projects. Analysis of innovator samples as and when provided. Analysis of development batches. Analysis of stability batches. Writing of experiments online in Laboratory Notebooks (LNB) with all details. Processing of raw data and calculations after completion of each analysis. Analytical method development of drug products. Analytical method verifications for drug substances. Preparation of Specifications-STP for Raw materials and finished products.

Laxmi Organic Industries Limited. We are looking for candidates interested in Technical Associate-Quality for Dahej. Job Title: Technical Associate-Quality Department: Quality Control/ Quality Assurance Location: Dahej. Job Purpose Analysis of Raw material, water sample, Packing material In-process & Finished products Role and Responsibilities Operational: Daily analysis of water, In-process, Daily Finished product sampling and analysis Daily sampling of RM, In-process, Finished product. Dispatch of finished product dispatches of tanker, drum, bags sampling and analysis. Counter samples storage, retrieval, instruments cleaning Detection of abnormalities during analysis and report it to the concerned authority. Raw Material inspection, sampling and analysis. Result recording in SAP. HPLC and GC Data storage Packing material sampling and analysis. Checking of certificate of analysis Report any near miss /incident or any non-compliance To Support Various ISO, Process safety and Responsible Care Initiatives Responsible to compete any other assignment given by the senior. Deviation reporting and recording OOS reporting and recording. Required Knowledge (of any equipment / Tools and techniques / Software) GC, HPLC, UV, Titrimetric, Karl Fischer, Potentiometer, QESH Education Essential: M.Sc in Chemistry Preferred: M.Sc in Chemistry (Analytical, Organic, Inorganic) Experience Essential: 2-4 years in chemical industry If you are interested, kindly share your updated cv on below email id. Email Id: siddhi.pathak@laxmi.com Telephone No: 9125652023

Role & responsibilities 1. Performing Stability analysis, Method transfer and Method Validation. 2. Preparation and review of Method Transfer Protocols, Validation protocols and all related protocols, procedures and reports. 3. To carry out analytical method development, method validation and testing of impurities in finished products on LCMS/MS and GCMS/MS 4. FG (HPLC) 5. Preparation, review of departmental SOPs and training of analysts. 6. Calibration and validation of instruments equipments. 7. Review and maintenance of all logbooks in the department. 8. Procurement of columns, chemicals/ reagents/ solvents and standards for Stability analysis, Method Transfer and Method Validation.

Role & responsibilities Execution of immunoassay method development based on ELISA platform. Method validation and study sample analysis for the estimation of antibodies in biological matrices for various vaccine projects using various immuno-analytical techniques. Handle multiple projects, work in a team, in co-ordination with team members, ensure smooth execution of immunology and clinical serology activities. Responsible for execution of assays / experiments, and recording of data in appropriate documents. Responsible for data analysis and communication of experimental results from time to time to supervisor or concerned personnel. Ensure that all instruments in immunology and clinical serology laboratory are maintained as per the schedule and calibrated on time. Preparation of SOPs, LCRs, GCRs, analytical plans and analytical reports etc. based on the requirement. Perform the activities in clinical serology laboratory in compliance with GCLP and approved SOPs. Follow appropriate safety practices using proper PPEs like apron, goggles and gloves etc. while performing laboratory activities. Take directions from the supervisor and work in a collaborative environment and being a team member mind set. Preferred candidate profile

For day to day sample extractions & instrument (LCMS/MS - GCMS/MS) sequencing Roles and Responsibilities Testing of various agriculture and food products for chemical and nutritional testing by standard and in-house methods Hands on expireance in Proximate Analysis Operating the lab instruments like pH meter, weighing balance, incubator, GCMS/MS & LCMS/MS, UPLC Preparation of standard solutions Daily maintenance of lab equipment. Following good laboratory practices Following disposal process for samples & solutions as per SOP. Accurate analysis and interpretation of test results Maintenance of laboratory documents and records Validation of methods and calibration/verification of instruments Ensuring purity and validity of CRMs Conduct sensory evaluations of food samples

Expertise in ICP-OES and ICP-MS techniques. Expertise in Ion Chromatography working knowledge of various chromatography and spectroscopy techniques, including HPLC GC. independently managed development tasks, consistently delivering within timelines. Required Candidate profile Ideal Candidate should Be M.sc With 5 + Years of Experience in ADL Department Must Have Experience in Method Development & Method Validation. Must Have Experience in Ion Chromatography

Operation and Calibration of Analytical Balance Method Development Method Validation Scale up Batch Analysis, Investigating Analysis HPLC Analysis Instruments handling

Eurofins Scientific is an international life sciences company that provides a wide range of analytical testing services to clients across multiple industries. From food and pharmaceuticals to environmental and cosmetic products, Eurofins ensures safety, authenticity, and accuracy. With a global presence and over 900 laboratories, Eurofins is a leader in food, environmental, pharmaceutical and cosmetic product testing, as well as in genomics, clinical studies support, and other specialized diagnostic testing. Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Read and understand analytical procedures Review documentation, generated data, calculated results, and final reports according to departmental, corporate, and client SOPs Gain a technical understanding of the techniques in which review is being performed Use MS Windows applications such as EXCEL, Word, Access, Outlook email Conducts all activities in a safe and efficient manner Performs other duties as assigned Qualifications M.Pharm (Pharmaceutical Analysis) / M.Sc Chemistry Additional Information Experience level : 0 - 2 years in Bio/Pharmaceutical Analysis Key Candidate Attributes: Self-motivation; excellent quality of work and attention to detail Ability to communicate effectively with coworkers and internal/external clients Ability to learn new tasks quickly and to move easily from task to task Ability to handle prioritization and multiple tasks simultaneously Ability to use a personal computer and learn necessary programs Good communication skills (oral and written) Organizational ability and good judgement Science background/education and/or laboratory experience

Job description: Leadership role to manage team size of 20+ scientists (Ph.D. and M.Sc.) Extensive knowledge in E&L Planning and excution of projets in Analytical services Extractable and Leachable experience in CCS as per USP monograph and medical devices as per ISO guidelines Ensuring the compliance related to all the activities Method development/Validation experience in LC-MSMS, GC-MSMS and ICPMS instrument Preparation and Implementation of SOPs related to E& L,Stability studies, general laboratory processes and best guidance. Good knowledge of 21 CFR part 11, Data Integrity principals, good documentation practices in cGMP lab Monitor and management of day-to-day laboratory activities Subject Matter Expert for guiding extractables and leachable studies, Stability studies, Nitrosamine studies, PSD, PXRD, HPLC, GC-MS/MS, LC-MS/MS, ICP-MS, IC, Dissolution, UV-Vis, etc., including designing the preparation of protocols and report Extensive knowledge of preparation, reviewing and approval capability for standard operating procedure (SOP) and COA Sound knowledge of structural elucidation and interpretation using analytical techniques such as NMR, IR, HPLC, GC, LC-MS etc. Resolving the team conflicts and provide training to the team for development and empowers team members Provide scientific and leadership direction to team members Knowledge on LIMS Supporting in setting up lab facility and instrument distribution Good knowledge of laboratory safety and be a strong promoter of SHE activities in the lab. Skills Required: For M.Sc, 20-25 years of Analytical R&D/QC experience in CRO environment Excellent technical, problem-solving, writing, influencing and communication skills Strong leadership with excellent interpersonal skills, proven success of analytical projects and managing cross functional teams Demonstrative communication skills and confident in conveying information to internal/ external customers Skill for resolving the team conflicts and provide training to the team for development and empowers team members Behavioral Competencies: Excellent oral / written communication skills and flexibility to work in a dynamic environment Excellent in Knowledge sharing at all levels. If you're a fit, send your resume to . Please share only relevant profiles. Qualifications M.Sc -Analytical Chemistry/Organic Chemistry/General Chemistry/Industrial Chemistry

Maintenance and use of GC FID To test and analyze proximate parameters like UV parameters, Analysis of Fatty acids Maintaining samples before and after analysis Maintaining the CRM Method verification & validation SOP preparation Interpretation of the results. Qualifications 6-8 years experience of working in food testing laboratory. Proficient in analytical techniques of wet chemistry, proximate analysis, watr analysis, Allergen testing, Meaurement of Uncertanity calculation. Greaduate Bsc/Msc in Chemistry Additional Information Good interpersonal and communication skills. Energetic, flexible and innovative. Able to work independently and to coordinate several activities simultaneously. Good in communication, read and write in English and local language. Acts quickly and decisively. Knowledge in Microsoft Office (such asMicrosoft Word, Excel, Power Point, & etc.),

Responsible for managing & operating all testing Labs & achieving revenue from all labs as defined by the management Responsible for implementation of quality policy throughout the labs Reviewing the contracts for new test methods as per the company norms Effective coordination with internal teams and other operational department or labs Ensures all lab staff have adequate resources to perform all aspects of work required Ensures all lab staff are adequately trained to safely perform all required job functions and that competency records are maintained Ensures corporate policy & procedures in the laboratory Provides employee motivation and champions the quality system, including, calibrations, quality assurance, training and lab quality system. Maintains an open door policy and communicates with lab staff to promote empowerment and accountability Obtains and maintains an in-depth knowledge of local market requirements Understands customer requirements and organizes lab procedures, schedules and staffing to provide for meeting/exceeding same Handles required disciplinary matters in a fair and consistent manner and maintains open communication with the all the departments Represents Spectro by appearance and conduct with strong ethical attitude Ensures laboratory practices meet or exceed company policy and industry standards Reads, understands and enforces the company quality and safety measures May on occasion be required to perform the duties of the lab supervisor and/or lab technicians Establishes or adjusts work schedules to meet testing requirements and control costs Markets actively for new clients Other duties as may be assigned by higher management Qualifications M.Sc/Phd/B.Tech Minimum 10 to 15 years of experience in managing Lab operations from NABL accredited testing company or testing labs

To Prepare sample for the determination of heavy metals, micro minerals and minerals in Food and Agriculture samples as per ISO, IS and Customer specific requirements adopting test methods ISO, AOAC and IS methods using Microwave digestor. Maintenance of standard Reference Materials, Chemicals, Reagents and Glassware used in the laboratory. Responsible for all the instruments related to Metal analysis. Maintaining samples; before, during and after analysis. Qualifications 3-4 years experience of working in food testing laboratory. Proficient in handling ICP-MS and method validation for heavy metals analysis Graduate B.Sc/M.Sc in Chemistry Additional Information Good interpersonal and communication skills. Energetic, flexible and innovative. Able to work independently and to coordinate several activities simultaneously. Good in communication, read and write in English and local language. Acts quickly and decisively. Knowledge in Microsoft Office (such asMicrosoft Word, Excel, Power Point, & etc.),

Job description: Leadership role to manage team size of 10+ scientists (Ph.D. and M.Sc.) Extensive knowledge in E&L Extractable and Leachable experience in CCS as per USP monograph and medical devices as per ISO guidelines Managing multiple instruments (LC-MSMS, GC-MSMS, ICP-MS, IC etc.) Method development experience in LC-MSMS, GC-MSMS and ICPMS instrument Preparation and Implementation of SOPs related to E& L , general laboratory processes and best guidance. Good knowledge of 21 CFR part 11, Data Integrity principals, good documentation practices in cGMP lab Monitor and management of day-to-day laboratory activities Extensive knowledge of preparation, reviewing and approval capability for standard operating procedure (SOP) and COA Sound knowledge of structural elucidation and interpretation using analytical techniques such as NMR, IR, HPLC, GC, LC-MS etc. Resolving the team conflicts and provide training to the team for development and empowers team members Provide scientific and leadership direction to team members Good knowledge of laboratory safety and be a strong promoter of SHE activities in the lab. Skills Required: For M.Sc, 16-18 years of Discovery Analytical R&D experience and for PhD, 14-16 years of experience in CRO environment Excellent technical, problem-solving, writing, influencing and communication skills Strong leadership with excellent interpersonal skills, proven success of analytical projects and managing cross functional teams Demonstrative communication skills and confident in conveying information to internal/ external customers Skill for resolving the team conflicts and provide training to the team for development and empowers team members Behavioral Competencies: Excellent oral / written communication skills and flexibility to work in a dynamic environment Excellent in Knowledge sharing at all levels Qualifications Qualification M.Sc./PhD/Postdoc Additional Information Specialization Analytical Chemistry/Organic Chemistry, Department E&L Experience (years) 16 - 20

Eurofins Scientific is an international life sciences company that provides a wide range of analytical testing services to clients across multiple industries. From food and pharmaceuticals to environmental and cosmetic products, Eurofins ensures safety, authenticity, and accuracy. With a global presence and over 900 laboratories, Eurofins is a leader in food, environmental, pharmaceutical and cosmetic product testing, as well as in genomics, clinical studies support, and other specialized diagnostic testing. The Project Manager Assistant (PMA) position is an administrative role working directly with a group of Project Managers, focusing on a specific area of the business. This role requires the use of technical functions to navigate Eurofins Lancaster Labs (ELLI) information systems, construct and develop relationships with ELLIs internal scientific and support departments, and assist project managers with a variety of tasks to allow the PMs to focus on client communication. Please note that this position does require direct client interaction. This is a great role if you also aspire to move into a PM position in the future. Employee Responsibilities: Support Sample and Project Management in building and maintaining studies including entering and review of material items, study start and end dates, and generating project plans for the PM teams. Managing incoming and in house Reference Standards by reaching out to the client for updated CoAs when expirations are approaching. Working with Pricing and Analytical Definition to generate quotes and build templates for sample entry of incoming samples. Track financial aspects of projects including purchase order and invoice management. This may also include generating Change Orders, special invoice requests and potentially End of Month billing for clients that qualify. Support Project Managers in an administrative capacity with a variety of other assignments Qualifications M. Pharm / M.Sc, Analyitical Chemistry PMP certification would be an additional advantage Additional Information Experience Level : 5 - 7 years in Bio/Pharmaceutical Analysis Key Candidate Attributes: Possesses excellent communication skills both oral and written Has a strong organization and attention to detail Computer skills Experience utilizing MS Office and MS Project or other project organization tools. Experience navigating a LIMS or equivalent is a plus Ability to learn new techniques, perform and prioritize multiple tasks simultaneously, keep accurate records, follow instructions, and comply with agency and company policies (GMP knowledge is a plus) Ability to work both independently and as part of a team, be self-motivated, adaptable, and maintain a positive attitude, even with critical deadlines Initiative/ Self-Starter proactively seek out work and training opportunities, offer to assist others, strive for high productivity and output in a fast-paced environment

Entire activity for Residue Lab operations Responsible for assignment, planning, Handling OOS Verification of Data & interpretation of Results Indents, procurement and costing Method development and validation Internal Training provider for the Team Responsible for Internal Audits Responsible for closure of customer complaints Technical support, answering Group lab queries Monitoring of Lab TAT Arrangement of chemicals, reagents, RMs, solvents and lab consumables on time Preparation of Standard Operating Procedures. Preparation of Method validation Reports Authorized to report, review and validation of results Qualifications 8-10 years experience of working in food testing laboratory. Strong knowledge of testing requirements of APEDA, FSSAI, EU etc. Strong understanding of ISO 17025 implementation and accreditation process. Proficient in analytical techniques of instrumental chemistry. Proficient in handling LC/MS-MS, GC/MS-MS, HPLC etc. Should be proficient in Method validation. Should have strong leadership skills to handle team of analysts, allotting and supervising the task to team and also monitoring and evaluating the work done. Preferrably a food analyst GraduateB.Sc / M.Sc in Chemistry Additional Information Good interpersonal and communication skills. Energetic, flexible and innovative. Able to work independently and to coordinate several activities simultaneously. Good in communication, read and write in English and local language. Acts quickly and decisively. Knowledge in Microsoft Office (such asMicrosoft Word, Excel, Power Point, & etc.),

Analysis of Pesticide residues in Food and Feed samples. Operation and Maintenance of LC-MS/MS and GC-MS/MS. Reference standards maintenance. Calibration of LC-MS/MS and GC-MS/MS. Recording and maintenance of temperature and humidity sheets. Calibration of Maintenance of micropipettes and analytical balances. Preparation of standard stock and working solutions. Qualifications 4-6 years experience of working in food testing laboratory. Proficient in analytical techniques of instrumental chemistry. Proficient in handling GC/MS-MS, Should be proficient in Method validation. Graduate in B.Sc/M.Sc chemistry Additional Information Good interpersonal and communication skills. Energetic, flexible and innovative. Able to work independently and to coordinate several activities simultaneously. Good in communication, read and write in English and local language. Acts quickly and decisively. Knowledge in Microsoft Office (such asMicrosoft Word, Excel, Power Point, & etc.),

Responsible to develop, implement and be responsible for the production plan for their respective departments. To deliver timely and accurate analysis of samples to meet customer commitments. Be responsible for record control, measurement traceability and testing results review and approve the testing reports. Maintenance of Standard Reference Materials, Chemicals, Reagents, and Glassware used in the laboratory. To support the installation of additional analytical equipment, methods for the analysis of all kinds of food/feed/water matrices based on the transfer of existing methods and knowledge form the Eurofins Group Preparation of standard operating procedures. Validation of non-standard test methods and non-routine test methods. Be responsible for skill training, reviewing, and appraising the laboratory staff. Be responsible for configuring and monitoring the instrument, equipment, and its environment conditions. Organize and supervise confirmation and verification of the testing methods. Estimation of measurement uncertainty for test parameters Scope preparation for new parameters Be responsible for control of nonconformity work, complaint, Retest request etc Reliable, independent, and service oriented approach to work Qualifications 8-10 years experience of working in food testing laboratory. Strong understanding of ISO 17025 implementation and accreditation process. Proficient in analytical techniques of wet chemistry, proximate analysis, heavy metals analysis. Should have strong leadership skills to handle team of analysts, allotting and supervising the task to team and also monitoring and evaluating the work done. Preferrably a food analyst Graduate in B.Sc / M.Sc in Chemistry Additional Information Good interpersonal and communication skills. Energetic, flexible and innovative. Able to work independently and to coordinate several activities simultaneously. Good in communication, read and write in English and local language. Acts quickly and decisively. Knowledge in Microsoft Office (such asMicrosoft Word, Excel, Power Point, & etc.),

Senior Chemist-Residues Analysis of Pesticide residues in Food and Feed samples. Operation and Maintenance of LC-MS/MS and GC-MS/MS. Reference standards maintenance. Calibration of LC-MS/MS and GC-MS/MS. Recording and maintenance of temperature and humidity sheets. Calibration of Maintenance of micropipettes and analytical balances. Preparation of standard stock and working solutions. Qualifications M.Sc Chemistry Additional Information Good interpersonal and communication skills. Energetic, flexible and innovative. Able to work independently and to coordinate several activities simultaneously. Good in communication, read and write in English and local language. Acts quickly and decisively. Knowledge in Microsoft Office (such asMicrosoft Word, Excel, Power Point, & etc.),

Were Hiring Analytical Development Role | Chennai Immediate Opening Position: Analytical Development – Formulation/R&D Location: Chennai Qualification: B.Pharm / M.Pharm / M.Sc (Analytical Chemistry, Pharmaceutical Chemistry, or related field) Experience: 1 to 4 years Industry Preference: Candidates from the Pharmaceutical / CRO / CDMO sectors Key Skills & Responsibilities Hands-on experience in HPLC, GC, UV, IR, and Dissolution Testing Method development and validation for drug substances and formulations Stability studies as per ICH guidelines Preparation of analytical documents, protocols, and reports Knowledge of regulatory requirements and GLP/GMP compliance To Apply: Send your resume to pna@softgelhealthcare.com Contact: 8608396077 Referrals are welcome – Help us connect with the right talent!

Job Summary We are seeking an experienced Lead in analytical development who can plan analytical projects based on priorities and established timelines, provide timely analytical delivery for stability testing, test method development/validation, method transfers and other related requests from Research & Development (R&D) or formulation development. Roles & Responsibilities • You will have to prepare and review of technical documents e.g. stability reports, method transfer and method validation protocol and reports, etc. • You need to manage communication with stakeholders such as project leaders, product development, analytical teams and other business partners • You need to facilitate productivity improvement through proper planning of analytical activities and resource optimization • You need to co-ordinate and follow up with external labs including training of their staff. • You will need to review of analytical data for accuracy, compliance to quality requirements and completeness e.g. lab notebooks, raw data, system entries, etc. • You will have to review of technical documents such as analytical reports, method transfer /method validation protocols, reports, etc. • You will have to participate in handling and resolution of laboratory non-conformances with related documentation • You will be responsible for analytical methods and process compliance as per quality assurance requirement. Education Qualification - MSc Chemistry, MSc Food Science, B.Tech/M. Tech in Dairy Technology Minimum experience required -10 15 years of experience in analytical development department and must have worked on nutritional product portfolio. Skill Attributes Technical Skills • Technical expertise related to chemistry, analytical techniques, stability study assessment and advanced research technologies • Efficient in MS Office, Word/Excel/PowerPoint functionalities • Ability to interact with external labs and 3rd party manufacturing site labs to support product development team. • Ability to understand analytical methods defined by global and local bodies • Ability to resolve analytical issue associated with different product matrix. • Should be familiar with analytical methods defined by national and international bodies like Association of Official Agricultural Chemists (AOAC), Bureau of Indian Standards (BIS) etc. • Excellent knowledge of Good Laboratory Practices (GLP), Quality systems, Standard Operating Procedures, latest regulatory trends, and Global regulations as appropriate • Data review, interpretation of analytical data and accurate documentation of laboratory investigations. Behavioural Skills • Systematic approach and strategic thinking • Possess excellent interpersonal skills, communication, coordination, and time-management skills • Ability to independently handle teams • Excellent oral/written communication and articulation skills • Passion for people development • Ability to prioritize work and change focus quickly • Ability to delegate effectively

Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications. Perks and benefits: Mention available facilities and benefits the company is offering with this job.

Job Track Description Performs tasks based on established procedures. Uses data organizing and coordination skills to perform business support or technical work. Requires vocational training, certifications, licensures, or equivalent experience. General Profile Requires limited prior training or licenses and training certifications. Has basic operational or analytical skills to perform tasks. Works within clearly defined standard operating procedures and adheres to quality guidelines. Work is completed with close supervision and under clearly defined procedures. Functional Knowledge Requires a basic understanding of theories, practices, and procedures. Business Expertise Understanding of how best teams integrate and work together to achieve company goals. Impact Responsible for the accuracy of own work. Receives close supervision and duties are clearly defined. Methods and tasks are described in detail. Leadership Has no supervisory responsibilities. Problem Solving Uses existing procedures to solve standard problems. Has limited opportunity to exercise discretion. Interpersonal Skills Exchanges information and ideas effectively. Responsibility Statements Maintains employee records through data entry. Performs calculations for outstanding payments due on termination or leave of absence. Coordinates termination details to ensure assets are returned/access is revoked on the employee\u2019s last day. Compiles data for review and reporting. May perform routine analysis for internal review. Performs other duties as assigned. Complies with all policies and standards. Conduent is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, creed, religion, ancestry, national origin, age, gender identity, gender expression, sex/gender, marital status, sexual orientation, physical or mental disability, medical condition, use of a guide dog or service animal, military/veteran status, citizenship status, basis of genetic information, or any other group protected by law. People with disabilities who need a reasonable accommodation to apply for or compete for employment with Conduent may request such accommodation(s) by submitting their request through this form that must be downloaded:click here to access or download the form. Complete the form and then email it as an attachment toFTADAAA@conduent.com.You may alsoclick here to access Conduent's ADAAA Accommodation Policy. At Conduent we value the health and safety of our associates, their families and our community. For US applicants while we DO NOT require vaccination for most of our jobs, we DO require that you provide us with your vaccination status, where legally permissible. Providing this information is a requirement of your employment at Conduent.

Role & responsibilities- Conduct analysis of samples using HPLC, GC, Spectrometer, and other basic analytical instruments of the lab with experience in developing and validating HPLC/GC methods Analysis of Sugars, Alcohols, Antibiotics, enzymes, active ingredients, and raw material using HPLC/GC Providing Technical support for internal and external stake holders Being the clear R&D player by working closely with cross-functional teams to drive execution across multiple projects while maintaining and achieving timelines to ensure speed to market. To conduct analysis of samples and provide inputs to R&D/QC teams Required Skill Sets: Hands on experience on HPLC, GC, Spectrometer, and other basic analytical instruments of the lab with experience in developing and validating HPLC/GC methods Experience in analysis of Sugars, Alcohols, Antibiotics, enzymes, active ingredients, and raw material using HPLC/GC Fair understanding of ISO/IEC 17025, ISO 9001, ISO14001, ISO 22000, ISO18001 Lab safety & GLP management

Job Summary Roles & Responsibilities Review and approval of all analytical test data of Quality control. Review and usage decision of analytical reports in LIMS, Empower and SAP. Electronic signatures level-2 for chromatography data station (CDS) and standalone instruments. Review the Analytical test report in LIMS. Review the reported results against specification and trends. Review the method validation and method transfer documents. Review the instrument calibrations and working standard qualification records. Handling the Incidents/ Deviations, Out of Trends, Out of Specification including investigations, Corrective and Preventive actions follow up and closure. Monitoring of analytical activities in Quality control laboratory. Verification of Specifications/standard test Procedures/Worksheets/Analytical Reports before Approval. Verification and review of the audit trails for Standalone, Empower and LIMS. Ensure cGMP / cGLP compliance. To follow Safety, Health and Environmental procedures and practices. Review and approval of excel sheet validations. Review results acceptance for API and Excipients and Packing material. Review of compiled of Stability Data and its verification/ Exhibit batch sampling protocols. Handling of Robotic Process Automation of Chromatography Data review (RPACD) To carry any other activities assigned by upward reporting staff. Qualification Educational qualification: A Bachelor’s/Master's degree in Pharmacy, Chemistry, Chemical Engineering, or a related field Minimum work experience : 3 to 7 years of experience in QC or AQA department is mandatory. 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/#!/

Role & responsibilities Responsible for performing and overseeing ELISA (Enzyme-Linked Immunosorbent Assay) testing, ensuring high standards of accuracy, quality control, and efficiency in laboratory operations. This role involves leading a team of technicians, optimizing assay protocols, managing lab inventories, and analyzing data. Deliver GLP and non-GLP ELISA/LBA, MSD ECL, and Luminex Multiplex Analysis for Pharmacokinetic (PK), Toxicology (Tox), Biomarker, Bioavailability (BA), Biosimilar, Immunogenicity, and other bioanalytical studies. Complete Method Development or Method Transfer of customized, robust, and highly sensitive Chromatographic Assay using necessary sample preparation Develop, validate, and optimize ELISA protocols and procedures to improve lab performance and efficiency. Conduct and supervise ELISA testing for various research, diagnostic, and quality control purposes. Analyze data generated from ELISA experiments, including quantification of analytes and assessing assay performance. Analyze and interpret test results, ensuring proper documentation and reporting of data. Well versed in Operation and Calibration of ELISA Instrument with advancements in ELISA technology and laboratory best practices. Manage Incidents, deviation and investigations of ELISA results with documentation. Prepare and review of SOPs, work instructions, method development and method validation protocols and reports. Ensure compliance with safety and quality standards, including SOPs (Standard Operating Procedures) and regulatory requirements. Client management, including acting as company representative to help existing and potential clients, and serving as operational lead in client visits, facility and pre-qualification audits. Supervise junior and senior scientific staff, including evaluating performance and ensuring that all bioanalytical service activities are performed in a safe manner and according to SOPs and GLP regulations. Train, mentor, and provide technical support to junior lab staff and technicians. Work with cross-functional teams to support ongoing research or clinical studies. Preferred candidate profile Bachelor's or Master's degree in Biology, Biochemistry, Biotechnology, or a related field (PhD preferred). Minimum of 8-10 years of experience working with ELISA assays, including advanced experience in assay development and troubleshooting. Ph.D. plus 8 years relevant industry experience or 6 years CRO experience Master's Degree plus 13 years relevant industry experience or 9 years CRO experience Bachelor's Degree plus 14 years relevant industry experience or 12 years CRO experience Interested and suitable applicants can mail their updated CV to hr@qpsbioserve.com