199 Glp Jobs

Job Purpose Responsible for the design and oversight of safety pharmacology, exploration, and GLP-compliant toxicology studies. Manage multiple projects efficiently across various stages of discovery, preclinical, and clinical development. Contribute to the preparation and review of regulatory submissions and engage with regulatory authorities and cross-functional asset teams This position is located in Hyderabad, Telangana, India. Duties And Responsibilities : Preclinical Pharmacology Design, supervise, and interpret in vivo efficacy studies using a range of disease models. Provide scientific and technical oversight for preclinical pharmacology programs. Prepare study proposals, budgets, and timelines. Lead and mentor scientific staff supporting pharmacology operations. Analyze and compile data, ensuring GxP-compliant documentation and reporting. Contribute to the drafting and revision of regulatory documents including investigator brochures and study reports. Toxicology & Safety Assessment Lead toxicology strategy across discovery, preclinical, and clinical development phases, with an emphasis on human risk assessment and elucidation of toxicity mechanisms for novel therapeutic targets. Act as the primary liaison with CROs, overseeing study conduct and coordinating with technical, veterinary, and scientific personnel. Manage outsourced GLP and non-GLP studies to ensure adherence to protocols, regulatory requirements, safety standards, and SOPs. Integrate expertise in toxicology, pharmacology, ADME, and regulatory guidelines to design robust nonclinical safety assessment strategies. Identify and apply innovative approaches to streamline and accelerate nonclinical development timelines. Critically evaluate study protocols, data sets, and reports to ensure scientific validity and regulatory compliance. Regulatory and Cross-Functional Support Lead or support the preparation of regulatory submissions (e.g., IND, CTA, IB, NDA, BLA). Develop and implement program-specific toxicology plans in collaboration with cross-functional project teams to support compound progression. Represent toxicology and safety pharmacology functions on multidisciplinary project teams. Author and review toxicology reports and regulatory documents; contribute to regulatory submissions and interactions with global health authorities. Represent toxicology function on multidisciplinary teams supporting all stages of drug development. Contributes to the development of high-quality regulatory submissions for global clinical trials and marketing authorizations. Communicate findings and recommendations effectively to project teams and senior leadership. Qualifications and skills : Ph.D. in Toxicology, Pharmacology, or a related field. Strong knowledge of regulatory guidelines (ICH, FDA, EMA) and GxP standards. Minimum 5 years of relevant industry experience in preclinical drug development, or equivalent regulatory experience. Proven experience in designing, managing, and interpreting non-clinical safety and efficacy studies. Demonstrated ability to prepare and review nonclinical sections of regulatory documents like CTA, IND, IB, NDA, BLA, etc. Effective leadership, project management, and cross-functional collaboration skills. Willingness to travel as needed. Strong communications skills and a track record of accomplishment managing client relationships as well as regulatory agencies for USFDA and EMA. Working conditions: This position operates primarily in an office setting and may include 10% of travel. Mandatory onsite presence is required. Physical Requirements: This is a largely sedentary role.

Role & responsibilities JD- Designation: Deputy manager Department: QA Role: vendor qualification Experience:6-10 years of relevant experience. 1)Preparation and Review of procedures related to Vendor management as per regulatory requirements. 2. Review of QMS elements like Change management (Change control), Deviation, CAPA, related to external testing laboratories, service providers. 4. Management of vendor qualification (Related to Contract services/ contract Labs /CMO) documentation i.e. initiation of vendor assessment, tracking of their audit and periodic monitoring. 5. Responsible for vendor Audit Schedule, Execution of site audit for Contract Testing Laboratories, Contract Service Providers. 6. Preparation of Vendor audit reports, reviewing Audit CAPA reports, regular Follow-up to vendor for closure of Audit Observations. 7. Updating of Approved vendor list. 8. Handling of Quality Agreements/CDA with Vendors (Contract Testing Laboratories, Contract Service Providers) 10. Preparation of annual periodic verification of Vendors. Preferred candidate profile

Dear Applicants, Greeting from Biophore India pharmaceutical Pvt Ltd, We have opening for Formulation Development Quality Assurance Department (Formulation) Handling of QMS documents and Ensure the SOP compliance Review of Formulation Analytical Development Documents & Formulation Product Development Documents. Method Validation and Transfer Protocols and Reports Product development with QbD approach Responsible for ensuring GMP/GLP/GDP compliance in the Formulation and Analytical areas as per the respective SOPs. Review of FRD activities (LNBs, BDRs, PDR’s, MFR’s and MPR’) SOP’s and Guidelines Preparation and Review and Approval of SOP’s. Responsible for conducting Internal Audits/External Audits for Cross functional Departments in Formulation Division and External Division. Conducting and Coordinating Employee Trainings. Responsible for Review and Approval of Vendor Qualification Should have experience in IPQA and Analytical QA (OSD/Injectable) Ref to Friends or colleagues. Please Share me update resume: careers@biophore.com Total Exp: Current CTC: Exp CTC : Notice Period: Designation:

DEAR CANDIDATE , WE ARE HIRING! LET'S JOIN OUR TEAM NOW! Department: R&D Position: Research Trainee / Research Associate Preferred Qualification: M.Sc. Biotechnology / M.Sc. Biochemistry Preferred candidate: Male Preferred Experience: 2 to 3 years of experience Should have good documentation skills and knowledge of GDP, GMP, GLP. Should have basic knowledge about proteins and protein purification. Should be a good team player with good interpersonal skills. Job description: Perform R&D related documentation like SOP preparation, data management and data analysis. Perform routine laboratory procedures, including buffer preparation, gel electrophoresis, western blot. Operation and maintenance of Akta systems, Tangential flow filtration, centrifugation etc. To involve in daily lab activities for process development and assist fellow researchers. LOCATION : Hyderabad. CTC : 4.5 LPA IMMEDIATE JOINERS ARE PREFERABLE" Interested candidates please attach your CV here. NOTE : Interviews will be face to face only ,no virtual interviews. For more details, please reach out Venkat - 9381915043

What you will do The Quality Compliance Manager is a global role and part of the Process Quality team for the RD Quality Organization. In this vital role you will work with a team of process-focused colleagues who work to complete Amgen s Process Quality strategy, which is vital to ensuring that Amgen s Research and Development Standards (SOPs and associated documentation) are adequate, clear, and up to all applicable current regulations and quality requirements. The RD Process Quality team supports the Quality Management System (QMS) across all areas of research at Amgen, including discovery through the full clinical development lifecycle. This team ensures that all Amgen s business procedures meet internal and external quality standards and are managed for optimum efficiency and effectiveness. The Process Quality team also ensures that Amgen s RD Business Process Network develops and manages fit for purpose standards (SOPs) that are continuously improved upon using quality by design (QbD), and risk management methods that include QMS analytics showing quality signals and trends. In addition, this individual will help support end users in RD with the digital quality management system (DQMS) with queries, deviations and Corrective and Preventive Actions (CAPAs). The Quality Compliance Manager will contribute to implementing strategies and providing leadership to ensure excellence in RD Quality Processes. As an integral team member working globally with Business Process Owners to ensure compliance with regulations and other requirements. Roles Responsibilities: This role will work both independently and in a team environment. Their primary responsibility is to support continuous improvement initiatives for RD quality, but they will also be responsible for any other operational or strategy activities assigned. Generate and review process area Knowledge Maps (spider maps, lessons learning, and data processing techniques, stored in a graph-based database for better search, analysis, and visualization) to help determine inherent and residual risks, document risk assessments, and collaborate with Business Process Owners and Quality Leads to ensure accurate risk classification and preventive actions. Supports Amgen s procedural framework so that all procedures maintain compliance to relevant laws, regulations, and internal quality standards; works to ensure that procedures maintain the ethical and safe treatment of all research subjects and that all data has integrity. Provide real-time, site-level quality oversight using analytical tools to identify trends, weaknesses, and data quality issues. Perform focused quality control checks on-site and remotely at clinical trial locations, especially key target sites. Offer independent and objective quality advice to local study teams Conduct risk assessments to inform audit site selection and pre-inspection/mock inspection visits. Support site/sponsor inspection readiness and management, including prep, conduct, response, and close-out phases. Ensures that all procedures are written clearly for the execution of Amgen s research tasks within a diverse, complex, and cross-functional team of researchers. Supports incoming procedural change requests, including the assessment of changes (impact to the QMS, including traceability of changes across other document sets. Supports the work of Business Process Owners and applies risk-based strategies consistently to identify and mitigate risks towards the continuous advancement of Amgen s RD QMS. Applies industry standard methodologies for optimal (standardized and lean) procedural documentation, and the use of technology to drive an efficient and effective knowledge management system. Supports the application of process metrics (KQI, KPI - leading and lagging) and modern analytic methods across the Business Process Network in order to enable Management Reviews (periodic review by management to ensure QMS health is maintained). Collaborates with other quality professionals within RD to support the QMS continuous improvement cycle (Plan, Do, Check, Act), including Deviation Management/ Corrective and Preventative Actions (CAPA). What we expect of you Basic Qualifications and Experience: Master s degree and 4-6 years in Pharma and Biotechnology RD Quality OR Bachelor s degree and 6-8 years of years in Pharma and Biotechnology RD Quality. Diplomas degree and 10-12 years of years in Pharma and Biotechnology RD Quality. Functional Skills: Must-Have Skills: Exceptional attention to detail and accuracy in all deliverables. Ability to work independently and proactively in a fast-paced environment. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and virtual collaboration tools (e. g. , Teams, WebEx) Solid understanding of SOP/Standards management, and methods/ technology used to drive knowledge management across a diverse RD environment. Good-to-Have Skills: Familiarity with project management tools and methodologies. Knowledge of GCP, GLP and/or GPvP. Experience working in a multinational environment with global teams. Experience within Biotech/pharmaceutical Research, including the application of Global Regulations. Direct experience working with standard procedural documentation, including their creation, change control (requests for change and the execution of changes. Soft Skills: Excellent verbal and written communication skills. High degree of professionalism and interpersonal skills. Strong problem-solving abilities and adaptability to changing priorities. Collaborative attitude and ability to build positive relationships across diverse teams. Resilience, discretion, and the ability to thrive under pressure What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Leading the Quality Control Teamaccording to the norms of GMP (Good Manufacturing Practices) to ensure international quality standards and adherence to various regulatory requirements. Developing and reviewing cGMP compliance related documents like global procedures, methods, standards, specification, validation protocols, summary reports. Implementation of management system for Change control, CAPA, OOS, Risk analysis, deviation management system, incidents (Lab ware LIMS, eQMS,Track wise) and complaint management system. Actively participated in QTA between CMO and receiving/transferring site. Review and approval of APQR. Root cause analysis/ Failure investigation and corrective and preventive action planning Change control management system, CAPA, OOS, deviation management system, incidents Corrective and preventive action planning (CAPA) against the regulatory requirement. Implementation of CAPA effectiveness checks against the regulatory and existing quality system requirements. Deep knowledge in LIMS (Caliber/ LabWare management system and Thermo LIMS). GAP assessment of the quality system for process optimization and to assess the regulatory requirements against the gaps observed. Development and review of cGMP compliance related documents like global procedures, methods, standards, specification and validation protocols, summary reports. Immediate Joiners will be prefered. Kindly share resume on dipika.parmar@milanlabs.com

Opening in Medicamen Biotech Ltd(ANVISA & EU), Bhiwadi, Raj. Pharma formulation exp. Preferred Qualification: B.Sc./B.Pharma Vacant Post: 10 Nos. QA - IPQA/Documentation/Validation QC - IPQC/HPLC/Chemical Testing/GC/KF Mail-ID: hrd@medicamen.com Required Candidate profile Immediate joiner prefer Experience : 2 to 6 Years Ready to Relocate Bhiwadi Self Motivated/ Team Player/ Committed for Performance. E-Mail: hr-ho@medicamen.com Mob: +91 7240001632/ 9992395009

Freshers can also welcomed for interview. QC Executive To monitor all process steps (physical, chemical & microbiological testing) and control points as per defined parameters and standards. To monitor effectiveness of overall cleaning and sanitation of the plant including all warehouses. To monitor GLP practices in lab, resources needed as per laboratory requirement. To monitor the product quality through compliance of specification for raw material, packaging material & finished products. To monitor testing plan, calendar & standard for inside & outside testing & to ensure outside testing as per schedule. To check and verify the daily deviation report, taking appropriate actions against the same. Determining and agreeing on in-house quality procedures, standards and specifications. Specifying quality requirements of raw materials with suppliers. To ensure that all the products confirm the quality specification. To identify, plan, documents and manage the practices, activities and resourced needed to meet quality goals and objectives. Responsibility for review and analyze quality index and carry out root cause analysis for failure and corrective action plan. Oversee the pre dispatch inspection related activities and ensure that the products dispatched meet the required standards. Analyze and resolve all matters related to quality issues and closure of customer complaints. Responsible for reviewing all customer complaint and provide RCA & CAPA. Continuous endeavor for zero customer complaint. Provide support to other departments in managing quality within their processes. Preparation labels for domestic and Export as per requirement. And Make data records as per buyer requirement in case of export /domestic example COA, Serial Number of Items to be dispatched etc. Provide trainings to workforce related with quality & food safety. Microbiologist Preparation of media and sterilization of media &glasswares. Microbiological analysis of raw material & finished products. Microbiological analysis of complaint samples. (whenever required) Perform hygiene tests like environment monitoring, hand swab, surface hygiene & swabs of packing material Microbiological analysis of RO & CIP water & testing Responsible for daily quality documentation & record keeping. Micro analysis of R&D & market samples with record keeping. Micro analysis of trial batches upto required time with record keeping. Assisting in calibration of laboratory equipment with documentation. To monitor & maintain incubation samples with record keeping. Validation of CIP, hygiene & environmental hygiene Preparation, Handling and destruction of media Good lab practices and arrangement of micro items. Provide trainings to workforce related with quality, microbiology & food safety. Product shelf life checking and its records. Lab Chemist / Process Controller Implementation of quality system schedule, preparation and recording Online quality control reports. In case of any deviation from standard and safety of product inform immediately to Lab In charge. Monitoring of CCPs & OPRPs and its Records and Control. Incoming Raw material ad Finished Product Testing and Records. Instrument Calibration of lab and Weighing scales. Recopies Verification and Online Parameters Check and Control if any deviation observed. Online Training to Plant Workers on Food safety/GMP/Personal Hygiene/product Parameters and Packing Parameters. Finished Product Coding Printing Verification and its records. Verification Plant GMP/ GHP . Incoming and Outgoing Vehicle checks and its records. Maintaining Keeping samples and its records. Monitoring all line labeling and Packaging of Finished product. Supervision of Plant cleaning through Housekeeping team. Ensure the PPEs monitoring wearing by Food handlers during Food Product packing. Freshers can also welcomed for interview.

Role & responsibilities Inventory Management: Maintain accurate records of all bulk packaging materials (e.g., bottles, blisters, foils, labels, cartons, etc.). Ensure proper stocking levels and avoid stock-outs or overstocking. Material Receipt & Inspection: Oversee receiving activities of packaging materials. Ensure materials are received as per purchase orders and conduct visual and quantitative inspection in coordination with Quality Assurance (QA). Storage Compliance: Store packaging materials under specified storage conditions. Ensure cleanliness, segregation, and proper labeling as per GMP and SOPs. Material Issuance: Issue materials to production as per batch manufacturing records (BMRs) and ensure traceability. Maintain First-In-First-Out (FIFO) and/or First-Expired-First-Out (FEFO) protocols. Documentation & ERP: Maintain and update inventory in ERP/SAP system. Generate GRN, issue slips, and other store-related documents in compliance with audit and regulatory requirements. Audit Readiness: Ensure all documentation, processes, and physical inventory are audit-ready for internal, external, or regulatory audits (e.g., USFDA, WHO, MHRA). Team Management: Lead and supervise store assistants and workers. Train them on SOPs, safety, and GMP standards. Coordination: Coordinate with Procurement, QA, Production, and Planning departments to ensure timely availability and release of packaging materials. Experience in store management of a Pharmaceutical Formulation manufacturing Company for bulk Packaging Material handling. Skills: Knowledge of GMP, GDP, and regulatory standards Proficiency in ERP/SAP Good documentation practices Strong organizational and communication skills

Role & responsibilities Responsible for compliance as per 9001:2015, ISO 14001:2015, ISO 45001:2018. Responsible for validation/ verification of Analytical Methods on ICP-MS, AAS, HPLC and instruments as per ICH Q2 (R2). Responsible for development of Cost-effective, rugged and robust analytical methods on ICP-MS, AAS, HPLC, and wet lab instruments as per ICH Q14 and Analytical QbD. To maintain GLP compliance as per OECD or other regulatory/ general guidelines in ARD lab. Responsible for performing technology transfer of analytical method in QC(Plant). Any other responsibility assign by ARD head, time to time on need basis. Preferred candidate profile Post graduate (M.Pharma/M.Sc) Must be from Pharmaceuticals (preferably API) background.

Role & responsibilities a. Perform routine testing of raw materials, in-process, and finished products as per approved methods. b. Operate analytical instruments like HPLC, GC, UV, FTIR, and dissolution apparatus. c. Maintain and document all test results accurately in compliance with cGMP and GLP guidelines. d. Support stability studies, method validation, and method transfer under supervision. e. Assist in investigation of OOS/OOT results and follow SOPs strictly. f. Ensure proper calibration and maintenance of laboratory instruments. g. Maintain lab safety, cleanliness, and participate in regular training programs. h. Coordinate with other team members to ensure timely completion of lab activities. Preferred candidate profile Candidates having experiences in Pharma formulation(OSD) in EU/USFDA units will be preferred

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

Company Description ProvenTech Consulting Pvt Ltd is a global digital native company with a focus on Lifesciences & Healthcare domains. Their commitment is to offer Services and products for the pharma industry through constant development, implementation and support. ProvenTech facilitate businesses to transform them into future-ready laboratories through pharma-4.0 state-of-the-art technology. Role Description We are seeking a highly motivated and detail-oriented individual to join our team as a LIMS Master Data Creation Specialist. In this role, you will be responsible for the accurate and timely creation and maintenance of master data within our LIMS platform. The successful candidate will possess a strong understanding of laboratory workflows and data management principles, along with excellent organizational skills and the ability to work independently and collaboratively within a team environment. Key Responsibilities: Utilize knowledge of laboratory processes and terminology to accurately translate requirements into LIMS master data configurations. Collaborate with laboratory staff and project stakeholders to gather requirements for master data creation and ensure alignment with business needs. Configure LIMS system settings, including sample types, test methods, analytical procedures, and other relevant parameters. Input and validate data in accordance with established Procedures and quality standards. Perform routine data maintenance tasks, including updates, corrections, and archival of obsolete data. Troubleshoot Master data-related issues and provide timely resolution to ensure system integrity and reliability. Document master data creation processes, standard operating procedures (SOPs), and system configurations. Provide training and support to end-users on master data management best practices and system usage. Collaborate with cross-functional teams, including IT, quality assurance, and laboratory operations, to support system integration and enhancement initiatives. Stay informed about industry trends and emerging technologies related to laboratory informatics and master data management.

To ensure the implementation of Good Laboratory Practice and Good Documentation Practice in Quality Control. Analysis of In-process, finished products, stability samples of various formulation products: oral solids, Topical, cosmetics. Responsible for investigation and initiation of change control, Laboratory incidents, CAPA, OOS, OOT. To Co-ordinate with Quality control Manager to prepared the Analytical Method Validation protocol and Report. To perform the analytical method validation as per requirmnet. To ensure the implementation of Good Laboratory Practice and Good Documentation Practice in Quality Control Also having sound knowledge about data integrity, ALCOA principals and respective regulatory guidelines.

Hello Candidate, Greetings from Hungry Bird IT Consulting Services Pvt. Ltd.! We're hiring a Quality Control Head for our client. Qualification: MSc in Chemistry, Biochemistry, or a related field Location: Vikarabad District, Telangana Experience: 5 to 8 Years Salary: 3.5 lakhs to 4 lakhs per annum Required: Male Note: Preferably with strong experience in the pharmaceutical or ethanol industry. Job Summary: We are seeking an experienced Quality Control Head to lead the QC team at our client's facility. The ideal candidate will have a strong background in analytical techniques, including Gas Chromatography (GC) and High-Performance Liquid Chromatography (HPLC), and will be responsible for ensuring the highest standards of product quality and regulatory compliance. Responsibilities: Lead, manage, and mentor the Quality Control team. Develop, implement, and oversee all QC procedures and protocols. Supervise analytical testing using GC, HPLC, Spectrophotometer, and other advanced techniques. Ensure all processes and products comply with regulatory requirements and industry standards (e.g., ISO, GMP). Collaborate effectively with production teams to identify and resolve any quality-related issues. Develop and implement robust quality control measures to guarantee final product quality. Train and develop QC team members to enhance their skills and performance. Requirements: Minimum of 5 to 8 years of experience in a Quality Control role. Strong hands-on knowledge of analytical techniques, especially Gas Chromatography (GC) and HPLC. Proven experience with regulatory compliance (e.g., ISO, GMP). Excellent leadership, communication, and problem-solving skills. Proactive, detail-oriented, and able to work in a dynamic environment. (Interested candidates can share their CV to aradhana@hungrybird.in or reach us at 9959417171.) Please furnish the below-mentioned details; that would help us expedite the process. PLEASE MENTION THE RELEVANT POSITION IN THE SUBJECT LINE OF THE EMAIL. Example: RAMESH, QC HEAD, 6 YEARS, 30 DAYS NOTICE Name: Position applying for: Total experience: Notice period: Current Salary: Expected Salary: Thanks and Regards Aradhana +91 9959417171

Job Objective: Plan, allocate and review testing for the release of all RM, processed material, finished products to achieve the committed lead time for Production and for achieving targeted OTDIF Maintain microbiological laboratory GLP compliant as per Schedule L of Drug and cosmetic act. Ensure implementation and sustain of safe environment in microbiology laboratory. SOP review & availability of current version Roles and Responsibilities: Daily review of testing of FP, RM, Water, Air, In-process & Swab as per given procedure and frequency. Daily work allocation to microbiologists. Daily review of records and logbooks maintained in microbiology laboratory. Daily communication to operation and QA for any OOS or OOT related to microbiology testing. Investigation and root cause analysis in case of microbiological failure (OOS/OOT) and implementation and sustenance of CAPA CAPA checklist audit as per define checklist and presenting data to higher management during global micro meeting. Review of microbiological trends for air and water as per define procedure and frequency. Surveillance of shop floor for GMP adherence. SAP entry for finished product in absence of microbiologists Maintaining microbiological laboratory as per laid down procedure. Review of Q & V documents related to microbiological risk involved. Review of validation activities in microbiology laboratory. Composite sample preparation and insurance in absence of microbiologist. Microbiology awareness training to shop floor people. Laundry audit / Monitoring of Housekeeping activities & Self inspection of various departments GLP and documentation, laboratory facility maintenance Microbiological testing of FP, RM, Water & Air in absence of other microbiologists

Job Description Version. no.: The Job Responsibilities of the position holder are : Responsible for performing the analytical activities as per Analytical competency matrix (Format No.BDI-QCSG004F23) and On job training and Practical Demonstration for Chemical and Instrumentation (Format No.BDI-QCSG004F19). Analysis of In process, SFG, Finished Goods, Raw material & stability sample, Analytical method validation/Verification, of OSD and LVP as per defined Protocol or procedure and related documentation as per GLP and GMP in time. Responsible for receiving sample and their documentation. Responsible Data entry in SAP. Responsible for sending the sample to outside laboratory and ensure their analysis as per requirement from Outside Commercial Lab as and when required. Calibration of instruments, as and when required. Preparation of volumetric solution, reagent, and test solution, as and when required. Ensuring the timely updation in the documents as per the Pharmacopeial amendments. Responsible for maintaining the resource in the quality control department. To ensure the compliance of the requirement of cGDP/cGDP and Data integrity while performing all activities in the laboratory. Ensuring the Compliance to EPD Global Guidelines. Facing internal and external audits and ensuring compliance. Implementation of GLP / GMP requirements. Coordinating and aligning the practices and procedures in line with the COBC requirements. SOP training in Isotrain of self-train within stipulated time. Any other task assigned by reporting manager. In absence of the position holder, the sub-ordinate Executive / Manager working in the section, or the authorized designee (as applicable) shall be responsible for day to day working. Signatures _____________ Position holder ______________________ Authorized by JOB FAMILY: Operations Quality t

Dalmia Bharat Group is looking for Shift Chemist to join our dynamic team and embark on a rewarding career journey Chemical Process Monitoring: Monitoring chemical processes, reactions, and operations to ensure they are running smoothly and in accordance with established procedures Quality Control: Conducting quality control tests and inspections on raw materials, intermediate products, and finished products to ensure they meet specified standards and regulations Sample Analysis: Collecting and analyzing samples of chemicals, compounds, or products using various analytical techniques and instruments, such as spectroscopy, chromatography, and titration Data Interpretation: Interpreting analytical data, test results, and laboratory reports to identify deviations or issues and take corrective actions Documentation: Maintaining detailed records of test results, procedures, and observations, as well as preparing reports for documentation and compliance purposes Instrument Maintenance: Calibrating and maintaining laboratory equipment and instruments to ensure accurate and reliable measurements Safety Compliance: Adhering to safety protocols, handling hazardous materials, and ensuring a safe working environment for oneself and others Compliance with Regulations: Ensuring compliance with regulatory standards, safety protocols, and industry-specific guidelines, such as Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP) Troubleshooting: Identifying and addressing issues or deviations in chemical processes and recommending corrective actions or process adjustments

Dalmia Cement Bharat Ltd is looking for Shift Chemist to join our dynamic team and embark on a rewarding career journey Chemical Process Monitoring: Monitoring chemical processes, reactions, and operations to ensure they are running smoothly and in accordance with established procedures Quality Control: Conducting quality control tests and inspections on raw materials, intermediate products, and finished products to ensure they meet specified standards and regulations Sample Analysis: Collecting and analyzing samples of chemicals, compounds, or products using various analytical techniques and instruments, such as spectroscopy, chromatography, and titration Data Interpretation: Interpreting analytical data, test results, and laboratory reports to identify deviations or issues and take corrective actions Documentation: Maintaining detailed records of test results, procedures, and observations, as well as preparing reports for documentation and compliance purposes Instrument Maintenance: Calibrating and maintaining laboratory equipment and instruments to ensure accurate and reliable measurements Safety Compliance: Adhering to safety protocols, handling hazardous materials, and ensuring a safe working environment for oneself and others Compliance with Regulations: Ensuring compliance with regulatory standards, safety protocols, and industry-specific guidelines, such as Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP) Troubleshooting: Identifying and addressing issues or deviations in chemical processes and recommending corrective actions or process adjustments

Prepare trending of Events/Incident and ensure completeness of its closure. Identify the gaps and provide appropriate training to analytical scientist to strengthen compliance level. Thorough review of clinical batch release data, method validation protocol & report, clinical stability sample analysis, as per cGMP and regulatory requirement. Ensure review of daily verification/calibration of pH meter, balances and TOC. Ensure review of calibration record of all analytical instruments and update of calibration planner in timely manner. Thorough review of method development report and investigation study report Randomly review and cross verify all analytical instrument logbook entries and laboratory notebook for its completeness for compliance point of view. Randomly review of standard, column and chemical management logbooks. Ensure in-house compliance system. Randomly review of QMS activities (i. e. change control, incident, deviation). Maintain hygienic condition in laboratory. Follow GxP (GMP, GDP, GLP) for all processes. Ensuring proper use of Personal Protective Equipment. Thorough review of IQ/OQ and PQ of instrument/equipment. Ensure computer System Validation according to CSV SOP and identify gap in qualification document according to CSV SOP. Perform internal audit of AD and provide appropriate training to AD team. Accompany the internal audit and provide appropriate response to audit observations. Training on GDP/GLP/DI to the scientist on quarterly basis to ensure compliance. Tracking and monitoring of calibration planner and preventive maintenance planner. M. Pharm/ M. Sc. Chemistry

Role & responsibilities :- Perform and approve Sterility Testing using direct inoculation or membrane filtration methods as per pharmacopeial standards (USP, EP, IP, JP). Supervise aseptic testing procedures in ISO Class 5 (Grade A) environments within validated sterility testing isolators or LAFs . Ensure environmental monitoring , personnel monitoring , and media fill (ASEPTIC Process Simulation) activities are conducted and reviewed as per schedule. Approve microbiological testing results, including bioburden , endotoxin , water testing , and identification of microorganisms . Conduct investigations of microbiological OOS/OOT results and deviations , and support implementation of corrective and preventive actions (CAPA). Maintain and review sterility testing records , SOPs, protocols, and reports for accuracy and regulatory compliance. Participate in regulatory inspections and internal audits. Provide training to QC microbiology staff on aseptic techniques, gowning, sterility testing, and contamination control. Ensure microbiological methods are validated and kept up to date per pharmacopeial updates. Maintain inventory and calibration status of microbiology lab equipment used in sterility testing. Review and approve environmental monitoring data related to aseptic processing areas. Preferred candidate profile :- Attention to detail and high level of documentation accuracy. Strong aseptic technique and contamination control awareness. Analytical thinking and sound decision-making in compliance-driven environments. Ability to work independently and in a team. Good communication skills (written and verbal).

Division Department Sub Department 1 Job Purpose Develop, optimise and execute the process for APIs to ensure on time implementation within budget Key Accountabilities (1/6) Develop API process in lab by literature survey, API intermediate characterization to ensure the quality and on time implementation Carry out literature survey and route selection for assigned project Prepare and execute development strategy for the assigned project Maintain record book of experiments carried out in lab, results received from the ADL Optimize process parameters to achieve process robustness for ensuring successful completion of lab trial and lab confirmatory batches with optimised costs Support creation of new IP assets for the company by performing experiments related to innovations like new process and polymorphs Maintain and calibrate the instruments in lab as per calibration schedule Follow individual safety procedures while working in lab by following GLP Follow the green chemistry approach while conducting experiments Key Accountabilities (2/6) Prepare development report and MPG on the basis of development work (carried out in lab) in order to successfully transfer the technology in plant Prepare tech Transfer documents like MPG, pre requisite, solubility chart, development report in coordination with ROC based on process developed in lab Coordinate with manufacturing units for carrying out pilot, pre-validation and validation batches under the supervision of group leader Key Accountabilities (3/6) Conduct QbD study, carryover study, impurity (genotoxic) identification / synthesis / characterization to achieve regulatory compliance and minimize the deficiencies in the DMF filling Perform QBD studies by conducting QBD experiments in coordination with QBD team Conduct impurity profile and carryover studies, impurity (genotoxic) identification / synthesis / characterization, Key Accountabilities (4/6) Support procurement in identifying and finalising the vendors for key raw materials by performing vendor qualification to achieve on time implementation Carry out experiments required for vendor qualification on receipt of material Compare and derive trend data for shortlisting vendors by comparing materials received Key Accountabilities (5/6) Ensure compliance of checklist for stage gate and milestone meetings to complete the project within time Carry out the listed activities in the stagegate and milestone checklists within time Key Accountabilities (6/6) Major Challenges Delay in getting analytical results from ADL causes delay in the overall development of project Re-conducting experiments in cases of incorrect quality raw material being received from procurement (due to rejections) Bring to the notice of group leader in such cases, Rework as more experiments need to be performed due to changing requirements for product development, Key Interactions (1/2) Manufacturing, SCM and ADL for receiving samples and delivering results (frequently) QA and QC for quality related procedures (frequently) IP for inputs regarding literature (need basis) ROC for documentation support (frequently) Safety for safety information (frequently) Engineering for machine maintenance (need basis) Key Interactions (2/2) Vendors and suppliers for raw materials and instruments, equipment (need based) Dimensions (1/2) Process development for 4 projects (last year) Execution of process on plant for 1 project (last year) Dimensions (2/2) Key Decisions (1/2) Use of Specific reagents, solvents, reaction condition Key Decisions (2/2) Route selection for development (to GL) Specific vendor for raw materials, instruments and equipment (to SCM) Education Qualification Educational Qualifications Sc Relevant Work Experience 3-5 yrs in process R&D

Sodexo Food Solutions India Pvt. Ltd.ces is looking for MIS Admin Assistant to join our dynamic team and embark on a rewarding career journey Oversee the design, implementation, and maintenance of the information systems, including hardware, software, and networking infrastructure Manage the database systems, including data backup and recovery, data security, and data integrity Develop and maintain procedures for managing the information systems and technology infrastructure, including disaster recovery plans, security policies, and user access controls Analyze the business processes and identify opportunities for improvement through the use of information systems and technology Collaborate with cross-functional teams, including IT, finance, and business operations, to integrate information systems and technology with other systems and processes Monitor system performance and provide technical support to end-users to ensure the smooth operation of information systems and technology Strong analytical and problem-solving skills Excellent communication and collaboration skills

We are seeking a meticulous and experienced Executive/Sr. Executive to spearhead chromatographic analysis and data review at Synnat Pharma Private Limited, a rapidly growing API manufacturer. In this pivotal role, you will be responsible for ensuring the accuracy, reliability, and compliance of analytical data generated within our QC laboratory. Your expertise will be crucial in adhering to stringent regulatory standards, including ICH guidelines and pharmacopeial requirements, while contributing to the overall quality and integrity of our pharmaceutical products. The ideal candidate will possess a strong understanding of HPLC and GC systems, coupled with proficiency in Empower CDS and a deep commitment to data integrity and GLP/GMP principles. This role demands a proactive individual capable of troubleshooting analytical issues, leading OOS/OOT investigations, and implementing effective CAPA measures. You will collaborate closely with cross-functional teams to maintain a robust Laboratory QMS and ensure seamless method of transfer and validation processes. If you are passionate about pharmaceutical sciences and dedicated to maintaining the highest standards of quality in API manufacturing, we encourage you to apply. Job Details: Industry: Active Pharmaceutical Ingredient (API) Manufacturing Department: Quality Control Role: Executive/Sr. Executive Location: Visakhapatnam Compensation: 4,00,000 to 8,00,000 INR per annum Experience: 4-7 years Qualification: Bachelor's or Master's degree Chemistry, or a related field Employment Type: Full-time Responsibilities: Chromatographic Analysis and Data Review Perform chromatographic analysis of raw materials, in-process samples, and finished products using HPLC and GC techniques, ensuring compliance with established test procedures and pharmacopeial requirements. Review chromatographic data generated by other analysts for accuracy, completeness, and compliance with data integrity and GDP. Troubleshoot HPLC and GC systems, resolving issues to ensure reliable instrument performance. Participate in method validation and transfer activities in line with regulatory expectations. Analyze stability samples and maintain data integrity in accordance with ICH guidelines. Prepare reports summarizing analytical results and findings. Quality Control and Compliance Implement and maintain a robust Laboratory QMS as per GLP, GMP, and internal quality standards. Lead OOS and OOT investigations and implement corrective actions to prevent recurrence. Manage and document CAPA activities effectively. Ensure data integrity through robust controls and secure data handling practices. Participate in audits and address regulatory observations. Maintain accurate documentation as per GDP guidelines. Laboratory Operations and Maintenance Oversee calibration and maintenance of HPLC and GC systems. Manage lab supplies and ensure proper storage and inventory control. Maintain a clean and compliant lab environment. Train junior staff in instrumentation, methods, and data practices. Develop SOPs and contribute to continuous improvement of test procedures. Support cross-functional teams in resolving quality-related issues. Stakeholder Management and Reporting Collaborate with R&D, production, and regulatory affairs teams. Communicate analytical findings effectively for decision-making. Prepare periodic reports for management summarizing QC trends. Participate in regulatory inspections and audits. Coordinate with external vendors for analytical services. Represent the QC department in internal/external meetings. General Expectations and Past Experiences: Possess a Bachelor's or Masters degree in Pharmaceutical Sciences, Chemistry, or a related field. Have 4-7 years of experience in a pharmaceutical QC lab, preferably API-focused. Demonstrate expertise in HPLC and GC, including troubleshooting and method validation. Exhibit a strong understanding of GMP, GLP, ICH, and pharmacopeial compliance. Proficiency in Empower CDS is essential. Strong skills in data review, OOS/OOT handling, CAPA, and documentation. Excellent team collaboration, problem-solving, and communication abilities.

FERRING THERAPEUTICS PRIVATE LIMITED is looking for Analyst QC to join our dynamic team and embark on a rewarding career journey Analyze data, interpret trends, prepare reports, and support decision-making through insights Develop models, work with tools like Excel, SQL, or Python Ensure data accuracy, and contribute to business optimization and forecasting efforts