447 Glp Jobs - Page 4

Eurofins Advinus is a premier preclinical and early development CRO offering drug discovery, preclinical and development stage contract research services in the areas of discovery services, regulatory Toxicology (Safety Assessment), DMPK, Analytical R&D Services and API CDMO. Eurofins Advinus manufactures drug substances to support Toxicology and early clinical studies. Experience (years) 20-22+ years relevant experience or PhD in Microbiology with at least 15+ years of relevant industry experience. Job description: In-depth scientific expertise in Genotoxicology, with significant experience in designing, executing, and interpreting genetic toxicology studies in both regulatory (FDA, EMA, ICH, and OECD guidelines) and non-regulatory environments. Responsible for the execution, planning, performance, reporting/archiving, and management of studies such as the Bacterial Reverse Mutation Test (Ames Test), Bone Marrow Micronucleus Test, Chromosome Aberration Test, and In Vitro Micronucleus Test etc. Preparation of study plans, protocols, amendments to study plans, study reports, creation, and review of SOPs. Lead and manage a team of genetic toxicologists, providing mentorship and guidance to achieve departmental and organizational objectives. Oversee study directors across multiple studies and ensure consistent performance. Train and onboard new staff, ensuring they meet expected proficiency levels for quality work in compliance with GLP standards. Prepare monthly forecasts and reports, and plan for the effective use of resources. Focus on maintaining strong client communication, ensuring timely delivery of services, and fostering repeat business. Oversee laboratory maintenance, equipment validation and calibration, and procurement of reagent supplies. Participate in GLP/NABL activities, inspections, and ensure adherence to regulatory compliance guidelines; address Quality Assurance checklists and GLP compliance. Collaborate with HOS/HOD in budgeting, costing, planning, and conducting studies, as well as in the development of new platforms and operational activities. Support to business development and marketing efforts, generate new business leads alongside the BD team. Standardize and implement new in vitro test procedures. Qualifications / Skills Required: Masters in Microbiology (M.V.Sc / M.Sc) with at least 20-22+ years of relevant industry experience or PhD in Microbiology with at least 15+ years of relevant industry experience Understanding of the agrochemical and pharmaceutical R&D process Strong problem-solving skills and the ability to develop innovative solutions. Experience in managing internal and external collaborations. Willingness to adapt to rapidly changing scientific and regulatory environments. Effective team collaboration skills to achieve project goals, objectives, and deadlines. Behavioral Competencies: Strong oral and written communication skills. Ability to adapt and work efficiently in a dynamic environment. Excellent time management skills to effectively handle multiple projects. Highly motivated, takes responsibility for personal improvement, learning from experience and new situations. Strong training, presentation, analytical, and computer skills Thinks of and/or encourages new ideas and keen to experiment and see ideas implemented. Qualifications Qualification M.V.Sc / M.Sc. in Microbiology / PhD in Microbiology

Shall have good knowledge on operation of Purified water system. 2. Shall have good knowledge on operation of Pure steam generator system. 3. Shall have good knowledge on operation of WFI system. 4. Shall have good knowledge on GMP and GDP.

1. Shall have good knowledge on operation of Purified water system. 2. Shall have good knowledge on operation of Pure steam generator system. 3. Shall have good knowledge on operation of WFI system. 4. Shall have good knowledge on GMP and GDP.

1.Responsible for Sample Management Activities like Sample collection, Handling, Labeling, Tracking, Chain of custody documentation and Sample Disposal 2.Responsible for arranging the samples to be sent to the vendor for the required external testing and receiving the appropriate reports 3.Responsible for following GLP/GDP practices and Compliance with respect to sample management. 4.Responsible for reagents / chemicals / standards / consumable / utilities receiving, labelling, proper maintenance, consumption records listing of procurements requirements.

1. Shall have good knowledge on operation of Purified water system. 2. Shall have good knowledge on operation of Pure steam generator system. 3. Shall have good knowledge on operation of WFI system. 4. Shall have good knowledge on GMP and GDP.

1. Responsible for review of specifications, STPs, GTPs and analytical test data sheets. 2. Review of analytical reports of raw material, packing materials, water samples, product samples, OOT, water trends and ensuring compliance. 3. Responsible to attend the training programs. 4. Responsible for monitoring of quality control Lab (Daily calibration, PMP, Instruments back up data, Excel work sheets lock, user log books). 6. Responsible for handling technology transfer documents. 7. Responsible for review of stability protocols, stability analytical data and summary reports. 8. Responsible for handling of change controls, OOS, OOT, Incidents and investigations. 9. Responsible for compliance of GLP in Lab. 10. Responsible for review and approval of LIMS related activities. 11. Approval and issuance of configured COA in LIMS. 12. Responsible for audit trail verification for QC lab instruments.

End-to-end formulation and development of injectable dosage forms (Liquid, Lyophilized, Emulsion, etc.) Handling of scale-up, exhibit batches, and tech transfer Cross-functional coordination with ADL, RA, QA, and Manufacturing

Design and execute experiments related to the formulation development of oral solid dosage forms using HME techniques. Operate and maintain HME equipment including twin-screw extruders, feeders, and associated downstream processing units (milling, compaction, etc.). Conduct pre-formulation studies, including excipient compatibility and thermal analysis (DSC, TGA). Perform process optimization and scale-up studies for HME-based formulations. Prepare solid dispersions, amorphous systems, and evaluate physical and chemical stability. Perform solid-state characterization using tools such as XRPD, FTIR, Raman spectroscopy, and microscopy.

1) Preparationof Analytical method validation Protocols and reports for the relatedsubstances and Assay by HPLC and residual solvents by GC 2) Preparation of Analytical methodvalidation Protocols and reports for the Identification analysis by HPLC,GC andparticle size analyzer and performing the analytical method validations for theIdentification, content and purity analysis by HPLC,GC and Particle sizeanalyzer. 3) Performing the Analytical methodvalidations by HPLC and GC. 4) R esponsible to follow and ensure strict compliance to GLP practices in the laboratory to meet the organizational goal which in line with procedural references. 5) Maintenance of log books and Calibration records as per procedural references. 6) Preparation of Analytical method validation Protocols and report for the Elemental Impurities analysis by ICP-MS and Perform the analytical method validations for elemental impurities by ICP-MS.

The Junior Analyst/Executive in Analytical Research and Development (ARD) Injectables plays a vital support role in the development and evaluation of sterile pharmaceutical products This position involves performing routine analytical testing of injectable dosage forms such as solutions, lyophilized powders, emulsions, and suspensions using instruments like HPLC, UV-Vis, FTIR, pH meter, and more Under the guidance of senior scientists, the junior analyst assists in method development, validation, and stability studies, ensuring that data is accurate and meets regulatory and internal quality standards Responsibilities include sample preparation, instrument handling, maintaining laboratory notebooks, and following Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) The role also includes preparing reagents, calibrating instruments, and maintaining documentation for analytical procedures and observations Junior analysts support data compilation for regulatory submissions and assist in investigations related to analytical deviations or out-of-specification results They collaborate with cross-functional teams such as Formulation RD, QA, and Regulatory Affairs to ensure timely and compliant development activities This position requires attention to detail, a willingness to learn, and the ability to follow procedures precisely Ideal candidates should hold a Pharm, MPharm (Pharmaceutical Analysis or Pharmaceutics

Development and validation of analytical methods for injectable dosage forms Stability study execution and data interpretation Support for formulation development and regulatory submissions (US/EU) Instrument handling: HPLC, GC, UV, KF, etc. Preparation of method validation reports, protocols, and SOPs

1. Responsible for review of specifications, STPs, GTPs and analytical test data sheets. 2. Review of analytical reports of raw material, packing materials, water samples, product samples, OOT, water trends and ensuring compliance. 3. Responsible to attend the training programs. 4. Responsible for monitoring of quality control Lab (Daily calibration, PMP, Instruments back up data, Excel work sheets lock, user log books). 6. Responsible for handling technology transfer documents. 7. Responsible for review of stability protocols, stability analytical data and summary reports. 8. Responsible for handling of change controls, OOS, OOT, Incidents and investigations. 9. Responsible for compliance of GLP in Lab. 10. Responsible for review and approval of LIMS related activities. 11. Approval and issuance of configured COA in LIMS. 12. Responsible for audit trail verification for QC lab instruments.

Responsibilities: * Ensure compliance with GMP, GLP & BPR review. * Conduct process validation, cleaning verification & change control. * Collaborate on batch manufacturing & release processes. * Prepare SOPs, BMRs & BPRs.

Role & responsibilities : 1) Having from OSD background. 2) Responsible for analysis of RM/IP/FG/Stability on HPLC. 3) Responsible for Calibration of HPLC 4)Having the Knowledge of the Pharmacopeia.IP/BP/Ph.Eur/USP Skill Required: 1) Handling of the HPLC, 2) Calibration Management. 3)Knowledge of the GLP Environment 4) Handling of the HPLC, 5) Calibration Management. 6)Working Standard, Ref. Standard, Imp Standard, Primary Standard Management Additional Remark: Required candidates background should be in Regulatory environments

HPLC, GC, UV-Vis, FTIR, Karl Fischer Titration GMP, GLP, FDA compliance Quality Management Systems (QMS) Lab equipment calibration Analytical method development/validation Wet chemistry techniques Data analysis, LIMS Problem-solving, troubleshooting

Dear All, Greetings from Vivo Bio Tech Limited! Job Title: Analytical Scientist, Phy-Chem Studies (Agrochemical & Pharma) Experience: 3+ years Location: Hyderabad MOI: - F2F/Virtual 6-day week Job Description: We are seeking a detail-oriented and skilled Analytical Scientist with hands-on experience in conducting Phy-Chem and validation studies for agrochemicals and pharmaceutical compounds. The ideal candidate will have strong knowledge of global regulatory guidelines and be capable of preparing study-related documentation while maintaining audit readiness at all times. Key Responsibilities: Conduct Physico-Chemical studies for agrochemical compounds in accordance with regulatory requirements. Perform method validation studies for agrochemical products as per SANTEE/SANCO guidelines. Execute validation studies for pharmaceutical compounds as per ICH guidelines. Carry out dose formulation analysis to support toxicological and regulatory studies. Prepare and maintain Standard Operating Procedures (SOPs) for newly initiated studies. Develop study plans and compile final study reports as per relevant regulatory guidelines. Ensure all studies are conducted in compliance with GLP, OECD, OPPTS, CIPAC, SANCO, and SANTEE guidelines. Maintain effective communication with Quality Assurance (QA) personnel throughout the study lifecycle. Utilize Microsoft Excel for accurate calculations, data analysis, and result interpretation. Remain audit-ready at all times for sponsor audits, NGCMA inspections, or other regulatory reviews. Desired Candidate Profile: Strong understanding of regulatory frameworks applicable to agrochemical and pharmaceutical studies. Prior experience working in a GLP-compliant environment. Excellent documentation and report writing skills. Detail-oriented with good communication and coordination skills. Flexible and proactive approach, especially regarding audit preparedness. Vivo Bio Tech Ltd Survey # 349/A, Pregnapur Village, Gajwel Mandal. Siddipet District, PIN 502311,Telangana, India. Regards, Chandra Kanth | HRD chandrakanth.k@virinchi.com

Dear All, Greetings from Vivo Bio Tech Limited! Job Description: Business Development (BD) role** in a CRO setting Experience: 3+ Job Title:** Business Development Manager Preclinical Services Location:** Hyderabad Reports To:** Head – Business Development / Executive Director Job Overview: We are seeking a proactive and results-driven **Business Development Manager** to independently drive lead generation and conversion across domestic and international markets. The ideal candidate should have strong networking skills within the **CRO industry**, and proven experience in securing business from **Pharma, Agrochemicals, Industrial Chemicals, Vaccines, Generics, and Medical Devices** clients. This role requires working knowledge of **GLP compliance**, **regulatory affairs**, **toxicology studies**, and familiarity with submission processes to global regulatory bodies. Key Responsibilities:** * Independently generate, qualify, and convert leads for preclinical research services. * Submit tailored technical and commercial quotations to potential clients. * Network extensively across Pharma, Agrochemical, Vaccine, Generic Drug, Medical Device, and Chemical industries. * Understand client requirements and align them with organizational capabilities in **GLP and non-GLP studies**. * Develop and maintain strong client relationships to drive repeat and long-term business. * Coordinate with internal scientific and operational teams to design study proposals and timelines. * Provide market intelligence and competitor analysis to support strategic planning. * Track, monitor, and support **regulatory submissions** to international authorities such as USFDA, EMA, WHO, PMDA, ANVISA, etc. * Stay updated with global guidelines relevant to **Mammalian Toxicology**, **Ecotoxicology**, and **Regulatory Submissions**. * Promote services across **small and large animal studies**, including rodent, canine, minipig, and non-human primate models. * Collaborate on proposals for government and international grants or tenders (if applicable). Key Requirements:** * Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or related fields. * Minimum 2–15 years of BD experience in a CRO or related preclinical research setting. * Strong understanding of **GLP requirements** and study types. * Working knowledge of **toxicology, pharmacology, ecotoxicology**, and **regulatory pathways**. * Familiarity with **GTC (General Toxicity Category)** studies and their scope. * Excellent communication, negotiation, and relationship-building skills. * Self-motivated and target-oriented with strong business acumen. * Willingness to travel domestically and internationally as required. --- Preferred Experience: * Exposure to **OECD, ICH, USFDA, EPA, REACH, and other regulatory guidelines**. * Experience in handling **multi-national clients** and long-term contracts. Vivo Bio Tech Ltd Survey # 349/A, Pregnapur Village, Gajwel Mandal. Siddipet District, PIN 502311,Telangana, India. Regards, Chandra Kanth | HRD chandrakanth.k@virinchi.com

Role: Officer - Quality Control / Quality Assurance Job Location: Nashik At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access Providing high quality trusted medicines regardless of geography or circumstance; Leadership Advancing sustainable operations and innovative solutions to improve patient health; and Partnership Leveraging our collective expertise to connect people to products and services. Every day, we rise to the challenge to make a difference and here's how this role, will make an impact: Role Purpose We have Openings in Both QC and QA(IPQA / Documentation / QMS / AQA) . Seeking for candidates (Male/Female) with sound qualification background to ensure the testing of drug product in Quality control lab and to ensure every product is of the highest quality. They shall be concerned with sampling, specifications, testing, documentation, release procedures which ensure that the necessary and relevant tests are carried out under the norms of cGMP. Role & responsibilities Candidate must have relevant experience in Quality control OSD and QMS and able to operate & maintain laboratory equipment/instruments (HPLC, GC, Malvern Particle sizer, dissolution apparatus etc.) as per procedure. To maintain documents as per GLP requirements. To ensure the calibration status of laboratory equipment & instruments. To report and involve in incidence/Deviation/OOS/OOT investigations. Candidate must have sound exposure in the Quality Control Laboratory to supervise and maintain documents and retention of records as per GMP requirements. To ensure the review of QC documents like analytical reports SOPS, Qualification, Logbooks, Raw data sheet, analytical records, calibration and ensuring compliance to observations with proper root cause and justifications. Candidates participate in initiation, review, and closure of OOS/OOT and monitor the CAPA with implementation in Track wise. To ensure the compliance of the Corrective and Preventive Actions (CAPA) necessitated through various activities such as Regulatory Audits, Market Complaints, and Product Recall & Annual Product Review in the QC if applicable. To support Quality Assurance / Compliance /Regulatory Systems, Processes and ensure Monitoring, Execution, Initiation of the Quality Management Systems in Quality Control laboratory. Qualification & Experience Candidate must be B. Pharm/ M. Pharma/ M. Sc In Chemistry Experience- Candidate must have 1 to 4 years experience in a reputed pharma industry. Candidates must be willing to work in shifts Candidate who have faced regulatory Audits like FDA & MHRA Audit will be preferred.

You will be responsible for performing wet lab testing and maintaining lab compliance in order to ensure the accuracy and integrity of analytical data. Your key responsibilities will include implementing SOPs and STPs accurately, analyzing samples and recording results, preparing and maintaining reagents and standards, storing control samples with proper documentation, and calibrating laboratory instruments as per schedule. You will also be expected to operate and maintain wet lab instruments, assist in the investigation of deviations and complaints, supervise the cleaning and upkeep of glassware, perform product sampling and analysis, and support in the preparation of specifications and STPs under senior guidance. Additionally, you will review QC documents and records for completeness and accuracy, as well as execute any other tasks assigned by seniors or departmental heads. The ideal candidate for this position should have an MSc in Chemistry and 1-4 years of experience in quality control. It is essential to possess skills in GLP, CAPA, and handling laboratory instruments effectively.,

Job Summary As a qualified candidate, you will be leading the Quality Assurance, QC Chemistry and Microbiology Laboratories for the site. Your role will involve developing Standard Operating Procedures (SOPs), ensuring compliance with current Good Manufacturing Practices (cGMP) and regulatory guidelines, and monitoring day-to-day department activities. Responsibilities include reviewing and approving documents, executing in-process controls, participating in investigations, vendor qualification, stability management, and ensuring safety practices. Roles & Responsibilities You will be responsible for organizing the recruitment and training of QA (Quality Assurance) and laboratory personnel for chemistry and microbiology laboratories. You will ensure adherence to systems and procedures by all QA and laboratory personnel. You will be responsible for organizing contract laboratory audits and certification. You will formulate systems and procedures for the effective implementation of cGMP, GLP (Good Laboratory Practices), and other industry practices and regulations for the manufacture, storage, and distribution of drug products. You will plan and monitor the daily activities of different sections of the department, ensuring the availability of required facilities and materials for daily functions. You will ensure timely review and approval of all Master documents, such as SOPs, guidelines, production records, specifications, validation protocols, and other necessary reports/documents. You will be responsible for proper sampling of in-process and finished products, management of reserve and stability samples, and collection of finished products. You will oversee the execution of in-process controls and checks during manufacturing and packing. Your role includes reviewing and releasing/rejecting finished drug product batches, evaluating product recalls, monitoring quantity and disposition of recalled/returned material. You will participate in investigations, providing suitable Corrective and Preventive Actions (CAPA) to prevent recurrence. You will review, approve, and implement CAPA for incidents, change controls, Out of Specifications (OOS) and Out of Trends (OOT) observations. You will manage vendor qualification, material management, vendor audits, stability management, and field alerts as required. As a qualified trainer, you will implement training programs, ensure compliance, and provide training on cGMP and SOPs. You will ensure compliance with CAPA for deficiencies noted in self-inspections, internal audits, and external audits. Your responsibilities include preparing and approving Annual Product Quality Reviews, reporting Adverse Drug Reactions, and ensuring departmental adherence to safety practices. You will also be responsible for ensuring the safety, strength, purity, and efficacy of the product, along with any other assignments from higher management. Qualifications Educational qualification: An M. Pharm/M.Sc. with experience in Sterile products. Minimum work experience: 15 to 20 years. Skills & Attributes Technical Skills Experience in recruitment and training of QA and laboratory personnel in Chemistry and Microbiology laboratories. Experience in establishing systems and procedures for cGMP, GLP, and other industry practices. Experience in handling investigations, audits, and implementing resulting CAPAs. Skills in vendor qualification, audits, and material management. Behavioural Skills Effective leadership and organizational skills for managing laboratory personnel and operations. Detail-oriented mindset for thorough review and approval processes. Strong communication and collaboration skills for audits, investigations, and compliance activities. Commitment to safety practices and reporting Adverse Drug Reactions. Additional Information About the Department Global Manufacturing Organisation (GMO) Dr. Reddy's Laboratories is dedicated to making an impact on global healthcare through precision manufacturing and innovation. With 19 state-of-the-art manufacturing plants across multiple locations, we are a leading force in the pharmaceutical industry. Our capability to deliver quality medicines to patients in 66 countries is driven by benchmarking manufacturing processes and operational excellence. Benefits Offered At Dr. Reddy's, we prioritize your career growth and professional development through personalized learning programs. Our benefits are designed to meet industry standards, including joining & relocation support, family benefits, learning opportunities, medical coverage, and life coverage. Our Work Culture At Dr. Reddy's, our employees are guided by the principle of "Good Health Can't Wait." We see healthcare solutions as a means to help patients lead healthier lives. Our work culture fosters empathy, dynamism, and teamwork, empowering individuals to make a meaningful impact on global healthcare. Visit our career website at [Dr. Reddy's Careers](https://careers.drreddys.com/#!/) for more details.,

The Quality Compliance Senior Manager plays a crucial role in the Clinical & Research Quality (CRQ) team for the R&D Quality Organization at Amgen. The CRQ team ensures that research and development activities are conducted ethically and responsibly, meeting the highest standards of quality and compliance to keep patients safe and protect their welfare. This position involves providing leadership to maintain excellence in R&D Quality Processes, mentoring Amgen staff in India, managing day-to-day activities, and ensuring compliance with regulations globally. Additionally, the Quality Compliance Senior Manager will support the digital quality management system (DQMS) and provide end-to-end quality support for managing Quality Incidents/Quality Events, including approving investigations and CAPA plans. Roles & Responsibilities: - Overseeing deviations, audits, and inspections across R&D Quality - Managing the Amgen India R&D Quality team - Facilitating deviation investigations and ensuring documentation within the electronic quality management system - Supporting Global Patient Safety and Global Development teams in inspection management activities - Leading continuous improvement initiatives for CAPA management practices - Collaborating with cross-functional partners to ensure effective processes aligned with industry best practices - Monitoring quality metrics, key performance indicators, and performing root cause trending - Maintaining knowledge of current regulatory and quality practices/issues - Managing archival and retention of audit documentation Basic Qualifications and Experience: - Masters degree with 10-12 years of Pharma and Biotech R&D or commercial manufacturing Quality experience - Continuous Improvement/Change Management experience preferred Additional Competencies/Skills: - Exceptional attention to detail and accuracy - Ability to work independently and proactively in a fast-paced environment - Proficiency in Smartsheet, Microsoft Office Suite, and virtual collaboration tools - Good team building skills and ability to develop employees over time - Familiarity with project management tools and methodologies - Knowledge of GCP, GLP, and/or GPvP - Experience working in a multinational environment - Excellent verbal and written communication skills - Strong problem-solving abilities and adaptability - Collaborative attitude and ability to build positive relationships across diverse teams Amgen ensures equal opportunities for individuals with disabilities throughout the job application process and employment. The company supports professional and personal growth through competitive benefits, a collaborative culture, and comprehensive Total Rewards Plans aligned with industry standards. Join Amgen to make a lasting impact on patient care and your career growth. Apply now at careers.amgen.com.,

As an enthusiastic salesperson, you will be responsible for client acquisition, relationship management, and promoting analytical services through technical sales, presentations, and industry networking. Your role will involve leveraging your life sciences background, strong communication skills, and willingness to travel extensively to achieve sales targets and provide market insights. In terms of client acquisition and relationship management, you will be required to identify and engage potential clients, build and nurture long-term relationships with clients and key decision-makers, as well as understand client needs and recommend appropriate analytical solutions. For technical sales and promotion, you will need to effectively communicate the technical capabilities of analytical services, conduct presentations and consultative discussions with customers, and attend industry conferences, exhibitions, and other networking events to promote analytical services. To achieve sales targets, you will develop and execute territory-wise sales strategies, track and meet sales targets, provide sales forecasts and performance reports to management, and collaborate with internal teams for timely proposals and service delivery. In terms of CRM and market insights, you will maintain up-to-date records in the CRM system, accurate records of client communications and sales progress, monitor market trends, competitor activities, and emerging customer needs, and provide feedback to the technical team for continuous service improvement. Your role will also involve extensive travel across India to meet clients, assess projects, and build market presence. Ensuring regular field visits and follow-ups with leads and existing clients, as well as providing post-sale support to ensure client satisfaction and repeat business will be crucial aspects of your responsibilities. The ideal candidate for this position would have an M.Sc. in Chemistry, Biotechnology, Biochemistry, Pharma, or related life science discipline, along with at least 3 years of sales experience in analytical services, CRO/CDMO, life sciences, or pharma/biopharma sector. A solid understanding of analytical techniques, proficiency in using CRM tools, excellent communication, negotiation, and presentation skills, and willingness to travel extensively across India are essential requirements for this role. Experience working with GLP/NABL certified labs, familiarity with regulatory requirements, a strong service ethos, go-getter attitude, and a knack for closing deals would be considered advantageous.,

You will be working at Jubilant Pharma Limited, a global integrated pharmaceutical company that offers a wide range of products and services across different geographies. The business is organized into two segments: Specialty Pharmaceuticals and Generics & APIs. Jubilant Generics (JGL) is a wholly-owned subsidiary of Jubilant Pharma with Research & Development units in Noida and Mysore, India. JGL operates manufacturing facilities in Mysore, Karnataka, and Roorkee, Uttarakhand, focusing on APIs and Dosage manufacturing. The Mysore manufacturing site, spread over 69 acres, is USFDA approved and manufactures APIs targeting Lifestyle driven Therapeutic Areas such as CVS and CNS. The Roorkee facility is a state-of-the-art site approved by multiple regulatory bodies including USFDA, Japan PMDA, UK MHRA, TGA, WHO, and Brazil ANVISA, primarily focusing on a B2B model for EU, Canada, and emerging markets. Both manufacturing units are supported by around 500 research and development professionals in Noida and Mysore, working on developing new products in API, Solid Dosage Formulations, Sterile Injectable, Semi-Solids Ointments, Creams, and Liquids. The R&D facility also conducts BA/BE studies in-house and has global regulatory accreditations. JGL's Regulatory Affairs & IPR professionals focus on maintaining a unique portfolio of patents and product filings in regulatory and non-regulatory markets. Jubilant Pharma's revenue has been consistently increasing, reaching INR 53,240 Million during the Financial Year 2018-19 compared to INR 39,950 Million in the Financial Year 2017-18. Your responsibilities will include managing Stability Chambers, handling Stability Samples, loading & withdrawing Stability samples, storage, and destruction of samples after testing, compiling Stability reports, timely analysis of stability samples, investigation of deviations, incidents, OOS & OOT results, recording analytical data, preparation & review of SOPs, self-auditing, adherence to SOPs, STPs, GTPS, and cGMP/GLP compliance. For more information about the organization, please visit www.jubilantpharma.com.,

ql-editor "> Job Summary: The Contract & Proposal (C&P) professional will be responsible for managing the end-to-end process of drafting, negotiating, and finalizing proposals and contracts related to bioanalytical services. This role bridges scientific understanding with commercial acumen, ensuring timely, compliant, and competitive proposals are delivered to clients and sponsors in alignment with business objectives. Key Responsibilities: Collaborate with Business Development, Project Management, and Scientific teams to understand client requirements and scope of work. Prepare detailed technical and commercial proposals for bioanalytical services (e.g. PK/PD studies, method development & validation, sample analysis). Coordinate internal costing exercises and build accurate pricing models based on resource and timeline inputs. Draft, negotiate, and finalize various contract types (e.g., MSA, CDA, SOW, Work Orders) with clients. Review RFPs and RFIs, and prepare responses ensuring compliance with client guidelines and internal standards. Maintain a database of approved proposal templates, standard pricing modules, and contract clauses. Track proposal status, feedback, negotiations, and closure timelines in coordination with BD. Support audit and compliance documentation related to contracts and pricing. Ensure alignment with regulatory requirements (GLP/GCP), industry standards, and corporate policies in all documentation. Build strong relationships with external sponsors and internal cross-functional teams. Required Qualifications: Bachelor s or Master s degree in Life Sciences, Pharmacy, Chemistry, or related field. 2-7 years of experience in C&P or Proposal Development roles in a Bioanalytical or Clinical CRO. Strong understanding of bioanalytical lab services, GLP/GCP compliance, and clinical study structures. Proficiency in MS Excel, Word, and PowerPoint; experience with CRM tools is a plus. Excellent communication, negotiation, and writing skills. Detail-oriented with strong analytical and time management skills. Preferred Attributes: Experience dealing with international clients (US/EU/APAC) in a regulated environment. Ability to manage multiple proposals simultaneously with tight deadlines. Familiarity with regulatory frameworks (USFDA, EMA, DCGI) relevant to bioanalytical studies.

Responsible for Engineering and Project Activity. To Ensure Opex & Capex budget of facility as per approved budget. To Ensure maintenance of process equipment as per respective SOP. To ensure operation & maintenance of utility like cooling tower, chilled water, Nitrogen, Steam, Brine & compressed air as per respective SOP. To ensure inventory management as per approved budget. To ensure newly projects design & Execution as per approved plans. To ensure compliance of qualification, SOPs, validation as per respective SOP. To ensure Preventive maintenance of equipment as per respective SOP. To support in investigation of deviation related to engineering. To ensure compliance of safety related observation related to engineering. To support for attending any breakdowns & investigations deviation related to engineering as per respective SOP. To support cross functional team for investigation as per respective SOP. To ensure qualification of equipment as per respective SOP. Co-ordination of QMS activity & ensure the compliance for the same. To provide training to Team members as per requirement and ensure all team members completed their training as per cGMP requirement. To fulfil the current needs of training with respective of GMP, GLP, Safety & Hygiene, application etc. To review the document for equipment & facility as per cGMP requirements. Co-ordination with team for handling of all external & internal audits / inspection. Adhere to all company policies & manuals (Business, safety& finance etc.)