1756 Gmp Jobs - Page 14

Job Location: Kochi, Bangalore/Chennai/Hyderabad Job Scope and Accountabilities: To conduct audits/ Trainings as per the requirements stated in audit criteria To remain updates on all skill development, code qualification, Regulatory and Industrial requirements related to audits and certifications. To be competent and qualified in Various standards like BRCGS food, packaging, FSSC, ISO 22000, GMP etc. Upgrade the knowledge of local social, economic, and business environment. To ensure TAT- Turnaround time for audit reports as per procedures established by Eurofins. Supervisory Responsibilities: Mentoring & Support of Technical executives, Auditors / Back office executives. Monitoring and support to Operational activities. Duties: To understand the role of impartiality when providing certification activities and the process of taking independent action where necessary, (e.g. informing authorities, accreditation bodies, stakeholders) To demonstrate the management expertise and ability to lead and take decisions. Review the decisions taken by technical manager relating to certification/verification. To demonstrate the ability to communicate with all stakeholders (e.g. Impartiality Committee, Directors) To ensure timely updating of qualifications and competency, satisfactory completion of training, calibration meetings, training audits, witness audits and approvals. Qualifications Bachelor"™s degree in appropriate discipline Preferably Food Science Lead auditor course FSMS/ FSSC /QMS or equivalent Minimum 5 year of experience in Operations, technical, Audits, preferably from a CB company. Minimum 4 years of experience in food industry preferably production or quality department. Additional Information Good at Communication Skill. Good at Presentations Good command on written and spoken English High leadership and supervisory skills Result oriented Problem solving Good at Retention Good at operating Microsoft Office. Proficiency in English. Customer Relationship management system (CRM) Professional Behaviour.

Eurofins Assurance network of companies helps customers identify and mitigate risks along their supply chain "“ with operations, processes, systems, people or capabilities. Whether you are in the Food , Consumer Product or Healthcare and Cosmetics industries, we offer a full-scope of services in product inspection, auditing, certification, training and consultation. Eurofins Assurance helps you eliminate potential risks in compliance, quality and safety failures at the early stages, thereby protecting your business from brand damage, product recalls and other undesirable scenarios down the track. Sustain your business growth and commitment with Eurofins Assurance, a global network of assurance experts that you can trust . Job Location- One Vacancy for North Region One Vacancy for West Region Note5-10 yrs experience required in Certification Bodies Job Scope and Accountabilities: To conduct audits/ Trainings as per the requirements stated in audit criteria To remain updates on all skill development, code qualification, Regulatory and Industrial requirements related to audits and certifications. To be competent and qualified in Various standards like BRCGS food, packaging, FSSC, ISO 22000, GMP etc. Upgrade the knowledge of local social, economic, and business environment. To ensure TAT- Turnaround time for audit reports as per procedures established by Eurofins. To understand the role of impartiality when providing certification activities and the process of taking independent action where necessary, (e.g. informing authorities, accreditation bodies, stakeholders) To demonstrate the management expertise and ability to lead and take decisions. Review the decisions taken by technical manager relating to certification/verification. To demonstrate the ability to communicate with all stakeholders (e.g. Impartiality Committee, Directors) To ensure timely updating of qualifications and competency, satisfactory completion of training, calibration meetings, training audits, witness audits and approvals. Mentoring & Support of Technical executives, Auditors / Back office executives. Monitoring and support to Operational activities. Qualifications Bachelor"™s degree in appropriate discipline Preferably Food Science Lead auditor course FSMS/ FSSC /QMS or equivalent Minimum 5 year of experience in Operations, technical, Audits, preferably from a CB company. Minimum 4 years of experience in food industry preferably production or quality department. Additional Information Good at Communication Skill. Good at Presentations Good command on written and spoken English High leadership and supervisory skills Result oriented Problem solving Good at Retention

Eurofins Assurance India Pvt Ltd is a leading certification body providing Audit & Certification , Inspections , and other services covering the broad spectrum of sustainable supply chain. Eurofins will help the customers to mitigate risks in their supply chain and to ensure the benchmarking performance with operations, processes, systems, people or capabilities. Whether you are in Food, Cosmetics, Consumer products or Health care sector, our global auditor and technical expert network will help to mitigate/eliminate your risks against supply chain and distribution flows: Regulatory and Industrial standards . We have accreditations for a number of different industry standards/memberships to ensure we service the entire supply chain. Please find the JD below. Planning and traveling for Food Safety audits Conducting Food Safety Audits as per FSSAI Schedule 4 requirements Generating the audit reports Submission of Audit Pack. Correction of audit reports as per technical review process Qualifications Minimum B.Tech/BE/B.SC- Food sciense/Biotech/Foodtech/Food processing/Dairy Tech etc. Minimum 2-3 years of experience in the industry Candidates having ISO/FSSC 22000 lead Auditor certification and Minimum 20-30 audits experience, will be given preference. Additional Information

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 ELLI"™s 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

Job Description 1. JOB DETAILS: Position Title: Executive Reports to: Manager QA Department: Quality & Food Safety Division: Hyperpure 2. JOB PURPOSE: Process and product control. Customer complaint handling. Create awareness among food handlers regarding good hygiene and safety practices. Implementation of Food safety, GMP and 5S in plant 3. KEY ACCOUNTABILITIES: Quality assessment measures of all the products during manufacturing Inspect the cleaning and sanitation and give clearance for production Verification of CCP, OPRP and PRP on daily basis Verification of recipe and process parameters. Inspection of raw material at the time of receipt Training of food handlers on food safety and GMP Customer complaint inspection and resolution. Ensure effective implementation of CAPA. Sampling of RM, SFG and FG as per sampling plan Ensure the Pest Control compliance - Zero sighting of pest in Operation area including right chemical dosage application ,100% service compliance & area wise pest performance monitoring Responsible for monitoring and maintaining quality and compliance targets Ensuring products comply with legislation and quality assurance codes Ensuring that all QA Tests are carried out on time and in full Identify training needs and recommendations to improve customer experience Keeping quality documentation up to date. Making sure that all QA records, data & information are available Label verification of the finished good. Verification of OOS in case of deviation in process and analytical parameters 5. Job Context: Executive IPQC responsible for checking incoming, in-process and outgoing products to ensure that they are free of defects and produced according to internal specifications and external guideline. 6. COMMUNICATIONS & WORKING RELATIONSHIPS Internal: All the cross functional team : SCM/Ops/IT/ Maintenance/HR, etc. External: Vendor (All Food & Non Food), Pest Control Agency, Certification Agency, Auditing Agencies, etc. 7. QUALIFICATIONS, EXPERIENCE, SKILLS,Competencies : Qualification : Minimum Graduate in Food Technology/ Microbiology/Biotechnology or equivalent science stream. Experience: 2-4 years in reputed Food industry/Retail Should have thorough knowledge of Food processing unit Excellent attention to detail, with the ability to work accurately in a busy and demanding environment. Strong analytical and problem solving ability. Good command over basic computer skills. Core competencies : Functional : Technical sound knowledge on products & processes & test methods Food Safety/Food Quality/GMP/ GHP Requirements/ Quality Tools Auditing Skills Core : Continuous learning Process orientation Strive for excellence Team work and collaboration Problem Solving & Innovation Team effectiveness Analytical and data control

Education: Degree in Chemical Engineering or a related field Experience: 15+ years in API Manufacturing Expertise: Proven leadership in large-scale manufacturing operations Key Responsibilities: Lead and manage the Technical Service Department Oversee process optimization and troubleshoot issues Ensure GMP, ICH, and regulatory compliance Provide technical support to customers and internal teams Drive continuous improvement in production efficiency, quality, and safety Mentor and grow a high-performing technical team If youre ready to take the lead in shaping the future of API production, we want to hear from you

Inventory Management : Assist in maintaining accurate records of stock levels, receipts, and dispatches. Conduct routine stock checks and update records accordingly. Material Handling : Ensure proper handling, storage, and organization of APIs as per GMP and regulatory guidelines. Maintain cleanliness and orderliness in the warehouse. Documentation Compliance : Assist in preparing and maintaining required documents, such as Goods Receipt Notes (GRNs), Material Issue Notes (MINs), and stock reports. Support adherence to regulatory requirements like FDA and GMP standards. Coordination : Collaborate with procurement, quality assurance, and production teams to ensure smooth operations. Coordinate with transporters and suppliers for timely delivery and dispatch of materials. Safety Measures : Ensure adherence to safety protocols while handling pharmaceutical ingredients. Skills and Qualifications : Educational Qualification : B.Com graduate. Skills : Proficiency in Microsoft Office (Excel, Word). Basic understanding of inventory and accounting concepts. Strong attention to detail and organizational skills. Good communication and teamwork abilities. Knowledge : Familiarity with warehouse operations or pharmaceutical sector (preferable but not mandatory).

1.Perform and monitor In-process Quality Assurance activities during the manufacturing process. 2.Responsible to perform line clearance activities in different stages of manufacturing and Monitoring of cleanroom behavior, aseptic activities. 3.Responsible to verify the In-process samples for quality testing and ensure the test results of products at various stages of manufacturing. 4.Review and verify documentation related to manufacturing processes i.e., BMR, BPR and GMP documents, ensuring accuracy and completeness. 5.Regularly inspect and assess manufacturing operations to ensure compliance with quality standards and procedures. 6.Responsible to Preparation Review of standard operating procedures. 7.Responsible to ensure cGMP and GDP during document preparation and review. 8.Ensure that all in-process activities align with Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP). 9.Responsible to review of Plasma inward, sampling procedures, Issuance and Reconciliation. 10.Responsible to Review and compliance of Down stream activities and Filling activities as per established procedures. 11.Responsible to involve in Change controls, Deviations, CAPA and other QMS activities. 12.To get involved in Process validation, cleaning validation and APQR activities. 13.To Involve in Risk assessment procedures with the coordination of SMEs. 14.Responsible to perform additional activities assigned by the superiors/ Head of the department.

1.To involve in plasma products manufacturing. 2.Follow shift and production schedules. 3.To complete the assigned trainings timely. 4.To Monitor the differential pressure, temperature and humidity of the classified area. 5.To Ensure the area, equipments cleaning and readiness of equipments for batch activity. 6.Preparation of buffers and other solutions for downstream process. 7.Handling of process related instruments and equipments in downstream process (DSP). 8.Perform all the assigned manufacturing activities as per the defined procedures (SOP, BMR, Protocols) and record the details in respective document. 9.Checking the availability of stock of chemicals, solvents, raw material etc. 10.Coordinate with cross functional teams for smooth batch operations. 11.To maintain the facility to compliance with GMP. 12.Responsible for execution of relevant documents as per GDP. 13.To involve in equipment qualification and validation of the downstream equipments. 14.To involve in execution of process validation batches and regular manufacturing batches. 15.Provide samples to QC and take follow up for QC testing result. 16.In case of any abnormalities/ deviation observed should be recorded and informed to process in-charge to avoid any quality issues in the product. 17.To ensure adherence to safety procedure and report unsafe conditions and incidents to Supervisor. 18.To Involve in the preparation of SOPs and QMS documents. 19. To involve in new facility layout, equipment commissioning (URS, DQ, DS, FAT and SAT) documents preparation / review

1. Preparation of buffers and other solutions for plasma fractionation process. 2. Batch manufacturing record samples sending to QC for analysis. 3. Performing PHT, CIP and SIP of all the process vessels. 4.Follow shift schedule and production schedule, planning of shifts for the subordinate as per process requirement. 5. Preparation Review of equipment IQ, OQ and PQ documents. 6.To involve in Production planning and execution. 7. To get involved in technical discussion and planning for execution of new product validation batches and commercial batches in plant. 8. To get involved in Batch-to-batch yield analysis and investigation for low yield or OOS routed through Change control or deviation.

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.

Responsible for following activities in purification area of BM/BU based on campaign basis 1. Following GMP, safety practices in production facilities and work place. 2. Responsible for production activities: Execution of area, line clearance before execution of activities. Execution of product changeover activities. Responsible for column cleaning, packing, unpacking, evaluation and maintenance. Responsible for drug substance (FDS) transfer/dispensing. Execution of production activities. Monitoring and review of batch parameters/performance. Ensuring material are arranged properly before activities. Verification of samples for analysis. Responsible for shift Monitoring. Handling of online reject material. Review of soft copy for batch monitoring and performance. Execution of process validation. Execution of cleaning validation. Execution of verification protocols/equipment specific protocols. Ensuring buffer preparation in respective shift. 3. Handling of documents: Preparation of new / revision of SOPs, protocols and reports. Preparation of MFRs and BMR's. Primary review of executed BMR's submission to QA. Ensuring online BMR's updation and review of log books. 4. Responsible for monitoring and operation of following production equipments (but not limited to): AKTA Process Purification system Conductivity meter TFF System Peristaltic pumps Weighing Balance Mixing Systems Biosafety cabinet Filter integrity tester pH meter Walk in cold Freezer room Heat Exchanger Mixing vessels Ensuring proper data backup of equipments. Provide clearance for calibration, PMP and validation of equipments. Participate in execution of equipment validations. 5. Responsible for Quality Management Systems Initiation / Review of breakdown request. Initiation of CRN's and Preparation of Risk Assessments. Initiation of incidents, investigation, CAPA. 6. Team member: Facility readiness for audits. 7. Training: Training team members on SOPs / GMP aspects. Attending training on related SOP's / GMP aspects. 8. Monitoring of PM/Qualification of purification area equipments. (Calibration / PMP/Qualification).ease enter job description

1.To involve in plasma products manufacturing. 2.Follow shift and production schedules. 3.To complete the assigned trainings timely. 4.To Monitor the differential pressure, temperature and humidity of the classified area. 5.To Ensure the area, equipments cleaning and readiness of equipments for batch activity. 6.Preparation of buffers and other solutions for downstream process. 7.Handling of process related instruments and equipments in downstream process (DSP). 8.Perform all the assigned manufacturing activities as per the defined procedures (SOP, BMR, Protocols) and record the details in respective document. 9.Checking the availability of stock of chemicals, solvents, raw material etc. 10.Coordinate with cross functional teams for smooth batch operations. 11.To maintain the facility to compliance with GMP. 12.Responsible for execution of relevant documents as per GDP. 13.To involve in equipment qualification and validation of the downstream equipments. 14.To involve in execution of process validation batches and regular manufacturing batches. 15.Provide samples to QC and take follow up for QC testing result. 16.In case of any abnormalities/ deviation observed should be recorded and informed to process in-charge to avoid any quality issues in the product. 17.To ensure adherence to safety procedure and report unsafe conditions and incidents to Supervisor.

1. Follow shift schedule and production schedule as per process requirement. 2.Handling of plasma collection, sanitization, washing, cutting, pooling and thawing. 3.Handling of plasma fractionation process steps. 4.Compliance to all approved procedure, documents and GMP activities. 5.Performing all the assigned manufacturing activities in confirmation to BMR, protocols and recording the details in record sheets and logbooks. 6.In process samples sending to QC for analysis. 7.Performing COP, CIP, PHT and SIP of all the process vessels and equipment. 8.Performing calibration of pH, conductivity meters, turbidity meter, weighing balances and other equipment. 9.Preparation of buffers and other solutions for plasma fractionation process. 10.Monitoring of area cleaning, equipment surface sanitization, differential pressure, temperature and humidity 11.Monitoring and recording the temperature of freezer room and cold room. 12.To get involved in trouble shooting and managing day to day activities. 13.Checking the availability of stock of chemicals, solvents, raw material etc. 14.Report unsafe conditions and incidents to shift in-charge. 15.Adherence to safety procedures. 16.Awareness on PPE usage.

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. To perform the equipment sanitization and cleaning. 2. To perform and ensure area cleaning and sanitizationactivities. 3. To prepare and filter disinfectant solutions. 4. To perform the CIP, PHT and SIP of the process vessels. 5. To operate the machines and equipments like autoclave,lyophilizer, vial washing, vial filling and vial capping machine, vialpasteurizer and manufacturing vessels. 6. To perform the vial washing, filling and sealing machinechange parts assembling and dismantling according to different vial sizes. 7. To perform activities like machine parts cleaning, loadpreparation, load wrapping and garments washing. 8. Adhere to cGMP practices during batch processing andoperation of equipment and GDP practices. 9. All the GMP documents e.g., BMR and logbooks to be filledon time and revise periodically. 10. Adhere to aseptic batch processing and gowning practicesduring performing aseptic activities in DPM area. 11. To plan and ensure availability of machine and material asper the batch requirement. 12. To participate in Media fill, Trial batch and Validationbatch activities. 13. To involve in batch execution. 14. To support the batch manufacturing activities. 15. To perform and coordinate in site acceptance test,Installation qualification, Operational qualification and Performance qualificationsfor new equipments. 16. To maintain the Inventory consumable required for dailyactivities. 17. To coordinate with other cross functional team for smoothfunctioning of departmental activitie s.

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.

1. Responsible for preparation of Validation Master Plan, validation related SOPs and schedules. 2. Responsible for preparation of facility, equipment, area qualification protocols and reports. 3. Responsible for execution of facility, equipment and area qualification activities. 4. Responsible for compilation and review of validation raw data and test certificates. 5. Responsible for preparation and review of Computerized system validation (CSV) documents and execution of CSV for equipments. 6. Responsible for preparation of User Requirement Specification, Design Qualification, FAT protocols, SAT protocols, Installation qualification, Operational qualification and Performance qualification, Revalidation protocols and reports. 7. Responsible for execution of IQ, OQ, PQ, Revalidation of Equipments. 8. Responsible for In-process assurance of Engineering department activities like utilities monitoring, verification of log books, PMP records, review of Schedules and calibration records. 9. Responsible for co-ordination with user department and validation service providers for execution of qualification activities. 10. Responsible for handling and review of risk assessments, deviation, change control and incidents related to qualification activities and user department activities. 11. Responsible for preparation of Utilities Annual summary reports.

1. Preparation, review and revision of SOPs, GTPs and Work sheets. 2. Execution of analytical method validation protocols for product samples. 3. Testing and review of product / Miscellaneous samples for AET. 4. Operation and maintenance of laboratory Instruments. 5. Monitoring of temperature, DP and RH of the Microbiology laboratory. 6. Involve in the execution of Media fill validations. 7. Cleaning, verification of laboratory cleaning and glassware cleaning in the Microbiology laboratory. 8. Receipt, storage, preparation, sterilization and maintenance of sterile media and reagents. 9. Performing the isolation, identification and confirmation tests for test organisms and Isolates. 10. Responsible for Growth promotion, inhibition test of Microbiological culture media. 11. Responsible for Biological indicator qualification, usage and testing. 12. Culture maintenance in Microbiology department. 13. Preparation and usage of disinfectants. 14. Review of outside COAs. 15. Review, checking and verification of all types Microbiology laboratory documents. 16. Responsible for implementation activities related to resource manager and sample manager of Laboratory information management System #40;LIMS#41;. 17. Verification of cleaning in the Microbiology laboratory. 18. Responsible for compliance to cGLP.

1.Responsible for giving line clearance between startup of various finished product formulation and filling operations. 2.Responsible for performing in process checks during finished product operations as per respective established procedures. 3.Responsible for Monitoring and Coordination of process validation, Hold time studies, media fill and cleaning validation activities. 4. Responsible for preparation of IPQA SOPs and review of finished product SOPs. 5. Responsible for preparation of Annual Product Review Reports. 6. Responsible for continued process verification reports. 7.Responsible for compliance to GMP in finished product area. 8.Responsible for review of all finished product log books. 9.Responsible for review of master MFR and executed BFRs. 10.Responsible to attend training programs and SOP trainings. 11.Responsible for preparation of media fill BFR, protocol and report. 12.Responsible for monitoring of stability samples. 13.Responsible for preparation and review of visual inspection qualification protocol and report. 14.Day to Day Manufacturing observations Report to Manager QA.

1. Preparation and Maintenance of SOPs, STPs, Specifications, GTPs and Worksheets related to Product testing. 2. Preparation, revision, review and execution of Analytical method Validation protocols and reports related to product testing. 3. Responsibilities for preparation of masters (Product, Specifications, Tests, worksheets, Test plans and TTD etc.) in LIMS. 4. Responsibilities for effective documents (STPs, Specifications and GTPs etc.) uploaded in LDMS. 5. Responsible for material management like weekly, monthly indent Ensure monthly indents are placed and materials received in timely manner, reservation placed through SAP. Ensure compliance `w.r.t expiry, usage and discard of materials. 6. Operation and calibration of QC Instruments related to product testing. 7. Testing and release of product samples by techniques such as: General tests (Physical appearance, pH, Color, Extractable volume, Osmolality, Conductivity, etc.) Gel Electrophoresis (IEF, SDS-PAGE, etc.) Colorimetric assays (Sialic acid, Quantification of Polysorbate 80 and Polysorbate-20, etc.) Quantification assays (Protein concentration by absorbance (Spectral scan)/Protein content by UV (OD @ 280 nm, Trehalose dihydrate, Mannitol, Sucrose, etc.) ELISAs (Host Cell derived Proteins, Protein A Leachate, etc.) Q-PCR (Host Cell DNA, Mycoplasma testing etc.) HPLC techniques (Product concentration by RP-HPLC, Size Exclusion chromatography, Peptide mapping, etc.) UPLC techniques (Cation exchange chromatography, Protein A Chromatography, N-Linked Glycans by hydrophilic liquid interaction chromatography, etc.) 8. Preparation of reagent solutions, buffers and maintenance of the records. 9. Temperature and humidity monitoring of labs and instruments. 10. Sample receiving, A.R. No allotment, Testing, Documentation and reporting of analytical results in LIMS for In process, batch release, stability and Miscellaneous samples related to product testing. 11. Withdrawal and aliquoting of batch release and stability samples for analysis. 12. Responsible for preparation of shift schedules and test planning activities. 13. Responsible for cGLP compliance. 14. Responsible for handling of OOT (Out Of Trend), OOS (Out Of Specification), Incidents, LIRs and Change controls related to product testing. 15. Responsible for change management: Ensure CRNs initiation and closure within target date. 16. Preparation, revision and review of miscellaneous protocols and reports related to product testing. 17. Review of analytical data and work sheets related to product testing. 18. Maintenance of stability samples and reserve samples related to product testing. 19. Responsible to execute the assigned activities in LIMS, TRIMS, DMS or any other software applications. 20. Responsible for usage, monitoring and verification of all kind of laboratory books. 21. Preparation, execution and review of reference standard qualification. 22. Maintenance of all QC documents related to product testing. 23. Assist in execution of Analytical method validations.

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

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

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.