706 Glp Jobs - Page 19

Role & responsibilities Planning and execution of experiments as part of process development, Upstream activities at shake flask and Bioreactor stages for recombinant molecules. Responsible for Media & Feed formulation & preparation, components role verification & utilization based on spent media analysis for overall process improvement Responsible for Process scale up & scale down operation at various scales of Bioreactors. Responsible for analysing scientific research data using statistical software to analyse trends and patterns to help interpretation & establish the robust process. To carry out day-to-day Cell culture works with minimal guidance, sample preparation, productive coordinati...

Department: PTS Job Overview: To perform AR&D actives as per GMP & Safety Travel Requirements: NA Reporting Structure: Reports to Research Scientist - AR&D (Service) Key Stakeholders: Internal: QC, QA, SCM & Safety Experience: 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities for Internal Candidates Key Roles & Responsibilities 1. Capable to handle independent projects 2. Analytical testing support to PDG synthetic group. 3. Coordinate with QA regarding method transfer, CCF and investigation reports. 4. Experience of handling of HPLC, GC, Potentiometer, Polarimeter instruments. 5. API Stability knowledge. 6. Capable to handle analytical...

Business: PPL Digwal Department: PTS Job Overview: To perform AR&D actives as per GMP & Safety Travel Requirements: NA Reporting Structure: Reports to Research Scientist - AR&D (Service) Key Stakeholders: Internal: QC, QA, SCM & Safety Experience: 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities for Internal Candidates Key Roles & Responsibilities 1. Capable to handle independent projects 2. Analytical testing support to PDG synthetic group. 3. Coordinate with QA regarding method transfer, CCF and investigation reports. 4. Experience of handling of HPLC, GC, Potentiometer, Polarimeter instruments. 5. API Stability knowledge. 6. Capable...

Job Description Business: PPL Digwal Department: PTS Location: Digwal Job Overview: To perform AR&D actives as per GMP & Safety Travel Requirements: NA Reporting Structure: Reports to Research Scientist - AR&D (Service) Key Stakeholders: Internal: QC, QA, SCM & Safety External: NA Experience: 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities for Internal Candidates Key Roles & Responsibilities 1. Capable to handle independent projects 2. Analytical testing support to PDG synthetic group. 3. Coordinate with QA regarding method transfer, CCF and investigation reports. 4. Experience of handling of HPLC, GC, Potentiometer, Polarimeter instr...

Experience: 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities for Internal Candidates Key Roles & Responsibilities 1. Capable to handle independent projects 2. Analytical testing support to PDG synthetic group. 3. Coordinate with QA regarding method transfer, CCF and investigation reports. 4. Experience of handling of HPLC, GC, Potentiometer, Polarimeter instruments. 5. API Stability knowledge. 6. Capable to handle analytical method development, Implementation, Validation as per requirement. 7. Should have experience of Analytical method transfer to QC. 8. Experience of making documents like method transfer protocol & report, method val...

Role & responsibilities 1.HPLC,UPLC and GC analysis of raw material, intermediate, finish product, stability sample, equipment cleaning and distilled solvent, Analytical Method development and validation 2.HPLC,GC, UPLC calibration HPLC and GC Analysis of all in-process,Intermediate, Finish Product,Stabiltity Analysis Equipment cleaning, Distilled Solvent and Raw materials. If required then sampling of finished product. Working Standard Qualification. Calibration of HPLC and GC. GCHS. R&D Analytical Metliod Development of new molecule. Analytical Method Validation. lnstnmrent Troubleshooting

Summary 6-to-8-year HVAC and Clean room design experience in Pharma, Biopharma, API facilities, well conversant with global standards for HVAC as well as Pharmaceuticals to implement in HVAC design like ASHRAE, SMACNA, ISO, ISPE, GMP, GLP, UKMHRA etc. BMS -EMS knowledge will be added advantage. Environment Sustainability knowledge. About the Role Key Responsibilities: Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows Hold accounts in workflow applications (such as SAP, Dragon, SUBWAY, etc. ) to ensure appropriate execution of service deliverables Generate and analyze predefined and ad-hoc reports in various applications (like AG...

Req ID: 329333 NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. We are currently seeking a Trakwise support to join our team in NOIDA, Uttar Pradesh (IN-UP), India (IN). Trakwise support resource Trackwise Support for onprimse and Digital version of trackwise for a lifesciences client. Need overall 4/ 5 yrs experience in supporting Trakwise both the on-prime and Digital versions. Work indepndently on the support issues, including admin activities and enhacements that are asigned. Minimum 4-5 years of administering and supporting applications/so...

Qualification:- M.Sc. (Chemistry)/ B. Pharma/ M.Pharma Experience:- 2-7 Years in API plant (HPLC/ GC/ LCMS/ HPI / method valication knowledge must)

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 labo...

Business: PPL Digwal Department: PTS Location: Digwal Job Overview: To perform AR&D actives as per GMP & Safety Travel Requirements: NA Reporting Structure: Reports to Research Scientist - AR&D (Service) Key Stakeholders: Internal: QC, QA, SCM & Safety External: NA Experience: 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities for Internal Candidates Key Roles & Responsibilities 1. Capable to handle independent projects 2. Analytical testing support to PDG synthetic group. 3. Coordinate with QA regarding method transfer, CCF and investigation reports. 4. Experience of handling of HPLC, GC, Potentiometer, Polarimeter instruments. 5. API S...

Job Description Strategic Responsibilities To understand the scope of the project assigned. Inputs in planning of analysis of samples received Log entries and calibration of assigned instruments (as applicable) Proper house- keeping and use of PPEs. Use relevant MSDS for safe handling and disposals of bio chemicals / samples Operational Responsibilities Co-ordination with Project Management in understanding sample receipt. Plan and conduct analysis Authenticity of the result generated Troubleshooting Data interpretation of microbial data ological experiments with appropriate controls On-line data logging into E-note book / LIMS System at ADL or any other platform (as applicable) Data compila...

Role & responsibilities Ensure the compliance of cGMP & EHS. Follow the cGMP requirement with appropriate housekeeping and documentation in manufacturing area. Co-ordination with other department for safe, successful and timely batch execution. Achieving plant production target w.r.t quality and yield. Active involvement in facing quality audits by vendor audit & regulatory audits. Lead from front to ensure safe behavior / GMP culture on the shop floor. Comply with online documentation with complete data integrity. Undergo safety, quality and operational training & comply with requirement. Maintain housekeeping standard to ensure a clean and safe workplace. Follow the SOP practices. Preparat...

Manufacturing (OSD) Officer/Executive: B. Pharma/M. Pharma with 2 - 7 years of experience in Tablet/ Capsule department with experience in Granulation, Compression, Coating, Inspection. Responsible to plan for the manufacturing of batches in coordination with PPMC. To monitor line clearance, cleaning of equipment, instrument, auxiliary items. To carry out qualification activities. To initiate QMS activities (Change control, deviation, CAPA, investigation). To handle manpower and allocate daily activities. Plant Operator / Technical Assistant: ITI / Diploma having 3 - 8 years of experience in operating machines like, Granulation (Glatt, GEA), Cadmach Roll Compactor, Compression machines (Cadm...

Supervise and coordinate QA lab personnel and activities related to sampling, testing, and reporting of raw materials, in-process samples, and finished products. Ensure compliance with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and regulatory guidelines (e.g., FDA, ISO, ICH, etc.). Review and approve analytical test results, COAs (Certificates of Analysis), and related documentation. Manage calibration, maintenance, and validation of laboratory instruments (e.g., HPLC, GC, UV-Vis, FTIR). Investigate out-of-specification (OOS), out-of-trend (OOT), and non-conformances; participate in root cause analysis and CAPA implementation. Ensure timely completion of stability s...

Division Department Sub Department 1 Job Purpose Perform sampling, execute and document the analysis of raw materials, packing materials, products assigned for testing and complete all the stability studies in order to ensure its compliance to the laid down quality parameters and predefined specifications / standards and meet SRB targets Key Accountabilities (1/6) Analyse the assigned samples and chromatographic tests for analysis by using the suitable valid procedure and calibrated instruments to ensure the compliance to the set specification / standards Perform analysis for release of RM, PM, FP & water analysis and process/cleaning validation as per commitment dates Perform analysis for s...

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 a...

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 ...

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com . Azurity Pharmaceuticals is proud to be an inclusive workplace...

QC Reviewer / Sr. Research Associate: Role & responsibilities Review analytical raw data, calculations, and reports for accuracy, completeness, and compliance with approved specifications and methods. Ensure all laboratory documentation meets regulatory and internal quality standards (e.g., USFDA, EU-GMP, ICH, WHO, etc.). Review chromatographic data (HPLC, GC), wet chemistry reports, and other analytical test results. Verify results for routine analysis, stability studies, and validation reports. Check instrument calibration records and ensure compliance before reviewing analytical results. Identify and report any data discrepancies, deviations, or non-conformities. Review and verify entries...

Strong knowledge of cGMP regulations, quality management systems, and industry best practices. Exposure to international regulatory inspections like USFDA, EDQM. Exposure to international regulatory inspections like USFDA, EDQM Required Candidate profile Bachelor’s degree in pharmacy or master’s degree in chemistry from a recognized university.6-9 years of experience in quality assurance roles within the pharmaceutical or API manufacturing industry.

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, an...

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 Pro...

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 ...

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 ...