746 Method Validation Jobs - Page 13

We are seeking a dynamic and experienced Quality Control (QC) Manager to lead and manage QC operations, ensuring that products and processes meet stringent quality and regulatory requirements. The ideal candidate will possess deep technical expertise, a strong leadership background, and a commitment to data integrity and continuous improvement within the life sciences industry. A detail-oriented professional with expertise in Nitrosamines/NDSRI method development and validation by LC-MS focused on detecting and quantifying nitrosamine impurities in APIs and Finished Dosage Forms. You will contribute to method development, validation, instrument calibration, and document preparation while ens...

Job Summary Roles & Responsibilities Review and approval of all analytical test data of Quality control. Review and usage decision of analytical reports in LIMS, Empower and SAP. Electronic signatures level-2 for chromatography data station (CDS) and standalone instruments. Review the Analytical test report in LIMS. Review the reported results against specification and trends. Review the method validation and method transfer documents. Review the instrument calibrations and working standard qualification records. Handling the Incidents/ Deviations, Out of Trends, Out of Specification including investigations, Corrective and Preventive actions follow up and closure. Monitoring of analytical a...

Conduct final inspection and testing of finished products to ensure compliance with quality standards and customer specifications. Hands-on experience in testing of Finished products Instruments must be handled like HPLC, GC, KF, IR, DT, and Dissolution. Hands-on experience like software like Empower and LIMS. Qualification M.SC/B.Pharma 3 to 6 years Additional Information

Role & responsibilities 1.Responsible for work planning and review of documents related to In process, DS, DP, stability testing, AMV and AMT activities within quality control laboratory. 2. To effectively plan and monitor shift duties of the QC analytical staff members to support 24*7 business operations. 3. Responsible for compliance to internal, external & statutory compliances as per quality policy of Enzene, pharmacopoeia guidelines and other regulated guidelines. 4. Responsible for periodic training management related to quality, GMP, regulatory aspects to quality control laboratory personnels and evaluation of effectiveness. 5. Responsible for the periodic assessments/audits to identi...

ApoPharma, a member of the Apotex group of companies, is a pharmaceutical company devoted to the discovery, development and provision of new medicines to help improve the quality of life of patients with debilitating and life-threatening diseases. Investigation into the pathological role of iron in human disease, and how to use novel medicines to treat conditions created or worsened by iron, is a major research focus of ApoPharma. Job Summary Perform and report of analysis of Stability, Inprocess and Finished products, Cleaning Method validation analysis by using various analytical instruments. Job Responsibilities Analysis of Stability, Inprocess and Finished products samples, Cleaning Meth...

Responsibilities: * Conduct HPLC & GC analyses with accuracy * Ensure method validation meets standards * Develop testing processes using SOPs * Collaborate on quality control initiatives * Manage analytical instruments effectively

Job Title Test & Verification Architect Job Description #EOS #PHILIN# Job title: Test & Verification Architect Your role: Ensuring right hardware verification strategy by delivering proper test coverage avoiding gap and overlap for release level requirements Leading verification work packages and assigning ownership within T&V team Ownership of planning, ensuring timely execution Ensuring high quality of verification evidence ( including compliance with processes, regulations and standards) Boosting the effectiveness of the team by optimization of verification process Supporting/ leading problem solving activities in order to define root cause of the problem Mentoring and supporting team mem...

We have a great opportunity in a reputed Pharmaceutical Manufacturing Company in Vapi, Gujarat. Minimum 5 -8 years of experience B.Sc/ M.Sc in Chemistry, B Pharma/ M Pharma- with FDA Approval Attractive Salary Required Candidate profile Interested candidates may share their updated CV at hire@hireindians.com or Call/WhatsApp at 8882212450.

Instrument Handling - pH Meter, Analytical Balance, Friability Tester, Disintegration Apparatus, Hot Air Oven, Moisture Balance, UV Sprct. Raw & Packing Material Testing Strong GLP Adherence Robust GMP Documentation Regulatory Compliance Awareness Required Candidate profile Experience: 2–3 years in pharmaceutical Quality Control Strong knowledge of analytical instruments and QC procedures Soft Skills: Detail-oriented, organized, good interpersonal & communication skills

Role & responsibilities Provide Support to routine analysis of API Synthesis R&D and Stability samples. Documentation of Daily analysis in corresponding product LNB. Development of analytical methods for drug substances, raw materials and intermediates. Perform AMV, AMDR, AMT activities. Preparation of Analytical method validation / AMT protocol & report. Preparation of Tentative STP/MOA during Development. Trouble shooting at the time instrument operation and analytical method related problem. Preparation of COA, MOA and provide to LIMS. HPLC and GC Calibration and Documentation and provide GLP for the same. Prepare method development report. Analytical method transfers and Documentary Meth...

Dear Applicants, Greetings from Biophore India !! We have opening for Formulation AR&D Department. Experience : 3 7 Years Qualification : B. Pharm /M. Pharm or M Sc Work Location: R&D Centre -Pashamylaram, Isnapur, Sanga Reddy. Job Description 1) Method Development and routine analysis of Assay, Dissolution, Related substances, Content Uniformity, Blend Uniformity. 2) Responsible for Analytical Method Validation activities for solid orals and injectables. 3) Responsible for Routine and Stability analysis activities for solid orals and injectables. 4)Responsible for the Review of documents generated in Method development activity. 5)Responsible for the Preparation and Review of Tentative meth...

NOTE: Only Male & Candidates from AP & Telangana Preferred. Kindly Understand the JD It's not for the Clinical Trails Department 2Years Bond & Need to Submit your 10th Original Mark list with us during the Bond Period. Qualifications required: Bachelors / Masters (0-4 yrs. experience) degree level in biological/ life science, pharmacy qualification. Role and responsibility: In process quality control of ongoing studies. Review of raw data, chromatograms and reports of the method validations and studies. Checking of all the instruments and equipments for the calibration status and appropriate labeling. Checking and monitoring of the day-to-day activities in the lab for compliance to SOPs and ...

Roles and Responsibilities : Responsible for drug metabolism and pharmacokinetic support for drug discovery programs. Develop and validate Bioanalytical method using LC-MSMS and other sophisticated instruments. Have a thorough knowledge of LC-MSMS, HPLC. Have knowledge of USFDA, MHRA, and M10 guidelines. Have excellent communication skills and the ability to co-ordinate with team members. Process good interpersonal and management skills. Strong basic knowledge of Operation, Calibration, and maintenance of laboratory equipment viz. Analytical balance, pH meter, centrifuge, Solid phase extraction unit and evaporator, and pipettes. Active involvement in method development of drug in In-vitro/In...

Role & responsibilities 1. To review batch release documents for raw material/packing material /in process/intermediate /finished product/stability like test protocol / report, electronic data, chromatograms, audit trail, spectra, etc. 2. To execute audit trails and review the activity to verify the integrity of data. 3. To review electronic data back up and verification of restoration study, computer system validation, etc. 4. To review calibration/qualification/PM schedule/installation documents for instruments in Quality Control department. 5. To review analyst qualification and training related documents of quality control department. 6. To review documents related to working standard / ...

As a Pharma Subject Matter Expert (SME) Trainer, you will be responsible for training candidates in various aspects of Quality Control (QC), Cell Culture Techniques, and Laboratory Procedures. Your role involves providing hands-on experience in analytical testing, microbiological testing, and pharmaceutical laboratory operations. It is essential to educate candidates on method validation, stability testing, and data integrity while ensuring compliance with FDA, USP, and cGMP regulations. Additionally, you will train individuals in utilizing HPLC, GC, UV-Vis, FTIR, PCR, ELISA, and Spectroscopy techniques. Your responsibilities include conducting mock interviews, assisting with resume preparat...

As a Calibration & Quality Lead at Prism Group of Companies in Ahmedabad, Gujarat, India, you will play a crucial role in leading the quality and calibration department. Your primary responsibility will be to drive operational excellence, ensure ISO/NABL compliance, and oversee a team of calibration engineers to deliver trusted service to our diverse client base. You will be responsible for managing the end-to-end calibration process, including electrical, thermal, and dimensional aspects. Ensuring that NABL documentation, audits, and compliance are maintained up to date will be a key focus area. Additionally, you will conduct technical reviews, uncertainty calculations, and inter-lab compar...

The ADL Research Associate role at our organization in Vadodara requires 1-3 years of experience and a qualification of BSc/MSc Chemistry. As an ADL Research Associate, you will be responsible for developing, validating, and implementing analytical methods to support pharmaceutical product development. Your expertise in analytical instrumentation and regulatory guidelines will ensure compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). Collaborating closely with R&D, Quality Assurance (QA), and Regulatory Affairs teams, you will contribute to formulation development, stability studies, and technology transfers. Your key responsibilities will include develop...

You will be joining a company committed to delivering high-quality pharmaceutical products and services, with a mission to enhance the quality of life through innovative healthcare solutions. The culture at Zydus revolves around collaboration, integrity, and excellence. As the ADL - Analytical Development Laboratory Executive/Senior Executive, your primary responsibility will involve method development, verification, and validation to ensure compliance with Pharmacopeial standards. You will also support various analytical activities within the department. Your key responsibilities will include method development, verification, and validation for Pharmacopeial standards, DMF updations, and ot...

Job Title: Quality Head/Quality Assurance (Manager/Asst.Manager/Dy.Manager) Location: Mayapuri Industrial Area Ph-II, New Delhi-110064 Role Overview Responsible for managing the laboratory&aposs Quality Management System (QMS) as per ISO/IEC 17025:2017 and FSSAI standards. Ensures compliance, accurate testing, audits, and continuous improvement to maintain accreditation. Key Responsibilities Manage QMS in line with ISO/IEC 17025 and NABL requirements. Ensure compliance with FSSAI regulations. Oversee audits, CAPA, document control, and proficiency testing. Monitor calibration, method validation, and measurement traceability. Train and guide staff on GLP and quality standards. Coordinate with...

Who We Are Together, were on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. Its a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the worlds leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organizations Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but were always looking for new ways to continue making a difference, and new people to make a difference with. The opp...

Role and Responsibility: Technical Support: Provide expert technical support to customers and field personnel on HPLC troubleshooting, and resolving application issues. Application Development: Develop and optimize analytical methods and applications using HPLC for various industries, including pharmaceuticals, industrial, environmental, food, and life sciences. Customer Training: Conduct customer training sessions, webinars, and workshops to enhance user proficiency and satisfaction. Collaboration : Work closely with the sales and marketing teams to identify customer needs and develop tailored solutions. Collaborate with R&D to provide feedback on product performance and enhancements. Docum...

Job Title: Senior Executive /Executive Analytical Development Business Unit: R&D1 Regulatory Affairs Job Grade G12A/G11B Location : Baroda At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys. Job Description: To work as per cGMP a...

Roles & Responsibilities Quality Control Analyst Prepare and review Standard Test Procedures (STPs) , analytical protocols, and reports. Perform Analytical Method Validation, Process Validation , and prepare validation protocols as per regulatory requirements. Conduct testing and quality control activities for raw materials, bulk, in-process, finished goods, and stability samples. Operate and maintain analytical instruments and techniques including HPLC, UV-Vis Spectrophotometer, Karl Fischer, and other QC equipment . Perform calibration, qualification, and preventive maintenance of analytical instruments and ensure proper documentation. Maintain accurate and complete laboratory records in c...

Primary Responsibilities: * Exposure for Analysis and documentation of tablets, capsules, Liquid/Cream. * Developing and validating analytical test methods for the testing of pharmaceutical products for manufactured to GMP and ICH requirements. * Developing and validation of Cleaning Method validation. * Transferring and documentation new analytical techniques to the Quality Control (QC) laboratory. * Controlling laboratory chemicals required for analytical activities. * Planning and organizing stability testing. * Writing/reviewing specifications and methods of analysis. * Writing/reviewing of Standard Operating Procedures (SOPs) as per regulatory requirement. * Participating in self-inspec...

Manage & guide team, coordinate with all concerned department, supervise method development/validation, review data/docs, oversee calibration, method transfers, customer calls & team training. Required Candidate profile M.Pharm/ M.Sc with team management skills in AR&D. Strong in method development/validation, data review, calibration, training juniors, client coordination.