GLP Jobs

We are seeking a dedicated Quality Control Analyst to join our team in Nalagarh. The ideal candidate will have 2 to 4 years of experience and possess a degree in B.Pharma or B.Sc. This role requires a strong focus on ensuring product quality and compliance with regulatory standards.**Key Responsibilities:**- **Conduct Testing**: Perform various tests on raw materials and finished products to ensure they meet quality specifications. This includes physical, chemical, and microbiological analysis.- **Documentation and Reporting**: Maintain accurate records of test results and document deviations or issues. Timely reporting helps in identifying trends and implementing improvements.- **Quality Assurance Compliance**: Assist in maintaining compliance with quality standards and regulations set by industry and government bodies. This includes understanding and following standard operating procedures (SOPs).- **Collaboration with Teams**: Work closely with production and R&D teams to address quality-related concerns. Effective communication is essential for improving processes and products.- **Problem-Solving**: Identify root causes of quality issues and propose corrective actions. This analytical approach aims to prevent reoccurrence of defects.**Required Skills and Expectations:**Candidates must have strong analytical and critical thinking skills to assess complex quality issues effectively. Attention to detail is essential to ensure accurate testing and documentation. Knowledge of quality control regulations and practices is required. Proficiency in software applications for data analysis and reporting is preferred. A collaborative mindset is crucial for working well within a team. Candidates should also demonstrate a commitment to continuous learning and improvement in quality processes.

Job Summary:We are seeking a detail-oriented and dedicated Quality Control (QC) Chemist to perform routine analysis and testing of raw materials, in-process samples, and finished products. The ideal candidate should have sound knowledge of analytical instruments such as HPLC, UV, IR, and dissolution apparatus, along with good documentation and GMP compliance understanding.Key Responsibilities:Perform chemical and instrumental analysis of raw materials, in-process, and finished products.Operate and calibrate analytical instruments such as HPLC, UV-Visible Spectrophotometer, IR, and others as per SOPs.Maintain and review analytical documents, logbooks, and test reports.Ensure all activities are performed in compliance with GMP, GLP, and regulatory requirements.Conduct stability studies and prepare required documentation.Assist in method validation, equipment qualification, and troubleshooting.Ensure proper sampling, labeling, and storage of reference standards and samples.Participate in internal audits, inspections, and quality improvement initiatives.Timely reporting and escalation of any deviations or non-conformance.Skills & Competencies:Sound knowledge of analytical techniques and instrumental analysis.Proficient in handling HPLC and other laboratory instruments.Familiarity with Good Laboratory Practices (GLP) and documentation practices.Strong attention to detail and a quality-oriented mindset.Good communication and team coordination skills.Eligibility Criteria:Educational Qualification: B.Sc / M.Sc in Chemistry, B.Pharm / M.PharmExperience: 0 to 2 years of experience in QC (Freshers with relevant academic background are also welcome)Should have basic understanding of GMP, GLP, and ICH guidelines.

Responsibilities:* Conduct HPLC analysis on raw materials & finished products.* Ensure compliance with GLP guidelines during formulation & manufacturing.* Perform UV testing, dissolution assays for tablets/capsules.

must have knowledge to perform analysis of Development, Routine and stability sample.

QA Manager / Asst QA Manager Responsibilities:-To handle calibration & validation activities at site.Preparation & review of Technical Documents like Site Master File, Validation Master Plan, Qualifications & Validation Protocols, Validation Reports, Master Formulas, Batch Manufacturing & Packing Records, Policies, Manuals Work Instructions, general and standard specifications and testing procedures & Standard Operating Procedures.To prepare, review & report annual product reviews & product stability reports.To investigate complaints, deviations, quality incidents and non-conformances and ensure implementation of CAPA.To control IPQC activities in production and packing of finished products.To handled external audits like regulatory audits and vendor audits.To indent QA requirements.To approve (sanction) leaves of QA department personnel..To conduct internal audits as per current Good Manufacturing Practices (cGMP) requirements.To issue Corrective Action & Preventive Action and to do follow up for effective implementation of Corrective Action & Preventive Action.To review and approve out of specification, quality incident, deviation, change control, validation documents.To Review and Release manufactured batch.Revision of SOPs & it's integration with Corporate Documents.Act as the pollution prevention, waste minimization and energy team member where applicable.Implementation of Quality Management System & Environment Management System requirements as applicable to IPQC function.To conduct training on Good Manufacturing Practices/Good Laboratory Practices in coordination with Human Resources department.Vendor development, evaluation & assessment of suppliers through auditsTo review Batch Manufacturing Records.To perform gap & risk analysis.To handle change controls.

Training & evaluation of new joinee as well existing staff.Manage process from Sample receiving to Job card release. Ensure accuracy of test results.Make sure to review technical masters & update.Review & sign the job card & test report (shelf life & Nutrition labels)Review of new license application.Resolve technical challenges related to admin and sales team.New scope development on regular basis.Ensure timely completion of all IQC (Internal Quality Control) & documents related to testing.Review of all purchase intends related to food department and Ensure availability of required chemical, reagents, glasswares, equipments, methods, CRM in proper condition.Method validation & verification.Ensure timely internal & external calibration of equipments, glasswaresEnsure that all safety guidelines are followed strictly at all times.Ensure success of all kind of external audits, internal audit & client audit.Review of senior person.

Formulation plant GLP qc

Job Responsibility: 1. To ensure that GLPs followed in the laboratory. 2. To establish, develop, validate testing Procedures. 3. To Prepare protocols, reports and monitor samples of Method validation andMethod Development. To perform the calibration of instrument/equipment. To ensure that instruments andequipment are calibrated as per given schedule and records are maintained accordingly. To perform analysis for Raw material, finish products and stability samples. To ensure that samples are analysed in time and results are conveyed todepartment head or reviewer as per requirement and as per the procedure. To maintain documentation for Regulatory Submission Maintaining of SOP as per regulatory requirements and periodically reviewed. To ensure all record are maintained as per the procedures. Any other work assigned by the superiors. To prepare Method of analysis (MOA) and Specification and any otherdocuments of new drug product. To perform Method transfer to Q.C Department.Qualification :B. Pharm / M. PharmExperience : 2-3 YearsJob Location :Vadodara

The Analyst must: Proficient in operating HPLC Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs). Analyse API, Raw Materials and Finished products for Assay, Impurities & Dissolution study using HPLC instrument with minimum supervision. Review technical data, documents, and proposals as required. Troubleshoot technical issues/ difficulties with methods. Coordinate with team members to perform method transfers between R&D group to QC group. Promote and maintain a safe and healthy working laboratory environment in compliance with established health and safety procedures. Strong interpretation of routine analysis or tests. Be able to write lab reports. Ability to work directly from the USP or EP pharmacopeia to write protocols and execute methods. Be able to work under GMP guidelines and be proficient with USP and pharmaceutical testing. Competent research and study skills to learn about innovative methodologies and equipment used for problem-solving and troubleshooting. Design, preparation, and production of study materials including procedure manuals. Responsible for the testing of raw materials, finished products and stability samples by instrumental and wet chemistry methods and described in compendia references or in-house methods. Perform other duties as assigned by the Laboratory manager.Note : The Analyst will have over minimum 3 to 5 years of laboratory testing experience Education:MSc in Analytical Chemistry, or diploma in related filed.A solid background and understanding of Chemistry is mandatoryExperience working with Pharmaceuticals.

The QC manager must have a minimum of 12 years of experience in a pharma QC lab.He/she must have hands-on experience in operation of HPLC, GC, IR, UV and other instruments used in pharmaceutical analysisResponsible for managing the QC laboratory in accordance with cGMPand GLP requirements. The Manager must be able to manage and lead a team of QC analysts in order to maintain smooth running of the laboratory. He will have to supervise regular testing on the incoming raw material, bulk and semi-finished product and finished product.Maintain regularity of testing and timely release of test reports.

Job descriptionPosition Of:- R&D - OSL Associate/ Officer/ ChemistRoles and ResponsibilitiesTo perform experiments as per instructions of project leaderTo monitor analytical data, LNB & documentsDo work as per GLPMonitor lab Chemicals, raw materials & MSDSKnowledge of process development for APIs and Intermediates/Cost reduction and plant troubleshooting/ OD at plant site for technology transfer as & when required/chemistry/regulatory guidelines/GMP

We have vacant of 3 Assistant Manager Jobs in Manesar, Gurgaon, Haryana, Sound Knowledge of GMP/GLP, Experience Required : 4 Years Educational Qualification : M.Sc, M.Tech Skill MIS-Management Information Systems, Accounting, Sound Knowledge of GMP/GLP etc.