Role and Responsibilities: Support for reagent and solvent management Support for Glassware management Support for reference standard management Support for Column management Support for record management Support activities like general lab inventory management etc. Support for Instrument inventory management Support for calibration of analytical accessories management Support in shipment management related activities eg: shipment of reference standards, samples etc. Receipt of material and GRN completion of purchase request(s) in applicable system on site. Responsible to support Life cycle management activities of instruments and equipments Responsible for handling data related to laboratory support activities as per the applicable lab procedure. Like CIMS data for reagent solvent management, COA for Column management etc. Minimum Qualification for the position: Science/Pharmacy Graduate and Adequate computer proficiency. Adequate knowledge of verbal and written communication skills in English Must be able to work independently with minimum supervision to meet deadlines and maintain a positive attitude. Minimum 2 years relevant experience.
Role Overview Responsible for review of qualification & calibration data of instruments and equipment as per procedures with QMS. Illustrative Responsibilities Ensure that qualification & calibration activities are planned and executed within time frame defined by the procedure and equipments are released on time as per the pre-defined schedule. Responsible for coordinating with lab supervisors / system owners for handling of any non-conformances or escalations Handling of QMS related activities like, Change control, CAPA and Deviation with its effectiveness check. Responsible for quality compliance activities for laboratory instruments qualification and calibration. Summarize, review, and report the analytical Instruments qualification and calibration for further approval. Ensure a disciplined work environment to provide expertise to subordinates colleagues in the proper performance of laboratory procedures. Ensure on time GDP in technical function with right first time (RFT) approach. Responsible for ensuring team compliance to EHS, Quality & Business policies Any other work given by management from time to time. Quality & Compliance Responsible for following GMP/GLP/ GDP/EHS policies by self as well as the team Required skills Technical expertise in Analytical instruments qualification, calibration, protocol preparation and QMS. Build cohesive team valuing team spirit Able to anticipate the implications and consequences of situations and take appropriate actions in the interest of Client as well as Cal Scientific without compromising quality. Clear thoughts and effective and crisp communication. Job requirement M.Sc – specializing in Chemistry/ M. Pharma with proven experience of min. 7-8 yrs. in Instrument qualification and calibration. In depth experience in Chromatography (HPLC, UPLC, GC), Spectroscopy (MS, FTIR, UV), Thermal techniques (DSC, TGA) and Particle size measurements. Expertise in analytical instruments qualification and calibration, protocol preparation, CAPA, Investigations, Deviations (QMS) Good Knowledge of ICH guidelines and different global regulatory authorities.
JD: Inventory Management FTE The employee is responsible for performing activities in compliance with current established procedures of Safety and Quality. Main and additional duties are mentioned below: Responsible for Inventory management for Lab chemicals/Solvent, Reference standard including procurement, receipt, issuance. Responsible for Inventory management for Glasswares, including procurement. Responsible for Inventory management for Lab stationary items, including procurement, receipt, distribution. Responsible for executing activities in EDMS as per assigned roles and as per applicable procedures. Responsible for Inventory management for chromatography columns, including Procurement. Responsible for creation of GRN for Lab related items. Responsible for maintaining various databases in the lab. To execute the task according to the cGMP guidelines. Responsible for filing of ELIMS worksheets and other documents. Responsible for all the activities assigned in the Lab responsibility list. knowledge of excel/ pivot table. Ability to extract technical information, such as given on SDS, COA, test method for a specified reagent and then place the order GMP Responsibility •To execute the tasks according to the cGMP guidelines and established laboratory procedures. •To document execution details contemporaneously and verify completeness of execution record as per established laboratory procedure. •To always comply with procedure and ensure lab is in state of audit readiness. Quality & Compliance Responsibilities •To ensure that respective guidelines on data integrity and laboratory control processes are followed as per established SOPs. •To ensure immediate escalation of issues/observations not in conformity with applicable procedures /policies etc.
Role Overview Responsible for qualification & calibration activities for defined instruments and equipment as per schedule & procedures with QMS. Illustrative Responsibilities Ensure that qualification & calibration activities are planned and executed within time frame defined by the procedure and equipments are released on time as per the pre-defined schedule. Responsible for coordinating with lab supervisors / system owners for handling of any non-conformances or escalations Handling of QMS related activities like, Change control, CAPA and Deviation with its effectiveness check. Responsible for quality compliance activities for laboratory instruments qualification and calibration. Summarize, review, and report the analytical Instruments qualification and calibration for further approval. Ensure a disciplined work environment to provide expertise to subordinates colleagues in the proper performance of laboratory procedures. Ensure on time GDP in technical function with right first time (RFT) approach. Responsible for ensuring team compliance to EHS, Quality & Business policies Any other work given by management from time to time. Quality & Compliance Responsible for following GMP/GLP/ GDP/EHS policies by self as well as the team Required skills Technical expertise in Analytical instruments qualification, calibration, protocol preparation and QMS. Build cohesive team valuing team spirit Able to anticipate the implications and consequences of situations and take appropriate actions in the interest of Client as well as Cal Scientific without compromising quality. Clear thoughts and effective and crisp communication. Job requirement M.Sc specializing in Chemistry/ M. Pharma with proven experience of min. 8-10 yrs. in Instrument qualification and calibration. In depth experience in Chromatography (HPLC, UPLC, GC), Spectroscopy (MS, FTIR, UV), Thermal techniques (DSC, TGA) and Particle size measurements. Expertise in analytical instruments qualification and calibration, protocol preparation, CAPA, Investigations, Deviations (QMS) Good Knowledge of ICH guidelines and different global regulatory authorities. Job Location-Mulund
Role Overview Responsible for qualification & calibration of Microbiology instruments and equipment as per procedures with QMS. Illustrative Responsibilities Ensure that qualification & calibration activities are planned and executed within time frame defined by the procedure and equipments are released on time as per the pre-defined schedule. Responsible for coordinating with lab supervisors / system owners for handling of any non-conformances or escalations Handling of QMS related activities like, Change control, CAPA and Deviation with its effectiveness check. Responsible for quality compliance activities for laboratory instruments qualification and calibration. Summarize, review, and report the analytical Instruments qualification and calibration for further approval. Ensure a disciplined work environment to provide expertise to subordinates colleagues in the proper performance of laboratory procedures. Ensure on time GDP in technical function with right first time (RFT) approach. Responsible for ensuring team compliance to EHS, Quality & Business policies Any other work given by management from time to time. Quality & Compliance Responsible for following GMP/GLP/ GDP/EHS policies by self as well as the team Required skills Technical expertise in Microbiology instruments qualification, calibration, protocol preparation and QMS. Build cohesive team valuing team spirit Able to handle biosafety cabinet, LAF, glass bead sterilizer, water bath, Autoclave, refrigerator, Incubator, Balance & pH meter etc. Clear thoughts and effective and crisp communication. Job requirement M.Sc – specializing in Microbiology/Biotech with proven experience of min. 2-3 yrs. in Instrument qualification and calibration. Awareness of analytical instruments qualification and calibration, protocol preparation, CAPA, Investigations, Deviations (QMS) Good Knowledge of ICH guidelines and different global regulatory authorities. Job Location - Mulund
Key Responsibilities Create Purchase Requisitions (PR) and Purchase Orders (PO) in alignment with internal procurement processes. Maintain and update Purchase Requisition (PR) records on the L: Drive. Oversee material goods receipt and perform Goods Receipt Note (GRN) entry in the EMP system, Manage and monitor stationery material inventory for the respective Departments. Coordinate with vendors to arrange required quotation, materials and services efficiently. Manage vendor master data , including code creation and modifications in SAP/ERP. Process advance payments for both imported and local materials/services as per procurement and finance protocols. Provide guidance to vendors regarding payment procedures and documentation requirements. Compile and report quarterly accruals based on open PO status. Follow up regularly with the payment team to ensure timely vendor payments. Collaborate with the finance team for GRIR (Goods Receipt Invoice Receipt) reconciliation and resolving discrepancies. Support asset capitalization in accordance with accounting and financial policies. Maintain working knowledge and hands-on experience with SAP/ERP modules relevant to procurement, finance, and vendor management. Key Requirements: Bachelors degree in commerce, Business Administration, or a related field. At least 2 years' experience with SAP or other ERP systems required. Proficient in Microsoft Excel with practical experience Strong communication and coordination skills. Detail-oriented with a proactive problem-solving approach. Ability to manage multiple stakeholders and deadlines effectively. Role & responsibilities Preferred candidate profile
Description: The Analyst is primarily responsible for supporting Lab Activities related to Equipment Life Cycle Management, Record Management, Training Management, Chemical Inventory Management System (CIMS), Document Management and Sample/Placebo/Reference Material Management within SMMD & Dissolution function. Responsibilities: • Responsible for computerized System Validation • To ensure proper Installation and Qualification of Analytical Instruments • Responsible for preparation of the SOPs, WI, protocols and operation procedures pertaining to Qualification, Calibration and Maintenance of instruments. • Responsible for maintaining calibration, breakdown and maintenance records • To maintain the stock of calibration kits including critical instrument spare parts. • Responsible for Record management • Inventory management (Issuance of books, labelling, closure of books, updation of Mater lists etc.) • Responsible for Chemical Management: e.g. Inventory management (stock and inuse, Issuance & reconciliation), Labelling, Keep up of all the records (COA's, MSDS etc.). • Glassware management • Responsible for Reference Standard Management: Ordering, Tracking, Stock and inuse inventory, Issuance & reconciliation, Labelling, and maintenance of supporting documents e.g. COA's, MSDS etc. • Training management (Curricula maintenance and updation, Daily FU for trainings, ILC creation, New users/existing users training management in CW, etc.) • ELN support activities (Spreadsheet validation, periodic review of users, user groups, templates etc.) • Truvault Docs handling (Controlled prints, Uploading & Routing of documents for review/approvals, Projects, SOPs, WI, forms etc.) • ECMMS related activities (e.g. planner, reviewer etc.) • Activities related to upgradation of existing systems/software (e.g. Windows 10 migration, Project Olympus, RIMS 5 etc.) Education: • Bachelor degree or equivalent experience. Experience: • 3 to 5 years of experience in supporting data integrity, Equipment Life Cycle Management and other lab support activities Other Skills: • Ability to prioritize multiple tasks in a rapidly changing environment • Excellent interpersonal skills • Effective written and oral communication • Efficient time management • Good knowledge on computer systems Job Location-Mulund
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