You will be working as an Officer/Sr. Officer/Executive/Sr. Executive with 2-8 years of experience in injectable Manufacturing. Your role will involve following instructions and procedures outlined in the Entry-Exit SOP for Grade C and Grade B areas, as well as ensuring proper functioning and behavior in the aseptic area. You will be responsible for adhering to personnel hygiene practices within the factory premises, following Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) as per SOP guidelines, and monitoring temperature, relative humidity, and differential pressure. Additionally, you will be tasked with overseeing the handling of material movement in the production area, maintaining documentation as per GDP and cGMP standards, and ensuring day-to-day records are accurately maintained. You will also be responsible for providing training to new chemists, workers, and operators, conducting line clearance before operations, and planning manufacturing based on raw material availability. Your duties will include supervising the preparation and filtration of cleaning/disinfectant solutions, ensuring equipment readiness before batch manufacturing, and overseeing the operation and cleaning of various machinery and utilities. You will verify load cell handling, monitor non-viable particle count, record operation and cleaning details, and handle equipment like homogenizers, pH meters, and foggers. Furthermore, you will be involved in activities such as aseptic process stimulation, media fill cleaning, and sanitization, as well as general area cleaning and sanitization in grade C and D areas. You will also be responsible for data entry in the pharmacloud system, audit preparation and execution, periodic medical checkups, and reporting unsafe acts/conditions/incidents to supervisors. Overall, you will play a crucial role in ensuring the smooth functioning of manufacturing processes and maintaining high standards of cleanliness, documentation, and safety within the pharmaceutical production environment.,
You will be responsible for preparing, reviewing, and implementing Standard Operating Procedures of Quality Assurance, ensuring that day-to-day QA Controls are in place, and empowering QA for the entire plant. Your role will involve establishing, implementing, and maintaining the necessary processes for the Quality management system. You will adopt a document control procedure to approve, review, and update all changes to documents within the scope of the Quality Management System. Issuance of Quality Management System related formats and maintaining the log accordingly will be under your purview. You will be required to follow up on deviations, change controls, incidents, material and product destructions, Internal Audits, re-packing activities, and corrective & preventive actions with the respective departments. As part of your responsibilities, you will prepare risk assessment documents and ensure that the performance of the Quality Management System is reviewed at planned intervals to ensure its continuing suitability, adequacy, and effectiveness. It will be your duty to maintain documents as per current Good Manufacturing Practices and to intervene and call meetings to resolve QMS and GMP related queries. You will provide documents for regulatory affairs and handle regulatory queries. Co-ordination with internal department personnel as well as external parties will be essential. Additionally, you will be responsible for audit preparation, execution, and compliance, as well as handling notifications to management regarding documents. Investigating and reviewing non-conforming events, including customer complaints and internal non-conforming events, and deciding on Corrective and Preventive Actions (CAPA) will be part of your role. You will prepare, review, and implement the Master list of Standard Operating Procedures and review qualification and validation documents. Reviewing and implementing the Annual Training Plan of GMP/Technical/SOP training, coordinating with the concerned departments for execution, and maintaining training records will be crucial. You will also be responsible for verifying and implementing the Batch Numbering system and allocating Equipment identification numbers, as well as reviewing and following up on the updating of equipment/instrument lists. Managing the update/review of the approved vendor list, vendor qualification planning, and documents will also fall within your responsibilities.,
The job involves various essential duties and responsibilities that you will be expected to perform: You will be responsible for processing rate difference credit note entries in Pharma Clouds across different divisions. This includes verifying supply proof and organizing them in specific folders. Additionally, you will be required to calculate the PDCN rate in conjunction with PTS and the discount allowed based on the supply proof. Furthermore, issuing CC/CX/CL division PDCN in accordance with the rate difference identified with RCRQ will be part of your responsibilities. You will also handle the calculation for FC/FL/FH divisions as instructed by Anita Maam. Your tasks will also involve updating an Excel sheet with the specified format across different divisions in the PDCN folder.,
The ideal candidate for this position should have 2-8 years of experience and will be responsible for various tasks including GPCB work, SOP preparation, periodic revision of EHS SOP, work permit system, documentation work, regulatory compliance, statutory audit, safety audit, risk assessment, incident investigation, hazard identification, safety training for new joiners, legal compliance, environment audit, knowledge of work permits, fire extinguisher and fire hydrant systems, EHS related training, mock drills, preparation of risk assessment reports, GPCB related work such as NOC, CCA, product mix, compliance in XGN, ETP operations, EC work, Parivesh Portal, and CGWA work.,
You will be responsible for understanding the current practices, medicines, and trends in the specific therapeutic area by engaging in doctor visits, attending scientific symposia, and reviewing key therapeutic journals. This information will be crucial for providing relevant insights to both internal and external stakeholders. Your role will also involve publishing scientific articles related to company products and creating presentations for doctors, including those for Continuing Medical Education (CME) and product launches. As part of the team, you will contribute to the implementation of the medico marketing strategy and engage in field visits to doctors for product management purposes, ensuring the development of Key Opinion Leaders (KOLs). You will be entrusted with approving various materials such as Labels (LBLs), Visual Aids (VAs), product monographs, and other medico-marketing content to promote the products effectively. Additionally, you will provide product rationale and clinical data for new products/indications and support regulatory affairs by assisting in the approval of pack inserts (PI) and other medical data. Furthermore, you will be involved in the preparation of Periodic Safety Update Reports (PSURs) and tracking their update dates for the pharmacovigilance process. Your attention to detail and proactive approach will be essential in ensuring compliance and maintaining accurate records.,
The Production Packing Assistant Manager/Manager is responsible for overseeing day-to-day production planning and execution to ensure requirements are met. You will be in charge of supervising and evaluating the performance of production personnel, organizing workflow to meet specifications and deadlines, and distributing staff/workers according to production planning. Additionally, you will review, approve, and implement departmental SOPs in accordance with current guidelines. You will also be responsible for monitoring online documentation such as BMRs, BPRs, log books, and other relevant documents. Monitoring the stage-wise process for product yield, reviewing QMS documents, qualification protocols, and other online documents for CAPA implementation will also be part of your duties. The ideal candidate should have knowledge of aseptic area practices, vial/ampoule filling and sealing, LYO products, regulatory audits, and packing and visual activities to ensure targets are achieved for packing, labeling, and visuals. Experience with cartridge printing, specifically Track & Trace, is also required for this role.,
You will be responsible for handling both export and import operations in accordance with company policies and procedures. Your main duties and responsibilities will include: For Exports: - Preparation of pre and post shipment documents for export shipments. - Coordinating with the marketing team for sales orders, the factory for stock availability, and the finance team for cross credit limits. - Liaising with the clearing and forwarding agent to ensure smooth clearance of shipments. - Approving checklists, AWB/BL drafts, and GST invoices. - Following up for the dispatch of goods with the plant. - Resolving customer queries promptly. - Coordinating with the bank for BRC and various export-related queries. - Maintaining the export register accurately. - Online release of Bank Realization Certificate. - Submitting export final documents to the bank. - Forwarding documents to the accounts team for proper accounting entries. - Addressing GST queries received from the accounts team. For Imports: - Preparation of LC applications and following up with the bank for LC drafts. - Making necessary entries in the import register. - Submitting proof of import to the bank. - Providing documents and details to the accounts team for import-related transactions. Your role will require attention to detail, effective communication with internal and external stakeholders, and the ability to manage multiple tasks simultaneously. You will play a crucial role in ensuring the smooth flow of export and import operations within the organization.,
You should have 2-7 years of experience in an Injectable plant. Your main responsibilities will include making entries of Bonding slips, preparing monthly statements for LL party and sales reports, generating GST invoices in Pharma Cloud, preparing E-way bills, creating and reviewing standard operating procedures for the BSR department, implementing departmental SOPs, managing quality system documents like Change control proposals, Deviations & Incident reports, updating and maintaining online departmental documentation, uploading all Third-party invoices on the party portal, following export consignment dispatch procedures, ensuring proper handover of charge before leaving the factory, coordinating transport arrangements for dispatch of finished goods, liaising with H.O., LL & TP parties for dispatch of finished goods, and carrying out any other duties assigned by the HOD or BSR designee/Head.,
Role Overview: As a Medical Affairs Executive, your primary responsibility is to understand current practices, medicines, and trends in the respective therapeutic area by engaging in doctor visits, attending scientific symposia, and reviewing key therapeutic journals. This knowledge will enable you to provide valuable information to both internal and external customers. Key Responsibilities: - Publish scientific articles related to company products. - Create presentations for doctors for Continuing Medical Education (CME) sessions and product launches. - Participate in implementing the medico-marketing strategy. - Conduct regular field visits to doctors for product management and Key Opinion Leader (KOL) development. - Approve Labelling (LBLs), Visual Aids (VA), product monographs, and other medico-marketing content for product promotion. - Provide product rationale and clinical data for new products/indications. - Assist regulatory affairs with pack inserts (PI) and other medical data approvals as needed. - Generate Periodic Safety Update Reports (PSURs) and update dates for the next PSUR with tracking sheets as part of pharmacovigilance.,
In this role, your primary responsibilities will include: - Checking and evaluating the price difference credit/debit notes of all divisions of CNF locations - Attending Marketing review meetings and working on sales initiatives as a cross-functional team member - Auditing tour expenses and other marketing-related activities as per SOP, including checking GST statewise, hotel expenses, and travelling costs - Verifying price difference credit notes/debit notes of third parties with cross verification of rates mentioned in purchase orders - Submitting pricing data to NPPA-Delhi - Checking outstanding party balances for evaluation purposes related to credit notes - Providing sales data regarding product pricing as requested by NPPA - Approving RCRQ rate group master & Account master of a new stockist for hospital billing in Pharma Cloud - Transferring debit/credit balances of parties for review under one party code if multiple parties are involved - Removing expired/hold stock from the system based on urgent requests from the distribution team - Resolving tax queries related to GST, TDS & TCS with the taxation department - Providing data related to MRP of all divisions to management for price revision - Performing product repack activities if required - Controlling and evaluating near expiry sales returns, discussing with area managers and management for decisions - Solving stockists" queries related to credit notes and debit notes - Providing data in various report forms such as Sales vs. Credit Notes - Providing yearly details for increasing MRP revision of all divisions - Coordinating with CNF & Factory for data requirements of Statutory auditors and evaluating the same - Submitting quarterly financial closing data to statutory auditors, particularly Sales Data - Resolving queries of statutory auditors effectively Please note that any other urgent tasks assigned by HOD will also be part of your responsibilities.,
You will be responsible for the following duties and responsibilities: - Passing rate difference credit note entries in Pharma Clouds in different divisions. - Verifying supply proof and saving it in particular folders. - Calculating PDCN rate with PTS and discount allowed as per supply proof. - Issuing CC/CX/CL division PDCN as per rate difference with RCRQ. - Issuing FC/FL/FH division calculation as given by Anita Maam. - Updating the Excel sheet in the PDCN folder as per the specified format with different divisions.,
As an Export and Import Coordinator, your role involves handling various responsibilities related to exports and imports. **Role Overview:** You will be responsible for preparing pre and post shipment documents for export shipments, coordinating with different teams such as Marketing, Finance, and Factory, and ensuring smooth clearance by working closely with clearing and forwarding agents. Additionally, you will be required to approve checklists, AWB/BL drafts, and follow up on dispatches with the plant. Moreover, you will play a crucial role in resolving customer queries, coordinating with banks for BRC and various export-related queries, and maintaining export registers. For imports, your duties will include preparing LC applications, following up with banks for LC drafts, making necessary entries in the import register, submitting proof of imports to banks, and providing documents and details to the accounts team. **Key Responsibilities:** - Prepare pre and post shipment documents for export shipments - Coordinate with Marketing, Finance, and Factory teams - Approve checklists, AWB/BL drafts - Follow up on dispatches with the plant - Resolve customer queries - Coordinate with banks for BRC and export-related queries - Maintain export registers - Prepare LC applications and follow up with banks for LC drafts - Make necessary entries in the import register - Submit proof of imports to banks - Provide documents and details to the accounts team **Qualifications Required:** - Proven experience in export and import coordination - Strong knowledge of export and import procedures and documentation - Excellent communication and coordination skills - Ability to work effectively with cross-functional teams - Proficiency in MS Office applications - Attention to detail and accuracy in documentation This job requires someone with a strong understanding of export and import processes, excellent coordination skills, and the ability to communicate effectively with multiple stakeholders. If you are organized, detail-oriented, and have a passion for international trade, this role could be a great fit for you.,
As an Officer/Sr. Officer/Executive/Sr. Executive with 2-8 years of experience in a Parental plant, your role will involve the following key responsibilities: - Prepare, review, and implement Standard Operating Procedures of Quality Assurance. - Ensure that day-to-day QA controls are in place and empower QA for the entire plant. - Establish, implement, and maintain process needs for the Quality Management System. - Adopt a document control procedure to approve, review, and update all changes to documents within the scope of the Quality Management System. - Issue Quality Management System related formats and maintain the log accordingly. - Take necessary follow-ups related to deviations, change control, incidents, material and product destructions, Internal Audit, re-packing activity, and corrective & preventive actions with respective departments. - Prepare risk assessment documents. - Review the performance of the Quality Management System at planned intervals to ensure its continuing suitability, adequacy, and effectiveness. - Maintain documents as per current Good Manufacturing Practices. - Intervene and call meetings to resolve QMS and GMP related queries. - Provide documents for regulatory affairs and handle regulatory queries. - Co-ordinate with internal department personnel as well as external parties. - Prepare for audit preparation, execution, and compliance. - Handle notifications to management related to documents. - Investigate and review non-conforming events including customer complaints and internal non-conforming events, decide on CAPA, and follow through for implementation. - Prepare, review, and implement the Master list of Standard Operating Procedures. - Review qualification and validation documents. - Review and implement Annual Training Plan of GMP/Technical/SOP training, coordinate with the concern department for the execution of ATP, maintain training records, and train departmental staff on their respective jobs. - Verify and implement the Batch Numbering system. - Allocate Equipment identification numbers and review and follow up for updating the equipment/instrument list. - Update/review approved vendor lists, vendor qualification planning, and documents. You will play a crucial role in ensuring the quality and compliance standards are met within the organization.,
As an Assistant Production Packing Manager/Manager, your role will involve overseeing the day-to-day production planning and execution to meet the requirements. You will be responsible for supervising and evaluating the performance of production personnel, organizing workflow to meet specifications and deadlines, and ensuring staff/worker distribution according to production planning. Your key responsibilities will include reviewing, approving, and implementing departmental SOPs based on current guidelines, monitoring online documentation such as BMRs/BPRs/Log books, and overseeing the stage-wise process for product yield. Additionally, you will be responsible for monitoring and reviewing QMS documents, qualification protocols, and other online documents for the implementation of CAPA. It is essential for you to have knowledge of aseptic area practices, vial/ampoule filling and sealing, LYO products, regulatory audits, packing and visual activities to ensure the achievement of packing, labelling, and visuals targets, and cartridge printing including Track & Trace.,
As an Assistant Manager/Manager in Production Packing, your role will involve the following responsibilities: - Responsible for day-to-day production planning and execution as per requirement. - Supervise and evaluate the performance of production personnel. - Organize workflow to meet specifications and deadlines. - Manage staff/ worker distribution, allocation, and arrangement as per production planning. - Review, approve, and implement departmental SOPs as per current guidelines. - Monitor and maintain the status of online documentation such as BMRs, BPRs, Log books, and other necessary documents. - Monitor the stage-wise process for product yield. - Review and monitor QMS documents, qualification protocols, and other online documents for the implementation of CAPA. - Possess knowledge of aseptic area practices, vial/ampoule filling and sealing, LYO products, Regulatory Audits, packing and visual activities to ensure the achievement of packing, labeling, and visual targets, as well as cartridge printing including Track & Trace. If there are any additional details about the company in the job description, please provide that information.,
As an Officer/Sr. Officer/Executive/Sr. Executive in the company, your role will involve the following key responsibilities: - Daily sampling and analysis of in-process and water samples as per procedure - Preparation and pouring of media plate - Performing BET (Bacterial Endotoxin Test) test and Micro assay - Conducting Sterility Test, Bioburden, and MLT (Microbial Limit Test) for water and product - Performing Growth Promotion / Inhibitory / Indicative Property Test of Media - Reporting results of analysis in raw data sheet issued - Entry and maintenance of all micro related logbooks - Following the QMS (Quality Management System) system (Out of Specification, Deviation, Incident) - Participating in validation activities - Observing and reviewing media fill container - Conducting environmental monitoring in clean room as per standard operating procedure - Running the autoclave cycles and unloading the loads as per SOP - Monitoring incubator condition daily, recording, taking print out and verifying - Maintaining GLP (Good laboratory practices) and following GDP (Good documentation practices) in the laboratory - Running washing and drying machine - Raising Out of Specification if noticed - Performing analysis of Analytical method Validation, Analytical method Transfer, reconstitute Solution stability, additional analytical test required as per party quarry reply - Preparing Analytical method validation protocol, raw data, report - Reviewing Analytical method validation protocol, raw data, report - Preparing excel sheet for analytical method validation, method transfer, Reconstitute Solution Stability study - Planning method validation activity and providing necessary resources to the analyst - Training analysts for analytical method validation and method transfer SOPs - Controlling and maintaining records like protocols, raw data, and report of method validation, method transfer, and reconstitute solution stability - Assisting HOD (Head of Department) for the preparation of regulatory inspection As per the provided job description, there are no additional details about the company mentioned.,
As an Officer/Sr. Officer/Executive/Sr. Executive with 2-8 years of experience in injectable Manufacturing, you will be responsible for the following key activities: - Following the instructions and procedures outlined in the Entry-Exit SOP (Standard Operating Procedure) of Grade C, decartoning area, and Grade B area. - Ensuring proper functioning and behavior in the aseptic area. - Adhering to personnel hygiene practices within the factory premises. - Following the GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices) as per the provided SOP. - Monitoring temperature, relative humidity, and differential pressure. - Monitoring the differential pressure of laminar air flow units and pass boxes. - Handling material movement in the production area. - Maintaining documents as per GDP and area per cGMP. - Keeping day-to-day records. - Providing training to new joining chemists, workers, and operators. - Conducting line clearance before starting operations. - Planning manufacturing based on the availability of raw materials and packaging materials. - Supervising the preparation and filtration of cleaning/disinfectant solutions and fogging solutions. - Ensuring equipment/machines and utilities are ready before batch manufacturing. - Supervising the operation and cleaning of various equipment such as steam sterilizer, compounding vessel, vial washing machine, etc. - Handling filters, filter integrity testing apparatus, silicon tubing, decartoning area, hose pipes, and cleaning/wrapping of glassware and machine parts. - Operating pH meter and stirrer. - Overseeing aseptic process stimulation, post-media fill cleaning, and sanitization procedures. - Managing the destruction of media-filled vials. - Supervising general area cleaning and sanitization of grade C and D areas and fogging activities. - Verifying load cell handling and waste generated in the production area. - Monitoring non-viable particle count (online and offline). - Recording operation and cleaning details in batch manufacturing records and equipment logs. - Handling equipment like homogenizer, rota evaporator, magnetic stirrer, ultrasonicator, pH meter, and fogger. - Following dispensing room procedures and handling raw materials and additional materials issuance. - Entering all batch manufacturing process data into the pharmacloud system. - Preparing for and participating in audits. - Undergoing periodic medical checkups arranged by the company. - Performing tasks assigned by supervisors. - Reporting any unsafe acts, conditions, accidents, or incidents to supervisors.,
As an Officer/Senior Officer/Executive with 2-7 years of experience in an Injectable plant, your role involves the following key responsibilities: - Making entry of Bonding slip. - Preparing monthly statements of all LL party sales reports. - Generating GST invoices in Pharma Cloud for all transactions. - Preparing E-way bills. - Developing and reviewing standard operating procedures for the BSR department. - Implementing departmental Standard Operating Procedures. - Documenting quality management system documents such as Change control proposals, Deviations & Incident reports. - Updating and maintaining online departmental documentation. - Uploading all Third-party invoices on the party portal. - Following export consignment dispatch procedures. - Ensuring a smooth handover of responsibilities before leaving the factory. - Handling other duties as assigned by the HOD. - Arranging transportation for the dispatch of finished goods. - Communicating with H.O., LL & TP parties for the dispatch of finished goods. - Performing all activities as instructed by the BSR designee/Head.,
As a Procurement Officer, your role involves the purchase of Lab Chemical, Production filters & consumables, Gas & fuel, Reference standard, Hi-Media chemical, HPLC & UPLC Column, Glassware & consumables, IT products, safety products, etc. You will be responsible for inviting quotations/offers from different vendors locally and all over India. Your key responsibilities will include scrutinizing quotes, negotiating prices, and preparing statements. Additionally, you will coordinate with suppliers by raising purchase orders and ensuring timely delivery of materials. It is crucial to secure acknowledgment via email upon receiving purchase orders and obtain delivery schedules for the same. Your daily tasks will also involve generating reports such as Pending order report, Pending Indent Report, GRN report, etc. Furthermore, you will play a vital role in coordinating between different departments in the factory and vendors to ensure timely delivery and arrangement of materials. No additional details about the company were provided in the job description.,