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.,