Position: QC Executive Location: Derma Unit, Karakhadi Role & responsibilities Analysis of In-process, Intermediates, Raw material, Packing material, Finished products, Stability study, Hold time study, Process validation, Cleaning samples, Vendor development and any analysis allocated by team leader and release with proper documentation.. Responsible for ensuring the quality and purity of pharmaceutical products using High-Performance Liquid Chromatography (HPLC) techniques Prepare samples for HPLC analysis according to established SOPs and specifications. Analyze HPLC data, interpret results, and generate reports documenting test results and deviations. Ensuring analysis is performed compliance to GLP. Ensuring analysis raw data is documented on-line. Initiation, Completion and filing of Daily analysis reports. Ensuring any abnormal results, incidents, deviations, discrepancies are reported immediately to the reporting Section Head. Ensuring all relevant log entries are made for every activity wherever applicable. Supervise compliance to all cGMP, GxP or any other regulatory requirements including EHS requirements. Report any quality concerns or suggestions for improvements to Department Head. Execute and supervise all tasks and activities as per the applicable SOPs and company policy. To maintain the safety norms while working in lab. (e.g. Wear goggles, PPE, Disposal of sample/media as per procedure etc). Ensuring analysis is performed as per valid procedures and by using calibrated instruments / Standards. Ensuring self-discipline with respect to wearing aprons, attendance and personnel hygiene and inter relations. To perform Labware LIMS related activities. Any other assignment given by the Section Head or Department Head.

Role & responsibilities Hands on experience required on handling of Process validation and Cleaning validation Design and execute validation protocols for process and cleaning validation activities, including IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), and CV (Cleaning Validation). Develop and maintain a validation master plan (VMP) that aligns with regulatory requirements and organizational goals. Conduct process validation studies to ensure manufacturing processes consistently produce products that meet predefined quality attributes. Analyze process performance and critical parameters during validation runs and document results. Ensure adherence to Good Manufacturing Practices (GMP) during all validation activities. Develop and execute cleaning validation protocols to confirm the effectiveness of cleaning procedures in removing residues, contaminants, and microorganisms. Establish acceptable residue limits and cleaning verification procedures based on product toxicology and batch size. Monitor cleaning practices and perform periodic revalidation as required.

Role & responsibilities Shop floor experience is required in the Tablets and Capsules section and sound knowledge of solid oral equipment functioning and operating principle Perform real-time monitoring of manufacturing and packaging processes to ensure adherence to GMP, SOPs, and regulatory requirements. Conduct in-process checks for critical quality attributes (e.g., weight, hardness, uniformity, and packaging integrity) at defined stages of production. Ensure timely documentation and approval of batch manufacturing records (BMR) and batch packaging records (BPR). Lead and coordinate qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment and utilities. Develop and review qualification protocols and reports, ensuring compliance with engineering and quality standards. Support the validation of facilities, equipment, and systems, including HVAC, water systems, and compressed air systems. Collaborate with the engineering team to ensure equipment and systems meet quality and regulatory requirements. Perform risk assessments for engineering processes, focusing on critical quality aspects during design and operational phases. Support maintenance and calibration activities by verifying adherence to predefined quality standards and documentation requirements.

Role & responsibilities Experience required in Quality Control Laboratory and investigation of OOS/OOT/LIR/OOC, with expertise in reviewing analytical documents such as AMV protocols and reports. Experience with analytical techniques like HPLC, GC, FTIR, and UV-Vis spectroscopy. Prior exposure to quality management systems and laboratory automation tools. Perform detailed investigations for OOS, OOT, LIR, and OOC results. Identify root causes and propose effective corrective and preventive actions (CAPA). Document investigation outcomes clearly and ensure timely resolution.

Position Title : Executive / Sr. Executive / Assistant Manager QMS Department : Quality Assurance (QA) – QMS Section Location : Formulation- IV, Jarod Experience : 5 to 8 years (in regulated pharmaceutical manufacturing, specifically solid oral dosage forms) Key Responsibilities: Ensure implementation, maintenance, and continuous improvement of the site Quality Management System in compliance with cGMP, ICH guidelines, and regulatory requirements (USFDA, MHRA, EU, etc.). Review and control of GMP documentation including SOPs, Quality Manuals, Validation Master Plans, etc. Handling of deviations, change controls, CAPAs, and risk assessments. Oversight and coordination of internal audits, self-inspections, and participation in regulatory and customer audits. Management of Product Quality Reviews (PQR/APQR) and Quality Metrics. Support in QMS training programs for cross-functional teams. Assist in the evaluation and qualification of vendors through QMS processes. Manage document lifecycle in the electronic documentation management system (EDMS). Drive quality culture and continuous improvement initiatives across the site. Qualifications: B.Pharm / M.Pharm / M.Sc. in a relevant scientific discipline. Strong knowledge of QMS principles and pharmaceutical quality systems in oral solid dosage manufacturing. Experience with regulatory inspections (USFDA, MHRA, WHO, etc.) and audit readiness. Proficiency in handling QMS software systems (TrackWise, Veeva, MasterControl, etc. is a plus). Good understanding of data integrity principles and quality risk management. Key Skills: Excellent documentation and communication skills. Analytical and problem-solving mindset. Ability to work cross-functionally and lead quality initiatives. Attention to detail and a proactive approach.

KEY RESPONSIBILITIES: Following are the job responsibilities for Development Quality Assurance. Review of analytical documents like Residual solvent statement, Risk assessment for Elemental impurities etc. generated during the product development at Injectable R&D. Review & Approval of Analytical method (including Extractables and Leachables) validation protocols & Reports (Including review of Raw Data). Review of all the protocol based studies related to Extractable and Leachables. Review of Protocol and Report related to Peptide Characterization. Review and approval of R&D specifications, GTPs and other documents. Review and approval of formulation and analytical study protocols and reports. (Equipment Qualification, Submission documents like Justification for specification, Residual Solvent Assessment and Elemental Impurities, Compatibility studies). Review of the logbook and register for completeness and correction as per Good documentation practices and cGMP norms. Review of Filter Validation Study Protocols and Reports. Review & Approval of Master Formula Record (MFR). Review of Product Development Report (PDR). Participation in incidences, investigation & CAPA review and approval. Review method validation protocols and reports for products to be executed at contract manufacturing or research organization. Review & approval of Computer system validation documents as per the defined procedure Review of IT related documents with respect to respective SOP

Role & responsibilities 1. Analysis of In-process, Intermediates, Raw material, Packing material, Finished products, Stability study, Hold time study, Process validation, Cleaning samples, Vendor development and any analysis allocated by team leader and release with proper documentation.. 2. Ensuring analysis is performed compliance to GLP. 3. Ensuring analysis raw data is documented on-line. 4. Initiation, Completion and filing of Daily analysis reports. 5. Ensuring any abnormal results, incidents, deviations, discrepancies are reported immediately to the reporting Section Head. 6. Ensuring all relevant log entries are made for every activity wherever applicable. 7. Supervise compliance to all cGMP, GxP or any other regulatory requirements including EHS requirements. 8. Report any quality concerns or suggestions for improvements to Department Head. 9. Execute and supervise all tasks and activities as per the applicable SOPs and company policy. 10. To maintain the safety norms while working in lab. (e.g. Wear goggles, PPE, Disposal of sample/media as per procedure etc). 11. Ensuring analysis is performed as per valid procedures and by using calibrated instruments / Standards. 12. Ensuring self-discipline with respect to wearing aprons, attendance and personnel hygiene and inter relations. 13. To perform Labware LIMS related activities. 14. Any other assignment given by the Section Head or Department Head.

Job Summary: To support the design, setup, coordination, and execution of Assessment Development Centre (ADC) aimed at identifying and developing high-potential employees and future leaders across the organization. Job Responsibilities: Assessment Development Center Support: Assist in the setup, logistics, and administration of assessment centers (virtual and on-site). Coordinate scheduling and communication with assessors and candidates. Maintain calendars, trackers, and reports related to ADC events. Support in the development and maintenance of assessment tools (e.g., role-plays, case studies, simulations). Prepare participant handbooks, observer guidelines, and feedback templates. Support the evaluation process by capturing data, assisting assessors, and managing candidate flow during events. Ensure adherence to the assessment SOP, guidelines, and data confidentiality standards. Contribute ideas for enhancing assessment center processes, tools, and participant experience. Field Engagement Activities: Execute field-level engagement events, ensuring maximum reach. Liaise with internal teams, local offices, and vendors to ensure timely delivery of engagement activities/material. Create communication on the engagement activities for internal circulation. Reporting & Documentation: Assist in compiling feedback reports and generating summary dashboards for post-assessment insights. Maintain records of assessments and field engagement outcomes. Prepare and share updates, attendance logs, and post-event summaries with relevant stakeholders. Required Qualifications: Graduation. 13 years of experience in assessment development center and employee engagement. Essential Skills required: Strong coordination and organizational skills Excellent written and verbal communication High level of discretion and confidentiality Proficiency in Microsoft Office and familiarity with digital tools. Willingness to travel for conducting assessment and field engagements if required. Additionally, Familiarity with tools like SHL, Hogan, or Thomas profiling (optional)

Alembic Pharmaceuticals is looking for hiring competent young professionals who have completed graduation in B. Pharm / D. Pharm / B.Sc for the position of Medical representatives. The age limit for this position is 25 years. As a Medical Representative, the responsibilities would include: Medical Representative 1. Demonstrate or present and promote products to healthcare professionals like Doctors and Pharmacists 2. Prescription generation 3. Managing distribution channel members such as Stockiest, Distributors & Chemists 4. Handle sales promotion activities. Attend and organize conferences and meetings Area Manager The age limit for this position is 35 years. As a Area Manager, the responsibilities would include: Job Responsibilities: Comprehensive pharmaceutical sales and marketing experience including, meeting doctors, chemists and managing the distributors. Responsible for achieving primary as well as secondary targets month after month for the HQs assigned Adept in implementing sales and marketing activities and accelerating the business growth. Monitoring sales team performance, analyzing sales data, periodical forecasting and reporting to Regional and Zonal heads. Present technical information clearly, concisely, and persuasively to customers. Develop and manage efficient distribution network for sales. Managing, training, motivating and developing existing sales team to drive revenue growth. Essential Skills required: Good communication skills Good analytical and problem solving skills Strong interpersonal skills Adaptability to work at any environment

Zonal Sales Manager -Ahmedabad - Cardio Diabetes Segment Job Responsibilities: Comprehensive pharmaceutical sales and marketing experience including, meeting doctors, chemists and managing the distributors. Responsible for achieving primary as well as secondary targets month after month for the HQs assigned Adept in implementing sales and marketing activities and accelerating the business growth. Monitoring sales team performance, analyzing sales data, periodical forecasting and reporting to Regional and Zonal heads. Present technical information clearly, concisely, and persuasively to customers. Develop and manage efficient distribution network for sales. Managing, training, motivating and developing existing sales team to drive revenue growth. Essential Skills required: Good communication skills Good analytical and problem solving skills Strong interpersonal skills Adaptability to work at any environment

Alembic Pharmaceuticals Ltd is looking for a Regulatory Affairs professional for the position of Executive / Sr. Executive based at our Corporate Office - Vadodara, Gujarat. Job Criteria: B.Pharm or M.Pharm qualification having experience between 4 - 8 yrs. with dossier filling experience in Middle east and southeast Asia Countries. Knowledge for review of quality documents like executed batch documents, method validation, change Good communication skills. Job Description: Review of product initiation /extension Review of technology transfer documents Dossier compilation / dossier checklist CTD/NeeS/eCTD Submission & correspondence with agency / customer CoPP Dossier online review, submission with customer / agency & assessment phase Post approval life cycle management i.e. variation, renewal, updated dossier, variation status Interested candidate can share CVs on creyesha.macwan@alembic.co.in

Alembic Pharmaceuticals Ltd is looking for a Regulatory Affairs professional for the position of Assistant Manager/ Deputy Manager based at our Corporate Office - Vadodara, Gujarat. Job Criteria: B.Pharm or M.Pharm qualification having experience between 10 - 15 yrs. with dossier filling experience in MEXICO Countries. Knowledge for review of quality documents like executed batch documents, method validation, change Good communication skill Job Responsibility: Should have through knowledge of Mexico submission. Should have understanding for requirements of Mexico. Should have understanding for review of regulatory documents like batch record, specifications, COAs, stability data, change control, process validation report etc. Should have knowledge of review of method validations, chromatograms, dissolution profile, raw data etc. Interested candidate can share cv on creyesha.macwan@alembic.co.in

Alembic Pharmaceuticals Ltd is looking for a Regulatory Affairs professional for the position of Executive / Sr. Executive based at our Corporate Office - Vadodara, Gujarat. Job Criteria: B.Pharm or M.Pharm qualification having experience between 4 - 8 yrs. with dossier filling experience in Europe & South Africa Countries. Knowledge for review of quality documents like executed batch documents, method validation, change Good communication skills. Job Description: Review of product initiation form /extension form Review of technology transfer documents Dossier compilation / periodic updates in dossier checklist CTD/NeeS/eCTD Submission & correspondence with agency / customer CoPP Dossier online review, submission with customer / agency & assessment phase Post approval life cycle management i.e. variation, renewal, updated dossier, variation status Interested candidate can share cv on creyesha.macwan@alembic.co.in

To prepare and review vendor qualification SOP, Contract Service Provider and Contract Manufacturing in line with current regulatory requirements To review and compilation of vendor qualification documents & to carry out Vendor Qualification/ Requalification, Service provider Qualification/ Requalification activity and Contract Manufacturer Qualification/Requalification activity. To perform risk assessment, performance evaluation of vendors, handling of change notifications. Handling of Vendor complaint management system. To maintain QM Info record in SAP & to block the materials in SAP. Updating & maintaining the Vendor list, Technical Agreements for Raw material, Packing material, Service provider and contract manufacturers. Responsible for Vendor Audit and Compliance of Vendors for Key Starting Materials, Advance Intermediates, APIs, Excipients, Primary Packaging Material, Secondary Printed Packaging Material, Contract Service Providers and Third Party Manufacturing Sites To prepare and review system related SOPs and other CQA SOPs/ documents respectively. To handle Customer/ Regulatory Audits relevant to vendor qualification activity. To review, approval of quality management documents i.e. change control. Deviation, Risk Assessment relevant to vendor qualification activity.

Regional Sales Manager - Viajayawada - Gynae segment Job Responsibilities: Comprehensive pharmaceutical sales and marketing experience including, meeting doctors, chemists and managing the distributors. Responsible for achieving primary as well as secondary targets month after month for the HQs assigned Adept in implementing sales and marketing activities and accelerating the business growth. Monitoring sales team performance, analyzing sales data, periodical forecasting and reporting to Regional and Zonal heads. Present technical information clearly, concisely, and persuasively to customers. Develop and manage efficient distribution network for sales. Managing, training, motivating and developing existing sales team to drive revenue growth. Essential Skills required: Good communication skills Good analytical and problem solving skills Strong interpersonal skills Adaptability to work at any environment

Zonal Sales Manager - Mumbai - Gynae- segment Job Responsibilities: Comprehensive pharmaceutical sales and marketing experience including, meeting doctors, chemists and managing the distributors. Responsible for achieving primary as well as secondary targets month after month for the HQs assigned Adept in implementing sales and marketing activities and accelerating the business growth. Monitoring sales team performance, analyzing sales data, periodical forecasting and reporting to Regional and Zonal heads. Present technical information clearly, concisely, and persuasively to customers. Develop and manage efficient distribution network for sales. Managing, training, motivating and developing existing sales team to drive revenue growth. Essential Skills required: Good communication skills Good analytical and problem solving skills Strong interpersonal skills Adaptability to work at any environment

Zonal Sales Manager - Mumbai - Gynae- segment Job Responsibilities: Comprehensive pharmaceutical sales and marketing experience including, meeting doctors, chemists and managing the distributors. Responsible for achieving primary as well as secondary targets month after month for the HQs assigned Adept in implementing sales and marketing activities and accelerating the business growth. Monitoring sales team performance, analyzing sales data, periodical forecasting and reporting to Regional and Zonal heads. Present technical information clearly, concisely, and persuasively to customers. Develop and manage efficient distribution network for sales. Managing, training, motivating and developing existing sales team to drive revenue growth. Essential Skills required: Good communication skills Good analytical and problem solving skills Strong interpersonal skills Adaptability to work at any environment

Position: Product Executive / Sr. Executive Requirements: B. Pharm + MBA or Pharma Management from a reputed institute Between 4 to 8 years of experience in product management or at least 1 years' experience in International Pharma marketing Experience in managing existing products and launching new products from Chronic Segments like Cardio Diabetic /CNS/Onco Experience in working for International markets, understanding diverse regulatory environments and market dynamics. Marketing : Ability to prepare brand plans with in-depth analysis of each market comprising competitive landscape, medical benefits , pricing and preparing a detailed marketing strategy for products with different launch strategies, communication strategy, tactics and activities Skills & Knowledge: Communication and Stakeholder Management: Good verbal and written communication skills to effectively collaborate with cross-functional teams, doctors, field force. Execution Skills : Regular follow up and feedback on implementation Market Research and Analysis: Conducting in-depth market research to identify trends, competitive landscape, and unmet patient needs Regulatory Knowledge: Familiarity with international regulatory requirements (e.g., FDA, EMA) Creativity skills in developing promotional tools like VA /LBL Presentation skills: To prepare launch medical presentations for field force. Interested Candidate can share CV's on bdcv@alembic.co.in

Alembic Pharmaceuticals Limited is seeking a skilled Cost Accountant with expertise in MIS Reporting, Product Costing, Inventory Valuation, Cost Sheet Management, Stock Summary, Aging Report, Cost Allocation, Receivable Management, and SAP. ICWA/CMA Fresher are welcome to apply for the opportunity ! Key Responsibilities: Prepare and present comprehensive MIS reports to support business decisions. Manage and evaluate product costing, ensuring accuracy and efficiency. Conduct inventory valuation and maintain cost sheets for effective financial planning. Prepare and analyze stock summaries and aging reports for inventory control. Oversee cost allocation processes to ensure proper financial distribution. Manage receivables, ensuring timely collections and accurate reporting. Leverage SAP for efficient financial operations and data management. Collaborate with cross-functional teams to provide financial insights and support strategic initiatives. Preferred Candidate Profile: Experience: Minimum 1 year in MIS Reporting and SAP will be added advantage. Qualification: ICWA/CMA Take the next step in your career with Alembic Pharmaceuticals Limited !

Job Responsibilities: Comprehensive pharmaceutical sales and marketing experience including, meeting doctors, chemists and managing the distributors. Responsible for achieving primary as well as secondary targets month after month for the HQs assigned Adept in implementing sales and marketing activities and accelerating the business growth. Monitoring sales team performance, analyzing sales data, periodical forecasting and reporting to Regional and Zonal heads. Present technical information clearly, concisely, and persuasively to customers. Develop and manage efficient distribution network for sales. Managing, training, motivating and developing existing sales team to drive revenue growth. Essential Skills required: Good communication skills Good analytical and problem solving skills Strong interpersonal skills Adaptability to work at any environment