304 Cgmp Jobs - Page 3

As a Senior Executive in Engineering and Maintenance at Syngene International Ltd., your primary responsibility will be to lead operations in the designated section, focusing on mechanical maintenance with API Pharma experience. You will play a crucial role in ensuring adherence to safe practices, development of procedures for safe operations, and compliance with quality standards. To excel in this role, you must have a BE/B.Tech in Mechanical Engineering with a minimum of 3 to 8 years of experience in shift maintenance with API process equipment. Your technical skills should include driving a corporate culture that promotes environment, health, and safety (EHS) mindset, ensuring compliance with cGMP regulations, and maintaining high-quality output from your operating unit. Your day-to-day tasks will involve breakdown and preventive maintenance of various process-related equipment, operation and maintenance of utility equipment, and ensuring the maintenance of infrastructure and facilities. You will also be responsible for qualification activities of equipment, preparation of SOPs, maintaining house-keeping standards, and managing the supply chain for required materials and spares. In addition to your technical skills, you are expected to demonstrate strong behavioral skills such as dedication to work, a result-oriented approach, self-drive, and team coordination. Your role at Syngene International Ltd. will be instrumental in contributing to the overall success and growth of the organization. Syngene International Ltd. is an equal opportunity employer where your skills and contributions will be valued and recognized.,

You should have over 15 years of experience in Warehouse operations, including at least 7 years in a supervisory role within injectable manufacturing. Your role will require a strong understanding of regulatory requirements, cGMP, and industry best practices. You should possess proven leadership abilities and excellent communication skills to effectively work cross-functionally and resolve quality-related challenges efficiently. Previous experience in successfully facing regulatory audits, including USFDA, EU-GMP, and ANVISA is mandatory. In terms of Material Receipt and Storage, you will be responsible for ensuring that all materials are stored and handled in compliance with cGMP and regulatory requirements. Regular recording of temperature, RH, and DP in designated logbooks is essential to maintain optimal storage conditions. Warehouse Maintenance and Cleanliness will also fall under your purview. You must ensure the cleanliness and organization of the warehouse at all times. Your duties will also involve Material Handling and Dispensing, where you will be required to dispense raw materials and issue packing materials following the FIFO (First In, First Out) system. Proper handling, storage, and distribution of materials in alignment with company procedures and safety standards are vital. Compliance and Documentation are key aspects of the role. You will need to ensure compliance with cGMP standards and regulatory requirements in all warehouse operations. Maintaining up-to-date inward registers, following good documentation practices (GDP), and participating in audits and compliance assessments are crucial responsibilities. Safety and Hygiene protocols must be strictly adhered to. This includes ensuring that safety protocols and hygiene standards, including personal hygiene and gowning procedures as per SOPs, are followed by the warehouse team during work operations. Quality Risk Management is another critical area where you will be involved. Handling rejected materials, coordinating their disposition, participating in Quality Management System (QMS) activities, and conducting regular quality risk assessments are all part of maintaining quality standards in warehouse processes. Your role will require you to ensure that warehouse processes, documentation, and operations are audit-ready at all times.,

As an experienced Quality Assurance professional in the Active Pharmaceutical Ingredient (API) industry, your main responsibility will be to implement and maintain GMP-compliant Quality Management Systems. Your focus will be on ensuring product quality, regulatory compliance, and operational excellence. This role requires expertise in validation, change control, and continuous quality improvement within a highly regulated API manufacturing environment. Your key responsibilities will include managing documentation, handling audits (both regulatory and customer audits), overseeing batch release, conducting deviation investigations, and ensuring adherence to global regulatory standards such as cGMP, ICH, and FDA regulations. You will also be involved in quality planning and scheduling, implementation of QMS, GMP, cGMP, ISO, and Food Safety Standards, compliance with statutory and regulatory requirements, document management and control, review and implementation of quality system procedures and SOPs, batch review, approval, and release, in-process control and material management, review of product stability and test data, handling of OOS, deviations, and batch failures, new product technology transfer, internal, vendor, and customer audit handling, annual product review, GMP and QMS training coordination, validation and calibration program control, quality oversight, and continuous compliance monitoring. To be eligible for this role, you should have a qualification in B Pharma or MSc Chemistry with 10 to 15 years of relevant experience. Your skills should include expertise in GMP, quality assurance, audit handling, quality management systems, change control, food safety standards, documentation management, ISO, API manufacturing, compliance, validation, and cGMP.,

The Plant Manager will play a crucial role in overseeing all operational aspects of a natural product extraction and food processing facility. Your responsibilities will encompass managing production, quality control, maintenance, and distribution to ensure compliance with safety regulations and operational efficiency. Your pivotal role in achieving productivity, cost-effectiveness, and continual improvement in plant operations will be instrumental in upholding the highest standards of food safety and product quality. In terms of Production & Operations Management, you will be tasked with supervising daily operations to facilitate smooth and cost-effective production aligned with organizational objectives. It will be essential to strategize, monitor, and enhance production schedules, resource allocation, and material flow. Driving enhancements in plant efficiency, yield, waste reduction, and operational costs will be a core aspect of your responsibilities. Furthermore, ensuring strict adherence to Standard Operating Procedures (SOPs) across all departments will be critical. As for Quality & Food Safety, you will lead the implementation of various food safety systems, including cGMP, HACCP, FDA, FSSAI, HALAL, KOSHER regulations, certifications, and standards throughout the facility. Upholding internal quality benchmarks and customer specifications for all finished products will be imperative. Establishing robust quality control systems, conducting root cause analysis to address deviations, and personally taking charge of corrective actions in the event of critical non-conformities will also fall within your purview. Additionally, you will be responsible for overseeing regulatory and customer audits and ensuring meticulous documentation for the same. In terms of Budgeting & Cost Control, collaboration with the finance team to develop annual operating budgets will be paramount. Monitoring and managing costs across various domains such as production, labor, maintenance, and utilities to align with budgetary targets will be crucial. Identifying opportunities for cost savings through process optimization and waste minimization will also be a key focus area. When it comes to New Product & Process Development, you will be expected to support the scaling up of new products from R&D and Sales, with a keen eye on ensuring commercial viability. Collaborating with cross-functional teams to trial and implement innovative extraction and processing technologies will be essential for driving continuous growth and innovation within the facility. To qualify for this position, you should hold a Masters or Bachelor's degree in Chemical Engineering, Chemical Technology, Food Technology, Biotechnology, Chemistry, or related disciplines. A minimum of 12 years of industry experience, including at least 5 years in a leadership role within food processing, food ingredient manufacturing, Nutraceuticals, or natural product extraction, is required. Demonstrated expertise in managing plant operations, production teams, and quality systems is essential. Sound knowledge of cGMP, HACCP, FDA, FSSAI, HALAL, KOSHER guidelines, and regulatory frameworks will be advantageous. Preferred experience includes prior involvement in fruits, vegetables, herbs, extraction and purification, or plant-based ingredient processing. Exposure to solvent extraction, spray drying, concentration, milling, conveying, blending, and packaging technologies will be considered beneficial for this role.,

Implement and maintain QMS per GMP. Conduct audits, vendor qualification, and quality reviews. Approve SOPs, BMRs, BPRs, specs, change controls, APQRs. Investigate OOS, OOT, complaints, oversee CAPA, and ensure compliance across all departments. Required Candidate profile QMS Implementation | cGMP Compliance | Internal & External Audits | SOP/BMR Review | Change Control | CAPA | APQR | Risk Assessment | Vendor Qualification | Regulatory Compliance | Root Cause Analyse

As a Senior Chemist at Scimplify, located in Kurkumbh, Pune, you will be responsible for various tasks related to sampling and analysis of raw materials, packing materials, and finished goods. You will be required to conduct analysis of finished products, in-process samples, stability samples, raw materials, and packing materials. Your role will also include maintaining and calibrating various lab instruments such as HPLC, Gas Chromatography, Karl-Fischer Titrator, Melting-Boiling Point Apparatus, Refractive Index, Moisture Analyzer, pH meter, and Weighing Balance. It is essential to work in compliance with approved methods, SOPs, cGMP, and CGLP standards. Additionally, you will be responsible for proper documentation of laboratory data and generating complete testing reports for in-process samples, finished products, and stability samples. You will also be involved in instrument handling, specifically with instruments like HPLC-Shimadzu-LabSolution, Gas Chromatography-Young Lin 6500-YL Clarity, Karl-Fisher Titrator-Spectra lab, Melting Boiling Point Apparatus-Spectralab, Moisture Analyzer-Mettler Toledo, Refractometer-ABBE, Way2s, Weighing Balance-Mettler Toledo, and pH Meter-Spectralab. As a Senior Chemist, you will play a crucial role in ensuring the accuracy and reliability of the analytical results while adhering to the quality standards set by the organization. Your contribution will be vital in maintaining the high-quality standards of the products manufactured by Scimplify.,

The ideal candidate should possess knowledge of cGMP. You should be able to handle independently the Receipt, Issue & Dispatch Activity of RM/PM/FG. It is important to have knowledge of QMS and Safety awareness.,

As a Senior Executive in the Engineering and Maintenance department at Syngene International Ltd., located in Mangaluru, your primary role will be to serve as an experienced mechanical maintenance engineer with API Pharma experience. With a minimum of 3 to 8 years of experience in shift maintenance with API process equipment, you will play a crucial role in ensuring the proper functioning and maintenance of various process-related equipment such as Reactors, Centrifuges, Dryers, Filters, and more. Your educational background should include a BE/B.TECH in Mechanical Engineering to qualify for this position. Your technical skills will be put to the test as you contribute to the development of procedures and systems that ensure safe operations, compliance with quality standards, and adherence to environment, health, and safety (EHS) requirements in the workplace. Moreover, you will be responsible for driving a corporate culture that promotes an EHS mindset and operational discipline at all times. Your responsibilities will also include ensuring compliance with cGMP regulations, audit readiness of the site, and maintaining high-quality output from your operating unit. As both the Mechanical In-charge and Shift In-charge, you will lead operations in your designated section, overseeing breakdowns, preventive maintenance, and operation of various equipment and utility systems using SAP and AMS applications. In addition to your technical expertise, your behavioral skills will play a crucial role in your success in this role. You will be expected to adhere to company systems and policies, demonstrate dedication to work, and exhibit a result-oriented approach during the execution of your duties. A self-driven individual with excellent team coordination skills will thrive in this environment. As an equal opportunity employer, Syngene International Ltd. values diversity and inclusivity in its workforce. If you are a proactive and experienced mechanical maintenance engineer looking to make a meaningful impact in the pharmaceutical industry, this role offers a challenging yet rewarding opportunity to showcase your skills and contribute to the success of a global organization dedicated to innovation and scientific excellence.,

As a Research Associate with a qualification of M.Sc in Industrial or Organic Chemistry and 3 to 6 years of experience, your primary responsibility is to ensure the smooth functioning of various activities related to manufacturing processes. It is essential to join within 2 months for better suitability. Your tasks include: - Acquiring training for each activity and equipment before execution, following the respective Training Needs Identification (TNI). - Adhering to the entry and exit procedures of manufacturing blocks, including chemical and Pharma areas. - Performing all process operations as per the Batch Manufacturing Records (BMR). - Cleaning all equipment according to the Standard Operating Procedures (SOP), Procedure, and Product Cleaning Record (PCR). - Following all current Good Manufacturing Practices (cGMP) requirements in the plant. - Operating all procedures in accordance with safety regulations. - Participating in discussions regarding ongoing and completed operations during shifts and ensuring appropriate charge handover. - Reviewing and verifying the status of equipment and activity logbooks. - Ensuring housekeeping and sanitation standards in the designated areas. - Conducting cGMP and safety talks for department employees. - Verifying raw materials, packing materials, and intermediates issued by the Warehouse. - Segregating raw materials, packing materials, and intermediates in manufacturing storage areas. - Updating equipment/area status board after operational activities. - Performing visual cleanliness verification of operational equipment before starting operations. - Operating various equipment including reactors, filtration equipment, dryers, and powder processing equipment. - Charging and discharging materials as per approved batch manufacturing records. - Sampling in-process and intermediate products and sending samples to Quality Control (QC) for analysis. - Packing and labeling intermediates, drug intermediates, and drug substances. - Operating utility systems as required. - Calibrating/verifying instruments such as pH Meters and weighing balances. - Ensuring completion of preventive maintenance and calibration of equipment and accessories as scheduled. - Ensuring completion of general/breakdown maintenance and permit system requirements. - Proper disposal of solid and liquid wastes along with necessary documentation. - Completing performance qualification/verification of equipment as needed. - Preparation of batch manufacturing records, cleaning records, and Bill of Materials. - Creation of process orders in SAP for raw materials and packing materials. - Preparation of material requisition slips for the issuance of raw materials and packing materials. - Recording activities in respective logbooks as per defined procedures. - Reviewing batch records post-activity completion. - Submitting completed batch records to Quality Assurance (QA) for review and archival. - Complying with QA review observations in batch records. - Verifying equipment and areas before line/area clearance activities. - Generating in-process and other status labels and affixing them as per defined procedures. - Reporting the final output (yield) in SAP. - Performing preventive/general/breakdown and calibration activities in SAP. - Complying with cGMP and safety norms. - Acquiring training on SOPs and batch records and providing training to subordinates as needed. - Participating in internal, customer, and regulatory audits. - Performing any other activities assigned by Head of Department (HOD) post-requisite trainings. - Escalating any issues related to discipline, manpower availability, hygiene, contamination, incidents, or deviations to the appropriate level.,

The position you are applying for will involve managing utility systems in injectable facilities, overseeing operations, ensuring compliance with regulations, and implementing efficient facility management practices. You will be responsible for leading the execution of greenfield/brownfield injectable facility projects from start to finish, which includes tasks such as design, budgeting, procurement, construction, commissioning, and qualification. Your duties will also include overseeing critical utility systems such as WFI, Pure Steam, RODI, HVAC, Compressed Air, Nitrogen, and chilled water systems to ensure they operate smoothly and meet compliance standards. It will be your responsibility to ensure that all systems and documentation adhere to cGMP, GEP, and regulatory standards such as USFDA, EU-GMP, and WHO-GMP. You will also need to prepare for and support audits and inspections. Collaboration with QA, Production, Validation, and EHS teams will be essential to align project deliverables with operational and compliance requirements. You will also be required to evaluate and manage third-party vendors, consultants, and contractors to ensure the timely and quality execution of projects. Driving initiatives for energy optimization, water conservation, and sustainable engineering practices will be part of your role. Additionally, you will need to mentor and lead a team of project engineers and utility specialists while fostering a culture of accountability, safety, and continuous improvement. Qualifications for this position include a Bachelor's or Master's degree in engineering (Mechanical/Electrical/Chemical/Instrumentation) from a recognized institution. Required skills for this role include a deep understanding of critical utility systems, regulatory guidelines, project budgeting, vendor evaluation, contract management, commissioning, qualification, engineering documentation, risk assessments, and audit readiness. Strong interpersonal and leadership skills are also necessary to effectively manage cross-functional teams. Preferred skills that would be beneficial for this position include experience with automation systems, exposure to sustainability programs and energy conservation initiatives, proficiency in engineering tools and design software (such as AutoCAD and MS Project), as well as knowledge of lean engineering and continuous improvement methodologies.,

Position Overview We are seeking a dynamic and results-driven Production Manager to lead manufacturing operations at our Gandhinagar facility. The ideal candidate will be a seasoned professional from a mechanical or engineering background, experienced in managing production teams, driving process improvements, and ensuring high operational efficiency while meeting quality and delivery targets. Key Responsibilities Production Planning & Execution Lead day-to-day operations of industrial filtration product manufacturing (pleated filters, housings, assemblies, etc.). Prepare weekly and monthly production schedules to meet On-Time Delivery and optimize resource utilization. Supervise production teams, assign roles based on skill and workload, and ensure timely job completion. Coordinate with SCM, Quality, and Design teams for seamless production flow and quick resolution of issues. Drive lean practices , implement Kaizen initiatives , and enforce 5S standards across shop floors. Quality, Compliance & Cost Efficiency Ensure adherence to ISO standards , SOPs , and customer specifications . Monitor in-process quality checks, minimize rework and reduce rejection rates . Maintain production documentation, log, and ensure audit readiness with zero major non-conformities . Contribute to cost control by reducing material wastage , optimizing cycle times , and enhancing manpower productivity . Team Leadership & Development Lead recruitment, onboarding, and skill development of shop floor teams. Conduct structured training programs to enhance technical competency and safety awareness. Monitor team performance, support career growth of high-potential employees , and align manpower deployment with production load. Foster a culture of accountability , collaboration , and continuous improvement . Technical Skills & System Knowledge Proficient in interpreting technical drawings , BoMs , and process instructions . Hands-on experience with ERP systems (Production & Planning modules preferred) and MS Excel reporting. Knowledge of pleating machines , sealing equipment , hydraulic presses , and other manufacturing tools is a plus. Candidate Profile Education Bachelors degree in mechanical engineering , Production Engineering , or Industrial Engineering . Experience Minimum 7 years of experience in industrial/manufacturing environments (filtration, automotive, components, fabrication, etc.). Proven experience in managing production lines , manpower planning , and driving operational excellence initiatives . Strong leadership , problem-solving , and communication skills .

Handle BMR and batch repacking records, Verify daily balance checks and calibration activities, Maintain production records, Perform and verify line clearance at manufacturing and packing stages, Issue and retrieve production documents Required Candidate profile Graduate candidates with 2-4 Year experience and knowledge about cGMP Practice, QMS tools knowledge, Production and Manufacturing documentation process. We are looking for local candidates ONLY.

Strong understanding of pharmaceutical warehousing & distribution systems Leadership skills with experience in team management and performance development Expertise in SAP (MM/WM/SD modules preferred) knowledge of GST invoicing & E-way bill processes Required Candidate profile 10+ years of hands-on experience in a pharmaceutical warehouse or distribution center. Experience in managing operations involving multiple dispatch destinations across India.

As a Quality Control Analyst at Piramal Pharma Limited in Pithampur, your primary responsibility will be to perform testing on in-process samples, raw materials, finished drug products, and stabilities to support production and regulatory filings. You will be reporting to the QC Lab Supervisor. To excel in this role, you should have 0-1 years of experience in a cGMP laboratory setting. It is essential that you are familiar with cGMP and FDA requirements to ensure the quality and compliance of the testing processes. Your attention to detail, analytical skills, and understanding of regulatory standards will be crucial in contributing to the quality control operations of the company. Join our team at Piramal Pharma Limited and be a part of our commitment to delivering high-quality pharmaceutical products that meet regulatory standards.,

Job Description :- Maintenance Officer / Sr. Officer Scicore Nutra Private Limited is a state-of-the-art facility, located in Sanand Gujarat, is dedicated to producing high-quality nutrition products that are safe, effective, and meet the highest standards of quality. Our team of experts is committed to ensuring that every product we manufacture is produced with the utmost care and attention to detail. At our manufacturing unit, we use only the best raw materials and employ advanced manufacturing processes to ensure that our products are of the highest quality. We also adhere to strict quality control measures to ensure that every product meets our rigorous standards. This starts with doing a rigorous vendor qualification as well as testing of all raw materials supplied by these vendors for every batch. We do in-house stability studies to make sure our products last the full shelf life and give the best results to our customers. Our goal is to provide our customers with nutraceutical products that promote health and wellness, and we are committed to using science-backed ingredients and formulations to achieve this goal. We are also committed to continuous innovation and improvement and are always looking for new ways to enhance our products and processes. Benefits Provided: 1 free Air-Conditioned Transportation to the Factory 2 Paid Leave 3 Tea/Coffee & Canteen Facility 4 Accident Insurance 5 Provision for Bonus & Gratuity 6 Training programs for professional advancement 7 Progressive work environment conducive to personal and professional growth Job Title - Maintenance Officer / Sr. Officer Role & Responsibility Follow the cGMP and GDP Procedure. Develop maintenance procedures and ensure implementation. Carry out inspections of the facilities to identify and resolve issues. Plan and oversee all repair and installation activities. Keep generator, lighting and electrical system in working order. Diagnose problems and then repair/replace defective parts. Preparing all the documents (like SOPs, related log sheets, etc.) related to the maintenance department. Inspecting the validation and calibration activity of the clean room and other equipment as needed. Perform mechanical and electrical maintenance repair work; install/ replace fixtures, switches, motor, receptacles, and wiring. Execute PPM (Planned Preventive Maintenance) of equipment, maintains records and logs as needed. Provides guidance and directions to less experienced personnel and others assigned to his/ her position. Performs all work in accordance with all established regulatory and compliance as per safety requirements. Responsible to source, negotiate and purchase materials from local vendors. Evaluate vendor s quotation to ensure that they are in line with the technical specification required for the project. Any additional job responsibilities as assigned by HOD. Perform other various task as instructed by management. Department : Maintenance Number Of Positions : 01 Experience : 1 to 6yrs Employment Type : Full Time, Permanent Education : UG: B.Tech, BEE (Mechnical / Electrical) Compensation : As per Industry norms & experience Key Skills : PPM, Maintenance Management, SOPs, cGMP and GDP Procedures, Utility Maintenance.

You will be responsible for performing commissioning and qualification of Pharmaceutical equipment, specifically systems for Oral Solid Dosage, Injectables, and Fill/Finish. This includes a variety of equipments such as RMG, CoMil, Tablet press, Coating Machine, blister packing machine, Vial Filling Line, PFS Line, Isolators (Negative & Positive), RABs (Open and Closed), GL Reactors, Dryer, Nutsche Filters, Centrifuges, Lyophilizers, etc. Your responsibilities will include developing CQMP, VMP, FRA, cGMP review sheet, interdependencies, System boundary, URS, SCA/SLIA, CLIA, DQR, SRA/QRA, SAT protocol, commissioning protocol, IQ protocol, OQ protocol, PQ protocol, process validation, and cleaning validation protocol. You will execute Commissioning, qualification, and validation activities for Pharma Process Equipments for API, Fill/Finish, and OSD. Additionally, you will review, analyze, and interpret system performance data, handle deviations/discrepancies, conduct investigations, CAPA, and ensure promotion of cGMP and regulatory compliance in assigned projects. Furthermore, you will exercise good judgment in selecting methods and techniques for obtaining solutions, maintain GDP, ALCOA practices, and have hands-on experience with Pharma Process Equipments. Drafting equipment operation SOPs will also be a part of your role. Qualifications & Other Requirements: - BS/MS in Engineering (Chemical, Pharma). - 4-10 years of experience in validation, quality systems, operations, engineering, or a combination thereof. - Experience in multiple GMP validation disciplines with advanced technical knowledge. - Knowledge of Validation Lifecycle approach, international regulatory requirements, and standards. - Experience with Documentum or Maximo is a plus. - Strong verbal and written communication skills, excellent organizational and time utilization skills. - Ability to work independently and within project teams. - Industry experience related to cGMP drug manufacturing, validation, and chemical process design. - Strong computer knowledge including Microsoft Office products.,

As a leader in utility systems management within an API manufacturing facility and drug product filling and packing line equipment, you will be responsible for overseeing the operation and maintenance of various utility systems including Brine chillers, Air compressors, HVAC, N2 plant, Air dryer, and Chilled water chillers. Your primary focus will be to ensure the 24x7 availability of utilities to support uninterrupted manufacturing processes. Your key responsibilities will include planning and implementing preventive and breakdown maintenance schedules, ensuring compliance with cGMP, USFDA, and other regulatory standards, and leading utility qualifications and supporting audits and inspections. You will work closely with engineering, production, and QA/QC teams to ensure smooth plant operations and manage energy efficiency, safety, and sustainability initiatives. In addition to maintenance and troubleshooting tasks, you will be responsible for preparing and reviewing SOPs, reports, and documentation, as well as handling deviations and change control forms. You will also play a crucial role in CSV-related activities, qualification processes, and material handling tasks including SAP transactions. As a supervisor, you will oversee the operations of the engineering team, allocate work orders, monitor progress, and ensure timely completion of tasks. Safety and compliance will be paramount, and you will need to follow safety permit procedures, implement preventive maintenance measures, and take corrective actions within defined timelines. To qualify for this role, you should have a B.Tech in Mechanical Engineering and possess strong skills in utility systems management, including knowledge of Brine chillers, Air compressors, HVAC, N2 plant, Air dryer, and Chilled water chillers. Your experience in pharmaceutical utility operations, maintenance, safety standards, and regulatory compliance will be highly valued. Join our team at Piramal Critical Care (PCC) and be part of a global player in hospital generics, committed to delivering critical care solutions for patients worldwide. Take on this challenging role and contribute to our mission of sustainable and profitable growth while upholding ethical and values-driven practices. Apply now and become a key player in ensuring the efficient and compliant operation of utility systems within our API manufacturing facility and drug product filling and packing line equipment.,

You will be responsible for strictly following cGMP, Safety, and Environmental Practices while performing tasks such as filling Batch Manufacturing records and equipment cleaning records. It is essential to adhere to Good Manufacturing practices during operations and maintain Good Housekeeping in the respective plant area and equipment. Ensure the usage of proper personnel protective equipment as required and plan for the availability of raw materials for daily production according to the production plan. Additionally, you will be responsible for maintaining documents such as Issue and dispensing registers, carrying out processes as per BMR without deviations, and ensuring data integrity in online documentation. Handling hazardous operations safely and effectively utilizing resources like Utility, Men, and Machine will also be part of your duties. Qualifications: - Master's degree in a relevant field, such as Chemical / Chemistry - Previous experience in a manufacturing or pilot plant environment is preferred - Strong understanding of cGMP, safety regulations, and good manufacturing practices - Excellent attention to detail and organizational skills - Ability to work collaboratively in a team-oriented environment - Strong communication skills, both verbal and written About Us: In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by core values, Piramal Group firmly pursues inclusive growth while adhering to ethical and values-driven practices. Equal employment opportunity is fundamental to our ethos, ensuring that all applicants and employees receive fair treatment in personnel matters. About The Team: Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end solutions across the drug life cycle. With a global network of facilities, PPS provides services including drug discovery solutions, process & pharmaceutical development, clinical trial supplies, commercial supply of APIs, and finished dosage forms. Specialized services such as highly potent APIs, antibody-drug conjugations, and biologics are also offered. PPS is a trusted service provider with experience across varied technologies, making it a preferred partner for innovators and generic companies worldwide. Job Information: - Job Identification: 8293 - Job Category: Production - Posting Date: 07/16/2025, 03:44 AM - Apply Before: 07/25/2025, 03:44 AM - Degree Level: Master's Degree - Job Schedule: Full time - Location: Piramal Enterprises Limited P.O Bag No: 5, Ennore Express Highway, Chennai, Tamil Nadu, 600057, IN,

You will be responsible for planning, executing, and documenting analytical method validation activities for raw materials, in-process samples, finished products, and cleaning validation. This includes assessing accuracy, precision, specificity, linearity, robustness, LOD/LOQ, and other parameters. You will review and approve validation protocols and reports in accordance with ICH Q2(R1), USP, and other regulatory standards to ensure compliance. Your role involves ensuring that all analytical method validation (AMV) activities adhere to GMP, GLP, and cGMP guidelines. Collaboration with R&D, QA, and Production teams is essential for seamless tech transfer and validation support. You will troubleshoot analytical method issues, propose enhancements, and recommend revalidations as needed. Maintenance and calibration of analytical instruments such as HPLC, GC, UV-Vis, and FTIR will be part of your responsibilities. In preparation for regulatory inspections and internal audits, you will participate in these processes. Additionally, you will play a key role in training and guiding junior QC staff on method validation procedures and regulatory expectations. It is crucial to ensure the completeness, accuracy, and proper archiving of all documentation as per standard operating procedures (SOPs). This position is based in Giloth, Neemrana, Rajasthan, and requires prior experience in a similar role. The job is full-time and permanent, offering benefits such as commuter assistance and provided meals. The work schedule is during day shifts with a yearly bonus component. The role necessitates on-site presence for work. If you meet the experience requirements and are adept at analytical method validation within a regulated environment, we invite you to apply for this challenging opportunity.,

As a Manufacturing Operator, you will be responsible for attending training sessions according to the schedule and ensuring that you apply the knowledge gained in Training Needs Identification (TNI). Your primary duties will include monitoring and performing all activities within the Manufacturing area, maintaining logs, Batch Manufacturing Records (BMRs), and other relevant documents as per Standard Operating Procedures (SOPs) and work instructions. Additionally, you will be in charge of adhering to the preventive maintenance schedule for machinery, instruments, and equipment in the manufacturing area, as well as overseeing their cleaning and sanitization. Line clearance activities before operations, Clean-in-Place (CIP), and Steam-in-Place (SIP) of Vessel operations will be under your responsibility. You will operate specific machinery such as the Manufacturing Vessel and CIP module. It is crucial that you promptly report any observations or disturbances in the aseptic area to the relevant supervisor. Maintaining personal hygiene, cleanliness, and following SOPs while documenting all activities within the area will be essential tasks. Furthermore, you must ensure that the Unit Area File (UAF) is up to date and operational within the designated area. Compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practices, and maintaining discipline within the department are also key aspects of this role. Qualifications: - Qualification Requirement: ITI/ Diploma in Mechanical Engineering - Experience: 3-6 years - Skilled Operator needed for CIP & SIP of Vessel, Filter integrity checks, and Batch manufacturing activities - Prior experience in the aseptic area for Manufacturing Injectable Products is preferred If you meet the qualifications and possess the necessary skills, we encourage you to apply for this position and contribute to our manufacturing operations effectively.,

You have an exciting opportunity to join as a Deputy Manager in Stores within the pharmaceutical sector located in Surendranagar, Gujarat, India. With over 10 years of experience in pharmaceutical warehouse operations, you will play a vital role in ensuring efficient and compliant warehouse management. Your main responsibilities will include overseeing warehouse operations, such as the receipt, verification, storage, and dispatch of raw materials, packaging materials, and finished goods while adhering to cGMP and GDP standards. You will be responsible for maintaining accurate inventory records through physical stock counts and reconciliation with SAP/ERP systems to minimize waste and identify non-moving or expired materials. In addition, you will develop, review, and implement Standard Operating Procedures (SOPs) aligned with cGMP, GDP, and regulatory requirements, ensuring proper labelling, segregation, and documentation of materials for traceability and prevention of cross-contamination. Leading and mentoring warehouse staff to enhance compliance and continuous improvement will also be a key aspect of your role. Collaborating with various departments such as Quality Assurance, Quality Control, Procurement, Production Planning and Inventory Control, and Finance will be essential to streamline operations and resolve any discrepancies. Your expertise in SAP/ERP systems, knowledge of cGMP, GDP, and pharmaceutical warehousing regulations, along with strong leadership and communication skills, will be crucial for success in this role. Furthermore, you will be responsible for maintaining a safe and hygienic warehouse environment through monitoring cleaning, sanitization, and pest control measures, while ensuring compliance with Environmental, Health, and Safety (EHS) standards. Managing dispatch of finished goods, accurate preparation of dispatch-related documents, and handling rejected materials as per PPIC instructions will also fall under your purview. To qualify for this role, a Bachelor's degree in Pharmacy, Science, or a related field is required, with a Master's degree or MBA in Supply Chain Management being preferred. Proficiency in SAP/ERP systems for inventory and warehouse management, along with a deep understanding of cGMP, GDP, and pharmaceutical warehousing regulations will be necessary. Your strong leadership, communication, and interpersonal skills will be key assets in successfully fulfilling the responsibilities of this position.,

Roles and Responsibilities: You will be assisting seniors in drafting Concept & Basic Engineering drawings (PFD, P&ID, layouts, 3D plans), Revit modeling of civil/structural drawings, and coordinate with the Detailed Engineering team. Required Candidate profile 5–10 yrs exp in pharma consultancy/design-build, Certified in AutoCAD/Revit (on-job cert accepted). Knowledge of cGMP. Concept/basic engineering for API/chemical plants. Skilled in MS Word/Excel.

Responsible for reviewing all QC lab documents (reports, chromatograms, test records) to ensure accuracy, compliance, and completeness as per cGMP, SOPs, and regulatory guidelines. Check HPLC/GC/UV data, assay results, and dissolution profiles.

1)Compliance and Documentation Management 2) Quality Control Performance Metrics 3)Stability study & Documentation Oversight 4)Quality Management System (QMS) Management 5 to 10 years of relevant experience Should be familiar with cGMP practices.

1.Perform and monitor In-process Quality Assurance activities during the manufacturing process. 2.Responsible to perform line clearance activities in different stages of manufacturing and Monitoring of cleanroom behavior, aseptic activities. 3.Responsible to verify the In-process samples for quality testing and ensure the test results of products at various stages of manufacturing. 4.Review and verify documentation related to manufacturing processes i.e., BMR, BPR and GMP documents, ensuring accuracy and completeness. 5.Regularly inspect and assess manufacturing operations to ensure compliance with quality standards and procedures. 6.Responsible to Preparation Review of standard operating procedures. 7.Responsible to ensure cGMP and GDP during document preparation and review. 8.Ensure that all in-process activities align with Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP). 9.Responsible to review of Plasma inward, sampling procedures, Issuance and Reconciliation. 10.Responsible to Review and compliance of Down stream activities and Filling activities as per established procedures. 11.Responsible to involve in Change controls, Deviations, CAPA and other QMS activities. 12.To get involved in Process validation, cleaning validation and APQR activities. 13.To Involve in Risk assessment procedures with the coordination of SMEs. 14.Responsible to perform additional activities assigned by the superiors/ Head of the department.