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3.0 - 6.0 years

7 - 9 Lacs

bengaluru

Work from Office

Role & responsibilities Responsibility of Upstream activities in bulk manufacturing facility. To ensure that upstream batches are carried out as per manufacturing instructions following relevant Process Development description document, MFR, SOPs, BMRs, Protocols etc. and to ensure appropriate documentation in order to maintain cGMP compliance. ESSENTIAL JOB FUNCTIONS: (Details of key job functions) 1. Preparation of process documents (PCS, MFR, BMR), SOPs, protocols, related documents for upstream activity. 2. Hands on experience in operations of seed and production fermenters, continuous centrifuge, homogenizer and continuous involvement and support for commercial batches etc., 3. Involving and supporting in Sun Pharma CQA audits, internal audits ,local DGCI audits CDSCO and any other third party/national &international regulatory agencies. 4. Review of batch manufacturing records and related documents in upstream. 5. To understand and follow the safety practices and usage of PPEs in Bulk Manufacturing facility and during process. 6. Execution of Scale up of Development batches, commercial batches and other assigned tasks in Bulk manufacturing facility as per the assigned shift schedule (A,B,C Shift) hours. 7. Ensure Facility monitoring, readiness & maintenance of BM facility. 8. Coordination with engineering department on tracking and completion of preventive maintenance and calibration of Upstream process Equipment and instruments. 9. Following good documentation practices such as online documentation like BMR, equipment log, record sheets, etc. in upstream process. 10. Following up with Vendors on equipment and instrument related to upstream process. 11. Support for creation of Process Order/material reservation related to SAP transactions and handling of QMS elements activities. 12. Support and fulfill for any additional job work activities /other job responsibilities/tasks assigning by reporting manager. Preferred candidate profile Candidates with core Hands on working experience in Biotech Pharma Companies

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8.0 - 13.0 years

5 - 7 Lacs

pune

Work from Office

Post- Manager - Supply Chain Location Pune Hadapsar , Magarpatta Experience - 08-10 yrs Skills - pharmaceutical supply chain management. Strong understanding of GMP, GDP Education - Bachelor's/Master's degree in Supply Chain Management, Business Administration Job Overview : The Supply Chain Manager oversees and manages the end-to-end supply chain operations, ensuring the timely delivery of pharmaceutical products while maintaining quality, compliance, cost efficiency, and customer satisfaction. JD Develop and implement supply chain strategies Manage warehousing, inventory management, and distribution activities. Ensure compliance with industry regulations and quality standards. Collaborate with vendors, manufacturing, and logistics teams to optimize supply chain processes. Monitor and analyse supply chain performance metrics; identify areas for improvement. Manage risk mitigation strategies related to supply chain disruptions. Oversee procurement activities for raw materials, packaging, and other supplies. Develop accurate demand forecasts Analyse sales data, market trends, and upcoming launches to predict future demand. Collaborate with sales, marketing, and supply chain teams to align forecasts. Monitor inventory levels and recommend adjustments to prevent stock outs or overstock. Prepare monthly, quarterly, and annual demand planning reports.

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7.0 - 12.0 years

30 - 40 Lacs

hyderabad, pune, bengaluru

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Job Title: Senior Guidewire Digital Developer / Engineer Experience: 7 10 Years Employment Type: Full-Time (FTE) Notice Period: Immediate 45 Days Location: Hyderabad, Pune, Coimbatore, bangalore Job Description We are looking for an experienced Guidewire Digital Developer with strong hands-on experience in Guidewire Digital Portal (GDP) and related modules to join our team. The ideal candidate will have 7-10 years of experience in developing and implementing digital solutions for insurance platforms, with a specific focus on Guidewire's Digital products. Key Responsibilities Design, develop, and implement enterprise-level digital solutions using Guidewire Digital Portal (GDP) . Work across different Engage modules including: Enterprise Engage Producer Engage Consumer Engage Engage (Core Module) Collaborate with business analysts, product owners, and architects to understand business requirements and translate them into technical specifications. Ensure application performance, scalability, and security are optimized. Troubleshoot and resolve issues across multiple environments (Dev, QA, UAT, Prod). Participate in Agile ceremonies, code reviews, and contribute to the overall CI/CD process. Mandatory Skills Guidewire Digital Portal (GDP) Hands-on development and implementation Experience with Engage modules (Enterprise, Producer, Consumer) Proficiency in modern JavaScript frameworks (React, Angular, or similar) used in Guidewire Digital Experience integrating Guidewire with third-party services and APIs Understanding of Insurance domain processes, especially in P&C Good to Have Certification in Guidewire Digital products Familiarity with Guidewire PolicyCenter, BillingCenter, or ClaimCenter Experience with cloud environments (AWS, Azure, GCP) Knowledge of RESTful services, OAuth, and other web security standards Mode of Hire Full-Time Employee (FTE)

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0.0 - 5.0 years

3 Lacs

aurangabad

Work from Office

Post Production Operator - Capsules Organization Context Position Title: Line Operator - Capsules Employee Name: Grade : DET Department: Manufacturing-Post Production Location: Aurangabad Reports to: Team lead/Hall In-charge Reported by: Job Objective Maintain line continuity, productivity, quality of product, reduce wastages and adherence to cGMP, GDP and safety in-shift for the allocated line(s). Primary responsibilities Strategic Planning Activities: Core: Check the allocated post production (ATS/Printing /camera)- line(s) in each shift as per the CTQ (critical to Quality) /CTP (Critical to Productivity) checklist Follow plan as per colour change note by ensuring minimal change over time at each sub section Follow instructions from shift lead for timely change over by ensuring availability of roller(s)/ink etc Execute IPQC after every roller cleaning and checking of rejections of camera(s) after every hour for achieving zero defect Execute camera operations as per SOP to achieve productivity and quality Coordinate with contract associates to follow SOP at ATS /Camera/packing /Sealing and tumbling Execute preventive maintenance plan for line(s) to achieve zero downtime of the line(s) Execute troubleshooting activity for entire line(s) to achieve productivity. In certain cases, seek help from maintenance team for uptime of machine Reporting and controlling post production loss of printing and camera to achieve Targeted AFOE@Despatch Follow cGMP and GDP for allocated line (s) for ensuring regulatory compliances during the shift. Follow instructions from shift lead/team lead to implement CAPA for any customer complaint(s) Assist other line operator during colour change /Break down for timely start-up of line Making downtime and rejection entries on daily machine performance report Communicate attribute defects to Production /line lead on continuous basis Machine cleaning Shift handover and takeover Safety A) Key Result Areas Productivity of line Print loss /print reject/camera loss Safety SOP Adherance Education: Diploma in Mechanical/Electrical/Mechatronics/Printing

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2.0 - 6.0 years

0 Lacs

maharashtra

On-site

As a member of the Group Company's Capsules team, your primary responsibilities will include checking the allocated post production (ATS/Printing/camera) line(s) in each shift according to the CTQ (critical to Quality) / CTP (Critical to Productivity) checklist. You will be required to follow the plan for color change noted, ensuring minimal change over time at each subsection. It is essential to follow instructions from the shift lead to facilitate timely changeover by ensuring the availability of rollers/ink, etc. You will execute IPQC after every roller cleaning, checking rejections of cameras every hour to achieve zero defects. Operating cameras as per SOP to meet productivity and quality standards is crucial. Collaboration with contract associates to ensure SOP compliance at ATS/Camera/packing/Sealing and tumbling is part of your responsibilities. It is imperative to implement the preventive maintenance plan for the line(s) to achieve zero downtime and execute troubleshooting activities to maintain productivity, seeking maintenance team support when necessary. Reporting and controlling post-production loss of printing and camera to achieve the targeted AFOE@Despatch, as well as following cGMP and GDP for the allocated line(s) to ensure regulatory compliance during the shift, are essential tasks. Moreover, you must adhere to instructions from the shift lead/team lead to implement CAPA for any customer complaints. Your key result areas will involve maintaining line continuity, productivity, product quality, reducing wastage, and adhering to cGMP, GDP, and safety regulations during the shift for the allocated line(s). Key Interfaces: - Productivity of the line - Print loss/print reject/camera loss - Safety - SOP Adherence Competencies: [Competencies not provided in the input],

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7.0 - 11.0 years

0 Lacs

ahmedabad, gujarat

On-site

As a member of our team at Meteoric Biopharmaceuticals, your role will involve various responsibilities related to Human Resources. You will be responsible for Talent Acquisition and Management, ensuring we have the right individuals on board to drive our organization forward. Additionally, you will oversee Onboarding and Offboarding processes, ensuring a smooth transition for new hires and departing employees. Employee Relations and Engagement will be a key focus of your role, as you work to foster a positive and inclusive work environment. Performance Management will also fall under your purview, as you support employees in reaching their full potential through feedback and development opportunities. Training and Development programs will be designed and implemented by you to enhance the skills and knowledge of our workforce. You will also be involved in developing Compensation and Benefits strategies to attract and retain top talent. Ensuring HR Policies are in compliance with regulations and effectively communicated to all employees will be crucial. You will also be responsible for HR Analytics and Reporting to provide data-driven insights to support decision-making. Change Management and Organizational Effectiveness will be areas where you will play a key role, driving initiatives to adapt to the evolving needs of the organization. Stakeholder Management and Leadership will be essential as you collaborate with various teams and guide HR functions. Furthermore, you will conduct HR SOP training for new joiners and refreshment training for all employees to ensure adherence to standards. Documentation in alignment with Quality Management System standards will also be part of your responsibilities, including GDP, CAPA, Change Management, Risk Assessment, Deviation, and maintaining Training Records. If you are a proactive and detail-oriented HR professional with a passion for driving organizational success through effective people management, we encourage you to apply for this role and be a part of our dynamic team at Meteoric Biopharmaceuticals.,

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0.0 years

0 Lacs

ahmedabad, gujarat, india

On-site

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. This position provides support to the Analytical development laboratory in technical and operational activities such as hands-on support for Physico-chemical analysis, Instrumental analysis , and material characterization or testing for product development. The successful candidate will need to possess solid hands-on technical abilities, excitement and energy for product development, and a passion for their work and the impact it has on meeting the needs of patients. The incumbent will perform other duties as assigned. . Define, organize, plan and execute analytical activities and materials characterization of pharmaceutical injectables in compliance with current international/regional/national regulations with the support of senior colleagues and team member s. . Execute experiments towards method development, failure analysis , and root cause analysis in new product development and sustaining product projects within specified timelines, under supervision. . Work with and interpret data of advanced instrumentation techniques, hyphenated techniques , and other analytical techniques. . Execution of work as per standard guidelines like cGLP, GDP, cGMP, Data Integrity, ALCOA, and as per Baxter's defined systems, whenever applicable. . Investigate and provide technical insights for observed adverse physicochemical issues during product devel opment, scale-up, or post-marketing phases. Engage in science-based troubleshooting of the issues. . Provide proposals for product development-related innovations, analytical method innovations, and product/process improvement initiatives in collaboration with senior scientists . Ensure good internal and cross-functional communication and regular status update of activities. . Preparation of scientific product development reports, proposals, and presentations . Work collaboratively with the multi-functional and international project team in activities such as sample preparation for analysis, and operation of analytical instruments as per project requirements. . Provide support as needed in calibration and maintenance of equipment in the laboratory. . Follow Baxter's Quality Manual, SOPs, and Environmental Health, Safety & Sustainability (EHS&S) guidelines in day -to-day activities, to ensure proactive compliance and continuous improvement Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .

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10.0 - 12.0 years

0 Lacs

bengaluru, karnataka, india

On-site

Job Title: Senior Supplier Quality Location: Bengaluru, Karnataka, India Employment type: Part-time Job Summary: We are seeking an experienced Supplier Quality Professional Trainer with 10+ years of expertise in managing supplier quality assurance , supplier development, and compliance in regulated industries (pharmaceutical, biotech, or medical devices). The role involves ensuring suppliers meet company , industry, and regulatory standards by leading audits, driving quality improvement initiatives , and building strong supplier partnerships. Job Responsibilities: Develop and manage supplier quality strategies, policies, and risk management processes. Lead supplier qualification, selection, and approval in alignment with regulatory standards (FDA, EMA, ISO 13485, ICH Q10, GMP). Conduct supplier audits, assessments, and performance reviews to ensure compliance with quality and regulatory requirements. Oversee supplier corrective and preventive actions (CAPA) , root cause analysis, and continuous improvement programs. Collaborate with cross-functional teams (procurement, R&D, operations, quality) to resolve supplier-related issues. Monitor supplier KPIs (on-time delivery, defect rates, deviations, complaints) and drive improvement initiatives. Support new product development (NPD) by ensuring supplier capability for components, raw materials, and services. Manage supplier change control processes and evaluate the impact on product quality and regulatory compliance. Train, mentor, and guide internal teams and suppliers on quality systems and compliance expectations. Ensure alignment with global regulatory requirements (FDA 21 CFR Part 11/210/211, ISO standards, EU MDR, ICH guidelines). Core Competencies & Skills Strong expertise in supplier quality management, auditing, and regulatory compliance . In-depth knowledge of GMP, GDP, ISO 9001, ISO 13485, IATF 16949 (if automotive/industrial) . Proficiency in risk management, root cause analysis, CAPA, Six Sigma, and Lean methodologies . Excellent communication, negotiation, and stakeholder management skills. Ability to lead supplier development programs and strategic quality initiatives. Experience in global supplier management and multicultural environments. Qualifications: Bachelors/Masters degree in Engineering, Life Sciences, or related field. 10+ years of experience in supplier quality assurance, preferably in pharma/medical devices/regulated manufacturing industries. Certified Lead Auditor (ISO 9001/13485, GMP, or equivalent) preferred. Six Sigma Green/Black Belt certification is a plus. Proven track record in managing global suppliers and delivering measurable quality improvements. Show more Show less

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2.0 - 6.0 years

0 Lacs

maharashtra

On-site

As a Quality Control Inspector, your primary responsibilities will include ensuring effective implementation of IQC/PQC inspections, ensuring that capsules produced comply with dimension specifications, ensuring compliance with GDP and cGMP requirements, ensuring compliance with safety regulations, and ensuring CAPA compliance for customer satisfaction. You will be responsible for performing and reviewing In Process quality control checks to meet the required quality compliance as per specifications. Additionally, you will be involved in key interfaces such as inspection of attribute defects, checking moisture of capsules, inspection of print defects, online & offline printing machine line clearances, DIS & ATS Line clearances, online and on-time gradation of boxes in SAP, offline printing checking and gradation, re-inspection of offline sorted boxes, brittleness checking of all machines, ink rub off test, printing first off inspection, extraction of composite/control samples of each box, and backtracking of unqualified boxes for attribute and print defects as per SOP. Your role will require strong competencies in quality control, attention to detail, adherence to specifications, and compliance with regulatory requirements. Your ability to perform thorough inspections and ensure high-quality standards will be crucial to the success of the production process.,

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0.0 - 5.0 years

3 Lacs

aurangabad

Work from Office

Post Production Operator - Capsules Organization Context Position Title: Line Operator - Capsules Employee Name: Grade : DET Department: Manufacturing-Post Production Location: Aurangabad Reports to: Team lead/Hall In-charge Reported by: Job Objective Maintain line continuity, productivity, quality of product, reduce wastages and adherence to cGMP, GDP and safety in-shift for the allocated line(s). Primary responsibilities Strategic Planning Activities: Core: Check the allocated post production (ATS/Printing /camera)- line(s) in each shift as per the CTQ (critical to Quality) /CTP (Critical to Productivity) checklist Follow plan as per colour change note by ensuring minimal change over time at each sub section Follow instructions from shift lead for timely change over by ensuring availability of roller(s)/ink etc Execute IPQC after every roller cleaning and checking of rejections of camera(s) after every hour for achieving zero defect Execute camera operations as per SOP to achieve productivity and quality Coordinate with contract associates to follow SOP at ATS /Camera/packing /Sealing and tumbling Execute preventive maintenance plan for line(s) to achieve zero downtime of the line(s) Execute troubleshooting activity for entire line(s) to achieve productivity. In certain cases, seek help from maintenance team for uptime of machine Reporting and controlling post production loss of printing and camera to achieve Targeted AFOE@Despatch Follow cGMP and GDP for allocated line (s) for ensuring regulatory compliances during the shift. Follow instructions from shift lead/team lead to implement CAPA for any customer complaint(s) Assist other line operator during colour change /Break down for timely start-up of line Making downtime and rejection entries on daily machine performance report Communicate attribute defects to Production /line lead on continuous basis Machine cleaning Shift handover and takeover Safety A) Key Result Areas Productivity of line Print loss /print reject/camera loss Safety SOP Adherance B) Key Interfaces Internal InterfacesExternal Interfaces C) Competency Technical Competency T CompassLeadership Competency L CompassCompetencyLevelCompetency Level Prepared By Date Signature

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2.0 - 5.0 years

6 - 7 Lacs

hyderabad

Work from Office

Role & responsibilities Job description Perform protocol for drug excipient compatibility studies and submit the protocol for review and approval Complete lab. experiment hands-on independently (Lab scale to exhibit batch and query handling). Dosage forms experience: Injectables predominantly more than 90% in career. Perform formulation development activities on differentiated formulations and innovative technologies as part of product development. Carry out /Support Scientific literature search (CVM/USFDA/Daily-med/publications). Follow good laboratory practices, good documentation practices (online LNB writing) and maintain the logbooks and forms for equipment/instruments. Compilation, interpretation and review of analytical results and stability data Maintain records of formulations, batch processes, and stability studies. Proficient in drafting, reviewing, and managing technology transfer document (MFR, MPR, stability protocols, justification of specifications etc. as part of TT). Exposure in oral liquids and oral solid dosage forms will have an added advantage Preparation of quality-based product development reports (PDR). Evaluation of alternate vendor Experience in preparing technical and regulatory submissions. Coordinate outsourced activities at the partner site by a regular communication plan. Provide timely technical inputs and timely escalation to ensure successful task completions. Communicate effectively with R&D, production, QA/QC, supply chain teams clients, vendors, and stakeholders regarding project progress and requirements. Qualifications M. Pharm or Ph.D. in Pharmacy with minimum industrial experience of 2 to 5 years in pharmaceutical development and scale-up of products. Support in Technical troubleshooting/ root cause identification/ Investigation/Corrective Action and Preventive Action pertaining to product development or manufacturing activities.

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2.0 - 7.0 years

3 - 8 Lacs

ahmedabad

Work from Office

Walk-in at Matoda We are hiring multiple positions for our manufacturing facility at Matoda as mentioned below. Please find our current job requirements and venue details mentioned. If any of the requirements match your current job profile, kindly walk in with your latest resume. Role & responsibilities Injectable Manufacturing & Visual Inspection & Packing Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspection / Packing / VI (Senior Officer / Officer / Associate) Experience - 02 to 07 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI Engineering (Instrumentation / Process Equipment Maintenance) (Senior Executive / Executive / Senior Officer) Experience - 03 to 10 Years Qualification BE / B Tech Time and Venue : 06/09/25, Saturday 09:30 Hrs to 18:00 Hrs ______________________________________________________ INTAS, Matoda facility Plot No. 457, 458 Sarkhej Bavla Highway, Matoda Village, Sanand, Taluka, Ahmedabad, Gujarat 382210 ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. *Having relevant qualification only can attend the scheduled walk-in.

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3.0 - 5.0 years

0 Lacs

gurgaon, haryana, india

On-site

It's more than a job When you work in Freight Logistics and Operations at Kuehne+Nagel, you play a key role in optimising processes and ensuring that inventory and shipments move efficiently. But that is not all. Your work also helps ensure that vital medicines reach patients on time and supports other essential deliveries, from wind turbines to semiconductors. At Kuehne+Nagel, our contribution counts in more ways than we imagine. ? The Quality Auditor is a vital member of the Integrated Logistics Team, responsible for ensuring quality and compliance throughout the supply chain. Reporting to the Integrated Logistics Quality Manager, they collaborate closely with the Excellence, Operations, Performance, and Business Analytics teams. The Quality Auditor also acts as a backup to the Quality Manager or Deputy when assigned. How you create impact Problem Solving Typical challenges include: Ensuring KN IL operations comply with GxP healthcare standards, meet customer needs, and follow best practices Managing CAPA through training, audits, and handling non-conformities Qualifying suppliers and assessing risks Managing changes effectively Development and Implementation of Quality Processes Follow quality standards to meet customer expectations Assist in creating and enforcing quality processes across departments Verify that quality processes are applied and effective Monitor and report on quality and business controls to meet targets Manage daily quality tasks, resolve issues, and keep stakeholders informed Serve as main contact for customer and LSP quality topics Participate in customer and LSP quality meetings Support compliance with customer quality standards Assist with change control procedures Supplier Qualification & Release Manage suppliers following customer and KN rules Help qualify suppliers per customer requirements Maintain KN Pharma Auditor certification if required Conduct due diligence, quality checks, change control, and monitor supply chain security Audits Organize and perform internal, global, authority, external, and customer audits Share audit reports and oversee corrective actions and CAPA follow-up Trainings Develop and maintain training programs for quality-related tasks Conduct internal GxP training, track training needs, ensure compliance, and verify training effectiveness Document Management Ensure good documentation practices (ALCOA+) for document storage and archiving Train staff on documentation accuracy and requirements Assist in developing and updating work instructions (WI) and SOPs to ensure consistency Keep documents current with KN IMS and industry standards Manage Technical Quality Agreements (TQA) with customers and LSPs as needed Non-conformity (NC) Handling Support management of customer complaints Review and approve deviations, ensuring effectiveness Identify gaps and create action plans to improve NC handling Create, assign, and manage CAPAs until closure and effectiveness are confirmed Report NCs promptly with proper documentation Monitor SLAs for NC and CAPA timelines Collaborate with LSPs and customers to ensure CAPA success Help develop preventive strategies for future issues Track and analyze NC and Delivery Service Issues (DSI) Continuous Improvement Ensure continuous improvement processes are implemented and followed Support quality improvement activities Assist in developing tools and processes to enhance productivity and profitability What we would like you to bring 3-5 years experience in the pharmaceutical industry, covering logistics, freight forwarding, warehousing, and transportation Certifications in ISO 9001, GxP, GDP, CAPA, Six Sigma Strong background in supplier qualification, risk assessment, and change control Excellent written and verbal communication skills in English Strong time management and ability to work under tight operational constraints Willingness to travel domestically and internationally What's in it for you ... Who we are Logistics shapes everyday life - from the goods we consume to the healthcare we rely on. At Kuehne+Nagel, your work goes beyond logistics it enables both ordinary and special moments in the lives of people around the world. As a global leader with a strong heritage and a vision to move the world forward, we offer a safe, stable environment where your career can make a real difference. Whether we help deliver life-saving medicines, develop sustainable transportation solutions or support our local communities, your career will contribute to more than you can imagine. We kindly advise that placement agencies refrain from submitting unsolicited profiles. Any submissions of candidates without prior signed agreement will be considered our property and no fees will be paid.

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3.0 - 7.0 years

0 Lacs

thane, maharashtra

On-site

As a QC Executive LCMS at QbD Research and Development Lab Pvt. Ltd., your primary responsibility will be to perform quality control tests and analyses using LCMS technique. This full-time on-site role based in Thane requires you to ensure compliance with regulatory standards while carrying out analytical method development and validation. To excel in this role, you must have experience in the Pharmaceutical Industry, proficiency in LCMS troubleshooting, and a solid understanding of analytical method development and validation. Familiarity with regulatory standards, guidelines (GDP, GLP, GMP), and the ability to prepare and maintain analytical protocols, reports, and records are essential. Additionally, you should be capable of working both independently and collaboratively as part of a team.,

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2.0 - 6.0 years

0 Lacs

maharashtra

On-site

The primary responsibilities of this role include ensuring the quality of all incoming PM, RM, in-process materials, stability samples, and finished products. You will be responsible for sampling and testing all PM, RM, in-process materials, and finished products within the specified lead time. Additionally, you will be expected to prepare testing reports in a timely manner and ensure correct labeling on materials such as sampled, approved, and rejected. You will also be responsible for sampling and testing raw water and purified water as per specifications. Other responsibilities include checking the dye strength of stock color solutions, verifying preservative traces in equipment used for preservative-free materials preparation, and monitoring various quality systems such as GLP, GDP, c-GMP, ISO, FDA, 5S, internal audits, and others effectively. You will need to ensure the effective implementation of in-process and final quality control checks, as well as the verification, calibration, and validation of all Q.C. instruments on time. Ensuring EHS compliance in the workplace is also a key part of this role. The qualification required for this position is a BSC/MSC degree.,

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12.0 - 16.0 years

0 Lacs

ahmedabad, gujarat

On-site

The role involves ensuring CGMP compliance and supervising overall production activities of the manufacturing area of multiple assigned manufacturing lines. Additionally, the position requires reviewing and maintaining online documents. You will be responsible for the preparation, review, revision, control, and implementation of standard operating procedures. You will also handle the preparation and review of master production documents, protocols, reports, and various document management tasks such as BMRs and BPRs. Your duties will include managing Change Control, Deviations, CAPA, Investigations, and ensuring line clearance activities are conducted before operations like manufacturing, filling, capping, and packing. Generating general purchase indents, preparing production planning, and daily production reports based on achieved goals will be part of your responsibilities. It is crucial to ensure that all equipment and lines are in validated and calibrated status and to uphold cGMP, GDP, and discipline standards within the department. Additionally, you will be responsible for providing training to subordinates, technicians, and operators, and following any additional activities as required by the Head of Department. Attending training sessions as per the schedule and ensuring compliance will be important aspects of the role. To qualify for this position, you must have a Bachelor's Degree in B. Pharm, with a Master's Degree in M. Pharm or M. Sc. being preferred. A minimum of 12 years of experience in the field is required. Your specialized knowledge, skills, and licenses will further enhance your ability to succeed in this role.,

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4.0 - 6.0 years

5 - 7 Lacs

mumbai

Work from Office

Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top management level professionals according to clients specific needs. We are BEST-FIT Recruitment Riders do exactly what our name tells. To know more about us please visit our website: www.bestfitrecruitment.co.in We would like to inform you that presently we have professional career opportunity matching to your profile with one of our esteemed client. Please see the following position summary: Client Name: CDMO Partner for Ophthalmic & Derma products for global markets. Position: Officer / Sr. Officer - IVRT R&D Markets: USA, Canada & ROW Products: Topical Formulations & Ophthalmic Preparations Location: Mumbai Job Profile: To carry out analysis as per work planning or based on the organizational requirement. To follow and perform all required activities in IVRT department as per Standard Operating Procedure (SOP). To follow and maintain quality service in IVRT department by enforcing periodical Quality Management system i.e. Good Laboratory Practices, Good Documentation Practices etc., while working. To perform operation and calibration of instruments and equipments as per respective SOP of instrument and equipment. To co-ordinate and support for work wherever applicable with the internal department of R&D centre, visitor, external vendors etc. To perform IVRT method development, IVRT method validation and IVRT comparison study, Analytical method development, method validation and method transfer for the project assigned by team lead / Management. To execute and complete the project work related to IVRT analysis within stipulated timeline as per organizational requirement. To prepare and review documents like Standard Operating Procedure, protocols and reports etc. related to IVRT Department. To be involve in preparation and review of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) documents (wherever applicable) for the instruments and equipments which is to be install in IVRT department. To attend the training but not limited to SOP, protocol training, safety training organized by internal department of R&D centre or external party. To follow all safety precautions while working in IVRT department and other departments of R&D centre. To upkeep of IVRT laboratory for all time audit readiness and to participate in audit work wherever required as per organizational requirement. To support in training and involve in analyst qualification work for the new joined employee in IVRT department. To follow all rules and regulations set up by the organization during work tenure. Desired Profile: M.Sc / M.Pharm (Pharmaceutical / Pharmaceutical Analysis / related discipline) with 4 to 6 years of experience in IVRT R&D for Regulated markets especially for topical and ophthalmic preparations to the pharmaceutical industries. Prior experience in IVRT method development and validation is essential. Familiarity with USFDA, Health Canada & ROW guidelines for topical dosage forms & Ophthalmic Preparations. Must have good experience in IVRT R&D as per SOP. Ensure Good Laboratory & Good Documentation Practices in IVRT department. Expertise to perform IVRT method development, IVRT method validation Should have experienced to prepare & review documents related to IVRT department. Good knowledge of preparation & review documents of Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) documents in IVRT department. Must have good Audit experience in IVRT laboratory. Strong documentation, technical writing, and regulatory compliance knowledge. Good problem-solving, analytical thinking, and team collaboration skills. Recruiter Details: BEST - FIT Recruitment Riders G-7, Amrit Complex, Opp: Mahavir Jain Vidhyalaya & Jain Derasar, R.V. Desai Road, Near Goyagate Circle, Vadodara-390001, Gujarat, India Mobile: 09722052906, 09722042906 E-Mail: career@bfrr.in Website: www.bestfitrecruitment.co.in

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2.0 - 6.0 years

0 Lacs

rudrapur, uttarakhand

On-site

As an experienced professional in the field of Analytical R&D, your primary responsibilities will include the calibration of analytical instruments, preparation, and maintenance of solutions and reagents. You will be entrusted with the critical task of analyzing development batches, stability samples, and comparative dissolution profiles. Leading the analytical method development and validation processes, along with preparation of method development reports, will be a key aspect of your role. Your expertise will be crucial in conducting drug solubility studies of active pharmaceutical ingredients, as well as executing API and excipient comparability studies. You will be responsible for the daily monitoring of temperature and humidity in the stability chamber, ensuring meticulous documentation of all Analytical R&D activities. Adherence to GLP, GDP, safety protocols, and compliance guidelines within the Analytical R&D team will be essential. Collaborating effectively with cross-functional teams (CFT) to facilitate seamless product development within specified timelines will be a key part of your responsibilities. Additionally, overseeing LER-related activities and analytical method development reports for API and FDF will be within your purview. Analyzing scale-up and PO batches, managing document issuance, maintenance, and sample submission for laboratory testing will also be part of your role. To excel in this role, you are required to have an MSc degree with 2-5 years of relevant experience. Strong expertise in analytical method development and validation is essential, along with experience in comparative dissolution profile analysis and stability studies. A solid understanding of GLP, GDP, and compliance requirements will be necessary for success in this position. Your ability to collaborate effectively with CFTs for smooth development activities and maintain a detail-oriented approach to documentation, monitoring, and reporting will be critical for fulfilling the requirements of this role.,

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2.0 - 6.0 years

0 Lacs

andhra pradesh

On-site

The responsibilities and duties of this role include: - Performing sampling and analysis of Raw materials, Packing materials, In process, Intermediate, and Finished products. - Conducting calibration of Quality Control instruments. - Carrying out Stability/Holding time studies. - Managing Reference Standards and qualifying Working Standards. - Ensuring Analyst qualifications are met. - Conducting Analytical Method Validation. - Managing Control samples (Retain sample). - Conducting OOS investigations (Phase-1). The ideal candidate should have: - 2-3 years of experience in Pharmaceutical Quality Control. - Educational background in M.Pharmacy/B.Pharmacy/M.Sc. (Chemistry)/B.Sc. (Chemistry). - Preferred experience in handling HPLC, GC, and other Quality Control instruments. - Good documentation skills with exposure to GLP, GDP, and cGMP practices. - Experience in Sampling and analysis, Calibration, Stability/Holding time studies, Analytical Method Validation, and OOS investigations. Benefits: - Competitive wages and benefits. - Yearly bonus. - Increments every year based on performance. - Training opportunities. - Lunch service. - Commuting support.,

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10.0 - 15.0 years

5 - 13 Lacs

ahmedabad

Work from Office

Role & responsibilities To supervise all IPQA/QMS function activity on daily basis and update to Section Manager. To conduct and participate in CAPA meetings and review summary report of the same within defined time period monthly. To ensure the implementation of GMP, GDP practices and review of issues and impact of the same, if any, and take corrective actions. To ensure the investigation for complaints and deviations and CAPA after reviewing instruments. To prepare, review, Implement and update SOPs according to current regulations systems. To review Master Batch Document (MBD) / Master Packing Document (MPD) and get approval in advance from Head of Department of Production & QA. To train/update about new procedures and current guidelines or changes in international regulatory requirements. To conduct CCN impact meeting and review the summary reports before sending for closure to Quality committee. To respond to queries received from international regulatory affairs (IRA department/business partner/regulatory agency) and start change procedure and report the queries and response to reporting authority. To carry out internal Audit in the plant. To conduct daily morning meeting and review weekly/monthly departmental activity and report the same to reporting authority. To ensure that all the deviations and OOS are reported to CQA for field alert Report assessment within required time frame. To ensure and review of documentation of Change Control Notes and verify effectiveness of changes carried out. To identify, monitor the deviation/abnormalities in process/documents/systems are captured and resolve them according to Quality management System. To approve sample/good destruction process and to review and report any gap to reporting authority and take corrective and preventive action in co-ordination with respective reporting authority. To prepare minutes of CAPA meetings. To investigate complaints form markets Preferred candidate profile Managerial skill Problem solving & Decision Making skill Guiding skill Team development skill System thinking Delegation Interested candidates can share their cv at Anee.Silas@otsukapharma.in

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3.0 - 7.0 years

0 Lacs

nashik, maharashtra

On-site

In this role, your responsibilities will include analyzing customer inputs and understanding requirements such as Design Specifications, P&IDs, Control Narratives, IO list, Instrument Index, Operating Philosophies, Cause & effect diagrams, FGS layouts, etc. You will need to follow Emerson FSM process and maintain all SIS-related documentation of the assigned activities as per safety lifecycle requirements. Ensuring compliance to IEC61511/other standards as per the assigned scope in the project, raising Technical Queries, developing Safety System SW Design, performing I/O to Safety Logic Solver Assignment, defining Software Concepts, third party interfaces, developing SW library, project-specific SW typicals, SW Typical Test, designing & developing I/O & SIS modules, ESD, FGS, BMS logic, developing graphics based on Cause & Effect, FGS layout file, third party interface database/modules, Internal test plan, Internal testing SW, Third Party Interface test, SW FAT plan, HW-SW Integration plan, Integrated testing between SW & HW, FAT with customer, As Built documentation, SAT plan, SAT at customer location, Loop checks at site, Startup & Commissioning support. Accreditations, Certifications Or Affiliations TUV Certified Safety Engineer, CFSP/CFSE would be an added advantage. Quality Control & Assurance You will be responsible for the implementation of EEEC IMS processes/documentation as & when required throughout the project. Adapting to WA quality requirements and Customers regulatory guidelines, practicing and promoting the First time right approach, and rigorously following GDP (Good Documentation Practices). Other Duties You may be required to perform other additional specific duties, typically strategic in nature, under the mentorship of a supervisor. Who You Are: You are someone who promotes high visibility of shared contributions to goals, takes action in evolving situations, seeks mentorship for informed decisions, and handles risks associated with uncertain outcomes. For This Role, You Will Need: 5 years of relevant work experience in safety instrumented system, process control, and automation. Experience in SIS (ESD, FGS, BMS) design in Engineering Industry is desired, preferably in Oil & Gas, Refineries, Chemical, Petrochemical SIS design & engineering projects. Preferred Qualifications that Set You Apart: A bachelor's degree in Instrumentation, Electronics, Electronics & Telecommunication. Our Culture & Commitment to You At Emerson, we prioritize a workplace where every employee is valued, respected, and empowered to grow. We foster an environment that encourages innovation, collaboration, and diverse perspectives. Our commitment to ongoing career development and growing an inclusive culture ensures you have the support to thrive. We believe diverse teams are key to driving growth and delivering business results. About Us Emerson is a global leader in automation technology and software, helping customers in critical industries operate more sustainably while improving productivity, energy security, and reliability. We offer equitable opportunities, celebrate diversity, and embrace challenges with confidence. Join our team and make a difference with Emerson.,

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2.0 - 7.0 years

3 - 8 Lacs

ahmedabad

Work from Office

Walk-in at Matoda We are hiring multiple positions for our manufacturing facility at Matoda as mentioned below. Please find our current job requirements and venue details mentioned. If any of the requirements match your current job profile, kindly walk in with your latest resume. Role & responsibilities Injectable Manufacturing & Visual Inspection & Packing Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspection / Packing / VI (Senior Officer / Officer / Associate) Experience - 02 to 07 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI Engineering (Instrumentation / Process Equipment Maintenance) (Senior Executive / Executive / Senior Officer) Experience - 03 to 10 Years Qualification BE / B Tech Time and Venue : 30/08/25, Saturday 09:30 Hrs to 18:00 Hrs ______________________________________________________ INTAS, Matoda facility Plot No. 457, 458 Sarkhej Bavla Highway, Matoda Village, Sanand, Taluka, Ahmedabad, Gujarat 382210 ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. *Having relevant qualification only can attend the scheduled walk-in.

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10.0 - 15.0 years

10 - 20 Lacs

navi mumbai

Work from Office

Job Title: Quality Assurance Manager Location: Rabale, Navi Mumbai Experience: 10 15 years Department: Quality Assurance Employment Type: Full-time Reports To: Quality Head About Fusion Scientific Laboratories Fusion Scientific Laboratories is a USFDA and EMA accredited pharmaceutical laboratory based in Rabale, Navi Mumbai , offering world-class services in Formulation Development , Analytical Solutions , and Integrated Pharmaceutical Services (CDMO) . We partner with pharmaceutical companies globally to deliver compliant and innovative solutions across the drug development lifecycle. Position Overview We are looking for a highly experienced Quality Assurance Manager to lead quality oversight for oncology product development, formulation, and pilot manufacturing , with a strong focus on compliance in both production and Quality Control (QC) Laboratory environments. The ideal candidate will have in-depth knowledge of GMP, regulatory compliance , and oncology product handling , with proven experience supporting regulatory inspections and audit readiness . Key Responsibilities General Quality Assurance Responsibilities Ensure end-to-end GMP compliance across formulation development, pilot manufacturing, and quality control functions for oncology products. Review and approval of Batch Manufacturing Records (BMRs) , analytical reports, and validation protocols for oncology drug substances and products. Lead deviation investigations , OOS/OOT management , and CAPA implementation in a timely and compliant manner. Maintain and improve quality systems such as Change Control, Risk Assessment, Quality Metrics, and Audit Trails. Ensure effective training programs are in place for staff involved in oncology manufacturing and testing, including PPE use and containment protocols. Support and host regulatory audits and client inspections; ensure constant audit readiness . Implement and monitor Data Integrity (ALCOA+) practices across all functions. Quality Oversight of cGMP QC Laboratory Oversee and ensure compliance of the QC laboratory with current GMP and GLP requirements specific to oncology products. Verify compliance with analytical method SOPs , regulatory compendia (USP, EP, IP), and internal specifications. Support implementation of Good Documentation Practices (GDP) in laboratory notebooks, logbooks, and electronic systems. Monitor proper functioning, calibration , and preventive maintenance of all critical QC instruments (e.g., HPLC, GC, ICP-MS, LC-MS/MS, etc.). Ensure environmental monitoring (EM) and microbiological testing for sterile oncology products are performed and reviewed per SOP. Facilitate timely investigation and closure of laboratory incidents, deviations, and out-of-specification (OOS) results. Collaborate with the QC and Analytical Development teams to ensure smooth and compliant execution of: Method transfers Reference standard qualification Sample management and chain of custody Oversee the archiving and retention of QC documents and raw data in accordance with regulatory and company requirements. Required Qualifications & Experience Master’s degree in Pharmaceutical Sciences, Chemistry, or a related discipline . 10–15 years of progressive experience in Quality Assurance , with exposure to oncology formulations , pilot-scale manufacturing , and cGMP QC laboratories . In-depth knowledge of ICH guidelines , USFDA, EMA regulatory expectations, and WHO GMP . Prior experience supporting regulatory inspections and/or client audits in a CDMO or oncology manufacturing setup. Strong understanding of HPAPI containment protocols , analytical method validation , and data integrity controls . Key Competencies Expertise in oncology product QA , QC laboratory compliance , and GMP system management Strong leadership and cross-functional collaboration skills Sound decision-making and risk assessment capabilities Proficiency in regulatory documentation and audit management Detail-oriented with a strong sense of ownership and accountability Why Join Fusion Scientific Laboratories? Be part of a growing, USFDA and EMA-accredited pharmaceutical laboratory focused on oncology innovation . Collaborate with top-tier pharmaceutical clients across the globe in a CDMO environment . Access cutting-edge technologies, a strong quality culture, and opportunities for professional advancement. Competitive salary, supportive leadership, and a high-performance work environment.

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4.0 - 8.0 years

0 Lacs

gujarat

On-site

As an Associate R&D (DQA) at our company located in Jhagadia, you will play a crucial role in the Research & Development department. You are required to have a qualification of M.Sc. in Chemistry or a related science field along with a minimum of 4 years of experience, preferably in the pharmaceutical industry. Your primary responsibilities will include reviewing Lab Validation Protocols/Reports (CRD) and Method Development/Validation documents (ADL), as well as reviewing specifications and STPs for raw materials, intermediates, and finished products. Additionally, you will be supporting DMF filings, stability studies, and regulatory documentation, preparing/reviewing SOPs, logbooks, and ensuring RA & GLP compliance. Collaboration with R&D, QA, ARD, and Regulatory Affairs teams is essential, as well as supporting internal and external audits (FDA, ISO) and handling DQ, IQ, OQ, and PQ documentation for equipment. Maintaining adherence to cGMP and regulatory standards is a key aspect of your role. Key competencies required for this role include having in-depth knowledge of GMP, GDP, and quality systems, along with proficient analytical, communication, and documentation skills. Having an energetic, resourceful, and audit-ready mindset is crucial for success in this position. If you believe you possess the necessary qualifications and skills for this role, we welcome you to send your CV to cv.hr@evokehr.com.,

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20.0 - 24.0 years

0 Lacs

maharashtra

On-site

The VP of Supply Chain at Piramal Critical Care (PCC) plays a pivotal role in overseeing and developing the Global Supply Chain operations under the strategic direction of the Executive Committee (Excom) and the EVP of Global Operations. In this position, you will be responsible for managing External Supply Operations, end-to-end Global Planning, Logistics, Procurement, revenue forecasting, and Supply Chain Operations across the three regions where PCC operates. As the VP of Supply Chain, you will collaborate with key stakeholders both internally and externally. Internal stakeholders include Regional Supply Chain heads, Excom Vice Presidents, Sales General Managers, and Alliance Management Head. External stakeholders encompass Customers, Third-Party Logistics (3PLs), Suppliers, and Contract Manufacturing Organizations (CMOs). Reporting directly to the EVP of Global Operations, you will lead a team of direct reports including the Director of Global Planning, Director of Supply Chain (USA), Chief Manager of Supply Chain, Deputy General Manager of Supply Chain, General Manager of Packaging Technology, Senior General Manager of Sales, and Director of Supply Chain (EU & ROW). To qualify for this role, you should hold a Bachelor's Degree in Business, Supply Chain, Engineering, or a related field. An MBA or Graduate level Supply Chain degree is preferred, along with certifications such as CPM, CPIM, CSCP, and CPP. The ideal candidate will have a minimum of twenty years of experience in manufacturing or supply chain roles within the pharmaceutical, life sciences, or medical device industry. Additionally, five years of experience leading global Supply Chain teams, especially within the generic pharmaceuticals sector, is desirable. Key responsibilities of this role include ensuring cost-efficient and sustainable supply chain operations across all regions, managing inventory working capital targets, overseeing Global Planning and B2B order processing, and serving as the de facto Kurla Site Administrative Head for PCC. You will also be responsible for developing team members, policies, and processes, as well as leading the SCM team to achieve the organization's strategic and financial goals. The ideal candidate should possess strong analytical skills, excellent communication abilities, and a collaborative and results-oriented mindset. Experience in managing global supplier relationships, knowledge of supply chain software, and familiarity with logistics and warehousing practices are key competencies required for this role. Piramal Critical Care (PCC) is a subsidiary of Piramal Pharma Limited (PPL) and a global player in hospital generics, specializing in Inhaled Anaesthetics and critical care solutions. With a commitment to sustainable growth and inclusive practices, PCC aims to deliver high-quality critical care products to patients and healthcare providers worldwide.,

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