92 Oot Jobs - Page 4

Kaliberr bioscience pvt ltd is looking for QA Executive to join our dynamic team and embark on a rewarding career journey You will also be responsible for identifying and resolving quality-related issues and ensuring that the company's products and services meet the requirements of customers Conduct regular quality audits to identify and resolve quality-related issues Develop and maintain quality metrics to track performance and identify areas for improvement Manage the documentation process for quality assurance procedures, including the creation and maintenance of standard operating procedures (SOPs)

Oversee the entire quality assurance process, from raw materials to finished goods, ensuring consistent quality & compliance, ensuring that products meet regulatory requirements & quality standards like ISO 13485, ISO 9001, 21 CFR 211 & 21 CFR 820 Required Candidate profile Bachelors in science 10-15 years' experience in quality in medical device/ pharma industry QMS implementation experience Must have regulatory audit exposure Like WHO/ USFDA & EU GMP

Job Summary Roles & Responsibilities Review and approval of all analytical test data of Quality control. Review and usage decision of analytical reports in LIMS, Empower and SAP. Electronic signatures level-2 for chromatography data station (CDS) and standalone instruments. Review the Analytical test report in LIMS. Review the reported results against specification and trends. Review the method validation and method transfer documents. Review the instrument calibrations and working standard qualification records. Handling the Incidents/ Deviations, Out of Trends, Out of Specification including investigations, Corrective and Preventive actions follow up and closure. Monitoring of analytical activities in Quality control laboratory. Verification of Specifications/standard test Procedures/Worksheets/Analytical Reports before Approval. Verification and review of the audit trails for Standalone, Empower and LIMS. Ensure cGMP / cGLP compliance. To follow Safety, Health and Environmental procedures and practices. Review and approval of excel sheet validations. Review results acceptance for API and Excipients and Packing material. Review of compiled of Stability Data and its verification/ Exhibit batch sampling protocols. Handling of Robotic Process Automation of Chromatography Data review (RPACD) To carry any other activities assigned by upward reporting staff. Qualification Educational qualification: A Bachelor’s/Master's degree in Pharmacy, Chemistry, Chemical Engineering, or a related field Minimum work experience : 3 to 7 years of experience in QC or AQA department is mandatory. Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

Tata Tele Business Services is looking for Solution Architect - Growth to join our dynamic team and embark on a rewarding career journey. Collaborating with clients, engineers, and other stakeholders to determine project requirements and goals Developing and presenting design concepts, plans, and models to clients for approval Conducting site surveys and analyzing data to determine the best design solutions for a particular location and purpose Preparing detailed drawings and specifications Staying current with relevant building codes, regulations, and industry trends Managing budgets, schedules, and other project-related activities Ensuring that projects are completed within budget, on time, and to the satisfaction of clients and stakeholdersAn Architect must possess a combination of technical, creative, and interpersonal skills

Hello, Greetings for day! Please find the below JD Preparation/ review of standard operating procedure (SOP), calibration procedures, specifications, standard test procedures, general test procedures etc. Conducting training on specification and method of analysis, SOPS and calibration procedures. Handling of QMS documents like Change control, CAPA, Incidents, OOS, deviations, Out of calibrations, OOT etc. To ensure timely closure of documents like Change control, CAPA, Incidents, OOS, deviations, Out of calibrations, OOT etc. To investigate the laboratory error / incident and its impact on quality and analysis of all samples. Participating as a cross functional team member for investigation of any QMS related issues. To observe and maintain Good Laboratory Practices. To prepare / review documents like stability schedule, hold time study schedule, preventive maintenance schedule, calibration schedule. Co-ordination with outside calibration agencies. To prepare/review instrument qualification data. Coordinating with other departments for smooth functioning of laboratory. Arranging standards required for the analysis. Arranging columns required for analysis. To approved sign in TRF( Intermediate) ,GRN,Hold time sample, stability sample Ensuring training of departmental staffs as per job requirement. Attending training program as per CGMP training schedule. To take part in method validation/transfer/verification activity. To maintain discipline in the laboratory. To prepare the analysis request form and send the sample to contract laboratory for analysis. To take part in customer/regulatory/internal audits. Responsible for follow the health, safety & environment norms as per company policy & procedures. To monitor the good housekeeping practices in all quality control area. To co-operate in achieving the quality control objective. Preferred candidates should be form CDMO industry or somebody who has handled multiple API product and handled 50 members team. Interested candidates can share their update resume and below details on 'jyotsna.sable@aartipharmalabs.com' Total years of exp: Current CTC Exp CTC: Notice Period: Are you open for move to Gujarat: Do you have experience in CDMO/API Manufacturing Industry: what is the team size did you handle?

Position Assistant Manager - Quality Control Business Unit / Function Department - Quality Control Location Bharuch; SEZ;;;; Reports to QC Head; Summary of Job (Purpose/ objective of the job Department Organogram to be enclosed) candidate is required having complete experience in API/Bulk/ Intermediates industries as per global regulatory requirements and responsible for implementation and compliances of 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP, ISO9001, FSSC, HACCP / global QMS requirements at SEZ site. Key Responsibilities (Performance Indicators) Regularize the QC activities as per cGMP requirements. Regulatory and Pharmacopeia requirement for lab compliance. Review of hybrid and electronic data for IPQC and FG analysis.; Analytical method validation, OOS and OOT.; Knowledge about IMS system (ISO 9001:2015, ISO 14001:2015 OHSAS 18001:2007, and cGMP. Analytical skill for QC instrument, i.e. GLC, HPLC, UV-Visible, FTIR, ICP, K/F, Melting point etc. Co-ordination with QC staff, R and D, Commercial and production for quality and dispatch related activities for on time dispatches. Resolve the trouble shooting related to QC activities.; Training to subordinate and employment of 21 CFR Part 211, 111 with data integrity (Part-11) compliance in lab. Awareness about responsible care (Environment, Health, Safety and Security) No. of Reportees 2-3 numbers Qualification and Experience M.Sc. (Chemistry) with 8-12 yrs. y Competencies; (Technical, Functional and Behavioral) Responsible for implementation and compliances of 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP. Hand-on experience as Reviewer of electronic data and hybrid system in regulatory environment (US-FDA, WHO etc.) Knowledge about 21 CFR Part 211, 111 with data integrity (Part-11)

Key Responsibilities: Oversight of Quality Control activities related to Raw Materials and Packing Materials . Supervision & review of analytical data, documentation & compliance for material release. Handling of Quality Management System (QMS) elements including OOS, OOT, deviations, CAPA, and change controls . Coordination with cross-functional teams for timely review and resolution of quality issues. Ensuring regulatory compliance as per current GMP standards. Leading audits, facing regulatory inspections, and supporting continual improvement initiatives. Candidate Profile: B. Pharm / M. Pharm / M.Sc. with 15 - 20 years of relevant experience in the pharmaceutical industry. Strong exposure to quality control of raw and packing materials in regulated environments. Hands-on experience in QMS implementation and review processes . Excellent documentation, communication, and leadership skills. Must be willing to relocate to Mysore, Karnataka .

Analytical QA Reviewer - Officer: Looking for a candidate with 2 to 4 years of work experience as QC analyst / AQA reviewer in reputed pharma companies. Should have Knowledge of handling/ analytical data review of HPLC , FTIR , UV spectrophotometer , KF Autotitrator , Dissolution apparatus. Have Basic knowledge of CGMP , GDP , Data integrity . Should have Basic knowledge of OOS (Out of specification), OOT, OOC

Roles & Responsibilities 1. To perform In-process and Finished product tests for Assay, Related substance, Residual solvent, UOD, Dissolution, and Water content. 2. To perform Exhibit, Hold time and process validation samples analysis. 3. To Handle HPLC, GC, Dissolution, UV and KF systems and its maintenance. 4. To handle Empower software, sample sets loading and processing independently. 5. Good experience in chromatography. 6. Knowledge on Investigations, Deviations, OOT and OOS. 7. To handle SAP, LIMS and DCMS activities. 8. To follow good laboratory practices (GLP) and good documentation practices (GDP). Qualification Educational qualification: MSC chemistry, B-Pharm Minimum work experience: 5-7 years years in QC. Additional Information

business development - Warehouse PPC/BD-W/1312211 Contract Logistics PPL Head Office Posted On 16 Apr 2025 End Date 31 May 2025 Required Experience 3 - 5 years ShareApply Basic Section No. Of Openings 1 Designation Grade Assistant Manager - M3 Freshers/Experience Experience Employee Bonus One Month Organisational GPCOMP Pon Pure Chemicals Group Company Name Pon Pure Logistics Private Limited Department Contract Logistics Country India State Tamil Nadu Region Chennai Branch PPL Head Office Skills Skill Sales & Marketing Skills Communication skills Customer Data Minimum Qualification Under Graduate CERTIFICATION No data available Working Language English Hindi Tamil About The Role Person should have experience in business development warehousing business and strong customer data base. person able to convert existing customers on a faced manner. Product knowledge and communication skills are essential capable enough to achieve the targets as per the time frame -from the date of joining within three JC business conversion should take place. .

Lake Chemicals Pvt.Ltd., (Sterling Lab), is looking for Quality Control- Senior Executive to join our dynamic team and embark on a rewarding career journey Understand customer needs and requirements to develop effective quality control processes Devise and review specifications for products or processes Set requirements for raw material or intermediate products for suppliers and monitor their compliance Ensure adherence to health and safety guidelines as well as legal obligations Supervise inspectors, technicians and other staff and provide guidance and feedback Oversee all product development procedures to identify deviations from quality standards Inspect final output and compare properties to requirements Approve the right products or reject defectives Keep accurate documentation and perform statistical analysis Solicit feedback from customers to assess whether their requirements are met Submit detailed reports to appropriate executives Be on the lookout for opportunities for improvement and develop new efficient procedures Qualification: MBA/BBA/BBM in Marketing Experience: Fresher / 1-2 years of experience in API Marketing

Company Overview: We are a reputed pharmaceutical company specializing in the manufacturing of Oral Solid Dosage (OSD) formulations. Committed to high-quality standards and regulatory compliance, we are looking for a dynamic and experienced professional to join our Quality Control team. Job Purpose: The Assistant Manager Quality Control will oversee and manage day-to-day QC operations to ensure compliance with cGMP, GLP, and regulatory requirements for OSD manufacturing. This role is critical for maintaining product quality and supporting internal and external audits. Key Responsibilities: Supervise and lead a team of QC analysts and chemists in routine testing of raw materials, in-process samples, finished products, and stability samples. Review and approve analytical data, reports, and documentation in compliance with regulatory standards (USFDA, MHRA, EU, etc.). Ensure adherence to SOPs and perform periodic reviews and updates of QC procedures. Investigate out-of-specification (OOS), out-of-trend (OOT), and laboratory incidents, and implement CAPA. Coordinate and support analytical method validation, method transfer, and instrumentation qualification. Maintain and calibrate laboratory instruments such as HPLC, GC, UV, IR, and Dissolution testers. Assist in audit readiness and participate in regulatory and customer audits. Maintain LIMS or other data management systems effectively. Prepare and deliver periodic training sessions for QC staff. Desired Candidate Profile: Education: M.Sc. (Chemistry), B.Pharm, or M.Pharm Experience: 6–10 years in Quality Control within a regulated OSD manufacturing environment Skills: Hands-on experience with HPLC, GC, and other analytical instruments Sound understanding of cGMP, GLP, ICH guidelines Good documentation and review skills Proficiency in handling OOS/OOT and deviations Strong communication, leadership, and team management abilities Why Join Us? Opportunity to work in a growing, globally compliant pharma facility Competitive salary and performance-based incentives Strong focus on career development and technical training

Creation and Maintain relevant master data in the LIMS, Ensure that the integrity, reliability and performance of the LIMS is maintained. Address and resolve issues arising with the system in a timely manner Required Candidate profile Ready to work in Morning or General Shift To manage the QMS processes—including OOS investigations, Deviations, Incidents & Change Control & to ensure strict adherence to GDP & GMP within lab

Planning of work Responsible for overall analysis work in lab by handing team Documentation Reports preparation Review AMV OOS, OOT SOP Preparation.

Role Summary: OSD Production QMS is responsible for ensuring adherence to quality standards within the production process. The role involves monitoring production activities, implementing quality control measures, maintaining compliance with regulatory requirements, and driving continuous improvement initiatives. Roles And Responsibilities Quality Compliance: Implement and monitor compliance with QMS standards Industry-specific standards. Conduct periodic audits of production processes to identify deviations and enforce corrective actions. Ensure all production processes align with regulatory and company quality standards. Documentation & Reporting: Maintain and update standard operating procedures (SOPs), work instructions, and quality records. Prepare detailed reports on quality performance, including non-conformance incidents and corrective actions taken. Process Improvement: Analyze production workflows and recommend improvements to enhance efficiency and quality. Participate in root cause analysis for production issues and implement preventive measures. Key Skills and Competencies: In-depth knowledge of Quality Management Systems and standards. Strong analytical and problem-solving skills. Excellent communication and interpersonal abilities. Proficiency in using quality management tools and techniques. Familiarity with relevant USFD, EU, TGA regulatory requirements and industry best practices.

Role & responsibilities To carry out investigations related to OOS, OOT, Incident and Extraneous Peaks to ensure their closure and implementation of CAPA. Responsible for execution of Regulatory Notification as per SOP. To ensure implementation of all proposed actions identified as a CAPA of investigations related to OOS, OOT, and incident. Review of investigation reports, hypothesis protocol and hypothesis reports related to OOS/OOT and Incidents. Co-ordination with R&D, Production, Central Cell, CQA and other responsible for investigations. To prepare and review Quality documents such as (but not limited to) protocols, reports, SOPs STPs Specification, Investigation. Preferred candidate profile Perks and benefits

Preferred candidate profile Looking for a candidate with 2 to 4 years of work experience as QC analyst /AQA reviewer in reputed pharma companies. Should have Knowledge of handling/analytical data review of HPLC, FTIR, UV spectrophotometer, KF Autotitrator, Dissolution apparatus. Have Basic knowledge of CGMP, GDP, Data integrity. Should have Basic knowledge of OOS (Out of specification), OOT (Out of rend), OOC (Out of calibration).