842 Capa Jobs - Page 15

Quality Assistant Manager / Deputy Manager: Hatari Cold Forge - Small Screws Manufacturing Key Responsibilities: Lead and manage the Quality Assurance (QA) and Quality Control (QC) functions in the plant. Implement and maintain ISO 9001 / IATF 16949 quality management systems. Monitor in-process quality control , incoming raw material inspection , and final product audits . Handle customer complaints, CAPA (Corrective and Preventive Actions) , and ensure closure within deadlines. Conduct internal quality audits and coordinate with external auditors. Develop and maintain quality documentation (SOPs, Work Instructions, Quality Plans). Use tools like PPAP, FMEA, SPC, MSA, 7QC tools to drive continual improvement. Train shop-floor employees on quality standards and defect prevention. Interface with production, maintenance, and R&D teams to ensure consistent quality output. Preferred Qualifications: Education: Diploma / B.E / B.Tech in Mechanical Engineering or related field. Experience: 5-10 years in quality control/quality assurance in a precision component or fastener manufacturing industry. Technical Skills: Knowledge of cold forging processes is a strong advantage. Proficiency in quality tools (PPAP, APQP, FMEA, 7 QC Tools). Exposure to calibration , gauging , and use of measuring instruments (Micrometers, Verniers, Profile Projector, etc.). Soft Skills: Strong leadership, communication, problem-solving, and analytical abilities.

Opening with an leading Pharma Company. Role & responsibilities : Continuous process Monitoring Batch Release of Finished product Collection of Sample ie in-process, Finished Product , Control, Stability and Tendor Knowledge of Collection of Validation samples i.e process validation, cleaning and hold time validation. Knowledge of review of Master and executed MFR/BMR and MPR/BPR Adequate knowledge of Inprocess checks of Tablet ,Capsule ,Liquid and Ointment. Adequate knowledge of Shop floor related Non-compliance ,its root cause and compliance. Adequate knowledge of calibration of instruments ie weighing balance , friabilator, DT apparatus, hardness tester, Vernier calliper, Moisture analyzer, leak test apparatus and Ph meter etc. Interested candidates shared resume on snehal@topgearconsultants.com

Role & responsibilities Job Summary We are seeking an individual for the Quality Control Microbiology team, responsible for review and approval of microbiology analytical data/record, review of EM and water trend, monitoring of aseptic process simulation. Review and approval of Analytical method validation related to Microbiological test. This role includes the participation into investigation related to Microbiology Roles & Responsibilities Responsible for Review and release of Microbiological Tests (Environmental Monitoring, Water Testing, Microbial Limit Test, Sterility Test and Bacterial Endotoxins Test). Responsible for review and Approval of Microbiological testing data/ Master data in LIMS. Handling of QMS elements like change control, Incident, OOS, OOT and CAPA related to Microbiology. Responsible to carry out the investigations related to Microbiology and timely closure of the same within the defined timeline. Review and approval of SOPs, protocols and reports related to Microbiology. Ensuring the compliance of Audit observations related to Microbiology. To review trends as applicable and to recommend any changes for the better control of the system. To review and approve STPs, Specifications, preparation of record of analysis and analytical test report. To ensure cGLP activity in lab and compliance in Microbiology laboratory. Responsible for the Monthly audit trail review of Instrument /Equipments related to microbiology. Responsible for the review and approval of Analytical method validation with respect to Microbiology. Monitoring of Media Fill/ Process Simulation and review of media fill protocols and reports. Educational qualification: A Master degree in Microbiology, or a related field. Minimum work experience : 5 to 8 years of experience in Pharmaceutical Microbiology / Quality assurance or a similar role Skills & attributes: Technical Skills • Knowledge of microbiology and aseptic practices and Aseptic Process simulation activities and disinfectant validation and handling of Microbiological Cultures. • Skilled in review of Microbiological data, EM, water and compressed air trends. • Review of EM and water trends, trends, Handling of Microbiological Culture. Behavioural Skills • Attention to detail in performing line clearance, verification, and record reviews. • Skilled in time management and coordination for sampling, testing, and execution of batch manufacturing and packing activities. • Communicates effectively with team members and stakeholders regarding batch-related activities and compliance. • Applies problem-solving skills in addressing issues related to line clearance, sampling, and record certification. • Demonstrates a focus on maintaining high-quality standards and adhering to regulatory compliances in manufacturing processes.

NAB is looking for Analyst to join our dynamic team and embark on a rewarding career journeyGather, analyze, and interpret complex datasets to identify trends, patterns, and insights that support strategic decision-making within the organization.Develop, maintain, and update detailed reports, dashboards, and visualizations to communicate key metrics and findings to stakeholders.Collaborate with cross-functional teams to understand business needs, translating them into data requirements and actionable insights.Conduct market research, competitor analysis, and customer behavior studies to inform business strategies and improve performance.Monitor data integrity and accuracy, implementing quality control measures to ensure reliable, consistent reporting.

Job Responsibilities: 1. Monitoring and Assessment of QMS related activities for all API sites (Nerul, Chiplun and Ambernath) and Govandi (CPRL, PAN, BRL etc.). 2. Change Controls: Review and closure of change controls, approval and closure of actions childs, CQA Assessment etc., 3. Review of Customer Complaints, Risk Assessments, Deviations, CAPAs, Investigations, Recalls etc., 4. Handling of Customer Quality agreement and co-ordination with cross functional team till execution of the agreement. 5. Tracking of CQA SOPs as per the review date, by maintaining the SOP Periodic review tracker and master SOP list. 6. Preparation/Revision of CQA SOPs and making master, effective after completion of training. 7. Review of Master formula and technology transfer documents for API sites. 8. Master product label information update in Traces application as per the site requirement. 9. To provide training of SOPs, cGMP, or other modules as per the requirement. 10. Review of SOPs related to various departments of corporate functions (e.g. CPRL, PAN Lab, HR etc). 11. Scheduling and participation in self-audits (Sites and corporate functions). 12. Regulatory and customer audit support to sites. 13. Review of Specifications for raw material, intermediate, finished API, working standard, GTPs of API Sites in DocuSign. Master and making effective through DocuSign and distribution of controlled copies to site and CFTs. 14. Handling Customer Questionnaires, Regulatory Agencies Questionnaires and Customer queries as per the requirement. 15. Participation in Quality related meetings. 16. Shall perform any other related work/projects assigned by CQA HOD/Section head.

1.Having good knowledge about maintenance basic concepts about MTTR , MTBF , technical knowledge about pharma equipments.

Job Summary We are seeking an individual to verify compliance for activities in the respective counter function regularly. This role involves reviewing real-time investigations, ensuring smooth batch manufacturing and testing activities, and evaluating practices against defined standards, to ensure consistent product quality and operational compliance within the regulatory framework and global standards. " Roles & Responsibilities You will be responsible for executing or assigning in-process activities during shifts, conducting line clearances, material verification, overseeing start-up of machines, and coordinating sampling activities to ensure product quality and compliance. You will be responsible for executing or assigning the execution of batch records and log books, filling in various applicable formats, including line clearance and sampling formats, along with batch records review sheets. Your tasks also involve reviewing the records maintained by the Production team, creating additional records as needed, conducting all documentation with respect to Quality Assurance (QA) activities, ensuring that documentation is happening online, and follow the incident reporting system in the case of deviations. You will be responsible for issuance, availability, and adherence of approved procedures to the manufacturing team. You will be tasked with checking the adherence to the Quality Management System (QMS) elements, such as change control, incident management, and CAPA (Corrective and Preventive Actions) management on the shop floor. Your responsibilities also include verifying whether the manufacturing facility meets basic Good Manufacturing Practice (GMP) requirements at all times, including facility upkeep, environmental conditions, segregation of materials, and status labeling. In case of deviations, you will follow the incident management process. You will provide essential support to the supervisor in conducting investigations related to complaints, batch failures, Out-of-Specification/Out-of-Trend (OOS/OOT) results, incidents, etc. by collating data and conducting interviews. You will coordinate with cross-functional teams to facilitate and drive the investigation process, conduct a thorough root cause analysis, document CAPA, verify implementation within the agreed timeline, and monitor its effectiveness over time. You will be responsible for supporting or assigning personnel to assist in internal and external audit activities, following the instructions of superiors, providing necessary information, documents, and clarifications to supervisors during actual audits, and maintaining appropriate records. You will follow up with respective user departments to share audit responses and diligently track and maintain the closure of action items arising from audits as needed. " Qualification Educational Qualification A B.Pharm. or Post-Graduation (Life Sciences) Minimum Work Experience 4 years of industrial experience with specific operational experience in Manufacturing, Quality Control, Quality Assurance or Engineering & Development Skills & Attributes Technical Skills: A solid understanding of Quality Systems and the ability to comprehend and navigate counter functions within the organization. In-depth knowledge and comprehension of the Bio Pharma and Pharma markets, including product knowledge, market trends, competitors, and customer needs. Understanding and familiarity with global cGMP (Current GMP) regulatory requirements, including those set by FDA (U.S. Food and Drug Administration), EU (European Union), and Indian regulatory authorities. Awareness of broader market dynamics, industry trends, and factors influencing the pharmaceutical market. Comprehensive knowledge of the specific products associated with the pharmaceutical organization, including their characteristics, manufacturing processes, and quality requirements. Ability to understand and implement organizational policies and ensuring compliance. Behavioural Skills: Demonstrates a commitment to continuous learning. Strong communicating and influencing skills. Displays analytical and logical thinking abilities. Is self-motivated and takes initiative. Adaptability to the work environment, along with being a team player. Ability to go beyond boundaries, showcasing a proactive and innovative approach. " Additional Information About the Department Biologics Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon... " Benefits Offered At Dr. Reddy’s, we actively help to catalyze your career growth and professional development through personalized learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards... " 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... For more details, please visit our career website at https://careers.drreddys.com/#!/ "

Implement and maintain the company’s QMS ISO 9001 Collaborate with cross-functional teams to ensure compliance with quality standardsDocumentation control and QMS records. Lead root cause analysis and resolution of quality issues and non conformances

Person should familiar with instrumentation and having working experience in DCS 800 X manufacturing ecosystem. Experience in repair and calibration of various process field DCS panels troubleshooting. Required Candidate profile Exposure in setting up testing stations for fast moving and reusable parts such as valves Should have knowledge of ISO system, documentation & possess strong analytical & communication skills. .

Job Summary We are looking for an individual for the SIT Team to oversee the investigation of major and critical deviations, working closely with Cross-Functional Team (CFT) members to identify root causes and implement corrective and preventive actions. The role involves active participation in investigating Out of Specification (OOS) cases, ensuring accurate classification in the DCMS deviations log, and providing support during regulatory inspections. Roles & Responsibilities • You will be responsible for overseeing the investigation of major and critical deviations from the outset, collaborating closely with Cross-Functional Team (CFT) members to identify root causes, corrective actions (CA), preventive actions (PA), and preparing comprehensive reports. Your will also be working on the trending of the deviations and identification of adequate action items for reduction of the same. • Your role involves active participation in investigating OOS (Out of Specification) and other relevant cases, working closely with CFT members to determine root causes, CA, PA, and report writing. • You will review minor and critical , providing constructive feedback for improvement. • Your responsibilities include periodically assessing the trending of minor deviations, highlighting or escalating key observations, regularly reviewing the deviations log to ensure accurate classification, and utilizing the Rubrics template for crafting investigation reports. • You will offer necessary support to the site in readiness for or during regulatory inspections related to investigations. Qualification Educational qualification: A Bachelor's or Master's degree in a relevant scientific field, such as Chemistry, Biochemistry, Pharmacy, or related discipline Minimum work experience : 7 to 10 years of experience in a pharmaceutical or related industry with a focus on investigations and quality assurance Skills & attributes: Technical Skills • In-depth knowledge and experience in overseeing investigations, and familiarity with root cause analysis, corrective actions (CA), and preventive actions (PA). • Expertise in investigating valid OOS and other relevant cases. • Familiarity with reviewing deviations / OOS log and ability to perform classification of data. • Ability to craft comprehensive investigation reports. • Experience in providing necessary support for regulatory inspections related to investigations. • Knowledge of regulatory requirements pertaining to deviations investigations. Behavioural Skills • Ability to collaborate closely with CFT members. • Analytical mind set for identifying root causes and developing effective solutions. • Strong problem-solving skills and attention to detail in reviewing deviations, reports, and trending data and implementing corrective actions. • Effective communication skills for report writing and escalation of key observations. • Commitment to ensuring compliance with regulatory requirements in investigations. • Ability to offer necessary support to the site in readiness for or during regulatory inspections. Additional Information looking someone with strong QC Microbiological investigation background. Should have exp in Microbiological compliance. Education :M.Sc. Microbiology Exp : 8-10 Years Industry : Injectable preferred/ OSD will be second preference Person will be responsible to manage 3 sites Microbiological compliance at Baddi

Experience: 7 to 14 years in Engineering for Automation and 21 CFR for Manufacturing Equipment Qualification: BE/B.Tech Designation- Senior Executive to Assistant Manager Level What is 21CFR Automation? 21 CFR Part 11 is an FDA regulation that defines the criteria under which electronic records and signatures are considered reliable and equivalent to paper. Roles involving 21CFR automation engineering typically lie at the intersection of automation, computer system validation (CSV), GMP compliance, and process control. Key Responsibilities: System Design & Integration Design , program , test , and implement automated systems (PLCs, SCADA) for manufacturing or laboratory use, ensuring they support FDA-regulated processes Validation & Compliance Develop and execute validation documentation including URS, FS, DSand protocols such as IQ, OQ, and PQ, all aligned with 21CFR Part 11, cGMP, and GAMP standards Ensure compliance with data integrity, user security, disaster recovery , and system backup provisions per Part 11 Support & Troubleshooting Provide day-to-day operational support , including on-call troubleshooting for upstream/downstream manufacturing systems Lead rootcause analyses for system failures and corrective/preventive action (CAPA) activities Documentation & Audit Readiness Document processes, software versions, maintenance logs, and validation reports to maintain audit trails Support audits ; act as subject-matter expert for internal and regulatory inspections Cross-Functional Leadership Collaborate with process engineers, QA, IT, production , and external vendors to align automation with operational and compliance requirements . Drive continuous improvement through smart manufacturing Cybersecurity & Regulatory Controls Maintain enterprise-level cyber resiliency , including OS patching, control system security, and user access compliance Key Skills and Competencies: Hands-on experience with 21 CFR and Automation in Engineering for OSD/Injectable Facility area equipment. Good knowledge of cGMP Hands on Technical exposure on PLCs,SCADA,HMI System specs, trace matrices, IQ/OQ/PQ, CSV per 21CFR Part 11 and cGMP Deep knowledge of FDA regulations (Part 11, data integrity, cyber security compliance) Troubleshooting, CAPA, on-site support, SOP development Role & responsibilities Preferred candidate profile

About the Role: Grade Level (for internal use): 08 The Role Implementation Engineer The Team The Portfolio Analytics (PA) Application Support team is responsible for onboarding and supporting clients on the Capital IQ platform. Historically focused on manual ingestion workflows and reactive troubleshooting, the team is now evolving to take on a more technical, proactive, and scalable approach. This role will be key in driving that transformation building automation, scripting ingestion processes, and supporting API-based integrations. The Impact This is not just another support role. You will be part of the teams next chapter helping shift from manual operations to automated, scalable solutions . Your technical contributions will improve the client onboarding experience, reduce turnaround time, enhance data accuracy, and free up the team to focus on more strategic tasks. Youll work across client use cases, internal tooling, and automation pipelines directly shaping the future of support within Portfolio Analytics. Responsibilities Support client onboarding by implementing batch ingestion jobs and API integrations Develop and maintain Python scripts for data preprocessing and validation workflows Help automate recurring ingestion tasks , moving away from manual interventions Troubleshoot ingestion or integration issues by working across data, scripts, and scheduling systems Build internal tools and reusable components to support ingestion and workflow scalability Collaborate with Product and Engineering on testing and deploying new ingestion features Maintain technical documentation to standardize and scale implementation support Partner with client-facing teams to deeply understand use cases and deliver technical solutions What Were Looking For 02 years of experience in a technical role (support, implementation, automation, or scripting) Proficiency or strong familiarity with Python and basic scripting logic Understanding of REST APIs and data formats such as JSON, CSV, Excel Exposure to SQL or file-based data manipulation tools (e.g., pandas, shell scripts) Interest in solving operational problems through automation and process improvement Ability to learn financial data structures such as portfolios, benchmarks, and securities Strong analytical and troubleshooting skills, with excellent attention to detail Bachelors degree in Computer Science, Engineering, or a related discipline Why This Role Matters Now As we scale Portfolio Analytics across a growing client base, ingestion and automation will be at the core of our success. This role is an opportunity to join that journey early helping redefine how support is delivered and building the technical foundation for what comes next. About S&P Global Market Intelligence At S&P Global Market Intelligence, a division of S&P Global we understand the importance of accurate, deep and insightful information. Our team of experts delivers unrivaled insights and leading data and technology solutions, partnering with customers to expand their perspective, operate with confidence, andmake decisions with conviction.For more information, visit www.spglobal.com/marketintelligence . Whats In It For You Our Purpose: Progress is not a self-starter. It requires a catalyst to be set in motion. Information, imagination, people, technologythe right combination can unlock possibility and change the world.Our world is in transition and getting more complex by the day. We push past expected observations and seek out new levels of understanding so that we can help companies, governments and individuals make an impact on tomorrow. At S&P Global we transform data into Essential Intelligence, pinpointing risks and opening possibilities. We Accelerate Progress. Our People: Our Values: Integrity, Discovery, Partnership At S&P Global, we focus on Powering Global Markets. Throughout our history, the world's leading organizations have relied on us for the Essential Intelligence they need to make confident decisions about the road ahead. We start with a foundation of integrity in all we do, bring a spirit of discovery to our work, and collaborate in close partnership with each other and our customers to achieve shared goals. Benefits: We take care of you, so you cantake care of business. We care about our people. Thats why we provide everything youand your careerneed to thrive at S&P Global. Health & WellnessHealth care coverage designed for the mind and body. Continuous LearningAccess a wealth of resources to grow your career and learn valuable new skills. Invest in Your FutureSecure your financial future through competitive pay, retirement planning, a continuing education program with a company-matched student loan contribution, and financial wellness programs. Family Friendly PerksIts not just about you. S&P Global has perks for your partners and little ones, too, with some best-in class benefits for families. Beyond the BasicsFrom retail discounts to referral incentive awardssmall perks can make a big difference. For more information on benefits by country visithttps://spgbenefits.com/benefit-summaries Global Hiring and Opportunity at S&P Global: At S&P Global, we are committed to fostering a connected andengaged workplace where all individuals have access to opportunities based on their skills, experience, and contributions. 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Overseeing the quality assurance function at our manufacturing sites located in Baddi & Rudrapur. Ensure that all products manufactured at the sites adhere to the required quality standards, regulatory requirements, and internal procedures. Required Candidate profile M.Sc/B.Pharm/M.Pharm 12+ year QA experience in a regulated pharma/CDMO environment Strong knowledge of cGMP, ICH & regulatory guidelines Hands-on experience in audits, documentation, quality systems

*Develop, implement, and monitor quality assurance policies and procedures for manufacturing. *Conduct inspections, testing, and audits at various stages of production to ensure adherence to quality standards and specifications. Required Candidate profile *Oversee after sales service operations, including installation support, troubleshooting, and maintenance. *Manage warranty claims, spare parts inventory, and logistics for replacement parts.

Responsibilities: Conduct reliability testing & failure analysis Implement FMEA, CPk, Failure Mode Analysis Perform root cause & defect analyses Experience in electronic product/module is preferable Exp in product quality functions

Title - CAPA Engineer Location Pune experience 5+ Notice period - Immediate to 30 days QA CAPA. CAPA Quality Engineer,• Independently produces and completes CAPA records . • Responsible for performing timely, detailed CAPA engineering tasks like assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis, and quality problem-solving.,Additional support for CD related activity as approved by Dan Leonard for Priority 2 APEX Resource General - needed to support both ongoing CAPAs as well as CAPAs related to CD. Anticipated influx of 40-50 new CAPAs associated with CD audits. Reduces probability of us missing commitment dates for CAPs and in turn reduces financial penalties that the company has to pay.

Immediate joiners are preffered. Interested candidates can share resume on dipika.parmar@milanlabs.com 1.To review and implement Quality Management System for cGMP compliance at site. 2.To review and approve of product design. 3.To review and approval of production and quality control documentation for compliance with GMP and GLP requirements. 4.To Handle Caliber BRM, QAMS, DMS, Nichelon 5 CMS, E-logbook, E-schedule, Microsoft Dynamic, NCR 5.To review and approve SOPs, Validation Protocols, Master Batch Production Records and other related documents at site. 6.To review and approve Change Control, Incident /Deviations and ensure its closure, within given timeframe as per respective SOP. 7.Approval signatory for all SOPs, Master Batch Records, Qualification, Validation, documents of Analytical and Manufacturing equipment, Specifications, Change Control, OOS investigations and other investigations, Stability Protocols, and other Master Documents. 8.Vendor Assessment. 9.Handling of OOS. 10Process validation and equipment cleaning validation. 11.To review batch production Records and Analytical documents, to assure that the batch has been manufactured and tested as per laid down procedure / specification. Deviation if any, are recorded, investigated, documented and authorized. 12.To export certification for batches intended for exports. 13.To release (approval or rejection) the batch manufactured at site. 14.To monitor qualification, validation and requalification activity at site. 15.To trend the data and analyses the trend. 16.To Prepare and approve Annual Product Quality Review for drug substance / drug product quality, Recommend the area of improvement, as applicable. 17. To investigate market compliant. Review response. 18.Handling of product recall. 19.To review Product License Application and support Regulatory department for obtaining the product license from the local Regulatory Authority. 20.To review and submit the data / information to Regulatory Affairs for preparation of DMF/dossiers/application for registration of the product with Regulatory Authority of the countries, intended to market the product. 21.To ensure implementation of the CAPA initiated as a result of self-audit, customer, regulatory audit.

Roles and Responsibilities Conduct BMR reviews, CAPAs, GMP audits, and IPQC activities to ensure compliance with quality standards. Perform incoming inspection, process validation, and equipment qualification tasks as per SOPs. Identify and report deviations/OOS/OOT events during production runs. Collaborate with cross-functional teams to resolve quality issues and implement corrective actions. Maintain accurate records of QMS documentation and participate in training programs. Desired Candidate Profile 3-8 years of experience in pharmaceutical industry with expertise in IPQA (In Process Quality Assurance). Strong understanding of Good Manufacturing Practices (GMP) regulations. Proficiency in performing BMR reviews, CAPAs, GMP audits, IPQC activities. Experience with Incoming Inspection, Process Validation, Equipment Qualification processes.

Roles and Responsibilities Ensure compliance with quality management systems (QMS) through implementation, maintenance, and continuous improvement of ISO documentation. Prepare SOPs for various processes such as BMR, CAPA, Change Control, Cleaning Validation, etc. Conduct qualification testing and validation protocol execution to ensure product quality and regulatory requirements. Develop and maintain accurate records of test results, reports, and certificates related to quality assurance activities. Collaborate with cross-functional teams to identify areas for improvement in quality control processes. Desired Candidate Profile 5-10 years of experience in pharmaceutical industry with expertise in QMS implementation. Strong understanding of GMP regulations and industry standards like ISO 9001:2015. Proficiency in preparing documents like BMR, SOPs, Capas, Change Control procedures. Experience with cleaning validation process validation protocol execution.

Expertise in computer system validation, QMS and IT Compliance. Good understanding of GAMP 5, 21 CFR Part 11, Annex 11, ICH Q9. QMS: Initiation/Review of change management, Investigation, CAPA, Deviation etc. WFO, Mumbai - Immediate - 15 Days

Job Title: QA Assistant / Executive - API Industry Location: Kakinada, AP Company: Lyfius Pharma About Lyfius Pharma is 100% subsidiary of Aurobindo Pharma. Its largest API Unit of Aurobindo. Lyfius spread across 236 acres in Kakinada SEZ and it is second largest API manufacturing facility in ASIA. Qualification: M Sc / B Sc/ B Pharm Experience: 2 to 10 Years Job responsibilities: Quality Management System QMS Handling & Responsible for: Change Control, Deviation, Out of Specification, Market Complaint, Corrective and Preventive Action (CAPA) Annual Product Quality Review. Audit Compliance Report Preparation. Document Controller All document Issue, Review & Retrieval COA preparation BMR & BPR Preparation & Review Specification, Method of Analysis & Protocol & Report preparation for Finished product, Intermediate product, In-process, Raw material, Packing material. Standard Operating Procedure (SOP) Preparation Site Master Plan & Validation Master Plan Preparation Technical Data Package (Tech Pack), Formula Master Preparation. All Declaration Preparation for regulatory submission, Customer Free Sample, Vendor Sample and Customer Query Related work. Policies & system procedures preparation. External Manufacturing & Toller documentation Control & Follow-up. Training Calendar preparation and control. Qualification / Calibration / Validation Responsible for all Calibration activity Internal & External and maintained the record. Responsible for Equipment Qualification & Documentation control Vendor Qualification and regular follow up for updated documentation by the supplier, Process Validation Protocol & Report Preparation Cleaning Validation Protocol & Report Preparation Analytical Method Validation Protocol & Report Preparation IPQA Issue and control of SOPs, BMRs, BPRs, BCRs and also finished product label/product container seals /sealing of the containers as the part of IPQA activities. Review BMRs, BCRs and analysis records before release of API. Perform sampling of APIs, maintain its records and ensure the cleaning of sampling tools. Provide line clearance at the time of product changes over. Perform the documentation control activity at site. Monitor/Maintain/Review of Records and Handling of controlled/Retained samples of Intermediates/Finished API.

Job Description Conduct all tasks/ activities as per the applicable SOPs. Report any difficulty or deviation in the procedures/instructions to immediate Supervisor/Managers. Report any quality concerns or suggestions for improvements to Supervisor/ Managers.Preparation and Review of Quality Assurance SOP’s. Review of other departments SOP’s. Review of Master Documents such as BMR/BPR, Test batch monitoring protocols / process validation protocol and reports etc. Initiation and log in of Quality System document such as Deviation, Change Control, OOS, OOT, market complaint, Annual product review and Non conformities. Work Experience 3-5 Years Education Graduation in Pharmacy Competencies

Key Roles and Responsibilities Prepare manuals, SOPs, and work instructions without errors. Conduct internal audits for IMS as per ISO 9001:2015, ISO 14001:2015, and ISO 45001:2018. Perform facility and 5S audits. Assist and guide departments in implementing 5S practices. Create and maintain documents as per RJC requirements. Prepare presentations and monthly review meeting reports. Explain processes or concepts in detail. Analyze problems and find solutions. Understand and apply standards and requirements. Be a self-learner and strive for continuous improvement. Work with a result-oriented mindset. Be self-motivated with a professional and ethical approach. Collaborate well with team members. Educational Qualifications & Experience Any UG degree or diploma with relevant experience 0-6 Years Experience Proficient in MS Office, Root Cause Analysis (RCA), and Corrective Action Preventive Action (CAPA). Experience working with ISO standards is essential. Strong communication and presentation skills. Fluency in English, Tamil, and Hindi (preferred). Good analytical and problem-solving skills. Detail-oriented with a focus on continuous improvement. Team player with a positive attitude. If you are interested in this position, please reach out directly at 8056907222 / 8056923339 or share your resume at sanjay.m@ejindia.com.

We are looking for a highly skilled and experienced Regional Manager to lead our Internal Control and Quality team in Noida, Sector 51. The ideal candidate will have a strong background in finance and quality control, with excellent analytical and problem-solving skills. This role requires 5-10 years of experience. Roles and Responsibility Conduct structured and periodic investigations to ensure process adherence in microfinance branches. Gather field intelligence and customer insights from a team of quality assurance executives. Act as a quality custodian across branches, analyzing reports and suggesting corrective actions. Ensure 100% quality compliance against observations highlighted by the quality team within specified timelines. Take disciplinary action against deviant behavior or deliberate attempts to violate processes. Anchor monthly quality reviews at the regional level, summarizing root causes and promising follow-up on overdue issues. Coordinate with the corporate office to support business functions related to reports, TAT, grievances, and project execution. Manage credit function for micro enterprise loans. Conduct market research as needed for specific purposes. Job CA / MBA Finance degree. Strong knowledge of banking operations, financial services, and broking. Excellent analytical, problem-solving, and communication skills. Ability to work independently and collaboratively as part of a team. Strong attention to detail and ability to meet deadlines. Experience in managing credit functions and conducting market research.

We are looking for a highly skilled and experienced Regional Manager to lead our Internal Control and Quality team in Hyderabad, Telangana & Madhya Pradesh. The ideal candidate will have 5-10 years of experience in the banking or financial services industry. Roles and Responsibility Conduct structured and periodic investigations to ensure process adherence in microfinance branches. Gather field intelligence and customer insights from quality assurance executives. Act as a quality custodian across branches, analyzing reports and suggesting corrective actions. Ensure 100% quality compliance against quality team observations within specified timelines. Take disciplinary action against deviant behavior or deliberate process lapses. Anchor monthly quality reviews at the regional level, summarizing root causes and promising follow-up on overdue issues. Job CA / MBA Finance degree with a strong academic record. Minimum 5 years of experience in internal control and quality management. Possess strong knowledge of credit functions, market research, and project execution. Demonstrate excellent communication and interpersonal skills. Ability to work independently and collaboratively as part of a team. Exhibit strong analytical and problem-solving skills. Additional Info The company offers a competitive salary package and opportunities for professional growth and development.