840 Capa Jobs - Page 6

The Quality Assurance Manager role at our organization in Bagru, Rajasthan requires a minimum of 5-7 years of experience and a Bachelors Degree (or higher) in Chemistry, Biochemistry, Food Science/Technology, Analytical Chemistry, Chemical Engineering, or related disciplines. As the Quality Assurance Manager, you will be responsible for ensuring that the lab's Quality Management System (QMS) complies with ISO/IEC 17025:2017 and other regulatory requirements. This will involve managing audits, maintaining lab safety and equipment, resolving customer complaints, and driving continuous improvement. Key responsibilities include implementing and maintaining ISO/IEC 17025:2017 QMS, managing client and regulatory audits, overseeing lab operations, safety, equipment, and records, reviewing and approving deviations, change controls, and CAPA, resolving customer complaints, and providing training on ISO/IEC 17025:2017 and quality practices. Additionally, the role requires conducting performance reviews, monitoring quality tools, and ensuring GLP compliance. To qualify for this position, you must have a Bachelors Degree (or higher) in a relevant field, 5-7 years of experience in quality assurance within a lab, strong knowledge of ISO/IEC 17025:2017 and GLP, excellent leadership, communication, and decision-making skills, as well as experience with audits, CAPA, and safety procedures. If you meet these qualifications and are ready to take on a challenging role in maintaining quality standards and compliance, we encourage you to apply for the Quality Assurance Manager position.,

This is an excellent opportunity at HCLTech for healthcare professionals with 2 to 3 years of experience in Quality (RCM and Denial Management). The role of Quality Analyst involves responsibilities such as daily quality review of transactions and calls, overseeing quality assurance and improvement, recommending and implementing quality improvement programs, enhancing process improvement, customer experience, and ensuring high-performing operation. This position requires working at night shifts and from the office for 5 days a week. The essential responsibilities of this role include achieving daily QA targets, reviewing and assessing transactions and calls, providing fair and objective feedback, reporting findings to agents and leads for training and improvement, collaborating on quality processes and scoring techniques, raising and resolving QA concerns promptly, coaching and providing feedback to monitored personnel and supervisors, identifying quality improvement opportunities, calibrating scores objectively, ensuring consistency across sites and teams, analyzing quality data, preparing QA reports, and working with leads and training team to address areas for improvement from QA results. The required skills and competencies for this position include providing regular coaching and feedback to agents, motivating employees for better results, strong communication and listening skills, coaching for performance improvement, knowledge about the US Healthcare industry, understanding healthcare provider business policies and practices, advanced interpersonal, presentation, and communication skills, effective problem-solving, decision-making, innovative thinking, and proficiency in Microsoft Office. Formal education and experience needed for this role include graduation in any stream, experience in denial management and calling, and 1-2 years of experience as a full-time quality analyst in US Healthcare. If you have the relevant experience in Quality - RCA, CAPA, Quality Tools, Agent feedback, and coaching in RCM & Denial Management, and meet the education and experience requirements, you can share your resume to maithreyee.a@hcltech.com for consideration. The mode of interview will be Virtual/Online.,

Role & responsibilities Quality Assurance Expertise QMS implementation Conducting root cause analysis and implementing corrective & preventive actions Coordinating with various departments to improve process control Preferred candidate profile Preferred candidate with experience & knowledge in plastic QMS implementation ( ISO 9001:2015 ) blow molding and injection molding quality tools inspection techniques and measuring instruments

Function:PMSRole:Post Market SurveillanceDesired Skills:PMS, complaint handlingCreate PMS plan, PMS report, PSUR report as per EUMDR, Trend report & Complaint analysis Risk management Risk assessment. Required Candidate profile Propose strategies and solutions to data issues or challenges that occur during the PSUR writing and conclusion process.

Manage electronic document control and version control on all project-related documents.Ensure adherence to the quality systems, design assurance SOPs, and Boston Scientifics PLCP. Required Candidate profile Working on product DHF, design input, design output, product risk management, usability, verification, and validation efforts (if required) for commercial products.

CMUs Operation - Quality (Executive / Sr. Executive ) Graduate/Post Graduate in Food Technology / science with minimum 3-6 years of experience in Food Production. Experience Audit or documentation Preferable in Green Belt Six Sigma Certification Location : Satara, Pune Department : Product and Technology Development Synopsis Candidate shall assist in developing and implementing the Food Safe products and practices. He / She will be responsible for continuous monitoring of compliance against desired Standards. He / She shall be required to support in building Quality & Food safety culture at the CMUs). The job profile will include - Verification of the Raw Material / Packaging Material analysis against relevant specification Perform In process quality analysis is conducted as per defined frequency and following relevant SOPs. To oversee the overall GMP and to ensure CMU rating meeting targeted levels Analysing quality trends , identifying potential quality failure proactively / potential source of food contamination and implement preventive actions Preferably having knowledge about application of six sigma approach in production process Preferably having knowledge of FSSC22K, FSSAI and Legal Metrology regulations and fair knowledge on Packaging Labelling Standards To evaluate and resolve urgent issues with CMUs Prepare food safety training programs & providing training to the production staff l Implementing and maintaining the Quality Risk Management system / Legal Register to ensure that risks are adequately controlled in accordance with the current food safety standards l To ensure periodic audit programme/GMP as per schedule l Perform RCA & ensure CAPA effectiveness. l Conduct market research / analysis on product quality during storage / supply chain and escalate on monthly basis

1. Factory & Warehouse Hygiene and Pest Control Ensure strict implementation of hygiene and sanitation protocols across the factory and warehouse. Oversee pest control measures and maintain compliance with food safety standards. Monitor and verify routine cleaning and deep cleaning (ALC) schedules in production and packaging areas. 2. Production & Packaging Quality Assurance Ensure adherence to quality parameters throughout the production and packaging processes. Conduct regular verification of quality control checks, including for online processes, gifting, and customized orders. Monitor CCP and OPRP to ensure process safety and consistency. 3. Material Verification & Warehouse Monitoring Monitor warehouse operations to ensure material storage, handling, and FIFO compliance. Perform Pre-Dispatch Inspections and ensure timely clearance of on-hold materials. Oversee Raw & packaging material checks and verify. 4. Laboratory Operations & Product Testing Supervise the preparation and use of chemicals for testing purposes. Conduct and validate physical, chemical, and shelf-life testing as per defined protocols. Coordinate with external laboratories for product and environmental testing (e.g., NI samples, water, air, swab, FSSR). 5. Training, Audits & Documentation Conduct internal training on personal hygiene, GMP, GHP, food safety, etc... and documentation practices. Prepare and maintain comprehensive quality documentation, including in-process, laboratory, and shift records. Lead internal and external audits in alignment with FSSC 22000 and BRCGS standards. Ensure timely closure of audit non-conformities and implementation of CAPA. 6. Regulatory & Interdepartmental Coordination Liaise with cross-functional teams to resolve quality-related issues effectively and promptly. Ensure compliance with applicable statutory and regulatory food safety requirements. Address customer quality complaints and drive root cause analysis and CAPA implementation. 7. Personnel Hygiene & Compliance Monitoring Ensure strict monitoring of personal hygiene practices across all staff and production areas. Validate and monitor hygiene compliance through regular audits. 8. Calibration & Equipment Validation Ensure timely calibration and maintenance of all quality and lab equipment. Maintain calibration records and ensure accuracy of instruments used in quality & production assessments. 9. Labelling & Artwork Compliance Ensure all product labels comply with FSSAI regulations (Nutritional information, Ingredients, Allergen Declaration etc...) and other applicable statutory guidelines. Review packaging designs and artwork for accuracy, legal compliance, and brand consistency. Coordinate with internal teams (Regulatory, Marketing, R&D) and external design agencies to finalize artworks. Ensure timely approval and closure of artworks to avoid production delays. Conduct online verification of labelling elements such as batch coding, MRP, expiry date, ingredient declaration, and allergen statements during production.

• Follow up with supplier for Quality documents required as per IS standard. • Performed root cause analysis to identify and resolve defects with the help of ,Ishikawa, 7QC,8D, Why-Why analysis. • Conducting meeting with supplier for CAPA to reduce overall rejection. • Timely coordination with supplier ,Internally sharing rejection report, queries regarding test certificate . • Prepare Quality Assurance Plane (QAP) as per scope of work. • Inspection of Pre & Post fabrication activity. • Preparation of Welding procedure Specification (WPS,WPQR,WPQ) • Handling all measuring instrument as well as Tachometer, Sound level, Vibration measuring Instruments. • Conduct FAT with the customers to get the acceptance before delivery . • Vender inspection, Coordinating third party inspection agency, Prepared MOM with clients. • Incoming material Inspection ,Stage Inspection, Final Inspection prepared all documents as per ISO,API and ASME standard. • Coordinating and Guide at the time of final Inspection with Client . • Attend ISO9001:2008,ISO9001:2015Internal And External Audit

Job Specification: Must have worked with an IT Services Organization Technical background (BTech, BE, BCA, MCA, MTQM) In-depth knowledge of Software Engineering, Project Management Lifecycles, Agile Scrum, Kanban, DevOPS, Continuous improvement and QA lifecycles Understanding of tools such as JIRA, Service now, TFS, Microsoft Project, VSS, Sonar cube, Fisheye, Jenkins, and all Office Tools Appreciation of new GenAI models and their applicability on software projects, impact on productivity, process changes due to the new techniques etc. Should have knowledge of software process implementation, Audits, Metrics and in identifying improvements Strong analytical skills and knowledge on Root Cause Analysis techniques such as Fish Bone etc. Knowledge on statistical techniques for process improvement Thorough knowledge of CMMI, ISO 9K Experience process definition of Quality Management System/ process databases Strong facilitation skills for driving quality and innovation in projects High inter-personal skills Strong communication skills (Written, Verbal, Presentation skills, Assertiveness) Strong negotiation, problem-solving skills Responsibilities: Ensure an environment of Zero surprises by identifying risks by: Ensuring the project setup is done considering all risks and Facilitating projects by propagating best practices, guiding teams on engineering practices, analysis project data, status reports etc. Conducting in-depth engineering reviews, Milestone reviews, Defect data analysis, Project plan reviews, CAPA reviews Mentor PMs for identifying risks, data analysis, innovations etc. Participate in senior management review of projects Conduct SQA reviews and ensure process compliance in projects Analyse findings from SQA reviews and identify improvement themes Highlight the risks to the management at the right time and with all the facts Use the escalation matrix to highlight the risks to Delivery head as and when needed in a timely manner Review write assigned processes Change Requests Participate in innovation program as Innovation facilitators for delivery and enabling function Follow up with projects to ensure closure of action items of CSAT, Escalations/Complaints Participate in Project team meetings Facilitate and participate in projects Root Cause Analysis meetings Ensure formal Configuration Management of QMS documents and other documents Ensure best practices are captured and shared in organization Work closely with project managers, account managers, delivery leadership to understand the expectations and deliver outcomes Articulate contractual risks and work with senior management to mitigate the same Mandatory Competencies Beh - Communication and collaboration Business Assurance - Business Assurance

Role & responsibilities Lead and manage the Quality function and teams across the plant. Lead Incoming Quality Control (IQC), In-Process Quality Control (IPQC), and Outgoing Quality Control (OQC) to ensure product conformance for regular and new products. Oversee the deployment and optimization of Inspection Activities. Oversee in-house calibration activities for instruments and gauges. Analyse quality data using advanced analytical tools (e.g. SPC, DOE, FMEA, and Root Cause Analysis). Support PPAP, FMEA, SPC, Product, Process & System audits. Develop, implement, and manage the Quality Management System (QMS) to meet company and industry standards. Design and support to make SOPs and Work Instructions for processes and operations. Handle customer concerns and claims, ensuring timely resolution and root cause analysis. Monitor and improve KPIs to ensure compliance with quality standards and efficiency goals. Leadership & Strategy - Develop and implement quality strategies aligned with customer requirement. Lead a team of QC engineers and inspectors. Act as the point of contact for all customer quality concerns and audits. Documentation & Reporting - Maintain quality documentation per QMS requirements. Track and report quality KPIs: PPM, rejection %, rework %, audit scores, etc. 7 QC tools and CAPA/critical analysis of process and product to improve the quality. Lead continuous improvement initiatives such as Lean, Six Sigma, and Kaizen to enhance product quality and reduce process variation. Analytical Requirements: 1. Data-Driven Decision Making Using quality metrics, SPC, and audit findings to guide improvements. 2. Corrective & Preventive Action (CAPA) – Identifying root causes and ensuring long-term solutions. 3. Trend Analysis & Reporting – Monitoring feedback, complaints, and quality KPIs for improvement insights. 4. Risk Assessment – Assessing potential risks in materials, suppliers, and internal processes.

Overall handling of Quality Procedures & Quality Management System (QMS). Handling & Issuance of NCs, CAPA and Change Control. ISO Audits, PDI, BMR, Audit Documentation, Customer Audits Required Candidate profile BE/ Btech/ Diploma- Mechanical Engineering, Min. 1 year exp as Quality Executive/ Engineer in Medical Devices or Automotive Industry. Prior exp of handling Quality Procedures & QMS, CAPA, Audits.

Performing audits of all Dr. Reddy’s Laboratories manufacturing, packing, testing, development centers and distribution warehouses as per the audit schedule. Primarily performing internal audits of CTO, FTO and R&D Sites. Performing GAP assessment of the new/revised regulatory guidance documents, USFDA warning letters / form 483s to evaluate the current approved documents for compliance / improvements or requirement of new procedures and harmonizing and implementing the best practices across sites. Review of audit responses and tracking the CAPA generated out of internal audits, regulatory audits, customer audits, cross-applicable CAPAs through OCMS, Warning letters & 483 forms gap assessment of all sites for timely and effective implementation. Performing on site verification or review of the documented evidence for compliance of previous audit observations. Preparation and review of harmonized Standard Operating Procedures and Guidance documents which shall be implemented at Global, FTOs, CTOs business units and related supporting functions. Assessing the impact on the procedures during implementation of changes in IT applications. Overview harmonization of CSV/IT compliance practices across Dr Reddy’s sites. Ensuring timely assessment and implementation of pharmacopeia and regulatory guidance updates w.r.t. CSV/IT compliance procedures across Dr Reddy’s sites. Ensuring review and implementation of simplification procedure for different CSV/IT compliance procedures across Dr Reddy’s sites to reduce redundancy. Tracking and revision of SOPs identified during SuCCEED drive and Re-Imagine QMS. Conducting training sessions for the approved documents before implementation of the procedure. Preparation of questionnaire for SOP in order to evaluate the effectiveness of training imparted. Initiation and review of quality notifications raised for revision, preparation of documents as per identified requirements. Timely communication to stakeholders about revision/implementation of SOPs. Providing data for monthly report. Providing support to sites during regulatory audits for review of systems / documents. Any work assigned by the Lead and Head of the Department Qualification M.Sc (Chemistry) with 15+ years of Pharma experience in IT/CSV quality 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

As a Manager-II in the MSTG department at Sun Pharmaceutical Industries Ltd, your primary responsibility will be to provide support for the execution and monitoring of trial, scale up, exhibit process qualification batches. You will be involved in preparing and reviewing new product documents such as material requirement sheet, master formula card, bill of material, master formula, risk assessment reports, sampling protocol, reports, exhibit batch manufacturing record, and exhibit protocols. Additionally, you will be required to prepare regulatory responses and share process knowledge with cross-functional departments through presentations for smooth technology transfer. You will play a key role in reviewing and evaluating product history and process parameters for technical remediation and improvement of product robustness. Your duties will also include preparing and submitting investigation reports for OOS, OOT, and any failure during exhibit/validation/commercial batch manufacturing and stability testing. Furthermore, you will be responsible for tracking activities related to change control, CAPA, planned deviations, unplanned deviations, and more. Your role will involve preparing and reviewing product containment approaches, risk assessment reports for new products, elemental impurities, Nitrosamine impurities, and residual solvent. You will also be tasked with arranging placebos for quality control testing, change part development, and evaluating the feasibility of products. Statistical evaluation for process assessment, preparation and review of standard operating procedures, training schedules, conducting training sessions, and participating in regulatory audits to support the plant will also be part of your responsibilities. Overall, as a Manager-II in the MSTG department, you will be at the forefront of ensuring the quality and compliance of processes and procedures while contributing to the continuous improvement and development of new products within the organization.,

As a Supervisor at Sigachi located in Dahej, you will play a crucial role in ensuring the smooth production operations in line with GMP standards. Sigachi, a renowned manufacturer of Excipients for Pharma, Nutra, and food industries, has been a key player in the market since its inception in 1989. With multiple facilities in Telangana and Gujarat, Sigachi has solidified its position as a leading producer of Microcrystalline Cellulose globally. Operating under various certifications like EXCiPACT GMP, SGMP, HACCP, EDQM CEP, and ISO 9001:2015, Sigachi has built a reputation for delivering high-quality products across continents. Your primary responsibilities will include planning and organizing production schedules to meet targets for output, quality, and yield. You will oversee all production operations to ensure compliance with SOPs and GMP standards. Collaborating closely with the Quality Control department, you will focus on continuous improvement and effective resource utilization to maintain quality parameters. Additionally, you will coordinate with cross-functional teams, particularly the Engineering Department, to ensure the production of top-notch quality products. It will be your duty to provide on-the-job training for production staff and maintain updated training records. You will be responsible for reporting deviations, conducting investigations, and implementing corrective and preventive actions as necessary. Moreover, your role will involve coordinating with QA for batch release, investigating non-conforming batches, and ensuring batch identification and traceability. Maintaining equipment/instruments calibration, practicing good housekeeping, and adhering to gowning procedures are also part of your responsibilities. In terms of qualifications, we are looking for candidates preferably with a B.Sc, M.Sc, B.Pharm, M.Pharm, or B.Tech (Chemical) degree. An experience of 8 - 10 years in the Pharma Industry or Excipient Manufacturing sector will be highly advantageous for this role. If you are a self-driven professional with a keen eye for detail and a strong background in production operations, this position at Sigachi offers a challenging yet rewarding opportunity to showcase your expertise and contribute to the company's commitment to excellence.,

You will be responsible for line clearance activities before commencing operations, following the preventive maintenance schedule of machines, cleaning and sanitizing the visual inspection and packing area, operating the machines, and filling the log of the general area according to SOP and work execution. Additionally, you must adhere to cGMP, GDP, and maintain discipline in the department, ensuring all employees follow the same standards. Your duties will also include ensuring that all equipment and lines are in a validated and calibrated status, preparing daily production reports, and creating production planning on a monthly and daily basis based on requirements and material availability. You will handle tasks such as change control, deviations, CAPA, investigations, as well as document management including BMRs, BPRs, and master SOPs. Moreover, you will be responsible for preparing and reviewing protocols and reports as needed, overseeing the preparation, review, revision, control, and implementation of standard operating procedures in the sterile manufacturing department. Line clearance activities before commencing operations like manufacturing, sterilization, and filling are also part of your responsibilities, as well as checking records and logbooks related to various manufacturing processes. In addition to your defined job responsibilities, you may be required to perform other activities as instructed by the Head of Department (HOD) and provide training to subordinates, technicians, and operators. You must attend training sessions as per the schedule and ensure training aligns with the Training Needs Identification (TNI) process. Key Skills required for this role include adhering to Good Manufacturing Practices (GMP) and regulatory norms (USFDA, EU, WHO), accurately completing BMRs/BPRs, understanding deviations, change control, and CAPA, as well as the ability to inspire and guide others towards common goals while fostering a positive team environment. Qualifications: M.Sc. / B. Pharm / M.Pharm.,

As a Shift Operation Engineer, your responsibilities will include handling the shift operation and completing related documentation as required by SOP. You will be responsible for achieving targeted production, ensuring smooth, efficient, uninterrupted, and trouble-free operation and maintenance of the water plant, HVAC, and other utility equipment as per SOPs. Implementing best practices to comply with quality, safety, and regulatory requirements will be crucial in this role. Your tasks will also involve preparing, ensuring, and monitoring compliance of SOPs and related documentation of the engineering department. Initiating Change controls and Deviations, CAPA in the electronic system as per the need is essential. Monitoring operation, filter cleaning, filter replacement, and preventive maintenance activity of the HVAC system as per SOP, as well as checking and reviewing utility, water system, and HVAC Log books are part of your duties. It will be important to keep awareness of operational standards such as ISO 9001, ISO 14001, ISO 45001, and 13485, as well as following the regulations of various agencies like USFDA, EU, TGA, MHRA, ANVISA, WHO, Schedule M, etc. You will participate in qualification & requalification of machine/equipment and provide functional support for qualification, validation, and calibration activity. Active participation in DMS, OE, and EHS activities, as well as engagement in the process, will be required. Executing preventive maintenance plans of the respective area and ensuring good documentation and record-keeping are key tasks. Ensuring compliance of service floor activity and smooth operation and maintenance of utilities to provide uninterrupted services are also part of your responsibilities. Allocating jobs to workmen, supervising work for quality, and timely completion, as well as identifying repeated breakdowns and planning corrective actions to avoid recurrence with the engineering manager, will be important. Providing guidance and support to executives and workmen and imparting induction activity to all new joiners are also expected duties. Overall, your role will involve ensuring the proper working of HVAC systems & air conditioning units to maintain operational efficiency.,

Role & responsibilities Leads and optimizes QA function that supports organizations QMS in compliance with respective international regulatory requirements. • Hosting and support in external/client audits and regulatory inspections hosted by Auriga. • Audits and inspection handling. • Conduct internal system and process audits within Auriga systems. • Conduct external audits including the audit of vendors, clients and/or clients business partners and service providers. • Lead and manage a team of clinical audit professionals, providing guidance, training, and mentorship. • Support the operations team for adequate root cause identification, conducting gap analysis and implementation of corrective action plan. • Participate in risk assessments and preparation of risk-based audit plan for auditing internal processes, vendors and customers. • Supporting the CAPA management in audit and Inspection related CAPAs. • Support the document life cycle management, deviation handling process and change control process. • Prepare audit reports to communicate outcomes of quality review activities. • Preparation and or/review of company standard operating procedures (SOPs) and such other quality documents. • Interpret and implement quality assurance standards within the organization. • Liaise with quality representatives, internal customers and external customers across Auriga global access offices as required to achieve quality objectives. • Ensure development and maintenance of a PV Quality System for Standard Operating Procedures, auditing, review CAPAs, Change control and deviations. • Evaluate client audit and regulatory inspection findings and prepare and distributes reports to observation staff, management and customers.

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

The ideal candidate for this position should have a Diploma/BE/ME in Electrical with 6 to 10 years of relevant experience. The job is located near Vadodara and offers a salary of up to 9 LPA. As a Quality Lead, you will be responsible for implementing quality systems, conducting audits, and obtaining certifications such as ISO, UL, and VDE. You will also oversee internal, supplier, and customer audits, and work towards resolving quality issues using methodologies like 8D, RCA, and CAPA. Monitoring QA/QC operations including inspections, testing, and documentation will also be part of your responsibilities. In this role, you will define and track Quality KPIs, lead continuous improvement initiatives, and manage the quality team to ensure operational excellence. Collaboration with cross-functional teams such as Production, R&D, and Global Teams will be essential for the success of the quality function. To apply for this position, please reach out via mobile at 78628 40966 or visit www.crownhrservices.com/job-opening. This is a full-time position with benefits including Provident Fund. The work location is in person.,

Title/Designation: Specialist/Lead Role: Quality & Regulatory Specialist - Medical Devices Exp: 5 to 8 years Location: Navi Mumbai/ Pune/ Bangalore/ Chennai/ Hyderabad Job Summary: The role involves managing Corrective and Preventive Actions (CAPA), ensuring compliance with healthcare regulations, and supporting quality improvement initiatives across imaging and clinical systems. We are looking for a detail-oriented CAPA Engineer with experience in the healthcare industry, particularly in radiology workflows and DICOM standards. Role & responsibilities: Lead CAPA investigations from issue identification through root cause analysis to resolution and effectiveness checks. Apply structured problem-solving methodologies (e.g., Fishbone, 5 Whys). Collaborate with cross-functional teams including Radiology IT, Product owners/managers. Clinical Engineering, and Regulatory Affairs. Ensure CAPA documentation complies with standards such as 21 CFR Part 820, ISO 13485, ISO 14971, and HIPAA. Support audits and inspections by regulatory bodies and internal quality teams. Analyze trends in non-conformances and CAPA data to identify systemic issues. Provide guidance on DICOM standards, PACS/RIS workflows, and interoperability issues in radiology systems. Develop and deliver CAPA process training to internal teams. Maintain awareness of evolving healthcare regulations and imaging standards. Required Qualifications: 5 - 8 years of experience in a quality or regulatory role within the healthcare or medical device industry. Hands-on experience with radiology workflows, DICOM, and imaging informatics. Strong understanding of FDA, ISO, and HIPAA regulations. Proficiency in quality tools and systems (e.g., QMS platforms, CAPA tracking software). Excellent communication and documentation skills. Preferred candidate profile: Bachelors degree in biomedical engineering, Quality Engineering, or related field. Experience with DICOM viewers and associated software platforms. Certification in Six Sigma, CQE, or similar quality methodologies. Familiarity with IHE profiles and HL7 standards. Our Mission: At CitiusTech, we constantly strive to solve the industry's greatest challenges with technology, creativity, and agility. With over 8,500+ healthcare technology professionals worldwide, CitiusTech powers healthcare digital innovation, business transformation, and industry-wide convergence for over 140 organizations through next-generation technologies, solutions, and products. We aim to accelerate the transition to a human-first, sustainable, and digital healthcare ecosystem with the world's leading Healthcare and life sciences organizations and our partners. Here is an opportunity for you to make a difference and collaborate with global leaders to shape the future of healthcare and positively impact human lives.

Monitoring and evaluating inbound and outbound calls and emails according to the criteria set by the supplier in accordance with Client requirement. Documenting quality issues and performance measure for management review and providing information to assist in agent feedback and formal education processes and, Sharing results with Team Leads (and Operations Leader, if appropriate) to help provide individualized feedback to agents Provide Quality evaluation report to Client & track actions taken for improvement Perform transactional audit through recorded calls, remote or SBS, internal error checking, data scrubbings, calibration and Quality certification process. Qualifications: - Graduate/Post Graduate (Exception Needed if experience is more than 2years as QA) Proficiency in Microsoft Office packages (Word, Outlook, Excel); Excellent interpersonal and communication skills; High attention to detail and accuracy. The ability to: Analyze, validate and interpret data/reports; Multi-task, work under pressure and cope with high volumes of work; Cope with pressures and setbacks; Document problems and assist in their resolution; Document processes and identify areas for improvement; Adapt to change quickly, in a fast-paced environment; Prioritize and manage workflow Additional Points: - Open to Travel Having a Valid Passport

Position: Analyst Developer Hardware - 6+ (15,00,000) Position: Development Lead - Hardware - 10+ (18,00,000) Position: Technical Architect - 13+ (25,00,000) Position: Principal Engineer - 15 + (32,00,000) Job Description We are looking for an experienced Analog Design Engineer with expertise in ADC selection, discrete circuit design, microcontroller integration, power supply design, and PCB design. Skill / Qualifications Education: Bachelor's degree in Electrical/Electronic Engineering or a related field. 7+ years of experience in analog circuit design, PCB layout, and power electronics. Analog Design Expertise: Knowledge of various ADC types and selecting suitable ADCs for AC signal measurement. Circuit Design: Hands-on experience with discrete circuit design using transistors, op-amps, and other components. Microcontroller Selection & Usage: Experience in selecting microcontrollers and utilizing their peripherals effectively. Power Supply Design: Expertise in SMPS design, DC/DC converters, and LDOs. Design for Manufacturability (DFM): Strong understanding of DFM principles and their application in product design. PCB Design: Experience in PCB layout with considerations for EMI/EMC compliance. Component Selection: Proficiency in selecting op-amps, microcontrollers, power switches, transistors, diodes, and capacitors. Quality Tools: Knowledge of 8D, FMECA, CAPA , and Why-Why analysis methodologies Product Reliability: Understanding of part and product reliability principles. EMI/EMC & Safety Standards: Practical knowledge of safety, EMI/EMC standards and their application. RF Design (Optional): Preferred for projects involving RF applications. Strong analytical and problem-solving skills. Excellent communication and teamwork abilities. Job Responsibilities Provide upfront technical architecture and high-level design to ensure manufacturability, serviceability, performance, reliability, cost, and feature requirements. Support Program Manager in overall program planning to ensure timely delivery of projects. Actively participate in requirement analysis and preparation of requirement artifacts during the definition phase. Ensure the design supports manufacturability and meets product cost targets by driving design innovation, selecting cost-effective components, and optimizing manufacturing, service, installation, and maintenance costs. Implement best practices such as design before implementation, unit testing, DFMA, FMECA/Fault Tree Analysis, and robust design methodologies to ensure first-time right designs. Accountable for pilot execution as per the program plan and ensure timely closure of pilot actions Benefits Competitive Market Rate (Depending on Experience)

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

Job Area: Finance & Accounting Group, Finance & Accounting Group > Internal Audit General Summary: Job Overview Qualcomm is a company of inventors that unlocked 5G - ushering in an age of rapid acceleration in connectivity and new possibilities that will transform industries, create jobs, and enrich lives. But this is just the beginning. It takes inventive minds with diverse skills, backgrounds, and cultures to transform 5Gs potential into world-changing technologies and products. This is the Invention Age - and this is where you come in. This is a unique opportunity to join Qualcomms finance and accounting organization based in Hyderabad in the Corporate Internal Audit & Advisory Services (IA & AS) team. The department focuses on assisting the Audit Committee and management teams in the improvement of processes that manage risks related to achieving Qualcomms business objectives. Using Qualcomms risk-based audit methodology, the senior auditor will assist in the execution of internal audits. Specifically, the responsibilities include: Providing U.S. based time zone coverage as needed (up to 50% of time) Supporting the creation of initial planning memos and process flowcharts Identifying and assessing initial risks and control activities Designing audit procedures to evaluate control effectiveness Performing audit testing, identifying deviations from expected control activities, and effectively communicating observations to the audit team Leveraging data analytics throughout the audit process where feasible Staying abreast of changes in business and industry to assess impacts on the companys risk profile Contributing to the development of new concepts, techniques, and making continuous process improvements for the overall IA team All Qualcomm employees are expected to actively support diversity in their teams, and in the Company. Minimum Qualifications Three to Five years of relevant experience in internal auditing, external auditing, or SOX compliance within a global public company (preferably in the high-tech industry), Big 4/mid-tier accounting firm or other fast-paced corporate setting Fluent English; multi-lingual capability is a plus Preferred Qualifications Successful candidate will possess the following characteristics: As feasible, ability to travel (infrequently) to Qualcomms domestic and international locations (e.g., U.S., Europe) Semiconductor business experience or familiarity Strong communication (oral and written) and presentation skills Fast learner with strong interpersonal, organization, analytical, critical thinking, and problem-solving skills Ability to work in a flexible and non-hierarchical team environment Willingness to get things done and take responsibility Ability to recognize and apply a sense of urgency, when necessary Comfortable with ambiguity Positive attitude, professional maturity, good work ethic Ability to work independently, handle multiple projects simultaneously and multi-task to meet deadlines with high-quality deliverables Keywords controls, risk assessment, risks, internal audit, SOX Educational Requirements Bachelors degree in accounting, Finance, Business Administration, or related field. CPA, CA, CIA, CFE, or other credentials, a plus. Minimum Qualifications: Bachelor's degree. 3+ years of Finance, Accounting, or related work experience. *Completed advanced degrees in a relevant field may be substituted for up to two years (Masters = one year, Doctorate = two years) of work experience. Job Overview Qualcomm is a company of inventors that unlocked 5G - ushering in an age of rapid acceleration in connectivity and new possibilities that will transform industries, create jobs, and enrich lives. But this is just the beginning. It takes inventive minds with diverse skills, backgrounds, and cultures to transform 5Gs potential into world-changing technologies and products. This is the Invention Age - and this is where you come in. This is a unique opportunity to join Qualcomms finance and accounting organization based in Hyderabad in the Corporate Internal Audit & Advisory Services (IA & AS) team. The department focuses on assisting the Audit Committee and management teams in the improvement of processes that manage risks related to achieving Qualcomms business objectives. Using Qualcomms risk-based audit methodology, the senior auditor will assist in the execution of internal audits. Specifically, the responsibilities include: Providing U.S. based time zone coverage as needed (up to 50% of time) Supporting the creation of initial planning memos and process flowcharts Identifying and assessing initial risks and control activities Designing audit procedures to evaluate control effectiveness Performing audit testing, identifying deviations from expected control activities, and effectively communicating observations to the audit team Leveraging data analytics throughout the audit process where feasible Staying abreast of changes in business and industry to assess impacts on the companys risk profile Contributing to the development of new concepts, techniques, and making continuous process improvements for the overall IA team All Qualcomm employees are expected to actively support diversity in their teams, and in the Company. Minimum Qualifications Three to Five years of relevant experience in internal auditing, external auditing, or SOX compliance within a global public company (preferably in the high-tech industry), Big 4/mid-tier accounting firm or other fast-paced corporate setting Fluent English; multi-lingual capability is a plus Preferred Qualifications Successful candidate will possess the following characteristics: As feasible, ability to travel (infrequently) to Qualcomms domestic and international locations (e.g., U.S., Europe) Semiconductor business experience or familiarity Strong communication (oral and written) and presentation skills Fast learner with strong interpersonal, organization, analytical, critical thinking, and problem-solving skills Ability to work in a flexible and non-hierarchical team environment Willingness to get things done and take responsibility Ability to recognize and apply a sense of urgency, when necessary Comfortable with ambiguity Positive attitude, professional maturity, good work ethic Ability to work independently, handle multiple projects simultaneously and multi-task to meet deadlines with high-quality deliverables Keywords controls, risk assessment, risks, internal audit, SOX Educational Requirements Bachelors degree in accounting, Finance, Business Administration, or related field. CPA, CA, CIA, CFE, or other credentials, a plus. Applicants Qualcomm is an equal opportunity employer. If you are an individual with a disability and need an accommodation during the application/hiring process, rest assured that Qualcomm is committed to providing an accessible process. You may e-mail disability-accomodations@qualcomm.com or call Qualcomm's toll-free number found here. Upon request, Qualcomm will provide reasonable accommodations to support individuals with disabilities to be able participate in the hiring process. Qualcomm is also committed to making our workplace accessible for individuals with disabilities. (Keep in mind that this email address is used to provide reasonable accommodations for individuals with disabilities. We will not respond here to requests for updates on applications or resume inquiries). Qualcomm expects its employees to abide by all applicable policies and procedures, including but not limited to security and other requirements regarding protection of Company confidential information and other confidential and/or proprietary information, to the extent those requirements are permissible under applicable law. To all Staffing and Recruiting Agencies Please do not forward resumes to our jobs alias, Qualcomm employees or any other company location. Qualcomm is not responsible for any fees related to unsolicited resumes/applications. If you would like more information about this role, please contact Qualcomm Careers.

Responsibilities: * Lead quality initiatives & drive continuous improvement. * Ensure compliance with regulatory standards. * Manage customer complaints & implement corrective actions. Health insurance Provident fund Annual bonus