833 Capa Jobs

As an Analyst, you will be required to possess knowledge of various analytical instruments such as HPLC, UV, FTIR, GC, Polarimeter, KF, Auto titrator, and more. You will be responsible for the QCC-QMS Section, overseeing test procedures, handling OOS, OOAL, Deviation, Change Control Note, Incident, and preparing Investigation Reports. Additionally, you will review instrument logbooks, raw data of materials, in-process, finished products, and water analysis. Your skills and proficiency should include expertise in Analytical Instrumentation Handling, Good Laboratory Practices (GLP) & Documentation Accuracy, Data Integrity & Documentation, Regulatory Compliance, SOP Preparation & Revision, Interpretation of Resulting Data from Analytical Instruments, Quality Control & Compliance, LIMS Operation & Data Management. You should also have a basic understanding of QMS Documentation (OOS, OOT, Deviation & Incident) and CAPA, Deviation, and Change Control Management. To qualify for this position, you should have a minimum of 1 to 4 years of relevant experience in the QCC Department. Candidates applying for internal job postings must have completed at least 2 years in their current job role.,

As a Production Manager, you will be responsible for overseeing and managing day-to-day production operations to meet quality, cost, and delivery targets. You will develop and implement production schedules to ensure timely product delivery while ensuring adherence to Good Manufacturing Practices (GMP) and compliance with USFDA regulations. Your role will involve maintaining and ensuring compliance with USFDA, WHO, and other regulatory standards in all production processes. You will coordinate with the Quality Assurance (QA) team to prepare for and manage regulatory audits, inspections, and proper documentation of manufacturing processes. Leading, mentoring, and training the production team will be essential to ensure optimal performance and awareness of regulatory requirements. You will foster a culture of continuous improvement, accountability, and teamwork among the team members. Identifying and implementing process optimizations to improve productivity, efficiency, and quality will be part of your responsibilities. Collaboration with cross-functional teams such as R&D, Quality Control (QC), and Supply Chain to resolve production-related issues is crucial. Additionally, you will be accountable for maintaining and calibrating production equipment and facilities, implementing safety protocols, managing inventory of raw materials, and preparing and managing the production budget to optimize costs without compromising quality. To qualify for this role, you should hold a Bachelors or Masters degree in Pharmacy, Pharmaceutical Sciences, Biotechnology, or a related field. A minimum of 5-7 years of experience in pharmaceutical manufacturing in a managerial role is required, along with proven experience in a USFDA-regulated environment. Knowledge of cGMP, CAPA, and regulatory submissions is essential. Your technical and functional skills should include a strong understanding of pharmaceutical production processes, familiarity with validation protocols, exceptional leadership, communication, and interpersonal skills, strong analytical and problem-solving abilities, and the ability to work under pressure and meet tight deadlines.,

As a Corporate Quality Assurance (QA) professional at Alembic Pharmaceuticals in Mumbai, your primary responsibility will be to ensure the effective implementation of Quality Management System (QMS), adherence to regulatory standards, efficient vendor management, and maintenance of product quality standards across various sites. Your key responsibilities will include managing QMS processes such as deviations, change control, investigations, and Corrective and Preventive Actions (CAPA). You will be entrusted with handling FDA and market complaints, ensuring their timely closure. Additionally, you will oversee the qualification/requalification of vendors for raw materials and packaging materials, as well as address any vendor-related complaints. You will be required to review laboratory QA compliance issues like Out of Specification (OOS) and Out of Trend (OOT) results, oversee technology transfer activities, and ensure the accuracy of product documentation. Furthermore, you will play a crucial role in supporting regulatory audits and ensuring compliance with Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP). To excel in this role, you should possess a Bachelor's or Master's degree in Pharmacy (B. Pharm / M. Pharm) and have a minimum of 12 years of experience in pharmaceutical Quality Assurance, with a preference for exposure to corporate QA and QMS. A strong understanding of GMP standards, QMS principles, vendor management practices, and regulatory requirements is essential. Effective communication skills, proficient documentation abilities, and the aptitude for cross-functional coordination are also key requirements for this position. Your top skills should include expertise in Quality Management System (QMS), GMP Compliance, Corrective and Preventive Actions (CAPA), Vendor Management, and the ability to handle Regulatory Audits effectively.,

As a Jr. Executive at Syngene International Ltd., you will be responsible for maintaining good aseptic behavior inside the Biologics operations facility and performing various downstream activities such as Assembly preparation, Dispensing of raw materials, Buffer Preparation, Harvest Clarification, Chromatography operation, and more. You will operate and clean downstream equipment according to standard operating procedures, monitor and control specific operations, maintain quality records, and perform in-process product sampling and storage. Additionally, you will be required to prepare and review operation-related documents, take ownership of the assigned DSP area and equipment/instrument responsibilities, initiate Complaint Slips for DSP related areas, coordinate with QA for line clearance, and ensure the process area is always ready for inspection and audit purposes. You will also support in batch execution, shipment of samples/final products, and timely closure of all documents. To qualify for this role, you should have a Masters or Bachelor's degree in pharmacy or Pharmaceutical Sciences, along with a minimum of 1-4 years of practical experience in mAbs downstream process. You must adhere to Environment, Occupational Health, Safety, and Sustainability practices, complete assigned trainings on time, comply with quality and compliance standards, and follow SOPs and operational control procedures. Furthermore, you will be responsible for reporting nonconformities and deviations, participating in investigations, CAPA, and change controls, adhering to organizational policies on EHSS, Data Integrity, and IT security, wearing applicable PPEs, and following safety protocols to ensure a safe work environment for all. Proactively identifying near-misses and potential incidents and communicating them to supervisors or line managers is also a key aspect of this role. Syngene International Ltd. is an equal opportunity employer committed to providing integrated research, development, and manufacturing solutions to various sectors. Visit https://syngeneintl.com/ to learn more about our company and our services.,

You will be joining Godrej Agrovet Limited (GAVL), a diversified agri-business company dedicated to enhancing the productivity of Indian farmers through innovative products and services. GAVL holds leading market positions in various sectors such as Animal Feed, Crop Protection, Oil Palm, Dairy, Poultry, and Processed Foods. With a pan India presence, GAVL annually sells over a million tons of high-quality animal feed and cutting-edge nutrition products. The company has actively developed large Oil Palm Plantations to bridge the demand-supply gap of edible oil in India. Additionally, in the crop protection segment, GAVL meets the niche requirements of farmers through innovative agrochemical offerings. Through its subsidiary Astec Life Sciences Limited, GAVL is a bulk manufacturer of fungicides & herbicides. The company also operates in Dairy, Poultry, and Processed Foods through its subsidiaries Creamline Dairy Products Limited and Godrej Tyson Foods Limited. Furthermore, GAVL has a joint venture with the ACI group of Bangladesh for the animal feed business in Bangladesh. As a Manager-Production at the Mahad location, your role will involve production planning, organizing, staffing, and directing plant operations. You will be responsible for executing monthly production targets, implementing new products, ensuring compliance, and contributing to long-range production strategies. Your expertise in validation processes, troubleshooting, and continuous improvement of technology, product quality, safety, and environment will be crucial. You will drive productivity improvement and cost reduction through innovative ideas, manage a team of professionals, and ensure high performance. Coordinating, establishing, implementing, and maintaining an Integrated Management System comprising all standard requirements will be part of your responsibilities. You should be well-versed in audit standards and compliance, legal requirements, risk assessments, and HSE training. The ideal candidate for this role should have a BE Chemical educational qualification with 12-15 years of experience. A diverse and inclusive mindset is valued at Godrej, with a strong emphasis on non-discrimination and embracing diversity. If you are passionate about contributing to the growth of Indian agriculture and possess the required skills and qualifications, we encourage you to apply for this position at Godrej Agrovet Limited.,

As a Senior Manager in the Global Actions Management sub-function of Corporate Quality Compliance at Sunpharma, your main responsibility will be to ensure the assessment and derivation of global actions based on regulatory inspection citations, 483s, warning letters, and internal learnings. This will involve tasks such as reviewing regulatory guidance, existing site practices, drafting global action recommendations, preparing reference procedures, and finalizing recommendations in collaboration with the global action committee and stakeholders. You will also be responsible for issuing and approving global actions in Trackwise, coordinating with sites for implementation, reviewing site action closure, circulating global action status to stakeholders, and facilitating compliance calls to share internal and external learnings. Tracking identified gaps across sites, maintaining a database for regulatory inspections at SUN Pharma, reviewing draft responses to inspection observations, and ensuring the trend analysis of Sun site regulatory inspection observations will be crucial aspects of your role. Additionally, you will be expected to handle all other duties as assigned by the Head of Corporate Quality Compliance and CQA. The role may require an estimated travel of approximately 30% and the following qualifications and skills: Educational Qualification: M.SC / M. Pharm Specific Certification: Not specific Skills: Quality Management System, Compliance, CAPA, Investigations, Audit Management, Supplier Qualification, Change Management, Manufacturing and Engineering Assurance (OSD and Sterile) Experience: Minimum 15 years If you are a detail-oriented professional with a strong background in quality compliance, regulatory affairs, and global actions management, this Senior Manager position at Sunpharma in Vadodara could be the next step in your career journey.,

You should have a minimum of 8-12 years of experience in the field of Electrical Engineering. Your role will involve various responsibilities as listed below: - Demonstrating a strong understanding of the basic principles of Electrical Components. - Creating and maintaining various documents in compliance with ISO standards. - Using tools such as Root Cause Analysis, Corrective Action, and Preventive Action processes for effective problem-solving. - Identifying and reporting Non-Conformities, conducting Root Cause Analysis, Corrective Action, and Preventive Action processes, and ensuring timely closure of NCs. - Supervising and ensuring preventive maintenance activities are carried out as scheduled for solar power plant equipment like Modules and Inverters. - Inspecting inverters and strings for faults, performing necessary rectifications, and addressing defective strings and modules. - Overseeing any breakdown maintenance activities. - Collaborating with OEMs for procurement of spares, Annual Maintenance Contracts (AMC), warranty claims, and service requests. - Managing contracts related to the project. - Maintaining SCADA (Supervisory Control and Data Acquisition) and WMS (Workforce Management System). - Monitoring SCADA and WMS parameters, identifying faults, and communicating them to maintenance technicians. - Verifying module cleaning activities as per the defined schedule. - Handling AMR (Automatic Meter Reading) and JMR (Joint Meter Reading) processes. - Ensuring proper Project Handover and takeover in accordance with the defined scope, protocols, and procedures. - Compiling a list of plant-related issues and escalating them to the relevant departments like engineering, contracts, accounts, and environment. - Building relationships with local communities, contractors, and suppliers. - Managing spare parts, workforce, and budget effectively. - Conducting energy audits and working towards reducing Power Loss through regular audits and reviews. - Conducting operational meetings with plant and Head Office teams. - Analyzing various plant performance parameters in comparison to the Plant design using tools like PV syst.,

The Quality GM/Quality Manager is responsible for leading the quality function across departments including fabric inspection, cutting, sewing, finishing, and final inspection. You will ensure that products meet buyer specifications and compliance standards while reducing defects and improving customer satisfaction. Your key responsibilities will include leading and managing Quality Assurance and Quality Control teams, establishing and monitoring quality standards and SOPs, overseeing quality from raw material to final product, coordinating with production, merchandising, and buyers to meet quality requirements, passing audits with minimal non-conformances, monitoring inspection levels, analyzing defect trends, providing training programs, resolving customer quality issues, conducting necessary inspections and tests, and maintaining quality documentation. Key skills required for this role include a strong technical knowledge of garment construction and quality standards, familiarity with quality tools and systems, leadership capabilities, experience in buyer interactions and audits, effective communication and problem-solving skills, and proficiency in Excel and other relevant software. Key Performance Indicators for this role will include metrics such as rejection rates, first pass rates, audit pass rates, on-time quality reports, NCs raised vs. closed ratio, and the number of quality training sessions conducted. This is a full-time position located in Sector-65, Noida, with a salary range of 1.20L to 1.60L per month.,

Date: 2 Jul 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Essential Functions Job Description Job Title: QMS Project Reviewer Job Location: Syngene International Limited, Bengaluru About Syngene : Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to companys integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Core Purpose Of The Role This is an exciting opportunity to play a role in drug substance development and manufacturing of Syngene. The role will provide exposure to handling clients across the globe, interaction with cross-functional departments and activities involved from product introduction to discontinuation. It provides an opportunity to learn different aspects of product development to commercial manufacturing. Role Accountabilities Follow GMP, GDP, and GLP procedures as applicable, while performing the assigned task. Create/ revise/ review of procedures (like SOP, protocols, calibration schedule, and other related documents as applicable.). Review and approval of Master BMR and PDR and its compliance. Review of TTD related to Late phase and commercial. Responsible for issuance and control of BMRs, PDRs, SOPs, EOPs and ECCs.Verify the product details, batch no., quantity, label, purchase order, RM issue slip, CoA, weights, packing and dispatch record, packing area (not limited to) and provide clearance to dispatch activity. Assessment of SOP vs guidelines for any gaps and taking appropriate actions. Investigate, review of investigation with respect to OOS/OOT and involve in the identification of root cause and to propose the CAPA for identified root cause. Preparation and review of QMS Trends (Deviation, LIR, OOS, OOT, Change control & Complaints). Handling of returned products and product recall. Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience Demonstrated Capability Education Experience 3 - 6 years into Project related QMS activities (Change control, Deviations, CAPA, OOS, LIRs) Must have handled clients Expertise in review of Master Batch Record, Batch Record and Analytical Documents Knowledge on Good Documentation and laboratory practices Good coordination among CFTs Skills And Capabilities Expertise in handling QMS Activities Good knowledge about project related activities Client handling experience Master Batch Record, Batch Record and Analytical Document Review skills Specification and Method of analysis review Good communication skills Education MSc. Chemistry Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities. Show more Show less

Summary Of Responsibilities Works with internal teams to progress quality issues in QMS. Tracks timeliness of cases in QMS. Supports teams in creation of CAPAs. Maintains strong working knowledge of QMS. Interacts with QA Lead Manager and above as required for quality issue case progression and client notifications. Supports QA Lead Manager and above in pulling metric data, trending, and tracking of QI. All other duties as needed or assigned. Qualifications (Minimum Required) A minimum of a bachelors degree in Life Sciences preferred (or equivalent Life Science experience). Experience (Minimum Required) 8 years in regulatory environment (experience in GXP roles). Strong understanding of QMS and CAPA process. Ability to work well within a team environment. Convey key details of quality issues internally. Communicate quality issue summary to clients where applicable. Knowledge of GCPs/GXPs. Preferred Qualifications Include Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Physical Demands/Work Environment Travel may be required. Office-Based (Hybrid), as requested by the line manager. Learn more about our EEO & Accommodations request here. Show more Show less

Urgent Hiring for Quality Assurance Goa ( Bethora) Experience 5 years minimum CTC 4 LPA Location : Goa ( Bethora) Qualification Bachelors degree (or equivalent) in mechanical/Electrical Engineering Industry consumer appliances companies. Responsibilities Plan, execute, and oversee product inspection and testing for quality and conformance to specifications and deliverables Investigate product quality issues in the market and at plant level. Drive Quality improvement projects using Quality tools for CAPA implementation Monitor risk-management procedures, maintain problem logs, and report issues to managers and Design Team Provide training and support to quality assurance team members that covers systems, policies, procedures, and core processes Interested candidate share your cv or 9311031194.

You will be joining Sporting Syndicate, the largest Sports Goods manufacturers and exporters in India, located in Jalandhar, Punjab. Since its establishment in 1960, the company has played a key role in driving India's Sports Goods industry forward. As a Quality Assurance Officer, your main responsibilities will include monitoring product quality based on established parameters, overseeing the QC process on the production line, adhering to protocols in case of defects, daily documentation of QC reports, and updating the systems accordingly. Additionally, you will be responsible for training and guiding Production personnel on QC Management systems, as well as implementing Quality Management tools such as CAPA, APQC, FTR, and Kaizen in daily operations. To excel in this role, you should have a minimum of 2 years of experience in a quality-related position, ideally backed by a bachelor's degree in Engineering or a related field. Proficiency in Quality Management Systems, experience in reporting and documentation, and strong communication skills are also essential attributes. If you meet these qualifications and are eager to contribute to our team, we encourage you to submit your application today. We are excited to review your candidacy and potentially welcome you to our dynamic Quality team at Sporting Syndicate.,

As a member of ACG Capsules in Shirwal, your primary responsibilities include checking the allocated post production line(s) such as ATS/Printing/camera in each shift according to the CTQ (critical to Quality) / CTP (Critical to Productivity) checklist. You will need to adhere to the plan outlined in the color change note, minimizing change over time at each sub-section. Following instructions from the shift lead is crucial for timely changeover, ensuring the availability of necessary equipment like roller(s) and ink. Furthermore, it is essential to execute In-Process Quality Control (IPQC) after each roller cleaning, checking camera rejections hourly to achieve zero defects. Operating the camera according to Standard Operating Procedures (SOP) is vital to maintain productivity and quality standards. Collaboration with contract associates is necessary to ensure SOP compliance at ATS, Camera, Packing, Sealing, and Tumbling sections. You will be responsible for implementing preventive maintenance plans for the line(s) to minimize downtime and conducting troubleshooting activities to enhance productivity. Reporting and controlling post-production losses of printing and camera operations are crucial for achieving the Targeted AFOE@Despatch. Adhering to cGMP and GDP for the allocated line(s) is essential to comply with regulatory standards during the shift. Additionally, following instructions from the shift lead or team lead to implement Corrective and Preventive Actions (CAPA) for any customer complaints is part of your duties. Key Result Areas for this role include ensuring productivity of the line, managing print loss, print reject, and camera loss, prioritizing safety measures, and adhering to Standard Operating Procedures (SOP). In this role, you will interface with ITI candidates, as well as freshers. The competencies required for this position include [Competencies to be filled based on the job description provided].,

The ideal candidate for this role should have 6-10 years of experience and possess the following competencies: - Punctual with a proven track record of dedication and reliability. - A team player who is equally capable of working alone. - Fluent in both written and spoken English. - Knowledge and experience in peptides Quality. - Reviewing the Batch Manufacturing Records. - Executing and Monitoring Process Performance Qualification (PPQ). - Preparing Cleaning Validation Protocol and Monitoring Cleaning Validation/Verification activities. - Reviewing the SOPs, Validation, and Qualification Record. - Handling Dispatch and Line clearance activities. - Preparing Annual Product Review. - Initiating various QMS elements like change control, deviation, CAPA, etc. - Investigating Customer complaints, Return Goods, Recall. - Reviewing Reprocessing and Reworking. The key stakeholders for this position include the QA Team and other departments in the plant. The reporting structure for this role is to the QA Head.,

Job Description Alembic Pharmaceuticals is hiring for a Corporate Quality Assurance (QA) professional to join our dynamic team in Mumbai . The role focuses on QMS implementation, regulatory compliance, vendor management, and product quality across sites. Key Responsibilities Manage QMS processes deviations, change control, investigations, and CAPA. Handle FDA/market complaints and ensure timely closures. Oversee vendor qualification/requalification for RM/PM and resolve vendor complaints. Review lab QA compliance (OOS/OOT), technology transfer, and product documentation. Support regulatory audits and ensure Good Distribution & Manufacturing Practices. Key Requirements Education: B. Pharm / M. Pharm Experience: 12+ years in pharmaceutical QA (corporate/QMS exposure preferred) Strong knowledge of GMP, QMS, vendor management , and regulatory handling Effective communication, documentation, and cross-functional coordination skills Top Skills QMS GMP Compliance CAPA Vendor Management Regulatory Audits Show more Show less

Hi, We are looking for Quality Manager for Wiring Harness Manufacturing OEM, Coimbatore If interested, Please share your CV to , Mob: 7092689999 Position Name: Manager Quality Systems Job Type : Full time/ Permanent Job Location : Coimbatore Qualification: BE/B.Tech - Electrical/Mechanical Experience: Min 7 years Job Summary: We are seeking a dynamic and experienced Manager Quality Systems to lead and oversee the quality management initiatives in the Wiring Harness industry. With a solid background in quality assurance, process control, and continuous improvement, the ideal candidate will ensure compliance with ISO/IATF standards, enhance operational efficiency, and uphold the highest product quality standards. Key Responsibilities: Lead the development, implementation, and maintenance of Quality Management Systems (QMS) in line with ISO 9001 and IATF 16949 standards. Drive process optimization and continuous improvement initiatives to minimize defects and improve production efficiency. Conduct and manage internal, customer, and supplier audits, ensuring full compliance with customer requirements and industry standards. Utilize methodologies such as 8D, FMEA, CAPA, and root cause analysis to resolve quality issues and implement preventive measures. Collaborate with cross-functional teams including production, design, and NPD teams to integrate quality standards into product development and manufacturing. Provide strategic direction and leadership to the quality team, fostering a culture of excellence and accountability. Interface with key customers to understand expectations, manage feedback, and ensure long-term satisfaction. Monitor quality KPIs and prepare regular reports for top management. Key Skills & Expertise: Extensive experience in Quality Assurance and Control within the wiring harness sector. Strong knowledge of automotive quality standards and regulatory compliance. Proficiency in problem-solving tools like 8D, FMEA, CAPA. Expertise in supplier development and customer audits. Solid experience in New Product Development (NPD) quality support. Excellent leadership, communication, and team coordination skills. Proven track record of reducing defects and improving operational performance. Educational Qualifications: B.E./B.Tech in Mechanical/Electrical Engineering or relevant field

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job Overview The Aerospace Defence & Marine (AD&M) business of TE Connectivity is uniquely qualified to provide innovative solutions for a variety of applications from ruggedized interconnects, fiber optic products, and sealed harness assemblies to high-performance relays and power distribution units. Responsible for the inspection of incoming components, Sub-assemblies,Finished goods and piece parts based on the Specifications, control Plans, or Customer specific requirements. Responsibility: Clearing the lots based on priority on daily basis.(EOU&DDS)Physical verification of the Inspection reports; SAP QA32 clearance. Inspection of lots monitoring and clearing it (FIFO) Training of Incoming Inspectors based on requirement. Daily MRB reviews, Blocked stock Management Ensuring Quality requirements are met for the incoming materials (Raw materials, Bought out ). Quality Documentation for incoming materials. Use of SAP for material management. Handling Non-Conformities / Quality Notifications Performing CAPA for all NCRs. Coordinate with Supplier, SQA for quality improvement and resolution of NCRs. Understanding and adherence to ISO 9001 2015, AS9100 5S management at Incoming inspection area. Continuous Improvement to Reduce 100% Inspection based on Customer Rejection Desired Candidate Profile: EDUCATION / KNOWLEDGE B. Tech ( Mechanical/ Electrical ENgg) 3 to 6 yrs FUNCTIONAL COMPETENCIES Read & Understand Drawings Read & Understand Key Characterstic Read & Understand Quality Inspection Plan Understand usage of Inspection Equipments & Machine Understanding & implementing problem solving tools Implementation of 5S at Work Product Knowledge QMS Documentation Exposure to incoming/outgoing inspections. Knowledge of CAPA, 7QC Tools, 8D. Exposure to ERP systems like SAP. Exposure to supplier Quality. Proficiency in both spoken & written English language is required. Competencies EOE, Including Disability/Vets

Seeking a detail-oriented and proactive CAPA Engineer / Specialist to lead and manage Corrective and Preventive Action (CAPA) processes across product and process quality systems. The ideal candidate will be responsible for driving CAPA investigations from issue identification through implementation and effectiveness monitoring, ensuring compliance with global quality standards and regulatory requirements. Key Responsibilities: Lead and facilitate CAPA investigations from initiation to closure, ensuring timely and effective resolution. Conduct root cause analysis using tools such as 5 Whys, Fishbone, 8D, DMAIC, and FMEA. Collaborate with cross-functional teams to define and implement corrective and preventive actions . Ensure CAPA documentation meets internal quality standards and regulatory requirements. Represent CAPA records during audits , inspections , and CAPA Review Board meetings. Monitor CAPA effectiveness and track metrics to drive continuous improvement. Apply statistical techniques and data analysis to identify trends and potential non-conformances. Ensure compliance with 21 CFR Parts 803, 806, 820 , ISO 13485 , ISO 9001 , and ISO 14971 . Required Skills & Qualifications: Bachelors degree in Engineering , Life Sciences , or a related field (Masters preferred). Minimum 5 years of experience in quality assurance , regulatory compliance , or CAPA management in a regulated industry (e.g., medical devices, pharma, manufacturing). Strong knowledge of CAPA systems , quality tools , and problem-solving methodologies . Excellent technical writing , documentation , and communication skills . Experience working in matrix organizations and facilitating cross-functional teams. Preferred Qualifications: Certified in Lean Six Sigma , Quality Engineering , or Regulatory Affairs . Experience with electronic quality management systems (eQMS) . Familiarity with metrology , risk management , and product lifecycle management .

Drawing Understanding. Layout Inspection, SPC, MSA, PPAP. Handling of QA Related IATF Audits. Customer Audit Handling Strong knowledge of plastic injection molding defects and process controls. Hands-on with Vernier, micrometer, gauges, and other inspection tools. Familiarity with 7 QC Tools, CAPA, 5 Why, etc. Exposure to IATF 16949 standards Education : - BE/ME Polymer /Post Diploma in Plastic Technology / CIPET / NTTF

Must have minimum 4 years experience in QMS activity Issuance and management of QMS Forms (e.g., CC, CAPA, Deviation, etc.) Participate in the evaluation and investigation of quality-related issues Coordinate with cross-functional teams (CFT) and relevant stakeholders for issue resolution Review and compile supporting documents for QMS processes Maintain and update QMS log registers Ensure proper documentation and records management of QMS activities Perform artwork review to ensure compliance with quality standards Job Location: Kadi, Gujarat ( Bus facilities are available) Note: Immediate joiners will be preferred first

Quality Manager will be responsible for implementation of Quality Management process as per company laid guidlines. Quality documentation Laboratory testing RM, WIP and FG Inspection CAPA, RCA - Customer complaint handling Vendor audit Suitable candidate must be a science graduate with minimum 3 years experience in QA/QC department. Candidae must have knowledge of ISO based documentation.

Job Purpose: To ensure effective implementation of quality systems, handle customer complaints, reduce internal rejections, and lead quality improvement initiatives in line with IATF 16949 and customer-specific requirements. Key Responsibilities: Conduct daily quality meetings with subordinates regarding customer complaints and previous days internal quality issues Perform root cause analysis (RCA) and implement Corrective & Preventive Actions (CAPA) for in-house and customer issues using tools like 5 Why, Fishbone Analysis, 8D Reports Handle and resolve customer complaints professionally and on time Supervise in-process, inward, and pre-dispatch inspections to ensure quality standards Lead quality cost reduction activities and improve overall PPM levels Apply 7 QC Tools for data analysis and quality problem-solving Coordinate and represent monthly quality performance reviews to management Lead and manage quality inspection manpower on the shop floor Manage supplier quality , handle PPAP documentation , and resolve incoming quality issues Conduct internal audits and ensure product compliance as per drawings, check sheets, and SOPs Maintain and update calibration records of measuring instruments and gauges Analyze, compile, and report test and inspection data to the cross-functional team (CFT) Support process engineering in design for manufacturing and process validations Collaborate with cross-functional teams on new product development and ramp-up Key Skills & Competencies: Strong understanding of IATF 16949, ISO 9001, PPAP, APQP Hands-on experience with plastic injection molding processes Proficient in 7 QC Tools , SPC , MSA , and Audit Systems Excellent communication, team leadership, and reporting skills Proficiency in reading and interpreting 2D drawings with GD&T Working knowledge of customer audit handling , VSA, and LPA audits Preferred Traits: Quality-first mindset with a proactive attitude toward improvement Ability to work independently as well as in a team environment Strong problem-solving and analytical thinking

Department: Quality Assurance / QMS Reporting To: Managing Director / Plant Head Location: Ahmedabad Job Purpose: To lead and manage all aspects of Quality Assurance and QMS across the Injection Moulding and Tool Room departments. Ensure product quality, compliance with international standards (ISO, IATF), customer requirements, and continuous improvement initiatives. 1. Quality Assurance (QA) Responsibilities: Develop, implement, and maintain QA procedures for Injection Moulding and Tool Room operations . Manage incoming, in-process, and final inspection activities. Handle daily rejection analysis and initiate corrective actions. Approve control samples and ensure sampling as per standard. Analyse customer complaints , lead root cause analysis (RCA) , and initiate 8D/5-Why/Corrective Actions. Establish gauge calibrations Ensure tool validation and dimension approval for new and modified tools. Conduct PPAP / FAI / Process validation activities. Oversee the approval and inspection of tool development, maintenance, and modifications. 2. QMS Responsibilities: Maintain and upgrade ISO 9001 / IATF 16949 QMS system for both Injection Moulding and Tool Room. Conduct and monitor internal audits , MRM , document control , and process standardisation . Coordinate and lead: Customer audits and inspections pre-dispatch, development approval, process validation. Certification body audits ISO/IATF recertification and surveillance audits. Supplier audits and evaluations including incoming quality issues and supplier development Drive continual improvement through Kaizen, 5S, and Lean Manufacturing. Lead customer and third-party audits , ensuring zero non-conformances. Monitor and report Key Performance Indicators (KPIs) like customer PPM, in-house rejection %, CAPA closure rate, etc. Maintain and ensure implementation of control plans, PFMEA, process flow diagrams . Conduct change management (4M Man, Machine, Material, Method) and maintain revision history. Coordinate training and competency building for QA/QC staff and operators. 3. Injection Moulding Focused QA: Monitor moulding parameter settings , first piece approvals, and batch consistency. Control flashing, short shots, burn marks, warpage , and other common defects. Review OEE and rejection trends for Moulding machines. 4. Tool Room QA Integration: Inspect new Mould tool development, maintenance & modifications as per design and dimensional standards. Ensure proper documentation and pre-dispatch inspection (PDI) for tooling. Monitor tool performance feedback loop from Moulding to toolroom for improvement. Qualifications: B.E./Diploma in Mechanical / Production / Tool Engineering. Additional certifications in Quality Management / Six Sigma / Internal Auditing preferred. Experience: 5+ years of QA/QMS experience, with at least 1 years in a leadership role. Hands-on experience in Injection Moulding and Tool Room QA/QC . Key Skills: Strong knowledge of ISO 9001 / IATF 16949 standards. Proficiency in 7 QC Tools, SPC, MSA, CAPA, 5S, and FMEA . Expertise in QA documentation , audits, and customer handling. Analytical mindset with strong problem-solving ability. Effective team leadership and cross-functional collaboration.

Experience : 3 to 6 Years Job Role: R&D QA Must Have Skills: Good communication skills to handle customers and clients Good to have skills: Knowledge on Deviations, change control, CAPA, market complaints, Qualifications, Validations, technology transfer documents. Job Role: Handling Day to Day QA activities in the site. Implementation of the SOPS (all departments) in the site. Preparation and review of the R&D development protocols and reports. Issuance and review of the documents to the user department. Ensure all the activities are performed as intended in the SOPS. Training to all employees and imparting training to shop floor personnel. Releasing or rejecting of raw materials and finished product. Responding to Queries from customer and Regulatory audits. Handling Deviations and change controls in the site. Monitoring and implementation of warehouse and R&D documentation activities.

Roles and Responsibilities: Monitor and control the operation of equipment and machineries with respect to Engineering in areas like utilities, HCM, mucilage preparation, Packaging. Monitor and control process parameters and ensure implementation of corrective actions for utilities and HCMs on regular basis Carry out root cause analysis for repeated failure and effectiveness of CAPA in co-ordination with Engineering maintenance lead Make sure availability of critical spares and consumables in ready to use condition to maintain plant up-time R Carry out corrective actions to reduce the capsule mechanical defects in coordination with Production Analyse data from available logbooks/SCADA/IIOT systems and accordingly review the line of actions to be implemented for effective mitigation Ensure proper online/ offline documentation is maintained related to process equipments, HCM and all Utility equipments Support to Develop alternate vendor & conduct risk assessments in order to mitigate risk and adhere to compliance Ensure adherence to safety guidelines, c-GMP, regulatory & statutory compliances, TPM and other applicable norms Upgradation of automation system for process synchronization / optimization. Ensure regular parameters monitor related to HVAC and WTP, Hot water generator and Air compressor. Support to ETP operation as and when required Implementation of online project tracker/planner for various ongoing improvement projects Coordinate with external & internal SMEs, stakeholders and consultants for designing and implementation of systems, wherever required Support other user functions in execution of cross functional projects Improve and sustain the productivity - Control the downtime of HCM as per the target and achieve the desired quality output to meet the budget Execution of innovative projects in various fields based on advanced technologies for synchronization of process/utility by automation, productivity increase and energy conservation Execute the automated system qualification / revalidation as per GAMP -5 requirement. Support to calibration on online compliance. Ensure execution of operation of HVAC, Water system and maintain as per schedule Carry out predictive / preventive maintenance of Utility equipment’s by utilizing equipment / Machine downtime. Support in executing revalidation activity as and when required as per schedule. Support to Project function for any upgradation in utility