59 Qms Documentation Jobs

Plan, execute, and monitor activities related to quality control (QC) in manufacturing processes. Review and implement Standard Operating Procedures (SOPs) within the QC department. Approve or reject raw materials, packaging materials, and intermediates based on quality standards. Release finished product results after thorough verification. Ensure all testing is conducted according to appropriate standard specifications. Verify the accuracy of test results and validate analyst skills; maintain detailed records. Approve sampling instructions, specifications, test methods, and other QC procedures. Train new analysts on day-to-day QC operations and documentation practices. Manage change contro...

As part of Frencken's IMS Division, you will be part of a team that focuses on delivering high-quality, end-to-end manufacturing solutions to various global industries. The division excels in integrating cutting-edge technology with world-class processes to meet the diverse needs of clients. You will have the opportunity to work in a dynamic environment that values innovation, collaboration, and excellence. **Key Responsibilities:** - Oversee the company's overall QC inspection and testing activities. - Prepare countermeasure reports related to product quality claims from customers. - Coordinate the handling of customer complaints. - Implement improvement plans for the QA department. - Monit...

Date: 4 Dec 2025 Location: Bangalore, KA, IN, 560099 Division: Development Services Job Title: FILL FINISH EXPERT Department: Formulation production Job Location: Bengaluru, India 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 ro...

POSITION - Product Engineer/Design Engineer DESIGNATION - Sr. Engineer/Asst Manager LOCATION -Electronic City, Bangalore QUALIFICATION - BE/Diploma - Mechanical / Electrical CUT OFF % -60% EXPERIENCE -5 to 10 Years JOB RESPONSIBILITES RFQ Management Customer visit to provide Technical support. Cable Harness design Costing- By understanding the customer documents/requirements. Monitor RFQ tracker to know RFQ status and publishing to higher management monthly. Product Execution Thorough study of the Purchase order to understand the customer terms and conditions, testing, and delivery requirements. Proactively supervise and implement project plan to ensure project is on-schedule and on-budget. ...

* Assist in maintaining and updating QMS documentation (SOPs, Work Instructions, Records). * Help coordinate internal audits and prepare documentation for external audits. * Support the training process by organizing sessions and maintaining training records. * Perform basic QC checks and inspections under supervision. * Assist with tracking and follow-up on CAPA actions. * Help maintain supplier documentation and support risk management files. * Ensure proper document control and record retention in compliance with ISO 13485. * Promote awareness of quality procedures across departments. Skills Required * Basic understanding of QMS principles and ISO standards. * Good attention to detail and...

Position: EHS Officer /Engineer Location : Manesar Report To : Head Quality Key Responsibilities 1. Environment, Health & Safety (EHS) Develop and Implement EHS policies, procedures, and risk control measures. Conduct hazard identification and risk assessment (HIRA), Aspect/ Impact, and implement corrective actions. Monitor compliance with regulatory requirements (ISO 45001, ISO 14001, local laws). Lead incident/accident investigations, root-cause analysis, and maintain records. Conduct safety training, emergency drills, and awareness programs. Perform regular site inspections, audits, and environmental monitoring. Maintain waste management, pollution control, and sustainability initiatives....

Assist in maintaining and updating QMS documentation (SOPs, Work Instructions, Records). Help coordinate internal audits and prepare documentation for external audits. Support the training process by organizing sessions and maintaining training records. Perform basic QC checks and inspections under supervision. Assist with tracking and follow-up on CAPA actions. Help maintain supplier documentation and support risk management files. Ensure proper document control and record retention in compliance with ISO 13485. Promote awareness of quality procedures across departments. Skills Required Basic understanding of QMS principles and ISO standards. Good attention to detail and documentation accur...

As a Lead Auditor, your role involves planning, executing, and documenting internal and external audits in accordance with ISO standards such as ISO 9001, ISO 14001, ISO 45001, etc. You will also provide technical support to the Sales Department by participating in client discussions, preparing compliance documents, and contributing to business development with quality-driven insights. Key Responsibilities: - Conduct internal audits and coordinate external audits for ISO standards including ISO 9001, ISO 14001, ISO 45001, etc. - Maintain, update, and manage Quality Management System (QMS) documentation to ensure continuous certification compliance. - Prepare comprehensive audit reports, deve...

Job Title: Operations Executive Location: Chennai Key Responsibilities: Manage stocking, storing, and safe handling of medical devices. Maintain inventory control, including inward/outward tracking and documentation. Assist in regulatory documentation, application submissions, and coordination with authorities. Support distribution activities, dispatch coordination, and delivery follow-ups. Identify and evaluate potential distributors for company products. Maintain QMS-related documents and support internal audits. Coordinate with vendors, logistics partners, and government offices for submissions and follow-ups. Ensure proper warehouse hygiene and adherence to safety standards. Required Qua...

Job Description Lead Auditor The Lead Auditor is responsible for planning, executing, and documenting internal and external audits in line with ISO standards (ISO 9001, ISO 14001, ISO 45001, etc.). The role also provides technical support to the Sales Department by assisting with client discussions, preparing compliance documents, and contributing to business development through quality-driven insights. Key Responsibilities Conduct internal audits and coordinate external audits for ISO standards (ISO 9001, ISO 14001, ISO 45001, etc.). Maintain, update, and manage QMS documentation to ensure continuous certification compliance. Prepare comprehensive audit reports, develop corrective action pl...

Role Overview: As a Deputy Manager at Syngene International Ltd., your main responsibility will be handling QMS documentations like CC, CAPA, and Investigations, as well as managing EDMS documents, study protocols, and qualification protocols. You will be in charge of performing activities related to Engineering & maintenance at Biologics Unit 03 while ensuring GMP compliance and error-free operations. It will be crucial for you to follow all EHS requirements at the workplace to ensure individual and plant safety. Key Responsibilities: - Handling QMS documentations like CC, CAPA, and Investigations - Managing EDMS documents, study protocols, and qualification protocols - Performing activitie...

Job Summary: The Senior Production Associate is responsible for overseeing the preparation, dispensing, and quality compliance of buffers and reagents for nucleic acid extraction kits. The role involves hands-on manufacturing, chemical handling, process documentation in SAP, and supporting process validation activities for new product development. Key Responsibilities: 1. Buffer & Reagent Preparation Independently prepare buffers and reagents for DNA/RNA extraction kits as per batch manufacturing records (BMR). Ensure pH, conductivity, and other specifications are met during preparation. 2. Chemical & Reagent Management Manage inventory and safe handling of laboratory chemicals and raw mater...

Key Responsibility: Quality Management System (QMS) Activities: Oversee and perform all Quality Management System (QMS) activities for the Quality Control Microbiology department. Conduct and review investigations related to microbiological laboratory OOS/OOT, environmental monitoring deviations, and sterility failures. Identify root causes and recommend corrective and preventive actions (CAPAs). Ensure timely closure of laboratory deviations and maintain thorough documentation. Lead the preparation, review, and approval of QMS documentation, including change controls, risk assessments, and quality records. Perform and oversee the preparation and review of documentation related to microbiolo...

QMS & Compliance of Warehouse activities Having 5 to 8 years of experience into Material Management, Area Qualification, SOP Compliance, Regulatory compliance documentation.

Role Overview: As a Supervisor for the packing operation, your main responsibility will be to manage the production activities in a shift by effectively utilizing available resources to achieve production targets. You will be required to maintain standard process parameters, update manufacturing records, and ensure compliance with cGMP requirements. Additionally, you will be responsible for handling granulation, compression, coating, capsule filling, tablet inspection activities, as well as non-process area maintenance as needed. Key Responsibility: - Verify dispensed materials before the start of the operation - Conduct environmental monitoring as per product specifications - Execute produc...

Role & responsibilities Maintain and enhance the Quality Management System (QMS) as per ISO 13485 and ISO 9001 requirements. Prepare, update, and control QMS documents including SOPs, Work Instructions, Forms, Manuals, and Records. Plan, execute, and report internal audits; track audit findings and ensure timely closure of corrective actions. Support external audits conducted by notified bodies, customers, and regulatory authorities. Lead CAPA processes including root cause analysis, corrective action planning, verification of effectiveness, and documentation. Coordinate and maintain Risk Management files in alignment with ISO 14971. Manage and monitor change control processes, ensuring eval...

Lead and coordinate customer audits from OEM clients. Ensure compliance with customer-specific quality standards and documentation Prepare and maintain audit-related records, CAPA reports, and inspection protocols Collaborate with internal departments to ensure readiness for audits Address non-conformities and follow up on corrective actions Maintain QMS documentation as per IATF 16949 / ISO standards Experience in handling supplier quality and internal audits Proficiency in MS Office and ERP systems Ability to work under pressure and meet tight deadlines Degree in Mechanical or Automobile Engineering Minimum 3-5 years of experience in QA, preferably in auto components manufacturing Hands-on...

Responsibility : Customer Interface Visit & Audit, QMS / MR,NPI Tech Review, Customer complaint) Experience in sheet metal Fabrication industry for at least 10 years. Understanding of ISO 9001 requirements, QMS documentation & MR activities faced Audits. Internal Auditor certifications & Six Sigma will be an added advantage. Worked in Cross function NPI department & prepared FAI , PPAP, Risk Analysis, PFMEA etc. Interaction with customer, Problem solving skill with 8D methodology. Understanding of ISO, IS, AWS, ANSI Quality standard in sheet metal industry. Visit customer place and understand the end requirement, support BDG during RFQ Coordinate customer visit and PDI inspection. Experience...

Lead and maintain QMS documentation and compliance.Certified Internal auditor for IATF 16949.Handled 3rd party audit like IATF 16949,45001,14001,50001 & NC closing in portal.APQP,PPAP,SPC,MSA,FMEA,MSA,CP. Required Candidate profile Strong understanding of ISO 9001 and other relevant standards. Experience in audit handling and MR responsibilities. Good communication skills in Kannada and English. Proficiency in documentation

Responsible for implementing and maintaining ISO & BIS quality systems, conducting audits, managing QMS, CAPA, and supplier quality. Ensure product compliance, process improvement, and zero-defect standards. Required Candidate profile Experienced Quality Manager with strong knowledge of ISO/BIS standards, audits, CAPA, and manufacturing quality. Proven expertise in QMS implementation and team leadership. Perks and benefits Company Accommodation, EPF, Health Insurance

The Project Engineer will be responsible for the preparation, review, and management of essential project documentation including User Requirement Specifications (URS), Piping and Instrumentation Diagrams (P&ID), Qualification documents (DO, 1Q, OQ), Gantt charts, and relevant QMS documentation. This role will work closely with the cross-functional teams to ensure alignment with GMP and regulatory standards from the early design phase through to final qualification. In addition to documentation, the role will require hands-on coordination with vendors and contractors for timely execution of site works. This includes floating enquiries, obtaining and reviewing technical and commercial offers,...

Required Experience: 2 to 6 years of hands-on experience in Downstream Processing Educational Qualifications: B.Sc / M.Sc in Life Sciences ITI / Diploma B. Pharmacy / M. Pharmacy B.Tech / Any relevant technical degree Key Skills & Responsibilities: Experience in handling equipment such as: Chromatography columns and systems Column Packing (BPG and Chromoflow) TFF (Tangential Flow Filtration) Systems Centrifuge Systems Filtration, Filter Integrity Testing, Buffer Preparation, CIP/SIP Systems Strong documentation skills QMS/GMP Compliance and process awareness Candidate Preferences: Immediate joiners are highly preferred Only male candidates are encouraged to apply Candidates with prior biolog...

Location - Jigani. compliance with AS9100 / ISO 9001 standards. conduct internal audits. Quality Management System documentation, certification audits, MRB (Material Review Board, activities. Required Candidate profile Location - Jigani. compliance with AS9100 / ISO 9001 standards. internal audits. Quality Management System documentation, certification audits, MRB (Material Review Board, activities.

Division/ Department : - Quality Assurance / R&D This Role Reports to : - Sr. General Manager - QA & R&D This Role Supervises : - Lab Engineers / Design Engineers PURPOSE OF THE ROLE : - To take care of the new product and process Design and Existing product and process Quality improvement IDEAL PROFILE : - Educational Qualification : - Essential : - B.E. / B.Tech /M.Sc. with specialization in Electronics/ Electrical Engineering, from a State/ Govt. recognized University Preferred : - Electronics/ Electrical/ Mechanical Work Experience Required (In yrs.) : - Total: 5-8 yrs. Years (Relevant experience) : - 3-5 yrs. Post Qualification experience: - Other Relevant Direct Skills : - AutoCAD / Re...

An Assistant Quality Manager to support and manage Quality Management System activities as per ISO/IEC 17025:2017 and the Integrated Audit Scheme of FSSAI, EIC, and APEDA. responsible for Maintain and implement QMS, infernal audits, CAPA, PT/ILC . Required Candidate profile Mandatory: Hands on experience of facing Integrated Audits (FSSAI / EIC / APEDA) under NABL, Strong understanding of ISO/IEC 17025:2017, excellent documentation, audit handling, coordination skills. Perks and benefits Best in the Industry.