92 Batch Manufacturing Jobs

QA & R Manager is responsible for functions under QA from R.M. Inspection to Customer complaints systems compliance, audits leading all the QA operations in the company initiating & implementing continuous improvements to enhance product reliability Required Candidate profile Production Manager is responsible for heading the manufacturing operations. Monitor production output adjust workflow to meet customer demands & deliveries. Utilization manpower, material, machines

*Experience in production operations in Intermediate 1 API industry, Equipment & Utility Operations, Filing BMR I BPR, Distillation Process, having exposure of handling CF, Multi-Milling, AGNFD, FBD equipment. Required Candidate profile * Experience of working in API industry I Bulk Drug, having exposure of handling and preparation of Production cGMP documentation, Change Control, Deviation, 005 Investigation and CAPA etc.

Responsible for schedule & coordination, handling of internal audits and its documents. Management of vendor qualification documents, responsible for Vendor qualification of raw material, packaging material and critical service providers for testing, calibration, validation, transporters etc. Review, approval, tracking and ensure the quality agreements for all the critical material vendors, service providers, etc and with the customers as applicable. Batch release & dispatch: Review and or approve, release of executed batch records (Batch manufacturing, filling and packing records), analytical data by review and assess the related QMS documents such as change controls, deviation, complaints, incident & OOT etc. If any and the product related stability data. Responsibilities Qualifications BSC/MSC/ B.Pharmacy / M.Pharmacy ( 10 Years Experience )

Nutrizo Advancis Healthcare Private Limited is looking for IPQA-Chemist to join our dynamic team and embark on a rewarding career journey Conduct in-process quality checks during manufacturing Ensure compliance with GMP and SOP standards Document results and report deviations Coordinate with QA and production teams

Role & responsibilities Ensure the compliance of cGMP & EHS. Follow the cGMP requirement with appropriate housekeeping and documentation in manufacturing area. Co-ordination with other department for safe, successful and timely batch execution. Achieving plant production target w.r.t quality and yield. Active involvement in facing quality audits by vendor audit & regulatory audits. Lead from front to ensure safe behaviour / GMP culture on the shop floor. Comply with online documentation with complete data integrity. Undergo safety, quality and operational training & comply with requirement. Maintain housekeeping standard to ensure a clean and safe workplace. Follow the SOP practices. Preparation to comply statutory audit, customer audit and regulatory audit. Batch charging and process work out as per written instruction. Shift handover / instruction/ information communication. Operation & cleaning of Equipments. Suggests changes in working conditions and use of equipment to increase efficiency of equipment. Initiates or suggests plans to motivate workers to achieve work goals. Maintaining cleanliness and hygienic practices in the plant premises.

Monitor and control batch processes and chemical reactions under supervision. Maintain accurate production records, logbooks. Ensure compliance with safety protocols and environmental guidelines. Basic understanding of organic and inorganic chemistry

Role & responsibilities Cell Culture & Production Support: Perform aseptic handling and maintenance of cell cultures (e.g., Vero, BHK or other cell lines) in adherent and/or suspension formats. Prepare and sterilize culture media, buffers, and reagents as per batch requirements and SOPs. Monitor and record cell growth parameters, viability, and morphology. Scale-up cell cultures for downstream processing or viral seed production. Facility & Environmental Monitoring: Conduct routine facility checks including temperature, humidity, pressure differentials, and cleanroom conditions. Coordinate and ensure compliance with environmental monitoring schedules (viable/non-viable particles, surface, and air sampling). Assist in maintaining facility readiness and hygiene per cGMP standards. Documentation & Quality Compliance: Prepare and review SOPs, batch manufacturing records (BMRs), logbooks, and calibration/maintenance records. Maintain data integrity and compliance with Good Documentation Practices (GDP). Participate in internal and external audits, ensuring timely closure of CAPAs. Quality Management System (QMS): Support implementation and maintenance of QMS elements: deviations, change controls, CAPA, risk assessments, and document control. Participate in training programs related to QMS and GMP compliance. Working knowledge of QMS software/tools is an added advantage. Desired Skills: Proficiency in aseptic techniques and cleanroom operations. Strong understanding of GMP, GLP, GDP, and ISO standards. Good written and verbal communication skills. Job Location: Kadi, Gujarat ( Bus facility available from Ahmedabad, Kalol & Kadi)

Role & responsibilities Job summary We are looking for an individual to perform filling/washing and sterilization operations within GMP (Good Manufacturing Practices), regulatory, and organizational guidelines. The objective is to produce products within defined volumes and timelines, ensuring compliance with quality standards, GMP, and regulatory requirements as per schedule. " Roles & Responsibilities Perform filling, washing, sterilization operations as per the day plan, executing batch production records. Participate in filling area line clearance activities and perform machine cleaning operations. Handle material dispensing and issuance from the warehouse. Issue discrepancies, work with cross-functional departments to close discrepancies, and implement appropriate corrective actions. Compliance with GMP, safety standards, and SOPs (Standard Operating Procedure) for designated manufacturing equipment. Maintain records in machine operation log books. Maintain manufacturing equipment to ensure correct functionality and calibration compliance. Actively engage in validation and qualification activities for all manufacturing area machines. Promote safety awareness and improvements, engage in continuous improvement activities, and adhere to the company's safety rules. Report all unsafe matters, near misses, and accidents. Preferred candidate profile Educational qualification and work experience Educational qualification: A Diploma or B.Pharm. Minimum work experience: 4 to 6 years of experience in batch formulation operations Skills & attributes Technical Skills Proficiency in comprehending and overseeing sterile and fill finish operations in pharmaceutical manufacturing, demonstrating familiarity with the processes involved. Practical experience and hands-on knowledge in executing sterile and fill finish operations, showcasing the ability to actively participate in and manage these critical manufacturing processes. Practical expertise in equipment validation, process validation, and cleaning validation, demonstrating the ability to validate and ensure the reliability of manufacturing equipment and processes. Behavioral skills Effective listening skills, ensuring a comprehensive understanding of information. A keen eye for detail, ensuring accuracy and precision in tasks. Awareness and sensitivity to deadlines, ensuring timely completion of tasks. Analytical skills and the ability to troubleshoot, enabling effective problem-solving. Strong interpersonal skills and the ability to work well in a team, fostering collaboration and positive team dynamics. Location: Pydibhimavaram Dr Reddy's Formulations Limited(DFL-02) Injectable Facility, Aseptic Manufacturing Hiring For : Filling,Compounding,Autoclave,Lyo Operators, PM(Preventive Maintenance),Documentation, MS Office

Job Description: Operate, monitor, and optimize chemical production processes. Prepare chemical batches according to Standard Operating Procedures (SOPs). Ensure quality control through in-process testing. Coordinate with Quality Assurance (QA) and R&D teams for process improvement and new product trials. Maintain production documentation, including batch records, logbooks, and reports. Adhere to safety protocols, chemical handling procedures, and environmental regulations. Troubleshoot equipment malfunctions and process deviations. Support in scaling up lab-scale processes to full-scale production. Monitor inventory levels of raw materials and reagents. Train and guide plant operators and junior chemists. Apply knowledge of chemical plant operations, instrumentation, and safety standards. Ensure compliance with Good Manufacturing Practices (GMP), ISO standards, and relevant regulatory requirements. Key Skills & Competencies: Strong understanding of chemical processes and reactions Analytical and problem-solving skills Proficient in using lab and production equipment (e.g., reactors, mixers, dryers) Basic computer skills (MS Office, ERP systems) Effective communication and teamwork Required Qualifications: Education: B.Sc. / M.Sc. in Chemistry, Industrial Chemistry, Chemical Engineering, or a related field Experience: 15 years for entry to mid-level roles 5+ years for senior roles in chemical or pharmaceutical manufacturing Additional Information: At Avid Organics, we believe that we can achieve our mission to enhance value creation for our stakeholders only through the quality and commitment of our people. We continuously strive to unleash the potential of each individual. We leverage human capital for competitiveness by nurturing knowledge, entrepreneurship, and creativity. These strengths help us compete successfully in a global business environment and exploit emerging opportunities. We reward the will to succeed and the desire to compete with the best in the world. Our employees are intellectually stimulated and given the freedom to make their own decisions, driving our growth through innovation and experimentation. Apply Now! :- hr@avidorganics.net Visit our website or contact us at https://www.avidorganics.net Job Location: Survey No. 460/1,,,GEB SUB STATION ROAD,,POICHA-Ra nia, Ta.- Savli , VADODARA, Gujarat, India

Responsibilities: * Oversee batch manufacturing & processing * Ensure chemical quality & safety standards met * Coordinate production schedules & resources allocation Log Sheet Verification: Regularly check and verify log Health insurance Annual bonus

Job Role: Junior/ Assistant Associates Manufacturing (Injectables) Eligibility criteria: Qualification: Any Diploma/ BSc (Full time) Years of Experience: 1 to 6 Years should be from injectable manufacturing plant. Job Description Operate production equipment such as Injectable , Sterile , Parenteral machines, Vial / Ampoule filling , Capping , Compounding , Washing ,Sealing, Terminal sterilization, Stopper process & Visual inspection. Monitor and control the production process to ensure quality products are produced within specified parameters. Maintain accurate records of production data and perform routine maintenance tasks on equipment as required. Collaborate with other team members to resolve issues and improve overall efficiency. Ensure adherence to Good Manufacturing Practices (GMP) guidelines. Must have experience with USFDA regulatory environment & process.

Roles and Responsibilities Prepare and review batch manufacturing records (BMR) and batch processing documents to ensure compliance with regulatory requirements. Monitor production processes to identify areas for improvement and implement changes to optimize efficiency and productivity. Collaborate with cross-functional teams to resolve issues related to product quality, process optimization, and equipment maintenance. Ensure adherence to cGMP guidelines throughout the production cycle.

Operate and monitor manufacturing equipment and Instrument used in various stages of API production, such as reactors, Centrifuge, Dryer, Miller, sifter etc. Maintaining accurate records and documentation of production activities, including batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch Packing Record (BPR) records, Equipment s usage logs and Deviation reports if, any. To co-ordinate with engineering department for the shift break down jobs. To monitor the utility operation in the plant and report any abnormality to engineering department. Collaborate with other shop floor personnel, shift in-charges, and cross-functional teams to ensure efficient and coordinated production. Before charging of batch, cleanliness of Equipment s to be verified by visual verification procedure. To maintain good housekeeping in respective manufacturing area during process. Receive, store, and handle raw materials, intermediates, and finished products. Maintain accurate reconciliation records and follow proper material handling procedures. Follow established procedures to maintain product quality and consistency. This may involve sampling and testing intermediates, raw materials, and finished products. To monitor the process online and record/fill the entire document legible. Continuously monitor & maintain process parameters as per the desired product specifications and quality. To record and maintain all the documents online as per CGMP. Execute batch processing tasks according to standard operating procedures (SOPs), Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch packing Record (BPR), and maintain the details of records in equipment usage logs Ensure that all steps are carried out accurately and in a timely manner. To monitor and record temperature, Humidity and differential pressure in clean area (Level-I, Level-II & III). To check and record daily weighing balance calibration and verification. To take training online in AIMS software. Participate in training programs to enhance knowledge and skills related to API/Intermediate s manufacturing and safety point of view. Adhere to and promote safety practices, including the use of personal protective equipment (PPE) and following safety procedures to prevent accidents or incidents. Be prepared to respond to emergencies, such as spills, leaks, or safety incidents, by following established emergency procedures. Participate in equipment cleaning and maintenance activities to ensure equipment is in good working condition. Identify and address issues or deviations in the manufacturing process, such as equipment malfunctions or variations in product quality. Comply with environmental regulations, including proper waste disposal and following procedures for managing hazardous materials. Identify opportunities for process optimization, efficiency improvements, and waste reduction and communicate suggestions to higher-level personnel. To co-ordinate with QA department for documents issuance/submission and warehouse for RM, Intermediate, API issuance/submission as per requirement. To be maintained plant/process related consumable items Inventory as per requirement. To review the manufacturing department executed documents like, Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch packing Record (BPR) etc..

To Prepare new SOPs as per required, revise existing SOPs based on periodic updation and as per internal & external audit recommendation after that review and implemented SOPs of Production department. To Carryout process validation and cleaning validation in coordination with R&D, QC and QA. To review the acceptance criteria is fulfilled for new molecules as well as modify process for existing molecules, also ensure all validation protocols and reports are reviewed accordingly. To Ensure the compliance for cGMP and Safety in production area to work in safe work environment and ensure the subordinate are working in safe condition. To ensure plant facility is always ready for facing internal and external audit. Review audit report and to provide CAPA for all observation and implementation of CAPA. To monitor and review temperature, Humidity, and differential pressure records in clean area (Level-II & III). To ensure that the required documents are maintained as per cGMP and USFDA guidelines and to verify filled documents BMR/BPR/BCR etc. To ensure adherence to SOPs and cGMP during manufacturing operation in the production department. To raise online incident, deviation (Planned/ Unplanned) and change control for new products and existing products etc. and to be closed after completion of activity along with preparation of supporting documents for closing. To investigate (OOS/ Incident/ Deviation) the failure of batches as and make a report with conclusion of root cause/ Probable root cause and CAPA. To initiate CAPA for evaluation and effectiveness of CAPA. After completion of activity CAPA to be closed along with preparation of supporting documents. To prepare and review BMR/BPR/BCR etc. for new products and enhance batch size of existing products as per process given by R&D with related to plant. To revise BMR/BCR etc. according to internal/external audit, validation report and RA recommendation. To prepare equipment and process mapping details, change summary, Equipment comparison, Process comparison, Risk assessment, Errata, Quality comparison/ equivalency and process flow diagram. To update list of authorised personnel entry into production area, Organogram, List of SOPs for revision, List of change control/ CAPA/ Deviation (Planned/ Unplanned)/ OOS/ Incident/ Errata/ Product details/ Equipment details/ Risk assessment for timely closing before due date. To prepare and review Protocols and Reports for area qualification & requalification, Calculator validation, Excel sheet validation for calculation of weighing balance accuracy and precision check log and Intermediate re-analysis for re-test period etc. To generate the online training in AIMS software through issuing/requesting related consulting with concern department. Functional and Cross functional training to be imparted to new joined employee for job specific and job oriented and existing employee as per training need identification and BMR/BCR/LCS etc. To prepare Limit calculation sheet (LCS) for new products of API for cleaning of equipments and existing product in case enhance batch size and change in API equipment based on validation recommendation. Co-ordinate with QA, QC, R&D, Warehouse, Engineering, ADL, and RA department for related to documents preparation, if any failure of products and compliance. To co-ordinate with QA department for documents issuance/submission and warehouse for RM, Intermediate, API issuance/submission as per requirement. To be maintained plant/process related consumable items Inventory as per requirement. Execute batch processing tasks according to standard operating procedures (SOPs), Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch packing Record (BPR), and maintain the details of records in equipment usage logs Ensure that all steps are carried out accurately and in a timely manner. To take training online in AIMS software.

1 Supervise & Monitor manufacturing and packaging activity. 2 To guide, supervise, co-ordinate, manage and lead a team of production officer and production operators in execution of manufacturing operation to achieve the stated goals. 3 Preparation, review and implementation of SOPs and Formats pertaining to manufacturing Department. 4 Preparation and review of URS for manufacturing department. 5 Imparting training of manufacturing SOPs and GDP to Production Operators and Production Officers. 6 Preparation and review of Performance Qualification batch record and protocol. 7 Executing and reviewing of manufacturing equipment qualification activity. 8 Execution and supervision of the Process Validation/Stability batches/Commercial batches. 9 Preparation and Review of Master Batch Manufacturing Records and Master Batch Packaging Record for Process Validation / Stability Batches / Commercial Batches and other relevant documents. 10 Review, execution and implementation of Batch Manufacturing Records, Process Study Protocols and Process Study Reports. 11 Management of day to day product related activities for timely execution of the assigned products through internal communications with internal departments like Purchase, Store, QA,QC,HR & Admin, Engineering, Maintenance team etc. and external communications with Tooling vendors and Equipment manufacturers. 12 Maintaining the department in accordance with the CGMP norms. 13 Responsible for initiation, assessment and closing of any deviation and change control regarding to manufacturing activity. 14 Work distribution to production officer and production operator. 15 Any work assigned by the Dept. head after proper training. 16 To raise the indent and capex as per requirement. 17 Activities other than defined in the Job Description are to be done, as per the requirement of HOD, by following HOD s instructions and guidance. 18 Coordination and management of training activity of Manufacturing department.

JOB DESCRIBTION Supervision of manufacturing, processing, packaging and holding of drug product as per define and approved procedures for stability batches and commercial batches. Maintaining the area and equipment in orderly manner as per cGMP requirements in a good state of repair and sanitized condition. To perform online documentation with respect to departmental procedures as per good documentation. To impart training of operation and cleaning related SOP to all subordinates and operators. Co-ordination for IQ / OQ for any new equipments / system. To perform PQ for any new equipments / system. To follow all concern departmental SOPs for day to day operation and cleaning. To handle and manage material movement as per defined procedure and approved Batch Manufacturing Record / Batch Packing Record. Review, execution and implementation of Batch Manufacturing Records, Batch Packaging Records, Process Study Protocols, Process Study Reports and all relevant Documents. To follow all safety rules and departmental general instructions. To perform work other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HODs instruction and guidance.

1 Supervise & Monitor manufacturing and packaging activity. 2 To guide, supervise, co-ordinate, manage and lead a team of production officer and production operators in execution of manufacturing operation to achieve the stated goals. 3 Preparation, review and implementation of SOPs and Formats pertaining to manufacturing Department. 4 Preparation and review of URS for manufacturing department. 5 Imparting training of manufacturing SOPs and GDP to Production Operators and Production Officers. 6 Preparation and review of Performance Qualification batch record and protocol. 7 Executing and reviewing of manufacturing equipment qualification activity. 8 Execution and supervision of the Process Validation/Stability batches/Commercial batches. 9 Preparation and Review of Master Batch Manufacturing Records and Master Batch Packaging Record for Process Validation / Stability Batches / Commercial Batches and other relevant documents. 10 Review, execution and implementation of Batch Manufacturing Records, Process Study Protocols and Process Study Reports. 11 Management of day to day product related activities for timely execution of the assigned products through internal communications with internal departments like Purchase, Store, QA,QC,HR & Admin, Engineering, Maintenance team etc. and external communications with Tooling vendors and Equipment manufacturers. 12 Maintaining the department in accordance with the CGMP norms. 13 Responsible for initiation, assessment and closing of any deviation and change control regarding to manufacturing activity. 14 Work distribution to production officer and production operator. 15 Any work assigned by the Dept. head after proper training. 16 To raise the indent and capex as per requirement. 17 Activities other than defined in the Job Description are to be done, as per the requirement of HOD, by following HOD s instructions and guidance. 18 Coordination and management of training activity of Manufacturing department.

Supervision of manufacturing, processing, packaging and holding of drug product as per define and approved procedures for stability batches and commercial batches. Maintaining the area and equipment in orderly manner as per cGMP requirements in a good state of repair and sanitized condition. To perform online documentation with respect to departmental procedures as per good documentation. To impart training of operation and cleaning related SOP to all subordinates and operators. Co-ordination for IQ / OQ for any new equipments / system. To perform PQ for any new equipments / system. To follow all concern departmental SOPs for day to day operation and cleaning. To handle and manage material movement as per defined procedure and approved Batch Manufacturing Record / Batch Packing Record. Review, execution and implementation of Batch Manufacturing Records, Batch Packaging Records, Process Study Protocols, Process Study Reports and all relevant Documents. To follow all safety rules and departmental general instructions. To perform work other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HODs instruction and guidance.

Hi, Greetings from Avani Consulting!!! Walk in Invitation: We have job opportunity with API Manufacturing Plant for Associate /Sr. Associate Production Profile for Mysuru Loaction. Interview Location BANGALORE We are having face to face interview on 21st June Saturday in Bangalore.- Single Round Face to face Company : A leading Pharma API Unit - in Mysore Position - Production Department Associate /Sr. Associate Work Experience Min 5 yrs in API in current Salary 20% to 25 % hike on current CTC. Note: No Charges If interested drop your CV to Shweta Gupta [ 7015954549|| shweta@avaniconsulting.com ] Thanks & Regards Shweta Gupta

Role & responsibilities Expertise in batch manufacturing and preparation related activities. To observe & follow all rules and regulations of the production department. Must be from Parenteral background & exposure to Aseptic vial / Bottle filling process is desirable. To be aware and responsible for achieving quality objective and fulfilling the requirements of applicable quality procedures. Technical exposure and expertise on filling & Autoclave machine. Exposure of USFDA audits. Preferred candidate profile Candidate should have relevant experience in USFDA regulatory approved pharmaceuticals (Preferred 21 CFR compliance) organization. Perks and benefits As Per Company Norms.

Job Description Rev. No.:00 Name : Department : Quality Assurance Division-Location : EPD Baddi Grade/Band : 1B Designation : Executive QA Employee Code : Qualification : B. Pharm Date of Joining : Reports to : Manager - QA Experience (as on date) : Followings will be the responsibilities of the position holder: Compliance of current Good Manufacturing Practices in the Oral dosage facility & to follow GDP with data-integrity compliance. Manufacturing and Packing process compliance in accordance with approved BMR/BPR. To carry out line clearance, In-process checks at the different stages of batch manufacturing and packing. Collection and management of control samples / stability samples / validation samples / other samples (as applicable) and maintain their record. Issuance of Batch records and review of executed batch documents. Issuance of controlled copies of Logbooks and formats. Compliance of IPQA related SOPs and records. Calibration of IPQA instruments and to maintain related records. To assist investigation activities. SOP training in ISOtrain of self-train within stipulated time. To follow all the practices related to safety and COBC. In absence of the position holder, designated Executive-IPQA shall be authorized designee and responsible for day to day working. JOB FAMILY: Operations Quality t SIGNIFICANT WORK ACTIVITIES: Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)

Managing all production activities during the assigned shift. Operating equipment’s Reactors, Centrifuges, and Dryers. Ensuring adherence to SOP, GMP and other relevant regulations. Maintain accurate production records, Online BMR, BPCR feeling.

Hi Greetings from Avani consulting , We have job opportunities with (pharma company) for the production department in mysore location NOTE :- We are going to conduct a Walk-in interview in Mysore on 21-june- 2025(Saturday) Whom ever are interested they can join for interview just share updated resume Job Description for Production-Associate Position- Associate Work Experience Min 3-12 yrs in API Drive Location : Banglore Work Location: Mysore ( Nanjangud) Gender Any Qualification- B.Tech Chemical Engineering/M Sc and Bsc Chemistry /Diploma in chemical Engg Roles & Responsibility 1. Responsible for appropriate production planning & execution of batches in line with targeted commitments complying cGMP& Safety requirements. 2. To ensure gowning practices, entry / exit procedures, usage of PPEs are followed by team while in the department. 3. To ensure adherence of process instructions as per Batch Manufacturing Record and respective departmental procedures. 4. To ensure good housekeeping in the production shop floor. 5. To ensure compliance to cGMP, Safety, Health & Environment in delivering the product of intended Quality. 6. To ensure batch records on completion are reviewed for adequacy prior to hand over to QA for review, compliance & release / rejection. 7. To report deviations / incidents immediately upon occurrence and to conduct investigation in coordination with cross functional teams. 8. To ensure all document entries are performed online with legible, errors corrected with signature and date. 9. Monitoring and control of the manufacturing environment and filling of daily log books. 10. To ensure preventive maintenance of equipment, calibrations of gauges / instruments are performed as per schedule & the outcome of verification is within control. 11. To ensure the sanitization activity is performed in the department. 12. To support QA in investigations related to OOS, Deviations, CAPA, Incidents, complaints or recalls, validations and any other support that would be required. 13. To ensure the raw material / Intermediates / API(s) are labelled at each stage of process and stored with appropriate segregation at recommended storage conditions ensuring no impact on product Quality. 14. To ensure that stocks are reconciled at regular intervals. 15. Any other assignment allocated by the Production head. if interested please share updated resume and Fill the details to 7780363938 or Jyotsna @avaniconsulting.com 1. Current CTC: 2. Expected CTC: 3 . Notice Period: 4. Total Experience 5. Current Location: 6. Preferred Location: 7. Reason for change:e 8. Relevant years of experience in on roll :

Responsibilities: * Conduct BPR reviews, process validations & batch manufacturing oversight. * Ensure compliance with industry standards through IPQA practices.

Responsible for maintaining and improving the Quality Management System (QMS) in compliance with ISO 13485:2016 and Local regulatory requirements (Indian Medical Device Rule). Responsible for internal audits, CAPA, change control, document control, risk management, and management review processes. Support external audits/inspections (Notified Body, regulatory, customer). Ensure compliance with applicable regulatory requirements and support quality system documentation updates. Collaborate with cross-functional teams to ensure quality and compliance across product lifecycle stages.