2376 Qms Jobs - Page 43

B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

Preferred candidate profile Graduate engineer (civil / mechanical / electrical) with min. 10 yrs. of experience in the field of construction, operation and maintenance of water distribution networks Should have good understanding of Water Distribution Networks, District Metered Areas, Pressure Management, consumer metering, AMR meters, flow measurement, bulk flow meters, etc. Minimum 3-5 yrs. experience in water audits, revenue management, leak detection, real loss and apparent loss management Experience with QMS Preferably experience with any of the major water supply and distribution utilities, and water and wastewater technology / process firms Preferably experience in business development and sales activities

Preferred candidate profile Graduate engineer (civil / mechanical / electrical) with min. 10 yrs. of experience in the field of construction, operation and maintenance of water distribution networks Should have good understanding of Water Distribution Networks, District Metered Areas, Pressure Management, consumer metering, AMR meters, flow measurement, bulk flow meters, etc. Minimum 3-5 yrs. experience in water audits, revenue management, leak detection, real loss and apparent loss management Experience with QMS Preferably experience with any of the major water supply and distribution utilities, and water and wastewater technology / process firms Preferably experience in business development and sales activities

Preferred candidate profile Graduate engineer (civil / mechanical / electrical) with min. 10 yrs. of experience in the field of construction, operation and maintenance of water distribution networks Should have good understanding of Water Distribution Networks, District Metered Areas, Pressure Management, consumer metering, AMR meters, flow measurement, bulk flow meters, etc. Minimum 3-5 yrs. experience in water audits, revenue management, leak detection, real loss and apparent loss management Experience with QMS Preferably experience with any of the major water supply and distribution utilities, and water and wastewater technology / process firms Preferably experience in business development and sales activities

JOB Description Designation/Role: Assistant Manager IP DRG Department: Quality Reporting to: Director - Quality Location of work:Hyderabad skillset : Excellent domain expertise and process knowledge of RCM for Hospital facility. Understanding of Hospital Facility IP DRG coding concepts, MS DRG, APR DRG, reimbursement methodology, ICD-10-CM, ICD-10-PCS guidelines, elements of UHDDS guidelines, query processes, documentation guidelines. Strong knowledge in human anatomy, physiology, pathophysiology, pharmacology, diagnostic studies, conservative and surgical treatments. Understanding of all document types, Operative Reports, Discharge Summary, Progress Notes, ED Report and all other report formats used in hospital care setting. Understanding of CMS IPPS payment methodologies Aware of consequences of risky practices like up-coding and down-coding, fraud and abuse, inflated documentation, OIG guidelines, and HIPAA rules. Skills: Strong interpersonal skills, excellent communication skills, and ability to effectively work with and coach team members. Ability to communicate with other stakeholders and clients, MIS team, and training teams for driving quality management. Possess operational skills to manage team with better resource utilization. Should have an aptitude to learn new things. Ability to read, writes, and performs basic computer operations. Must be a self -starter, motivated, organized and able to prioritize tasks. Managing reports daily, weekly, monthly and monitoring and being active participant in client calls and maintaining good client relationship. Research, analyze and respond to inquiries regarding compliance,

JOB DUTIES AND RESPONSIBILITIES (Please Mention In Below Table) 1 Manage release of product batches, including owning the QA product release workflow in SAP. 2 Lead and supervise a team of QA professionals to perform operations as described above. 3 Review and approve Deviation and Laboratory Investigations 4 Review and approve Purchase Specifications and Analytical Standards 5 Review and approve Issue Reviews and CAPA 6 Assist with Non-Conformance Investigations and provide guidance in identifying potential product impact and determination of final product disposition 7 Review and update Standard Operating Procedures (SOPs) for GMP compliance 8 Follow all regulatory guidelines, cGMP guidelines, Environmental Health and Safety regulations as required by the job function Review validation protocols and completed documents, including process qualification protocols for validations of commercial processes. 9 Work to create an environment of open communication, participation and information-sharing within and between teams within QA and throughout facility

We are looking for a highly skilled and experienced professional to join our team as a Manager - Sample Collection at Vijaya Diagnostic Centre. The ideal candidate will have a strong background in healthcare, with excellent leadership and management skills. Roles and Responsibility Manage and supervise the sample collection team for efficient operations. Develop and implement effective strategies for improving sample quality and reducing errors. Collaborate with other departments to ensure seamless communication and coordination. Analyze data and metrics to identify areas for improvement and optimize processes. Ensure compliance with regulatory requirements and industry standards. Train and mentor new team members to enhance their skills and knowledge. Job Requirements Minimum 5 years of experience in a similar role, preferably in healthcare or a related field. Strong knowledge of laboratory procedures and protocols. Excellent leadership, communication, and interpersonal skills. Ability to work in a fast-paced environment and meet deadlines. Strong analytical and problem-solving skills with attention to detail. Familiarity with quality control measures and quality assurance procedures.

We are looking for a highly motivated and detail-oriented individual to join our team as a Trainee in Sample Transit at Vijaya Diagnostic Centre. The ideal candidate will have excellent analytical skills, attention to detail, and the ability to work effectively in a fast-paced environment. Roles and Responsibility Manage and process samples efficiently. Ensure accurate labeling and tracking of samples. Collaborate with other departments to ensure smooth sample flow. Maintain high standards of quality control and safety. Develop and implement effective sample management systems. Provide exceptional customer service to clients and stakeholders. Job Requirements Strong understanding of healthcare industry practices and regulations. Excellent communication and interpersonal skills. Ability to work independently and as part of a team. Strong problem-solving and analytical skills. Familiarity with laboratory equipment and software. Ability to maintain confidentiality and handle sensitive information. Industry: Healthcare. Company name: Vijaya Diagnostic Centre. Reference number: a4883202d55843bf.

BE/ MSc/ Electronics / Electrical / Mechanical /Production Engineering Job Related Experience: 8 to 10yrs and above Position requirements: Provide industrial strategy inputs to the cluster in full alignment with GSC-T(Global Supply Chain Transformation), LoB (Line of Business) and GSC India management team Understand, contribute drive the Long Term Industrial Plans (LTIP) for the plants in the Cluster in close co-ordination with GSC-T and LoB Identify, prepare and successfully drive the rebalancing program for the plants of Cluster i.e. localization, manufacturing transfer projects, regionalization etc. Drive all the non-purchasing productivity for the plants of the Cluster; using levers such as localization, transfers, QVE, subcontracting etc. Be a key contributor collaborator to challenge and drive the industrial performance of all plants within the cluster through effective project management, QVE and Localization projects Manage a team of industrial cross functional leaders in project for New development projects, regionalization, feasibility studies etc. Based in Bangalore but requried to travels to vendors, factories etc Responsibilities : Profile required : Others (e.g. Attitude and Behavioral skills): Developing a schedule for the project with clear Action Plans as per the requirement. Ensure supply chain set up in the system. Ensure manufacturing readiness of all departments. Planning conducting Pilot reviews / Pilots / Post Pilot reviews initial build. Handing over the product to Plant management after initial build. Responsible of product quality and cost, industrial planning and capital expenditure (investments, expenses and engineering cost) from concept to mass production release Build industrial scenarios according to SE industrial strategy and select the most efficient. Estimates cost, capex, ROI and risk Define the best manufacturing process and technology to be used for components fabrication, assembly process and control Optimise supply chain process and purchases Assess and select suppliers and manufacturing location from both internal and external sources Leads industrial projects for productivity achievement for the plants For OCP projects, work closely with design engineering, marketing departments to ensure the best manufacturability of a product Optimise product cost, quality and ROI by proposing solution to rationalize or to optimise commercial offer (number or references) Coordinates all industrial functions (tools, electronic, assembly, advanced quality and cost) and purchasing Leads and coordinates industrialization resources, internal and external manufacturing plants as well as international resources, suppliers and subcontractors Take a lead on Strategic projects and submit the feasibility study to management and execute the same based on management approval Strong experience in project management in related industries. PMP certificate may be an added advantage Experience of managing team of cross functional leaders in project management Good knowledge of many industrialization field (assembly, tooling, manufacturing process, advanced quality, value analysis, lean manufacturing) Good understanding of manufacturing processes. Exposure to mass production process is desirable. Must have knowledge of Jigs Fixtures. Good knowledge in Purchasing and Finance functions Experience in quality management system 6 sigma knowledge may be an added advantage People management skills Exposure to various experiences (different companies, different positions, international experience) are very much appreciated Very good team player. Very open minded, creative Able to foresee problems raise alarm to management in case schedule is getting extended. Able to articulate the problems across to team members. Tactful, diplomatic Self-motivated, Very dynamic, team leader Result oriented, effective and efficient Can withstand stress and high work load Able to collaborate as well as to influence Very analytic and able to take decisions Very adaptive, keen on changing. Ready to accept project scope modifications

Job Description Education: BE/ MSc/ Electronics / Electrical / Mechanical /Production Engineering Job Related Experience: 8 to 10yrs and above Position requirements: Provide industrial strategy inputs to the cluster in full alignment with GSC-T(Global Supply Chain Transformation), LoB (Line of Business) and GSC India management team Understand, contribute drive the Long Term Industrial Plans (LTIP) for the plants in the Cluster in close co-ordination with GSC-T and LoB Identify, prepare and successfully drive the rebalancing program for the plants of Cluster i.e. localization, manufacturing transfer projects, regionalization etc. Drive all the non-purchasing productivity for the plants of the Cluster; using levers such as localization, transfers, QVE, subcontracting etc. Be a key contributor collaborator to challenge and drive the industrial performance of all plants within the cluster through effective project management, QVE and Localization projects Manage a team of industrial cross functional leaders in project for New development projects, regionalization, feasibility studies etc. Based in Bangalore but requried to travels to vendors, factories etc Responsibilities : Profile required : Others (e.g. Attitude and Behavioral skills): Developing a schedule for the project with clear Action Plans as per the requirement. Ensure supply chain set up in the system. Ensure manufacturing readiness of all departments. Planning conducting Pilot reviews / Pilots / Post Pilot reviews initial build. Handing over the product to Plant management after initial build. Responsible of product quality and cost, industrial planning and capital expenditure (investments, expenses and engineering cost) from concept to mass production release Build industrial scenarios according to SE industrial strategy and select the most efficient. Estimates cost, capex, ROI and risk Define the best manufacturing process and technology to be used for components fabrication, assembly process and control Optimise supply chain process and purchases Assess and select suppliers and manufacturing location from both internal and external sources Leads industrial projects for productivity achievement for the plants For OCP projects, work closely with design engineering, marketing departments to ensure the best manufacturability of a product Optimise product cost, quality and ROI by proposing solution to rationalize or to optimise commercial offer (number or references) Coordinates all industrial functions (tools, electronic, assembly, advanced quality and cost) and purchasing Leads and coordinates industrialization resources, internal and external manufacturing plants as well as international resources, suppliers and subcontractors Take a lead on Strategic projects and submit the feasibility study to management and execute the same based on management approval Strong experience in project management in related industries. PMP certificate may be an added advantage Experience of managing team of cross functional leaders in project management Good knowledge of many industrialization field (assembly, tooling, manufacturing process, advanced quality, value analysis, lean manufacturing) Good understanding of manufacturing processes. Exposure to mass production process is desirable. Must have knowledge of Jigs Fixtures. Good knowledge in Purchasing and Finance functions Experience in quality management system 6 sigma knowledge may be an added advantage People management skills Exposure to various experiences (different companies, different positions, international experience) are very much appreciated Very good team player. Very open minded, creative Able to foresee problems raise alarm to management in case schedule is getting extended. Able to articulate the problems across to team members. Tactful, diplomatic Self-motivated, Very dynamic, team leader Result oriented, effective and efficient Can withstand stress and high work load Able to collaborate as well as to influence Very analytic and able to take decisions Very adaptive, keen on changing. Ready to accept project scope modifications Schedule: Full-time Req: 0099DA

Shree Rama Multitech Ltd. are seeking a highly experienced Manager QA/QC who will be responsible for overseeing and driving all quality assurance and quality control functions in the manufacturing plant. The role is key in implementing robust systems, ensuring compliance with industry standards, reducing customer complaints, and promoting continuous process improvements across all operations related to tubing, printing, blown films, and extrusion.

Manage release of product batches, including owning the QA product release workflow in SAP. Lead and supervise a team of QA professionals to perform operations as described above. Review and approve Purchase Specifications and Analytical Standards Required Candidate profile Work to create an environment of open communication, participation &information-sharing within & between teams within QA &throughout facility Pls mention this Feel free to reach me email Visit our website for more details: Follow Capital Placement Services Linkdein Profile for more updates :

Job Duties and Responsibilities (Please Mention In Below Table) 1 Manage release of product batches, including owning the QA product release workflow in SAP. 2 Lead and supervise a team of QA professionals to perform operations as described above. 3 Review and approve Deviation and Laboratory Investigations 4 Review and approve Purchase Specifications and Analytical Standards 5 Review and approve Issue Reviews and CAPA 6 Assist with Non-Conformance Investigations and provide guidance in identifying potential product impact and determination of final product disposition 7 Review and update Standard Operating Procedures (SOPs) for GMP compliance 8 Follow all regulatory guidelines, cGMP guidelines, Environmental Health and Safety regulations as required by the job function Review validation protocols and completed documents, including process qualification protocols for validations of commercial processe 9 Work to create an environment of open communication, participation and information-sharing within and between teams within QA and throughout facility 10 Work to create an environment of open communication, participation and information-sharing within and between teams within QA and throughout facility 11 Assist with complaint investigations for internally produced commercial product 12 Ensure compliance to all compendial, internal and client-specific requirements (SOPs, Quality Agreements, General and Informational Chapters in multiple compendia as applicable). 13 Ensure all work is performed and documented according to approved standard operating procedures, in general compliance with cGMPs and in a timely manner consistent with agreed upon schedules

Experience in Roller Grinding Responsible for skill building & Manpower Planning Responsible to achieve productivity in Roll manufacturing Department Responsible for adherence and improvement in effectiveness of QMS in Roll Grinding Required Candidate profile Responsible for problem solving and trouble shooting Coordination with Logistics , SCM to get input material and to deliver as per plan

Education -MBBS/BDS/BHMS + MBA /MHA in Health Care Experience - Minimum 5 years in the Health Care Job Specification : Develops and administers the quality education process formulating quality improvement programmes for employees. Prepares Internal Audit Schedules, assisting with Internal Audits and Audit results. Recommends quality tools and techniques to be used in measuring the Hospital s quality performance and variations; and solving quality problems. Recommends procedures and guidelines to direct the practices used in performing corrective action and preventive actions. Reviews Non-conformances, Corrective Actions, Observations, and Patient Complaints for repetitive trends, recommendations for changes and/or processes. Develops, writes, and implements Hospital s Quality Standard Operating Procedures, Standing Instruction and our Work Instructions. Actively supports and participates in Quality Management System training programs and other quality-related training. Actively supports, participates and maintains the integrity and on-going function of the Hospital and facilities safety programme. Quality Coordinator for NABH accreditation process and JCI, QAI accreditation process Establish policies and procedures compulsory according to NABH and JCI, QAI standards Maintained compliance with applicable governmental, regulatory agency and hospital policies, procedures, regulations and accreditation requirements. Conducted routine internal and external audits Analyzed quality audit results and developed, implemented and monitored corrective action plans, appropriately. Reported quality system requirements to hospital management and staff, on a regular basis. Training and Evaluation of staff for Quality standards Collection and analysis of Quality Indicators and prepared yearly trend reports Collection and analysis of Incident Reports. SOP formation and Implementation. Customer Satisfaction Enhancement. Team Building and Training. Salary - As per the Market Standard

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment If someone asks for payment on our behalf, it is a scam Please report the incident to the local police or cybercrime unit Your trust and safety are important to us Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare Job Title: Executive-Manufacturing Job Requisitions No : 13983 Job Description Purpose of Job Requirement in DSP Manufacturing (Protein Purification) (Plasma Fractionation Centre) Skill Required Chromatography System AKTA Process TFF System QMS Handling cGMP Understanding Roles and Responsibilites Execution of Batches in shift operation Maintains and documents proper records / log book / BPCRs / Reports as per GDP Handling of Chromatography, sterilization & Filtration techniques Coordination with other department VIZ engineering, QA, QC and R&D for smoothly execution of Technical Documents Coordination with QA for timely issuance, completion, filling of BPCR and other GMP documents Preparation of Performance Verification and PQ and commissioning protocol Understanding & execution of work in line with cGMP Preparation of SOP, BPCR and other Technical Documents Handling of QMS Documents, Handling of DMS Execution of Training related activities of DSP area To ensure the timely dispensing of raw material and Handling of SAP To support in qualification activities of DSP area In addition of above responsibilities, any responsibility assign by superior/HOD Qualification Required Experience: 2 to 5 Years Industry: Biotech industry experience required Relevant professional / Educational background Sc /B Location: Plasma Fractionation Unit, Ahm, GJ, IN, 382210 Travel: 0% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape Date: 18 Jun 2025

Maintain the Laboratorys Quality System. , Perform analytical tests in the laboratory, Assist with laboratory administrative duties, Maintain smooth laboratory work flow, Obtain lab certifications and complete QA/QC assignments, Promote good customer relations with all clients. Sample collections , Analytical and problem solving abilities as well as team building ability, Strong and efficient verbal and written communication skills, Ability to adapt and drive change, Experience with ISO standards; ASTM and/or DIN standards Must have strong Knowledge of ISO 17025:2017 & Must have implemented the same in any Lab. Knowledge of GC, HPLC shall be an added advantage. Candidate must be well conversant with MoU Qualification- Graduate with Training of ISO 17025:2017

We are looking for a skilled Finance Risk Fraud Professional to join our team at IDESLABS PRIVATE LIMITED. The ideal candidate will have 3 to 8 years of experience in finance risk fraud. Roles and Responsibility Develop and implement effective risk management strategies to mitigate financial risks. Conduct thorough analysis of financial data to identify potential fraudulent activities. Collaborate with cross-functional teams to investigate and resolve financial irregularities. Design and maintain comprehensive reports on risk management and fraud prevention measures. Provide expert guidance on financial risk assessment and mitigation techniques. Stay updated with industry trends and regulatory requirements related to finance risk fraud. Job Requirements Strong understanding of financial markets, instruments, and regulations. Excellent analytical, problem-solving, and communication skills. Ability to work effectively in a fast-paced environment with multiple priorities. Proficiency in financial modeling and data analysis tools. Strong attention to detail and ability to interpret complex financial data. Experience working with risk management frameworks and methodologies. Company name: IDESLABS PRIVATE LIMITED. Industry: Recruitment / Staffing. Title: Finance Risk Fraud Professional.

We are looking for a skilled SAP GRC professional with 5-8 years of experience to join our team in Pune. The ideal candidate will have expertise in SAP GRC and be able to work immediately. Roles and Responsibility Implement and maintain SAP GRC solutions to ensure compliance with regulatory requirements. Conduct risk assessments and audits to identify vulnerabilities and provide recommendations for improvement. Develop and implement security policies and procedures to ensure data integrity and confidentiality. Collaborate with cross-functional teams to integrate SAP GRC with other systems and applications. Provide training and support to end-users on SAP GRC best practices and features. Monitor and report on SAP GRC performance metrics to senior management. Job Requirements Strong knowledge of SAP GRC architecture, features, and functionality. Experience with SAP GRC implementation, configuration, and customization. Excellent analytical and problem-solving skills with attention to detail. Strong communication and interpersonal skills, with the ability to work effectively with stakeholders at all levels. Ability to work independently and as part of a team, with minimal supervision. Strong understanding of security principles, including access control, encryption, and data protection. Employee type: C2H. Notice period: Immediate joiners.

We are looking for a skilled CSV Lead with 15-25 years of experience to join our team at IDESLABS PRIVATE LIMITED. The ideal candidate will have a strong background in CSV and excellent leadership skills. Roles and Responsibility Lead the development and implementation of CSV strategies to ensure compliance with regulatory requirements. Collaborate with cross-functional teams to identify and mitigate risks associated with CSV. Develop and maintain relationships with key stakeholders, including regulators and industry partners. Provide training and guidance on CSV best practices to team members. Conduct audits and assessments to ensure adherence to CSV standards. Develop and implement process improvements to enhance CSV efficiency and effectiveness. Job Requirements Strong knowledge of CSV principles and regulations, including FDA guidelines. Excellent leadership and communication skills, with the ability to motivate and guide team members. Experience working in a fast-paced environment with multiple priorities and deadlines. Strong analytical and problem-solving skills, with attention to detail and the ability to identify risks. Ability to work collaboratively with cross-functional teams, including sales, marketing, and engineering. Strong understanding of quality management systems and ISO standards. Location- Bengaluru,Chandigarh,Dadra & Nagar Haveli,Daman,Diu,Goa,Haveli, Jammu, Lakshadweep, Nagar,New Delhi,Puducherry,Sikkim

Role & responsibilities Responsible for development, implementation, maintenance, and overall success of the companys quality and regulatory programs and strategies, including articulating quality standards and objectives, developing methods to embed quality into the product development and manufacturing processes, establishing vendor relationships and quality standards, and developing and implementing innovative programs to focus employees on improving product quality. Develop, implement, and support a comprehensive regulatory compliance strategy to meet global market requirements for our products and ensure alignment with our overall business strategy. Proactively partner with R&D, Marketing, and other groups to provide regulatory advice and guidance on meeting necessary requirements to place products on global markets. Ensure that regulated processes and systems are always inspection ready. Oversee the performance of internal and external audits. Review, edit, and maintain all departmental policies and procedures, including trainings, CAPAs, ECRs, and ECNs. Oversee the development of employees, talent, processes, and technology necessary to reach annual and long-term objectives as organizational leader for the QA/RA functions Serve as person responsible for regulatory compliance (PRRC). Other duties as assigned. Preferred candidate profile Extensive experience hosting regulatory inspections and interacting with regulators Strong understanding of global registration requirements and demonstrated track record of successful market access. Experience with computer software validation (CSV) and implementation for QMS and ERP software packages, including user requirements gathering and specification development, process workflow documentation, validation script writing, and IQ/OQ/PQ test case execution General understanding of ICH, cGMP, cGDP, FDA, ISO, MDR, Healthcare compliance and applicable regulations and industry standards regarding clinical research and regulation of medical devices Effective manager with ability to mentor and develop members of the QA/RA teams through coaching and effective performance management Proven ability to create culture of accountability and ownership Proven track record with establishing and maintaining strong internal and external partnerships. Must be able to work effectively at all levels in the organization in a matrix environment .and with external partners. Must demonstrate excellent written and verbal communication skills and work well with diverse teams and stakeholders in multiple locations. Must possess the ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities to meet deadlines and prioritize work on multiple projects. Highly independent and self-motivated and integrates well within a team. Physical Demands Ability to travel. Qualifications: Bachelors degree required in a science, engineering field or related discipline. MBA is a plus Experience: 10 years of QMS experience and demonstrated leadership experience. Proficiency with ISO 13485, Good Clinical Practices (GCP), and Quality System Inspection Techniques (QSIT); CFRs parts 210 &211.

01 Managing the entire QA activities in the plant & Overall implementation of Quality Systems in all units. 02 Design, Develop and approve all Quality systems in all units. Monitoring, Documentation, and implementation of process development. 03 Responsible to handle regulatory audits USFDA ISO 9001-14001, EU,WHO, and their compliance in all units without any Major Non Compliance. Making sure that there is stability data to support retest or expiry dates and storage conditions on APIs and/or intermediates where appropriate; and Performing product quality reviews 04 Handling of statutory audits like Quality, EHS, KSPCB, -CDSCO, weight & scale inspector, Director of Factories & Boilers, Social audits etc and their compliance (Evaluated by No show cause notice and no complaints) 05 Making sure that critical deviations are investigated and resolved; 06 Approving all specifications and master production instructions, Test methods, Qualifications 07 Approving all procedures impacting the quality of intermediates or APIs 08 Making sure that quality related complaints are investigated and resolved 09 Adhering to QA budget. 10 To qualify company for various certifications. 11 Assuring QMS in all Units. Experience 15 - 20 Years Salary Not Disclosed Industry Pharma / R&D / Biotech Qualification B.Pharma, M.Sc Key Skills Quality Assurance Supervisor USFDA Compliance and Audits Pharmaceutical Quality Assurance

Key Responsibilities: Build Relationships: Develop strong relationships with external suppliers, customers, and internal stakeholders such as Purchasing, Manufacturing, and Engineering. Supplier Selection: Support the cross-functional supplier selection process for components. Process Validation: Collaborate with external suppliers to ensure manufacturing processes conform to engineering standards and customer requirements. Quality Planning: Apply Advanced Product Quality Planning (APQP) processes, Automotive Industry Action Group (AIAG) tools, and Cummins specialty tools to develop zero defect components. Continuous Improvement: Contribute to product and process improvement projects using methodologies like lean and six-sigma. Supplier Audits: Conduct audits to mitigate risks, ensure readiness, and improve performance. Quality Improvement: Support quality improvement plans to enhance supplier performance. Problem Resolution: Lead root cause analysis, develop corrective actions, and verify their effectiveness. External Qualifications and Competencies Qualifications: Education: College, university, or equivalent degree in Engineering or a related technical or scientific subject. Licensing: May require licensing for compliance with export controls or sanctions regulations. Competencies: Communication: Develop and deliver multi-mode communications that convey a clear understanding of different audiences' needs. Customer Focus: Build strong customer relationships and deliver customer-centric solutions. Auditing: Apply auditing skills and Quality Management Systems knowledge to appraise manufacturing processes. Technical Interpretation: Apply Geometric Dimensioning and Tolerancing principles and Engineering Standards to interpret technical requirements. Process Design: Design manufacturing processes that consistently meet technical and customer requirements. Process Validation: Use core Automotive tools (DFMEA, PFMEA, Control Plan, SPC, MSA, Source Release, PPAP) to validate manufacturing processes. Measurement Design: Design measurement systems that meet industry and customer requirements. Problem Solving: Use systematic analysis processes and industry methodologies to solve problems and mentor others. Quality Influence: Engage stakeholders, drive constructive conflict, and influence outcomes to ensure balanced decisions. Quality Standards: Apply knowledge of ISO9001:2015 and IATF16949 to develop procedures and processes. Statistical Foundations: Use statistical tools to influence decision-making and drive improvement actions. Supplier Improvement: Develop and execute quality improvement strategies to enhance supplier performance. Project Planning: Apply APQP skills to develop and execute quality plans for external suppliers. Value Differences: Recognize the value of different perspectives and cultures. Additional Responsibilities Unique to this Position Skills and Experience: Work Environment: Ability to work from the office. Hands-on Experience: Experience in Heat Treatment, Casting, and Machining. Metallurgical Skills: Control of heat treating processes, furnaces, and auxiliary equipment; quench & temper of wrought steel; carburizing processes; induction hardening; steels for quenching & tempering; steel mill selection & approval. Forging Skills: Technical feasibility, simulation, die design; material certifications; steel bar quality; heating practices; types of forging & application; process defects RCA & corrective actions; machinability hardness, mechanical & chemical composition; defects. Machining Skills: Understand part design; determine material (tools, inserts, coolant); machining features; machining methods; setups & tool changes; sequence of operations; tolerance and surface finish requirements; tool and machine limitations. Self-Motivation: Ability to take ownership and drive actions at the supplier end. Coordination: Close coordination with regional plants (NA, SA, Europe). Team Player: Ability to work effectively in a team environment. Experience: Preferably, a minimum of 3 years in a Manufacturing or Engineering role in the automotive industry or a similarly regulated industry.

Walk-in @ GOA We are hiring multiple positions for our manufacturing facility at AHMEDABAD as mentioned below. Please find our current job requirements and venue details mentioned. If any of the requirements match your current job profile, kindly walk in with your latest resume. Engineering (Instrumentation / QMS / Process Equipment maintenance) (Senior Executive / Executive / Senior Officer) Experience - 03 to 10 Years Qualification BE / B Tech with relevant functional experience in Calibration / Instrumentation / QMS activities QUALITY ASSURANCE QMS / Documentation / Validation and Qualification / Market Compliance / IPQA - (injectables) (Officer / Senior Officer / Executive/Senior Executive) Experience - 02 to 09 Years Qualification - B. Pharmacy/ M Pharmacy / M.Sc. QUALITY CONTROL (Officer / Senior Officer/ Executive) Experience - 02 to 07 Years Education - B.sc / M.Sc. (Organic Chemistry / Analytical Chemistry) B. Pharmacy / M Pharmacy MICROBIOLOGY (Officer / Senior Officer/ Executive) Experience - 02 to 07 Years Education - B.sc / M. Sc (Microbiology) Injectable Manufacturing (Executive/Senior Officer / Officer / Associate) Experience - 01 to 06 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma with relevant functional experience in injectable manufacturing/ Aseptic area operations/ Visual inspection / QMS activities OSD Manufacturing (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Diploma with relevant functional experience in OSD manufacturing and Packing operations / QMS activities Time and Venue : 06th July 2025, 09:30 Hrs to 17:00 Hrs ______________________________________________________ The Fern Kesarval Hotel, Verna Plateau GOA -403710 _____________________________________________________ We would be very happy if you forward or refer any of your colleagues matching the requirement. *Having relevant qualification and experience only can attend the scheduled walk-in.

Overseeing all training activities to ensure team competency and compliance. Help in Conducting audit planning and executing audits of various applications and departments. Reviewing validation documents to ensure compliance and accuracy. Performing peer reviews of audit plans, reports, and observations, and effectively communicating with auditors to clarify findings, ratings, and supporting evidence. Managing change requests, deviations, quality issues, CAPA (Corrective and Preventive Actions), effectiveness checks, and conducting root cause analysis. Assisting in the development of Key Performance Indicators (KPIs) for Quality Management System (QMS) performance monitoring and management oversight. Supporting the continuous improvement and operational success of the quality assurance function. Perform the assigned activities given by them as defined in the SOP Ensure that QA practices and deliverables comply with regulatory requirements and industry standards. Oversee the planning, execution, and documentation of all QA activities, including functional testing, regression testing, performance testing, and validation testing. Collaborate with development teams to identify and resolve defects and ensure the timely delivery of high-quality software releases. Collaborate with stakeholders to develop validation plans and protocols, including but not limited to Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and User Acceptance Testing (UAT). Prepare and maintain validation documentation, including validation plans, protocols, reports, and traceability matrices, in compliance with regulatory requirements and internal procedures. In-depth knowledge of regulatory requirements and guidelines governing CSV, including FDA regulations (21 CFR Part 11, 21 CFR Part 210/211), GxP, GAMP, Annex 11, and other relevant standards (e.g., ISO 27001, ISO 9001). Strong analytical and problem-solving skills, with the ability to interpret and apply regulatory requirements to validation activities and systems. Qualifications: Strong understanding of quality assurance processes and regulatory requirements. Excellent analytical and communication skills. Ability to work collaboratively within a team and manage tasks effectively. understanding QA terminologies, exposure to any QMS database will be of added advantage