2361 Qms Jobs

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.,

You will be responsible for Vaccine Manufacturing (Cell Culture), including tasks such as cell revival, subculture, and cell counting of MRC-5 cells. You will also be involved in the preparation of MCB/WCB and handling Roller bottles, Cell stacks, and TCFs. Experience in virus infection, virus harvesting procedures, and working with Chicken embryo fibroblast cells will be required. In the Quality Control department, you will be expected to perform various biochemical techniques, chromatography techniques, electrophoresis techniques, and immunoassay techniques. Your responsibilities will also include cell culture techniques, molecular techniques, analytical method validation (AMV), and analytical method development and transfer quality control (QC). Knowledge of cGMP, cGLP, and QMS will be essential for this role.,

Ensure Lenox Production (welding, cutting, packing) Frequency -Daily. Implement QMS/EMS/OHSAS / ISO17025 standard Knowledge of - Kaizen, 5S, Production increase Productivity. Knowledge of Drawings, Inspection, Measuring & test equipment Process audit skills, Ability to manage time effectively Knowledge of relevant testing standards Knowledge of operation Excellence Problem-Solving Skills Communication Skills Authorities Drive Tier 1 meeting Escalation for any operational issue Qualifications Qualifications include: Education: Diploma in Engineering -Mechanical/Electrical/ENTC Skills: Good Communication Skills, establish production process. We Dont Just Build The World, We Build Innovative Technology Too. Joining the Stanley Black & Decker team means working in an innovative, tech-driven and highly collaborative team environment supported by over 58,000 professionals in 60 countries across the globe. Here, youll get the unique chance to impact some of the worlds most iconic brands including STANLEY TOOLS, DEWALT, CRAFTSMAN, MAC TOOLS and Black + Decker. Your ideas and solutions have the potential to reach millions of customers as we work together to write the next chapter in our history. Come build with us and take your career to new heights. Who We Are Were the Worlds largest tool company. Were industry visionaries. Were solving problems and advancing the manufacturing trade through innovative technology and our Industry 4.0 Initiative. We are committed to ensuring our state-of-the-art smart factory products and services provide greater quality to our customers & greater environmental and social value to our planet. We are unique in that we have a rich and storied history dating back to 1843, but that hasn&apost stopped us from evolving into a vibrant, diverse, global growth company. Global Benefits & Perks Youll be rewarded with a competitive salary plus receive entitlements and benefits unique to your country of hire. What Youll Also Get Career Opportunity: Career paths arent linear here. Being part of our global company with 60+ brands gives you the chance to grow and develop your skills along multiple career paths. Learning & Development: Our lifelong learning philosophy means youll have access to a wealth of state-of-the-art learning resources, including our Lean Academy and online university (where you can get certificates and specializations from renowned colleges and universities). Diverse & Inclusive Culture: We pride ourselves on being an awesome place to work. We respect and embrace differences because thats how the best work gets done. Youll find we like to have fun here, too. Purpose-Driven Company: Youll help us continue to make positive changes in the local communities where we work and live as well as in the broader world through volunteerism, giving back and sustainable business practices. 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

We are looking for an ISO Coordinator with complete knowledge of Quality Management Systems (QMS). Your role will involve coordinating with various departments for internal audits and new client factory visits for quality audits. It is essential to have good communication skills, particularly in English. Proficiency in Excel is also important for this role. This is a full-time position with benefits such as health insurance and provident fund. The schedule is day shift with a yearly bonus. The ideal candidate should be located in or willing to relocate to Thane, Maharashtra. Preferred education for this role is a Diploma. The preferred total work experience is 1 year, with 2 years of experience in data entry. Proficiency in English language is preferred for this position.,

You will be joining HCL Tech as a Back Office QA professional in the BFS Domain. The walk-in interviews are scheduled for the 30th of September and the 1st of October, 2024, from 12:30 PM to 3:00 PM at HCL TECH ETA 1, Navallur. The role requires you to work in UK/US shift timings and have 3 to 8 years of experience in a QA role in the BFS domain, with a preference for experience in leading a QA team. Your responsibilities will include developing and deploying a Quality Approach mechanism for the services delivered, monitoring and maintaining quality and compliance targets of Service, deploying tracking, reporting, and feedback mechanisms from a QA standpoint, and structured problem solving using lean Six Sigma tools. You will need to develop Root Cause Analysis for any reported incidents, analyze historical data to identify top contributors of errors, and develop action plans based on QA scores. You will be responsible for ensuring adherence to the Quality Management System (QMS) through process and ISO audits, preparing and maintaining QMS documentation, and being an innovator and out-of-the-box thinker who is willing to go the extra mile. Strong presentation and communication skills are essential for this role. Functional competencies required include an excellent attitude with a willingness to learn, strong analytical and interpretation skills, excellent communication skills for interpretation and conversation, decision-making skills, email etiquettes, reporting skills, and leadership skills. Perks and benefits of this role include working in an MNC environment, two-way cab facility for up to 20 Kms, competitive salary, excellent working environment, free cab for female employees, international trainers, and world-class exposure. Additionally, at HCL Tech, you will have continuous opportunities for career growth and development with transparent communication, learning programs, and the chance to explore different roles and industries. HCL Tech is a fast-growing global tech company with offices in over 60 countries and a diverse workforce representing 165 nationalities. You will have the opportunity to work with colleagues from around the world in a virtual-first work environment that promotes work-life integration and flexibility. The company is committed to your growth, offering learning and career development opportunities at every level to help you discover your unique strengths and talents.,

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

About The Role Barry Callebaut Digital (BC Digital) is on a mission to lead the digital revolution in the chocolate industry, and we&aposre looking for a Senior Business Analyst in the field of Quality, assessing stakeholder requirements for digital solutions. Reporting to the Head of Digital Quality, you will be the point of contact to advise and support internal customers in formulating and concretizing their requirements and the creation of respective digital solutions. You will also closely collaborate with product owners and support the development of strategies to optimize business performance. Key Responsibilities Analyze and optimize quality processes to improve efficiency, streamline workflows, and ensure compliance with industry standards and regulations Collaborate with business stakeholders through interviews, workshops, and surveys to gather and document business requirements for digital solutions Create user stories, use cases, functional specifications, and perform feasibility studies to evaluate proposed changes or enhancements to systems Work closely with other digital teams to design and implement IT solutions that meet business needs, with a focus on systems like SAP QM, QMS, Lims Provide recommendations for business process improvements and system enhancements to drive efficiency and effectiveness Oversee the design, execution, and monitoring of user acceptance testing (UAT) and other relevant testing phases Maintain close cooperation with application management teams to ensure smooth implementation, maintenance, and operation of applications Collaborate with global stakeholders, with key locations in Europe (Wieze, Lodz, Zurich), and support initiatives across our global footprint. About You Graduate degree in (industrial) engineering, food sciences, business administration, IT, or a comparable field Minimum of 5 years of experience in relevant fields, with advanced knowledge of IT solution design, feasibility studies Solid understanding of ERP systems, particularly SAP QM module, or other Quality systems (QMS, LIMS); experience in other SAP modules (PPPI, IM, PLM) is a plus Familiarity with business analysis tools and techniques Experience with project methodologies, including both waterfall and agile approaches Knowledge of industry regulations and compliance standards related to food safety and quality is an advantage Strong analytical and problem-solving skills, with the ability to interpret complex data and draw actionable insights Excellent communication skills, both written and verbal, capable of presenting to diverse audiences and stakeholders at various levels Independent and self-driven, with a passion for innovation and the ability to take ownership of tasks and see them through to completion Collaborative mindset, capable of building positive relationships across global, diverse teams and supporting team success Willingness to learn and adopt new technologies, staying current with emerging industry trends Fluent in English (both verbal and written). At Barry Callebaut, we are committed to Diversity & Inclusion. United by our strong values, we thrive on the diversity of who we are, where we come from, what weve experienced and how we think. We are committed to nurturing an inclusive environment where people can truly be themselves, grow to their full potential and feel they belong. #oneBC - Diverse People, Sustainable Growth. Show more Show less

Role & responsibilities Preferred candidate profile

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

Role & responsibilities Roles and Responsibilities 1. Stability study documents compilation and its management. 2. Stability charging, withdrawal, trend and stability report preparation. 3. Review of DRS, Log book entry and related documentation to be make online. 4. Preparation of release COA and compilation of all related documents. 5. Provide training to new person or existing person for QC testing. 6. Preparation and review of Specification/STP/SOP/DRS/protocol/data recording sheet for QC documentation on routine basis. 7. Instrument and Equipment calibration activity. 8. QMS (change control/deviation/Incident/LIR etc.) related Activities. Desired Candidate Profile -Male Candidate Required -Candidate should have experience in Biotech or injectable industry.

Responsibilities : Verification and Validation: Lead the verification and validation of analytical and microbiological methods, ensuring they meet all regulatory and internal quality requirements. Design, execute, and document method validation protocols, including accuracy, precision, specificity, and robustness studies, in compliance with FDA, TGA, ICH, and EMA guidelines. Review and approve validation protocols and reports, ensuring they are scientifically sound and fully compliant with Good Laboratory Practice (GLP) and other relevant regulatory standards. Analytical and Microbiology Methods: Provide expert review and oversight of analytical and microbiological testing protocols, data, and reports, ensuring compliance with regulatory standards and internal quality systems. Oversee the development, validation, and implementation of new analytical and microbiological methods and, including but not limited to chemical analysis, sterility testing, microbial limits testing, and endotoxin testing. Ensure that all methods are validated to provide reproducible and accurate results, adhering to FDA, TGA, ICH, and EMA requirements Data Review and Integrity: Conduct thorough reviews of raw data and final reports related to analytical and microbiology testing and method validation. Ensure that all data generated during analytical and microbiological testing is accurate, complete, and adheres to the approved protocols and SOPs. Identify and resolve any data discrepancies or deviations from established protocols. Regulatory Compliance: Ensure that all analytical and microbiological methods and validations comply with FDA, TGA, ICH, and EMA regulations. Assist in the preparation of documentation for regulatory submissions, providing quality assurance support for analytical and microbiological data and validation reports. Continuous Improvement: Contribute to the development and continuous improvement of quality systems related to analytical and microbiological methods and validation processes. Participate in root cause analysis of quality issues and support the implementation of corrective and preventive actions (CAPAs). Training and Development: Provide guidance and training to R&D staff on best practices in analytical and microbiological testing, method validation, and quality assurance. Act as a mentor and resource for junior staff in the areas of analytical development, microbiology and quality assurance What youd gain: Invaluable hands-on experience working alongside seasoned developers. Opportunity to learn and grow in a supportive environment. Gain exposure to the entire software development lifecycle. Contribute to real-world software projects and make a positive impact. Qualifications: Bachelors degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, or a related scientific discipline is required. Advanced degree (Masters or Ph.D.) in a related field is preferred. Minimum of 5-7 years of experience in quality assurance with a focus on analytical, microbiology, method verification, and validation within the pharmaceutical, biotech, or life sciences industries. Extensive experience with analytical and microbiological testing methods, including method verification, validation, sterility, microbial limits, and endotoxin testing. Strong expertise in analytical and microbiological methods and their application in product development. Excellent attention to detail and analytical skills with a focus on data integrity and accuracy. Strong written and verbal communication skills, with the ability to document and present complex technical information clearly. Ability to work effectively in a team-oriented environment and collaborate across multiple departments. Proficiency with quality management systems and software tools. This position is remote and may require occasional travel to other sites or meetings. The role may involve working in a laboratory environment with exposure to chemicals and biohazardous materials.

About the role What are my responsibilities? PQE (Project Quality Engineer) is responsible for implementation of process across the assigned projects, Process facilitation to project teams from Initiation till Release of the project Conduct audit to identify process gaps in the project Review the project deliverables and provide feedback to project teams Improve process awareness amongst employees by conducting training programs Define relevant project metrics and Perform statistical analysis on metrics data collated Conduct Lessons Learned session Regulatory related documents to be maintained in the centralized tool What do I need to qualify for this job? Education: BE / B.Tech / MCA / ME / M.Tech/ Graduate from a recognized university 8 -10 yrs of experience in Software Quality Assurance / Medical Devices / Regulatory Desired Skill Set: Preparation of Quality Procedures & maintenance of QMS Experience in implementation of Design Controls across projects Knowledge on various software development life cycle methodologies Good knowledge of ISO 13485, 14971, 21 CFR Part 820, IEC 62304 Proficient in using Microsoft office Strong presentation skills and ability to interact with Global Stakeholders Excellent interpersonal skills and ability to work independently Strong written and oral communication skills

Looking for a skilled professional with 8 to 14 years of experience to join our team as a Manager - Delivery Quality in Bengaluru. Roles and Responsibility Manage and oversee the delivery quality process to ensure high standards. Develop and implement effective quality control measures to identify areas for improvement. Collaborate with cross-functional teams to resolve issues and enhance service quality. Analyze data and metrics to measure performance and make informed decisions. Provide training and coaching to team members on quality procedures and best practices. Identify opportunities for process improvements and recommend changes. Job Requirements Minimum 8 years of experience in a related field, preferably in healthcare management services. Strong understanding of CRM/IT enabled services/BPO industry trends and principles. Excellent leadership and communication skills, with the ability to motivate teams. Proven track record of delivering high-quality results in a fast-paced environment. Ability to analyze complex data sets and make informed decisions. Strong problem-solving skills, with the ability to think critically and creatively.

We are looking for a skilled Senior Manager - Delivery Quality to join our team at Omega Healthcare Management Services Pvt. Ltd., with 8-14 years of experience in the field. Roles and Responsibility Manage and oversee the delivery quality process to ensure high standards of service. Develop and implement effective quality control measures to identify areas for improvement. Collaborate with cross-functional teams to resolve issues and enhance overall performance. Analyze data and metrics to measure quality and identify trends. Provide training and coaching to team members on quality procedures and best practices. Ensure compliance with regulatory requirements and industry standards. Job Requirements Proven experience in managing delivery quality, preferably in healthcare or related industries. Strong understanding of quality management principles and methodologies. Excellent analytical and problem-solving skills, with the ability to interpret data and make informed decisions. Effective communication and interpersonal skills, enabling collaboration with diverse stakeholders. Ability to work in a fast-paced environment and adapt to changing priorities. Strong leadership skills, including mentoring and coaching team members to achieve their goals.

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

Jindal Stainless Limited is looking for Associate - Quality to join our dynamic team and embark on a rewarding career journey Understand customer needs and requirements to develop effective quality control processes Devise and review specifications for products or processes Set requirements for raw material or intermediate products for suppliers and monitor their compliance Ensure adherence to health and safety guidelines as well as legal obligations Supervise inspectors, technicians and other staff and provide guidance and feedback Oversee all product development procedures to identify deviations from quality standards Inspect final output and compare properties to requirements Approve the right products or reject defectives Keep accurate documentation and perform statistical analysis Solicit feedback from customers to assess whether their requirements are met Submit detailed reports to appropriate executives Be on the lookout for opportunities for improvement and develop new efficient procedures

1. Testing certification 2. Process control of stainless steel wire rods rebars (Long products) 3. Able to understand, collect analyze the process control parameters by analytical tools. 4. Understand customer's technical requirements work accordingly for process requirements. 5. Working knowledge of SPC, SQC

Jindal Stainless Limited is looking for Associate - Quality to join our dynamic team and embark on a rewarding career journey Develop and implement quality assurance strategies and processes. Conduct audits and inspections to ensure compliance with standards. Monitor and analyze quality performance metrics. Collaborate with production and engineering teams to address quality issues. Provide training and support to QA team members. Stay updated with advancements in quality assurance methodologies. Participate in quality improvement initiatives. Contribute to the continuous improvement of quality assurance processes.

Seeking a CSV Consultant to work on a variety of validation projects including manufacturing systems, lab systems, risk assessments, etc. Some of the work may be done remotely, some at client sites and others at one of our offices. Immediate start date Job Responsibilities: Responsible for the Computer System Validation processes of the company Maintain expertise in current and emerging cGMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11) Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule Lead system qualification efforts and be the primary client contact for coordinating work, reporting status, resolving issues, and addressing change orders as they apply Minimum Requirements: Minimum degree requirement - Bachelor's degree with at least 10+ years of experience Must be willing to travel regionally and/or nationally throughout India Candidates must have excellent verbal communication and technical writing skills Experience in generation and execution of protocols and procedures related to different areas of qualification and validation Expertise in ISPE GAMP5, ICH Q8, ICH Q9, ICH Q10, 21 CFR Part 11, Computerized System Validation, Equipment Qualification, and Validation Change Control Working knowledge of protocol development for validation of complex computer systems (e.g., multiple GAMP classes of systems); ability to develop Installation, Operational, and Performance Qualification documents Experience in execution of system validation lifecycle deliverables Experience in project execution within at least one area of systems validation (e.g., laboratory equipment, facilities utilities, manufacturing equipment) Proficient in Microsoft Word, Excel, Power Point, and Project Ability to plan and manage own work All candidates must be legally eligible to work in India

Job Role: Supplier Quality Engineer Duration: 3 months contract Top 3 skills are: Experience with maintaining supplier qualification documentation within GxP systems Experience in creating and maintaining data reports for Supplier Quality function Proficient in Microsoft Excel. Requirements: Minimum 3 years of work experience, preferably in Quality within Pharmaceutical, Life Sciences, Medical Devices, or similar industry Bachelor's degree required Data administrative support for the Global Supplier Quality team including: Maintain weekly Supplier Quality data report in SharePoint Create and/or maintain Supplier Quality reports including monthly KPI bowler, quarterly PO/QSL report, etc. in SharePoint Maintain supplier certificates by monitoring expiration dates & obtaining updated certificates from suppliers to upload into supplier quality system of record Log and communicate supplier change requests upon receipt into specified trackers, as needed Support overall Supplier Quality Operations team with data maintenance in Supplier Quality system or creating/supporting project data reports, as required

SUMMARY Associate - Procurement (Purchase) Ahmedabad, INDIA Position Code: 1214AA About the Role: We are looking for an Associate - Procurement (Purchase), who thrives in a high performance and fast paced technical environment. As an Associate within the Procurement (Purchase) team, you will be responsible for independently performing most function tasks, ensuring that our customer receives a great product. What you'll deliver: Work to team plan & deliver your tasks on-time & within budget Evaluate your work progress to the plan and make required course corrections Compliance to company code of conduct in all purchase & store activities and immediately report non-compliance Support Purchase and store processes for consumable, capital goods and services Support "Request for Quotation" "Request for Proposal" documentation Support supplier selection, competitive bidding & offer evaluation process Support supply continuity risk mitigation framework Support goods receipt, store and inventory management framework Support Supplier compliance with statutory and customer requirements Optimise inventory and spend with demand forecast Support, Purchase orders, purchase agreements and rate contracts frameworks Work with Supply Chain and Finance function to fulfil organisation needs and swift payments Swiftly resolve non-conformance to minimise impact on project objectives Deliver your work 'right first time' & 'on time in full' Understand project goals and objectives and complete your task within budget Follow processes, standard operating procedure (SOP) and apply best practices in your work Follow function's performance and improvement processes in your work Apply lean & 5S visual work environment principles in your work Align your work to meet your KPIs to achieve your growth goals Evaluate your KPI trend and implement required course corrections Utilise learning material & proactively participate in discussion forums Make your learning program to enhance your skills & knowledge & competency Make & implement your performance & economic growth plan What you'll need: Passion for our Vision: Transform Manufacturing 2+ years of total working experience in related domain In-depth domain knowledge & competency gained at an education institution or self-learnt Proficient Knowledge & Competency of purchase & store organisation with P&L responsibilities Proficient Knowledge & Competency of purchase terms and conditions, bidding process & contracts Good analytical and negotiation skills in order to get the best price and value products and services Proficient Understanding & Competency of application taxes, customs duty & statutory compliances Development Knowledge & Competency of high verity low volume store & inventory management Proficient understanding & competency of quality management systems and ISO9001/AS9100 standards Proficient understanding & competency of lean & six sigma principles Proficiency in engineering fundamentals and emerging technologies Proficient ability to identify risks, manage them and implement mitigating actions Flexibility to go beyond normal work hours in time of need and support other functions Must have: Attitude to positively work with cross functional teams Respectful behaviour and willingness to adapt company code of conduct Attitude to learn, do your best work and grow Initiative and courage to explore new ideas and learn from the mistakes Perfectionist approach and meticulous to the finest detail in everything that you do Clear and concise written & verbal English language communication as well as presentation skills Prompt and on-time communication of operational matters Proficiency in Excel, Outlook, PowerPoint, Teams and other MS Office software Readiness work in different shifts to support customers in different time zone Nice to have: Experience in Engineering Purchase and Supply chain Experience of working with leading ERP software like - Epicor / SAP / NetSuite Great sense of humor

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.

**Job Description:** As a CSV Lead in the Drug Safety domain, you will be responsible for overseeing the validation process of safety systems, including but not limited, or other drug safety databases. You will lead cross-functional teams and manage CSV lifecycle activities, including planning, executing, and documenting validation efforts for drug safety systems. **Key Responsibilities:** - Lead validation efforts for drug safety systems such other similar platforms, ensuring compliance with industry standards (21 CFR Part 11, GxP, and other relevant regulations). - Develop, review, and approve validation documentation, including Validation Plans, Protocols, Reports, and Traceability Matrices. - Perform risk assessments and impact analysis of software changes or upgrades to ensure compliance with validation requirements. - Collaborate with cross-functional teams (IT, Quality Assurance, Pharmacovigilance, and Compliance) to ensure effective implementation and maintenance of validated systems. - Provide guidance and training on validation processes and regulatory requirements. - Support audits and inspections related to CSV activities and respond to findings or inquiries from regulatory bodies. - Manage the CSV lifecycle, including requirements gathering, testing, and system releases for safety systems. - Ensure that all system-related issues are identified, tracked, and resolved in a timely manner. **Qualifications:** - Bachelor's degree in Computer Science, Life Sciences, or a related field (or equivalent experience). - Minimum of 2years of experience in Computer System Validation, with a focus on drug safety systems (Argus, ArisG, or similar). - In-depth knowledge of pharmaceutical and regulatory requirements, including 21 CFR Part 11, GxP, and ICH guidelines. - Strong experience in system validation and lifecycle management of computer systems, including testing, documentation, and quality assurance processes. - Familiarity with the pharmacovigilance domain and the processes for adverse event reporting and management. - Excellent communication and leadership skills with the ability to work in cross-functional teams. - Experience with audit readiness and regulatory inspections (FDA, EMA, etc.) is a plus. - Certification in Computer System Validation or related fields is a plus.