2371 Qms Jobs - Page 34

Quality Assurance: Develop and implement quality assurance policies and procedures for the manufacturing plant. Monitor and inspect raw materials, in-process production, and finished goods to ensure compliance with company quality standards. Conduct regular audits and inspections to identify potential issues and ensure adherence to quality control protocols. Process Improvement: Collaborate with cross-functional teams to identify areas of improvement in the manufacturing process. Analyze production data, identify trends, and recommend corrective actions to enhance product quality and process efficiency. Implement continuous improvement initiatives to reduce defects, waste, and production downtime. Compliance and Regulatory Standards: Ensure that the manufacturing plant complies with all relevant industry standards, regulations, and quality certifications. Keep abreast of changes in quality requirements and communicate updates to the relevant teams.

Job Description Responsible for Toxicological assessment of genotoxic and nitrosamine impurities. Responsible to support the development of nitrosamine and other genotoxic impurity risk assessment and carryover limits. To support the site management team in reviewing cleaning, nitrosamine and genotoxic impurity and keep sites up to date according to current regulatory requirement /expectation. Reviewing Permissible Daily Intake, Occupational Exposure Limits, Toxicological Justification, Quality Risk Assessment document. Responsible for preparation and revision of corporate procedures like SOP related to the assessment of potential carryover or cross-contamination of genotoxic/carcinogenic impurities. Harmonization of Cleaning and validation procedures across all sites of Lupin. Work Experience 10-12 years Education Masters in Science Competencies Collaboration Customer Centricity Developing Talent Innovation & Creativity Process Excellence Result Orientation Stakeholder Management Strategic Agility

Job Description Overall project management Quality IT Projects (such as LIMS, Chromatography, QAMS, EDMS, LMS etc.) Helping in Finalization of URS in alignment with sites (India + Global). Helping in Harmonization of system and processes in line with regulatory requirements and compliances. Helping in Testing and Validation of IT applications in line with URS for QA/ QC/ Common applications. Helping in SOP writing and training of personnel. Supporting operational team. Facing Regulatory Audits at site as and when required. Keeping sites ready for all time audits. Checking compliance status of the sites. Work Experience 10+ years of experience Education Masters Post Graduation in Science Competencies 1. Strategic Agility 2. Innovation & Creativity 3. Customer Centricity 4. Developing Talent 5. Result Orientation 6. Process Excellence 7. Collaboration 8. Stakeholder Management

Job Description Overall Single Point of Contact for Quality IT Projects (such as LIMS, Chromatography, QAMS, EDMS, LMS etc.) Finalization of URS in alignment with sites (India + Global). Harmonization of system and processes in line with regulatory requirements and compliances. Testing and Validation of IT applications in line with URS for QA/ QC/ Common applications. Keeping organization up to date on the requirement for smart QA/ QC. Defining SOP and training of personnel. Supporting operational team. Keeping senior management updated on the organization status. Keeping senior management updated on the organization status. Facing Regulatory Audits at site as and when required. Keeping sites ready for all time audits. Work Experience 18 to 20 Years Education Post Graduation Masters in Science Competencies 1. Strategic Agility 2. Innovation & Creativity 3. Customer Centricity 4. Developing Talent 5. Result Orientation 6. Process Excellence 7. Collaboration 8. Stakeholder Management Budgets/Cost Control

Single window to customers for all QA related activities Customer complaints Target Zero/As per agreement with cust. Repeat complaint from cust-Target Zero Complaint closure–As per agreed timeline System compliance audit from Existing and New cust. Required Candidate profile Overall coordination for New development parts/ECNs Manufacturing feasibility of new RFQs/ECN received from new/existing customers Development (APQP) timeline preparation & agreement with customer

Responsibilities: * Develop analytical methods using HPLC, ELISA , colorimetry & spectrophotometry. * Validate methods according to GLP & GDP guidelines. * Conduct quality control testing on biologics products.

Role & responsibilities Handling of pre and post approval regulatory activities of US/EU/CA submissions. Review of developmental documents for regulatory submission. Good knowledge of handling CMC documentation for Dossier submission Compilation and Submission of Annual reports and Supplements. Having the experience of solid orals and injectables. Preparation of Sterility Assurance Package for injectable Dossiers. Preparation of Pre-IND/scientific advice meeting packages Drafting, compiling & eCTD publishing of dossiers for regulatory filings. Review of specifications and test procedure as per pharmacopoeia requirements. Providing regulatory support for customer filings and customer queries. Evaluation of regulatory authority deficiencies and preparation of action plan accordingly. Also follow up of response documents with concern stake holders. Evaluation and approval of QMS documents, wherever applicable. To update cross functional teams for different regulatory compliance & requirements. Responsible for outlining requirements for labelling, storage and packaging. Review of product development report and QBD concepts. Updating product approval package to plant team. Preferred candidate profile Should Have Formulation Regulatory Affairs Relevant Experience in US/EU/Canada Perks and benefits

Role & responsibilities Contribute to the creation and implementation of best practice capacity planning vision, strategy, policies, processes, and procedures to aid and improve operational performance Contribute to new business initiatives, projects, review and communicate the impact on Quality Management Systems (QMS). Develop the Management Systems strategy and the management arrangements for key milestones, demonstrating solid progress against plan. Contribute to the creation and implementation of best practice capacity planning vision, strategy, policies, processes and procedures to aid and improve operational performance, Work collaboratively, negotiate, and engage with key stakeholders to facilitate delivery and compliance with the quality strategy. Automotive Quality Management System Auditing experience and managing audit programmer Preferred candidate profile Knowledge of Process & Product audit is an advantage. Excellent written, verbal and presentation skills Excellent organizational and follow-up skills Competent in problem solving, team building, planning and decision making. Ability to manage a variety of cross-functional team members. IATF Internal/ Lead Auditor Certification (Preference).

PPC Incharge Location Surat Gujrat Production planning as per the rules set and accordingly implement through effective MRP runs. Knowledge of SAP is Mandatory

MS professional in the valve mfg industry needs a strong understanding of API std & application to valve design, manufacturing, & testing. knowledge of API 600, API 602, API Q1,also experience with QC procedures, testing , & documentation .

Role description: Technical Director - Highways We are seeking to recruit an ambitious and dynamic Technical Director for our growing team in India to work alongside our US/Canada counterparts on the technical delivery with a skill set concentrated in either highways/ infrastructure projects. The individual should be conversant with the US standards like ASSHTO and multiple DOT regulations with expertise in the Design and Build Environment. It is desirable the the candidate be a PE in any part of the United States or Canada. As a Technical Lead in the business, you ll play a major role in the delivery of Major projects. You would typically be leading large projects and supporting multiple countries or service lines. You are highly recognized in the countries and actively influence the growth of the GECs. You are highly recognized as subject matter expert in the countries and actively influence quality deliveries in the GECs. You need to have a strong technical skill and will have to lead design and production of major Highway/multidisciplinary projects comprising of design, 3D Modelling, CAD production and quantities. Should have work experience as project lead and should have led projects team on multiple occasions for large Projects. Experience on Major Highways Projects - Concept Design, Alternative Technical Concepts and Detailed Design of project is mandatory. Should have handled Design - Build projects for any of states within United States of America Should be able to manage multi-disciplinary projects, lead a team of Civil Engineers and interact with the Lead region, internal and external stakeholders on a regular basis. Operate partly outside the project environment to support professional leadership in their discipline at a technical level, establishing and consolidating relationships with Lead region, managing the technical delivery of projects or specialized components of projects, supporting the development of Arcadis capability in the discipline and building and maintaining a professional reputation as an individual and for Arcadis. Take a technical leadership role with the project team, providing direction and leading by example where appropriate. Manage the delivery of projects in accordance with GEC Quality Management Systems to meet time, quality, budgetary and health and safety targets. Working to ensure maximum client satisfaction, championing client care and proactively working with the client. Specific US experience is most desirable Role accountabilities: 1. Supporting Pursuits: Assist the BA in evaluating pursuit opportunities, and contributing insights on capacity and capability. Collaborate with the pursuits team to streamline decision-making processes for pursuing projects. 2. Bid Writing Assistance: Work closely with the team to enhance bid writing capabilities, ensuring alignment with established standards. Provide support in preparing and editing proposals to meet quality and consistency standards. 3. Cross-Disciplinary Coordination: Facilitate communication and coordination between the lead office and other disciplines. Collaborate with cross-functional teams, creating compelling proposals and presentations to ensure a unified approach to strategic pursuits. 4. Resource Acquisition Support: Assist in identifying resource needs for pursuit projects and contribute to strategic resource acquisition plans. Support in coordinating with other departments or external partners to acquire necessary resources. 5. Knowledge Transfer Assistance: Support initiatives for knowledge transfer from bid team to delivery team, aiding in the documentation and sharing of best practices. Collaborate with team leads to ensure insights from past pursuits are effectively communicated and applied. 6. Team Mentor: Ensure the development of the regional-focused team to develop and grow according to the market needs of LO both in terms of Capacity and Capability thereby setting the growth targets. Developing high competencies in comprehensive project reviews, forecasting, and resource management, collaborating closely with regional leads to capture project needs, timelines, required skills, and the number of resources needed. Oversee competence and quality through a robust Quality Management System, ensuring the timely submission of deliverables. Actively liaise with project managers and BA offices, to connect with senior leadership, develop growth roadmaps, and drive continuous improvements. 7. Major Projects: Handling and delivering Design & Build and State DoT projects with understanding in various tools used in NA for Roadway design, 3D Modelling, CAD production and quantities. D & B projects - concept design, alternative technical concepts, detailed design of projects, and involved in construction support. Leading Design Build multi-disciplinary projects for in Arcadis at Global Level including complex interdependencies of other disciplines. Qualifications & Experience: Masters in Transportation / Highway Engineering. Minimum 15+ years of experience in Infrastructure Design Consulting industry as of May 31, 2025. Minimum of 10 years of working experience for International Multi-disciplinary Projects for Highway / Roadway in delivering various design and modelling tasks. Having work experience in Design & Build Projects is an added advantage. He/she should be at Arcadis Level 9 and designated as Associate Technical Director in the appropriate discipline. Proficient in written communication and capable of contributing to bid writing processes. Familiarity with the industry and Arcadis service offerings. Strong organizational and coordination skills with the ability to assist in strategic decision-making. Ability to collaborate effectively with diverse disciplines and support resource acquisition initiatives. You will have substantial postgraduate (or equivalent) experience and either have been awarded Professionally recognized (PE, CEng, MICE, MIHT or MCIWEM), have equivalent international qualification. Good written and spoken communication skills and be fluent in English Cultural awareness and an open mind and excellent communication skills are essential ? Together, we can create a lasting legacy. Join Arcadis. Create a Legacy. Our Commitment to Equality, Diversity, Inclusion & Belonging

Number of Openings 1 ECMS ID in sourcing stage 532058 Assignment Duration 12 months Total Yrs. of Experience 8+ Relevant Yrs. of experience 6+ Detailed JD (Roles and Responsibilities) Implementing and updating the QMS in accordance with relevant standards (e.g., ISO 9001) and organizational goals. Performing internal and external audits to assess compliance with quality standards and identify areas for improvement. Ensuring all quality-related documentation (procedures, work instructions, etc.) is accurate, up-to-date, and readily available. Collaborate with IT, engineering, and production teams to ensure seamless QMS adoption. Facilitating the investigation of quality issues, identifying root causes, and developing and implementing corrective and preventive actions. Developing, collecting, and presenting quality metrics to various stakeholders, including management, to track performance and identify trends. Ensure compliance with industry standards, including ISO, SEMI, and regulatory requirements. Keeping up-to-date on industry trends, regulatory changes, and best practices related to quality management. Mandatory skills 6 8 years of hands-on experience with QMS. Familiarity with relevant quality standards like ISO 9001, IATF 16949, and others, and the ability to ensure compliance through the QMS. Strong understanding of quality management principles and methodologies (e.g., ISO 9001, Six Sigma, Lean). Strong knowledge of semiconductor manufacturing processes (front-end and/or back-end). Experience with quality audits and assessments. Proficiency in relevant software and tools for quality management and data analysis. Excellent problem-solving, communication, and stakeholder management skills. Desired/ Secondary skills Experience on Siemens Quality softwares. Domain Hi-Tech/Semiconductor Max Vendor Rate in Per Day (Currency in relevance to work location) 13331 INR/day Delivery Anchor for tracking the sourcing statistics, technical evaluation, interviews, and feedback etc. Ashish Duragkar Work Location given in ECMS ID India, Any location WFO/WFH/Hybrid WFO Hybrid WFO BG Check (Before OR After onboarding) No Is there any working in shifts from standard Daylight (to avoid confusions post onboarding) YES/ NO No

We are inviting you to join Howden, a Chart Industries Company become a trusted and valued member of our Business Intelligence Team. AS part of this vital team, you will play a crucial role in developing and maintaining business intelligence solutions that driver data-driven decision-making across the organization.Howden was acquired by Chart Industries in 2023. Chart Industries is a leader in innovation focused on our transition to a greener energy environment. We are a leading global manufacturer of highly engineered equipment and solutions serving multiple applications in the Energy, Industrial gas end sectors. We supply cryogenic systems and have a global presence in 40 countries, and more than 11,000 employees. Howdens long heritage and technology enable this transition on a more efficient level. Our vision is to enable the vital processes of our customers and thereby promote a more sustainable world via our Nexus of Clean Strategy. What Will You Do? End to End Quality Assurance and Control activities for the Cooling fan starting from Inward material Quality Assurance to Warranty / Customer complaints handling. Need to create and maintain Quality Management System requirements in the Product line. Create and Maintain In-process PPAP for new products Create Rework procedure for FRP blades and conduct periodic Process Audits to improve the process. Liaison with Customers and TPIs for Stage clearance and Product clearance, Coordinate with internal stakeholders to adhere & meet Product, Process, QMS & Customer requirements. Your Physical Work Environment Will Require Need to be on the shop floor coordinating and overseeing activities for 5 to 7 Hrs. a day. Able to conduct NDT test (Level 2) on a requirement basis Open to travel to Customer site/office to understand and discuss Quality requirements, and observe the product running conditions and support trouble shooting of the product supplied (Approx. 30 days in a year) Your Experience Should Be... Bachelor s degree in mechanical engineering / chemical technology / Diploma in Plastic technology 7 to 8 Years Experience in Quality Assurance Activities, 2 or more years of FRP parts NDT Level 2 - UT (experience in FRP is a must) Experience in overseeing Rework / Repair activities in FRP blades. Experience in FRP Blade products is preferable Six Sigma Green Belt certification is preferable

We are inviting you to join Howden, a Chart Industries Company become a trusted and valued member of our Business Intelligence Team. AS part of this vital team, you will play a crucial role in developing and maintaining business intelligence solutions that driver data-driven decision-making across the organization.Howden was acquired by Chart Industries in 2023. Chart Industries is a leader in innovation focused on our transition to a greener energy environment. We are a leading global manufacturer of highly engineered equipment and solutions serving multiple applications in the Energy, Industrial gas end sectors. We supply cryogenic systems and have a global presence in 40 countries, and more than 11,000 employees. Howdens long heritage and technology enable this transition on a more efficient level. Our vision is to enable the vital processes of our customers and thereby promote a more sustainable world via our Nexus of Clean Strategy. What Will You Do? End to End Quality Assurance and Control activities for the Reciprocating Compressor starting from Inward material Quality Assurance to Warranty / Customer complaints handling. Need to create and maintain Quality Management System requirements in the Product line. Establish and maintain SOPs for QA activities to ensure quality standards & procedures are met and aligned with customer requirements. Create and Maintain In-process PPAP for new products. Liaison with Customers and TPIs for Stage clearance and Product clearance, Conduct Manufacturing and design reviews (DFMs) for new products and projects. Ability to train small teams in Quality Practices and Systems. Your Physical Work Environment Will Require Need to be in Shopfloor coordinating and overlooking activities for 3 to 5 Hrs. a day. Able to demonstrate NDT test (Level 2) on requirement basis Use of quality engineering methods in inspection Coordinate with internal/external stakeholders to adhere & meet Product, Process, QMS & Customer requirements. Open to travel to Customer site / office to understand and discuss Quality requirements, and observe the product running conditions and support trouble shooting of product supplied (Approx. 30 days in a year) Your Experience Should Be... Bachelor s degree in mechanical engineering 10 to 13 Years Experience in Quality Assurance Activities, 2 or more years in handling end-to-end Quality activities Experience in Reciprocating compressor products is preferable NDT Level 2 in RT / UT and MPI / DPT methods preferable Six Sigma Green Belt certification preferable

Job Description: Service Delivery Manager - QMS Position Overview: We are seeking an experienced and strategic Service Delivery Manager to lead our global team in delivering high-quality QMS Application Management Services (AMS) support to pharmaceutical and medical device clients. This role will oversee operational delivery and client satisfaction across a suite of SaaS based Commercial and R&D technology platforms, including MDM, CRM, Data Warehousing, and Veeva Vault solutions. Core Responsibilities: Lead global managed services operations across the U.S., India, and EU, ensuring consistent, high-quality support for QMS AMS. Oversee service delivery for solutions involving QMS AMS, Veeva Vault, Salesforce, Reltio, Egnyte, Power BI, Snowflake, and SQL Server. Develop and implement service-level agreements (SLAs), KPIs, and operational excellence frameworks. Act as an executive point of contact for key clients, ensuring alignment with commercial and R&D business objectives. Provide resolutions to data issues and manage data loads into multiple client systems. Work on enhancements to existing QMS AMS. Generate technical reports as requested by the business team. Partner with internal practice leads to continuously improve service delivery models and solution offerings. Ensure compliance with relevant regulatory standards (e.g., GxP, HIPAA, 21 CFR Part 11) in service operations. Skills & Experience: 10+ years of experience in IT service delivery or managed services. Strong domain knowledge in life sciences commercial and R&D systems. Proven experience with managed services for Veeva Vault, MDM, CRM, Snowflake, DataBricks, with a deep understanding of at least three core platforms. Demonstrated ability to sit at the intersection of technology and business while driving results. Success in managing globally distributed teams and supporting enterprise clients. Excellent client-facing communication, stakeholder management, and problem-solving skills. Familiarity with regulatory requirements specific to pharmaceutical and medical device industries.

Ensure implementation, maintenance, control and verification of quality management system and processes, develop quality strategy and initiatives, implement methods, tools and qualification to ensure customer satisfaction. Set up and manage the quality management organization and networks, allocate necessary resources, and oversee the planning and control of the quality budget. Design, implement, and consistently enhance quality management systems, including its guidelines, processes, strategies, goals, and structure of organization. Act as the first point of contact to provide technical guidance on quality system, processes, audits, methods, tools, initiatives and customer-related quality topics. Encourage and drive implementation and sharing of lessons learned, foster standardization and ensure availability of technical and methodological know-how, provide methods, tools and related trainings. Develop and maintain quality reporting and inform accountable management regularly. Your Qualifications Graduate Degree in Engineering, Business Administration 10 to 15 years Your Contact INA Bearings India Private Limited Gauri Somwanshi For Keywords: Experienced; Manager; Full-Time ; Unlimited ; Quality; Job Segment: Quality Manager, Manager, Engineer, Quality, Management, Engineering

Job Description Batch Manufacturing and Filling activity. Batch manufacturing experience of Solution, Emulsion, suspension and gel eye drop products. Preparation and review of Deviation investigation, Risk Assessment, Impact Assessment, Equivalency reports, URS and various other production related documents and monthly intervention reports. Responsible for audit preparation (Internal and regulatory) and compliance. Reconciliation of product at various stages of batch manufacturing and filling. Preparation and reviewing of SOP and compliance after implementation. QAMS related activity. Approved GMP trainer for provide training to team members. Preparation of Media fill BMR. Planning for production activities by coordinating with PPIC, PDL, Engineering, validation and QA. Work Experience 8 to 10 Years Education Graduation in Pharmacy Competencies Developing Talent Innovation & Creativity Result Orientation Strategic Agility Process Excellence Customer Centricity Collaboration Stakeholder Management

Roles and Responsibilities Develop and implement quality management systems (QMS) policies, procedures, and guidelines to ensure compliance with regulatory requirements. Conduct internal audits to identify areas for improvement and implement corrective actions to address non-conformities. Prepare and maintain accurate records of quality documentation, including standard operating procedures, work instructions, and training materials. Collaborate with cross-functional teams to develop new products or processes that meet customer needs while ensuring adherence to quality standards. Ensure ongoing monitoring of production processes to detect deviations from specifications and take corrective action as needed. Desired Candidate Profile 14-20 years of experience in Quality Assurance & Regulatory Affairs with expertise in QMS implementation. Strong understanding of pharmaceutical regulations such as FDA, GMP, ISO 9001:2015 etc. Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma).

Role & responsibilities 1. Primarily Responsible for Vendor Qualification and Vendor Approval accordingly and compilation of documents. 2. Handling of Issuance and Retrieval of batch number, batch manufacturing record, batch packing record, Register, Logbooks, SOPs, Formats, worksheets protocols, Analytical protocols of all departments. 3. Preparation, Review and compilation of the Annual Product Quality Review. 4. To prepare and review of quality and other departments SOPs. 5. Responsible for preparation and up-dation of quality assurance SOPs. 6. Responsible for preparation and up-dation of SOP’s Index of all the departments. 7. To handle and maintain specimen signature, job description etc. 8. To support the practice of documentation and data control. 9. To review the Analytical records, Batch manufacturing records and Batch packing records. 10. To identify and reporting of any non-conformance or any discrepancy related to manufacturing, packing and warehouse. 11. Preparation, planning, coordination and execution of Annual Training Program, assessment and handling of training records of all departments and to monitor/ Supervision and control over the workman in their designated premises at the site. 12. To ensure maintenance of environmental conditions (Relative Humidity, Temperature and Differential pressure) in respective areas. 13. Ensure to implementation of cGMP, GDP and Data Integrity in Plant Premises. 14. To handle the artworks approval, shade cards and other packing material. 15. To handle the preparation of material code in SAP & up-dation of BOM in SAP. Preferred candidate profile Qualification: B. Pharma/ M. Pharma Experience: 3 to 7 Years

Required Quality Head in a Multispeciality Hospital Mini-8 Years of Experience in Hospital Qualification: MBBS/BDS/BHMS/BAMS/Nursing with MHA/MPH/MBA (Healthcare/Quality)/Certified NABH Assessor Regards Arti Call/whatsapp-8090286126/7897900209

ISO 9001 14001 45001;TPI Internal External Audits;BPVC-ASME;IBR CBB;ASTM DIN BS ANSI EN;API AWS; SOPs;FATs/SATs;Quality Dossier;TQM;Documentation;QAP;Overall QMS

As a Solution Tester, you will be responsible for: 1. Designing and automating test suites to ensure reliability of the system z(s390x) platform technology 2. Having a client-first mindset to test at scale and imitate customer-like environments 3. Creating strategies and scripts to test new features and functionalities 4. Contributing and reviewing code for internal and external repositories 5. Documenting processes (Test plans) and procedures for clarity and reproducibility 6. Interacting with counterparts in US/Germany teams and Red Hat Required education Bachelor's Degree Required technical and professional expertise Required Technical and Professional Expertise with relevant experience of 6-9 years: 1. Comfortable working with any of the three major Linux distros (Redhat, Sles, Ubuntu). Preferably on a Z system (s390x) 2. Knowledge on Web Services, API Testing 3. Understanding of virtualization and containerization concepts. z/VM and KVM are preferred. 4. Experience building pipelines for automation servers such as Jenkins etc 5. Skilled in a scripting language. Python, Ansible or bash is preferred. 6. Quick learner and a strong team player with good communication and interpersonal skills 7. Self Driven and Proven ability to work effectively in a global team environment. 8. Good decision making skills 9. skills on z/OS, CICS,Db2,IMS,MQ,DFSMS VSAM & VSAM ,RLS Preferred technical and professional experience 1. Leading and Guiding Team. 2.Providing direction and support to the team to achieve shared goals. 3. Taking initiative and anticipating needs or challenges before they arise

To review validation master plan of the plant and comply with the validation requirements of various regulatory authorities and customers. To review the process validation/ cleaning validation qualification protocols. To review SOPs, batch manufacturing and packing records, specifications, and test methods of the products. To monitor, control and review deviations, change controls, out of specifications may occur at all stages of storage, dispensing, manufacturing, packing, testing and distribution. To ensure issuance, control, distribution, storage, retention and destruction of quality documents and corporate guidelines as per Food safety Quality management system. To ensure that all critical equipment and utilities that are used to manufacture the product are under qualified status, calibrated and are under routine preventive maintenance program. To ensure proper investigation of market / customer / regulatory complaint by root cause analysis, corrective actions and ensure effective implementation of CAPA initiatives, close the complaints, send responses to the complainants, and verify effectiveness of CAPA periodically. To evaluate batch records, COAs and release finished products for sale. To ensure that, all the operations are carried out are as per GMP and laid down procedures, that each production batch complies with the provisions of Food safety standards (FSS) act and other legal, customer and regulatory requirements. To ensure compliance to the regulatory, customer, legal requirements and face audits and comply non-conformities observed during the audits. To ensure compliance to the current ISO 9001, DC Act, FSS Act 2006, FSSC 22000 (including HACCP), FAMI-QS, WHO-GMP and other customer and regulatory requirements. To carry out self inspections and ensure compliance to the audit observations of manufacturing, testing, warehousing facility. To ensure completion of APRs of products and take appropriate actions in case of deviations. Recommendation to recall approving authority on product recall, review, and disposition of recalled and returned goods. Handling of online and in process rejections and take appropriate actions to avoid the recurrences and disposition. To co-ordinate with CQA for up gradation in the SAP systems as per any changes or new product at Mahad site. To monitor stability of products, control sample storage and compilation of analytical reports and take appropriate action in case of failures. To identify and provide resources with co-ordination with other departments to carry out quality functions effectively. To liaison with regulatory authority for new product permissions, licenses and renewals, certificates, and approvals. Ensuring implementation and execution requirements of food regulations for export market (US)-21 CFR Part 110 111. Ensuring avoidance of breach of data integrity at all the levels. Ensuring implementation of effective sanitation activities at all the levels. Imparting required training to shop floor personnel. Adherence to the requirements of EHS norms. To raise the PR for procurement of miscellaneous items, external trainings, certification fees and capex related items. To sign the Excess Material Requisition, LRA notes, BMR return notes and other QMS documents in absence of Head- QA. To perform MSC2N transactions in SAP. Review of Change Control, Deviation, CAPA in trackwise. Implementation and execution of various initiatives as are suggested by corporate functions (SEEDS, Learning university, Quality mindset). SOP, BMR/BPR, layouts, STP review and approval in ENSUR system. To conduct vendor audits for RM/PM. To lead and guide the IPQA team for shopfloor activities. To set, review and evaluate KRA of reportees. To share the RR nominations of team members on quarterly basis. To identify and implement the OE projects. Patient/ Customer centricity. Qualifications B. Pharm/ M. Pharm

JOB OVERVIEW: To perform and author Computer System Validation activities of GxP Computerized as per defined processes at Corporate IT and across Piramal Pharma sites. KEY STAKEHOLDERS: INTERNAL Business Site / Corporate functions IT Team (e.g. SAP/ Infra / Quality IT / Allied / SAP Basis) KEY STAKEHOLDERS: EXTERNAL IT Vendors IT Contractors/Consultants REPORTING STRUCTURE: Will report to Chief Manager- IT CSV EXPERIENCE: Candidate with 3- 6 years of experience in Pharma/Life science domain working knowledge in authoring on Computer System Validation Deliverables, Part 11/Annex 11, Data Integrity Work experience in Pharmaceutical Sector will be desirable SKILLS AND COMPETENCIES Experience in Authoring all CSV deliverables e.g. URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc. as per V Model for IT projects Experience on validation of any of the enterprise level applications. e.g. Trackwise, Ensur/Documentum, LIMS, LMS, SAP/HANA, Chromatographic, Serialization, etc. Author, review and approval of SOPs, Guidelines/Policies as applicable. To have functional knowledge of Regulatory guidelines, Quality and Manufacturing processes. A team player with good communication skills (verbal written) KEY ROLES RESPONSIBILITIES To have thorough understanding, practical approaches for Computer system validation (CSV) of enterprise level applications. Accountable to ensure compliance of CSV documentation during various phases (project, operational retirement) of software lifecycle (SLC).Well aware with GAMP5, CFR Part 11/EU Annex 11 and Data integrity requirements. To create infrastructure ((Network, Servers, Cloud, Database) qualification documentation. To create QMS documents e.g. Change control/Deviation/Incidents-Discrepancy/User access forms. To perform Root cause analysis and define CAPA based on QMS documents review. To perform periodic and audit trail review of computerized systems as per defined frequency. To support the initiatives undertaken by Quality eCompliance and CSV team across the Corporate/PEL sites. Perform IT Supplier assessment and ensure compliance of audit observations. To liaise with Site ITC SPOCs for CSV activities and IT Compliance initiatives. To guide and train IT CSV teams (Corporate Site) for CSV, Data Integrity and Regulatory Compliance activities. Knowledge of IT systems and ITIL processes (e.g. Backup/Restoration, Infrastructure qualification, User access Management, etc.) Ability to represent during regulatory audits and can able to perform Corporate DI Audits of sites. To work along with CSV Project Manager to ensure project timelines are met. Knowledge Required:- Good knowledge of 21 CFR Part 11 / Annexure 11 (Must) Good knowledge of CSV, GAMP 5 (Must) Good knowledge of Data Integrity requirements for Pharma (Must) Experience of working at Pharma Site QC, QA, IT, CSV etc. (Plus) Experience of validation on automation/digitization projects (Plus) Good Verbal and Written communication skills (Must) Good Knowledge on Computer Software Assurance Aware of industry best practices and knowledge about Pharma 4.0 (Plus) Functional knowledge of Regulatory guidelines, Quality Control and Manufacturing processes. (Plus) Knowledge of IT systems and ITIL processes (e.g. Backup/Restoration, Infrastructure qualification, User access Management, etc.) (Must) QUALIFICATION: Graduate in Science/Pharmacy/Engineering Post Graduation Science/MBA (Desirable)

Formulation development of NCE projects, generic projects and line extension projects Preparation/review of literature summary and development report to the assigned product. Involve in execution and/or supervision of formulation development, process development and manufacturing of GMP batches of assigned product. Preparation/review of technical documents, which includes but not limited to MFC, BMR, BPR and Stability protocol following GDP. Representation in departmental audit Follow GxP (GMP, GDP etc.) for all processes and train the subordinates to follow the same. Execution and/or supervision of scale up/pilot scale batches in pilot plant under GMP condition. Preparation and/or review of technology transfer documents and technology transfer to manufacturing site, whenever required. Preparing/reviewing of QMS includes but not limited to change control, deviation, SOPs and OOS Communication with cross-functional team and client via mails, meetings and oral communication Provide training on but not limited to SOPs, technology, guidelines and project specific activities Performing and/or supervision calibration and maintenance of R&D instruments and equipment Procuring materials and machines change parts related to concern projects Maintain safe and hygienic condition in respective department Ensuring the use of personal protective equipment whenever required during batch execution Attending training related to FD, EHS, QA or any other department (if applicable) Ensure comply with EHS requirements while working in FD lab and Pilot plant. Support to proposal preparation for upcoming new projects Support to any additional responsibility/activity within or other department as and when required Qualifications Master of Pharmacy (Preferred Subject: Pharmaceutics)