118 Cqa Jobs

About The Role Kotak Mahindra Investments limited (KMIL) is a subsidiary of Kotak Mahindra Bank Limited and is involved in Corporate Real Estate Lending and Structured Finance Business. The KMIL Internal Audit department conducts risk based internal audit (RBIA) for various functions as per the audit plan. Job Role: Performing Internal Audit of Lending business functions and support functions including Compliance, Risk, Secretarial, Accounts, Treasury and Taxation departments as per risk based audit plan. Ability to demonstrate business understanding, assess process, risk and controls and drive improvements. Document audit findings and maintain quality audit paper work. Independently discuss and conclude audit finding with stakeholders Delivering on time quality audit reports Follow up on the recommendations with stakeholders and monitor the compliance for effective closure. Monitor compliance with Industry standards, laws and guidelines Working as a Team Player with a one team mind-set & commercial acumen Collaborating with staff of co-sourcing firms Job requirements: Knowledge about key Regulatory requirements and Internal Policies Professionally qualified CA, CIA would be an added advantage 3 to 8 years of exposure / experience to Internal Audit/ Internal risk control practices of a Financial institution Critical thinking, analytical skills, strong communication, efficient data handling skills High energy, Passion & Self starter attitude with good presentation skills Ability to work under pressure Willing to travel as needed

Job Title: Executive FRD Non Orals Business Unit: R&D1 Regulatory Affairs Job Grade G12A Location: Baroda At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys. Job Description To design and conduct experiments for preformulation, formulation optimization of Microsphere and long acting complex non oral dosage form (Implant, In-situ-gel, etc. ) based on QbD approach. To execute the experiments as per Design of experiments To do literature search, prepare summary report and review for ANDA projects. To prepare product development study protocols and reports as per regulatory requirements. To enter the experimental details, observations and test request in the eLNB/METIS software. Experimental trials and stability study results compilation and interpretation using MINITAB software. To prepare Technology Transfer documents like MF, Risk Assessment based upon CPP & CQA, To prepare justification for import material, documents for form 29 application and Common Pharmaceutical Document for DCGI submission. To execute scale up / exhibit batches at plant and prepare scale up summary report To prepare Stability protocol as per regulatory requirement. To prepare Product Development Report, Risk assessment report for Elemental impurities, Residual solvents and Extractable for regulatory submission. To prepare pre-ANDA meeting package, scientific justification and /or report for various regulatory agency To prepare SOPs related to laboratory equipment / instrument. To be a part of Equipment / Instrument Qualification activity in case of procurement of any new Equipment / Instrument and prepare and review qualification documents. To comply with the internal quality system while performing any activity. To co-ordinate with cross functional departments like ADD, RA, CQA, Plant for project / product related activity. Travel Estimate NA Job Requirements Educational Qualification M. Pharm Experience Tenure : 1-3 years Your Success Matters to Us At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let s create a brighter future together!

. Job Title: Senior Executive /Manager 2 = Formulation Development Non Orals Business Unit: R&D1 Regulatory Affairs Job Grade G11B / G11A Location : Baroda At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys. Job Description Experience in end-to-end topical product, parenteral product (injection) product development activities for generic product development ANDA (Cream, ointment, gel, solution, lotion, foam, patch, solution injection, depo injection, prefilled syringe, cartridge based injection etc. ) as well as NDA 505(b)(2) and 505(b)(1). Experience in execution of lab scale manufacturing, reverse engineering, analytical know-how, plant level manufacturing activities; scale-up and exhibit batches based on quality principles QbD, QTPP, CQA, CMA, CPP, RA, FMEA. Experienced scientist to perform experiments for development of optimum prototypes (generic, non-infringing composition and robust manufacturing process) with diverse class of drugs & prodrugs (sensitive to pH, acid, base, temperature, oxygen, humidity). Experience in regulatory documentation CMC, MF, BMR, PDR, controlled correspondence for CMC, Biowaiver & Dossier preparation for US-FDA, EU-EMA, AU-TGA & DCGI through successful filing. Experience in working with cross-functional teams (ADD, MSTG, production, QC, QA, RA, IPC, PMO, BD, Microbiology, Pharmacology etc. ) to achieve project goals - Filings and subsequent approvals. Knowledge and develop continuous understanding on competitive intelligence, due diligence, US-FDA quality concepts, statistics and global pharma trend analysis to support new product evaluation & introduction Travel Estimate NA Job Requirements Educational Qualification M. Pharm or PhD Experience Tenure : 6 to 8 years if M. {harm or 3. 5 years if PhD Your Success Matters to Us At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let s create a brighter future together! Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

Responsibilities Plan and execute complex, risk-based operational, compliance, and financial audits across various business units and functions globally, designed to enhance and protect organizational value. Lead audit engagements and execute audit procedures in conformance with our quality standards, policies, and procedures to provide assurance and identify risks, issues, and/or best practices. Ability to manage multiple projects and meet deadlines. Must be able to write test objectives and test procedures clearly and concisely. Identify and assess key business risks, understanding the relationship between business strategies and risks. Evaluate the adequacy and effectiveness of associated control activities (e.g., internal control design and effectiveness) and apply a risk-based approach to achieve audit test objectives. Prepare comprehensive audit reports, synthesize audit testing results, analyze root causes of issues, draft audit findings, risks, and recommendations for process improvements, and communicate to management. Utilize data analytics and audit software tools to enhance audit efficiency and effectiveness. Lead and mentor newer audit team members, providing guidance and support throughout the audit process. Use audit tool (TeamMate+) to document audit work contemporaneously when procedures are performed. Abilities / Skills Analytical and Problem Solving - Ability to define, clarify and propose solutions that align to audit methodology. Attention to Detail - Execution of the task-in-hand with accuracy. Intellectual Curiosity - Natural desire to learn new things and independently pursue a stronger understanding of the topic. Personal Courage - Uphold GIA principles of independence and objectivity while identifying when escalation is needed. Effective Communication (verbal and written) - Ability to communicate to stakeholders the role of internal audit and translate audit terminology into digestible language to aide in business adoption. Teamwork and Collaboration Ability to work effectively in a team environment as well as independently. Education & Experience Undergraduate degree, in Accounting, Finance or related business field. At least 4-6 years of internal audit experience , with a strong emphasis on the execution of audit testing procedures, and quality work paper documentation in conformance with internal audit (or relevant) methodology. Self-discipline and the ability to balance multiple priorities in a deadline-driven environment. Experience with broader capabilities, such as risk assessments and monitoring activities, is a plus. Awareness and exposure to fundamentals of internal audit, risk and controls including the IIA, IPPF and COSO. Relevant Professional certification (CIA, CISA, CA, CPA) or desire to obtain, is a plus.

Responsibilities Plan and execute complex, risk-based operational, compliance, and financial audits across various business units and functions globally, designed to enhance and protect organizational value. Lead audit engagements and execute audit procedures in conformance with our quality standards, policies, and procedures to provide assurance and identify risks, issues, and/or best practices. Ability to manage multiple projects and meet deadlines. Must be able to write test objectives and test procedures clearly and concisely. Identify and assess key business risks, understanding the relationship between business strategies and risks. Evaluate the adequacy and effectiveness of associated control activities (e.g., internal control design and effectiveness) and apply a risk-based approach to achieve audit test objectives. Prepare comprehensive audit reports, synthesize audit testing results, analyze root causes of issues, draft audit findings, risks, and recommendations for process improvements, and communicate to management. Utilize data analytics and audit software tools to enhance audit efficiency and effectiveness. Lead and mentor newer audit team members, providing guidance and support throughout the audit process. Use audit tool (TeamMate+) to document audit work contemporaneously when procedures are performed. Abilities / Skills Analytical and Problem Solving - Ability to define, clarify and propose solutions that align to audit methodology. Attention to Detail - Execution of the task-in-hand with accuracy. Intellectual Curiosity - Natural desire to learn new things and independently pursue a stronger understanding of the topic. Personal Courage - Uphold GIA principles of independence and objectivity while identifying when escalation is needed. Effective Communication (verbal and written) - Ability to communicate to stakeholders the role of internal audit and translate audit terminology into digestible language to aide in business adoption. Teamwork and Collaboration Ability to work effectively in a team environment as well as independently. Education & Experience Undergraduate degree, in Accounting, Finance or related business field. At least 4-6 years of internal audit experience , with a strong emphasis on the execution of audit testing procedures, and quality work paper documentation in conformance with internal audit (or relevant) methodology. Self-discipline and the ability to balance multiple priorities in a deadline-driven environment. Experience with broader capabilities, such as risk assessments and monitoring activities, is a plus. Awareness and exposure to fundamentals of internal audit, risk and controls including the IIA, IPPF and COSO. Relevant Professional certification (CIA, CISA, CA, CPA) or desire to obtain, is a plus.

Overview This individual plays a pivotal role within the Global Capabilities team, significantly impacting PepsiCos business by developing, deploying, and continually supporting Market teams with core Insights on Superiority. They elevate the broader Insights function, pushing it to new horizons and enhancing efficiency through streamlined, standardized processes. By identifying connections across business needs, they ensure seamless capability integration into strategic processes, driving operational excellence. Focusing on the Superior Proposition Capability, this individual masters the art and science of being chosen by consumers: Enhanced Product Development: The new Proposition Testing methodology provides comprehensive diagnostic insights that can lead to product reformulation capitalizing on market opportunities. Improved Brand Equity: By going beyond traditional CQA, the Proposition Testing methodology offer deeper insights into Brand Equity that can retrofit the way we recommend Marketing to strengthen brand connections. Optimized Product and Packaging Design: Insights gathered from external vendors and internal PepsiCo experts (e.g., R&D) through the Proposition Testing methodology can led to the redesign of product packaging, impacting on consumer preference. Additionally, this individual collaborates with Global Insights, CX, R&D and market teams to interrogate data and answer specific business questions, providing analysis and insights that inform strategic decisions. Responsibilities Develop and Deploy Insights Capabilities: Develop, deploy, and continually support Global and Market teams with core superiority capabilities. Elevate the broader Insights function by pushing it to new horizons of Insight capability. Enhance efficiency by streamlining, standardizing, and identifying connections across business needs. Ensure products worldwide meet and /or exceed consumer expectations. Proposition Testing Methodology: Implement the new Proposition Testing methodology to provide comprehensive diagnostic insights. Enhance understanding of Methodology and interconnections with Brand Equity. Performs analysis of business and user needs, documenting requirements. Mine and analyse the data from such company databases to drive optimization and improvement of product development, marketing techniques and business strategies Assess the effectiveness and accuracy of new data sources and data gathering techniques. Collaboration and Consultation: Collaborate with Global Insights, CX, R&D, and market teams to interrogate data and answer specific business questions. Qualifications Post Graduate Degree (MBA Preferred, Statistical background preferred) 8+ years of experience in data analytics, using custom quantitative - product, pack testing Must have experience. Additionally good to have brand equity background Experience with integrating multiple data sets and systems for integrating new incoming data efficiently Advanced Excel skills a must Excellent project management skills: can manage project delivery, including estimating timelines and identifying risks Comfortable with statistical modeling Comfortable with a broad range of data sources and metrics, such as economic data, social listening data, etc. Strong analytical thinking with proven ability to connect data & to digestible representations to generate insights Structured thinker / problem solver who works independently Excellent organizational skills and attention to detail Great Collaborator / Team Spirit Language: English Fluent Post Graduate Degree (MBA Preferred, Statistical background preferred) 8+ years of experience in data analytics, using custom quantitative - product, pack testing Must have experience. Additionally good to have brand equity background Experience with integrating multiple data sets and systems for integrating new incoming data efficiently Advanced Excel skills a must Excellent project management skills: can manage project delivery, including estimating timelines and identifying risks Comfortable with statistical modeling Comfortable with a broad range of data sources and metrics, such as economic data, social listening data, etc. Strong analytical thinking with proven ability to connect data & to digestible representations to generate insights Structured thinker / problem solver who works independently Excellent organizational skills and attention to detail Great Collaborator / Team Spirit Language: English Fluent Develop and Deploy Insights Capabilities: Develop, deploy, and continually support Global and Market teams with core superiority capabilities. Elevate the broader Insights function by pushing it to new horizons of Insight capability. Enhance efficiency by streamlining, standardizing, and identifying connections across business needs. Ensure products worldwide meet and /or exceed consumer expectations. Proposition Testing Methodology: Implement the new Proposition Testing methodology to provide comprehensive diagnostic insights. Enhance understanding of Methodology and interconnections with Brand Equity. Performs analysis of business and user needs, documenting requirements. Mine and analyse the data from such company databases to drive optimization and improvement of product development, marketing techniques and business strategies Assess the effectiveness and accuracy of new data sources and data gathering techniques. Collaboration and Consultation: Collaborate with Global Insights, CX, R&D, and market teams to interrogate data and answer specific business questions.

General Summary: Job Overview This is a unique opportunity to join Qualcomms finance and accounting organization based in Hyderabad in the Corporate Internal Audit & Advisory Services (IA & AS) team. The department focuses on assisting the Audit Committee and management teams in the improvement of processes that manage risks related to achieving Qualcomms business objectives. Using Qualcomms risk-based audit methodology, the senior auditor will assist in the execution of internal audits. Specifically, the responsibilities include: Providing U.S. based time zone coverage as needed (up to 50% of time) Supporting the creation of initial planning memos and process flowcharts Identifying and assessing initial risks and control activities Designing audit procedures to evaluate control effectiveness Performing audit testing, identifying deviations from expected control activities, and effectively communicating observations to the audit team Leveraging data analytics throughout the audit process where feasible Staying abreast of changes in business and industry to assess impacts on the companys risk profile Contributing to the development of new concepts, techniques, and making continuous process improvements for the overall IA team All Qualcomm employees are expected to actively support diversity in their teams, and in the Company. Minimum Qualifications Three to Five years of relevant experience in internal auditing, external auditing, or SOX compliance within a global public company (preferably in the high-tech industry), Big 4/mid-tier accounting firm or other fast-paced corporate setting Fluent English; multi-lingual capability is a plus Preferred Qualifications Successful candidate will possess the following characteristics: As feasible, ability to travel (infrequently) to Qualcomms domestic and international locations (e.g., U.S., Europe) Semiconductor business experience or familiarity Strong communication (oral and written) and presentation skills Fast learner with strong interpersonal, organization, analytical, critical thinking, and problem-solving skills Ability to work in a flexible and non-hierarchical team environment Willingness to get things done and take responsibility Ability to recognize and apply a sense of urgency, when necessary Comfortable with ambiguity Positive attitude, professional maturity, good work ethic Ability to work independently, handle multiple projects simultaneously and multi-task to meet deadlines with high-quality deliverables Keywords controls, risk assessment, risks, internal audit, SOX Educational Requirements Bachelors degree in accounting, Finance, Business Administration, or related field. CPA, CA, CIA, CFE, or other credentials, a plus. Minimum Qualifications: Bachelor's degree. 3+ years of Finance, Accounting, or related work experience.*Completed advanced degrees in a relevant field may be substituted for up to two years (Masters = one year, Doctorate = two years) of work experience.

About The Role Job Title - Internal Audit Manager Management Level :07 - Manager Location:Bangalore Must have skills:Chartered Accountant with Internal or external audit experience Good to have skills:Certifications - CIA or CFE Experience: Minimum 8 years of experience is required Educational Qualification: Chartered Accountant Job Summary : As the Internal Audit Manager at Accenture, you will develop and implement a risk-based audit plan, conduct audits in emerging risk areas such as revenue recognition, contract accounting, compliance, fraud, operations, and outsourcing, and report findings to leadership and the Audit Committee. This role entails overseeing all audit processes, leveraging data analytics and automation for comprehensive risk coverage, and providing advisory services to help business partners manage risks in new technologies, market offerings, and corporate initiatives. You will participate in operational excellence initiatives, maintain current technical skills through training, foster trust and collaboration with clients and team members, stay updated on company policies and industry developments, and supervise a multinational team across various time zones. Roles & Responsibilities: Participate in the creation and execution of the risk-based audit plan, reporting results to Accenture Leadership and the Audit Committee of the Board of Directors. Conduct a wide-ranging scope of audits with an emphasis on assessing emerging areas of risk including revenue recognition, contract accounting, compliance, fraud, operations and outsourcing. Responsible for end-to-end audit oversight including scoping, staffing, planning, fieldwork, workpaper documentation, leading audit meetings, reporting, and follow-ups; ensuring that methodologies governing internal audits are followed. Leverage the power of advanced data analytics and automation techniques to achieve comprehensive risk coverage and deliver high-quality audit results. Through advisory services, work with our business partners to help them proactively identify and manage risk in new technologies, new go-to-market offerings, and critical corporate initiatives. Shape the future of the Accenture Internal Audit through involvement in operational excellence and best practice initiatives. Ensure technical skill set and business acumen stay current and relevant through participation in our robust training program. Through interaction with clients and team members, develop strong professional relationships that foster trust and collaboration and, as a leader, set a solid example for the staff. Keep abreast of company policies and procedures, current developments in accounting and auditing professions. Supervise and work with a multinational team and flexibility to work across time zones. Professional & Technical Skills: Chartered Accountant with 8 - 10 years of post-qualification experience in external or internal auditing, preferably in Big 4 or a global organization. Highly motivated and self-driven with limited guidance from the supervisor and provides appropriate direction to the Internal Audit staff. Experience in leveraging advanced data analytics in all phases of the audit lifecycle. Excellent people management, mentoring, and project management skills. Strong working knowledge of financial, operational, compliance, and systems auditing techniques. Strong verbal and written communication, report drafting, and presentation skills, and proficiency with the English language. Ability to think outside the box and challenge the status quo. Must be able to work in a dynamic and fast-paced environment with flexibility to adjust to time zones. Additional relevant professional or technical certifications (CIA or CFE) is preferred. Readiness for domestic and international travel, as and when required. Additional Information: This position is based at our Bengaluru office. About Our Company | Accenture Qualification Experience: Minimum 8 years of experience is required Educational Qualification: Chartered Accountant

About The Role Kotak Mahindra Investments limited (KMIL) is a subsidiary of Kotak Mahindra Bank Limited and is involved in Corporate Real Estate Lending and Structured Finance Business. The KMIL Internal Audit department conducts risk based internal audit (RBIA) for various functions as per the audit plan. Job Role: Performing Internal Audit of Lending business functions and support functions including Compliance, Risk, Secretarial, Accounts, Treasury and Taxation departments as per risk based audit plan. Ability to demonstrate business understanding, assess process, risk and controls and drive improvements. Document audit findings and maintain quality audit paper work. Independently discuss and conclude audit finding with stakeholders Delivering on time quality audit reports Follow up on the recommendations with stakeholders and monitor the compliance for effective closure. Monitor compliance with Industry standards, laws and guidelines Working as a Team Player with a one team mind-set & commercial acumen Collaborating with staff of co-sourcing firms Job requirements: Knowledge about key Regulatory requirements and Internal Policies Professionally qualified CA, CIA would be an added advantage 3 to 8 years of exposure / experience to Internal Audit/ Internal risk control practices of a Financial institution Critical thinking, analytical skills, strong communication, efficient data handling skills High energy, Passion & Self starter attitude with good presentation skills Ability to work under pressure Willing to travel as needed

Roles and responsibilities: Should automate the test suite of web (and mobile preferable) test cases Work with teams to incorporate the automation into the existing automation framework Help the team set up robust test environments Detect and track defects and inconsistencies Execute all levels of testing (System, Integration, and Regression) Selection or identification of test cases for automation from existing test case documentation Applying Design and Test Automation Strategy Document Creating a test plan for sprint and getting approval Participation in testing tools setup Automation framework design and implementation according to the project structure Creating, Enhancing, Debugging, and Running Test Cases Organizing, and monitoring defect management process Handling changes, and conducting regression tests Find solutions for issues related to object identity issues and error handling Must be able to use all web methods like GET, PUT, POST, DELETE, etc. Validate feedback, response time, and error code Able to Load and Security testing on web services Able to read and understand API documents To validate API and DB data elements, SQL queries should be good Conduct performance system testing to verify system scalability, efficiency, and reliability Coordinate with the testing team to develop performance test plans and cases Analyze the test results and coordinate with the development teams for bug fixes Create a test summary report for management review Analyze the underlying causes of performance issues and provide corrective action Organize job training and provide assistance to junior test engineers as needed Suggest new tools and techniques to improve test efficiency Should provide performance reports of individual tester quarterly Responsible for QA server updates and testing at the client site by self/team members Skills/Qualifications: Should have 4+ years experience in Testing (i.e. manual & automation for functional, database, load & API) and at least 3+ yrs. In automation tools like Selenium, JMeter, Postman, etc Expertise in Mobile & web automation testing for native applications will be preferable Experience in leading and mentoring QA teams Experience having automated in an Agile environment Knowledge of Performance testing on Web/mobile applications Good written, analytical and verbal communication skills Should have any one/many certifications from the following: ISTQB, ISEB, CQA, CSTE, QA, LSEG, DB, OS, AWS, CTFL DB, OS, AWS, CTFL Degree in Computer Science, Engineering, or a related subject or relevant certifications or experience Problem solver, thinker, and analyzer. Solution challenger when relevant. Excellent communication and writing skills with the ability to understand and end-user directly Synthetic communication. Formality, details level, and options of documentation should be in accordance with talkers. Organized and practical

Overview This individual plays a pivotal role within the Global Capabilities team, significantly impacting PepsiCos business by developing, deploying, and continually supporting Market teams with core Insights on Superiority. They elevate the broader Insights function, pushing it to new horizons and enhancing efficiency through streamlined, standardized processes. By identifying connections across business needs, they ensure seamless capability integration into strategic processes, driving operational excellence. Responsibilities Focusing on the Superior Proposition Capability, this individual masters the art and science of being chosen by consumers: Enhanced Product Development: The new Proposition Testing methodology provides comprehensive diagnostic insights that can lead to product reformulation capitalizing on market opportunities. Improved Brand Equity: By going beyond traditional CQA, the Proposition Testing methodology offer deeper insights into Brand Equity that can retrofit the way we recommend Marketing to strengthen brand connections. Optimized Product and Packaging Design: Insights gathered from external vendors and internal PepsiCo experts (e.g., R&D) through the Proposition Testing methodology can led to the redesign of product packaging, impacting on consumer preference. Additionally, this individual collaborates with Global Insights, CX, R&D and market teams to interrogate data and answer specific business questions, providing analysis and insights that inform strategic decisions. Develop and Deploy Insights Capabilities: Develop, deploy, and continually support Global and Market teams with core superiority capabilities. Elevate the broader Insights function by pushing it to new horizons of Insight capability. Enhance efficiency by streamlining, standardizing, and identifying connections across business needs. Ensure products worldwide meet and /or exceed consumer expectations. Proposition Testing Methodology: Implement the new Proposition Testing methodology to provide comprehensive diagnostic insights. Enhance understanding of Methodology and interconnections with Brand Equity. Performs analysis of business and user needs, documenting requirements. Mine and analyse the data from such company databases to drive optimization and improvement of product development, marketing techniques and business strategies Assess the effectiveness and accuracy of new data sources and data gathering techniques. Collaboration and Consultation: Collaborate with Global Insights, CX, R&D, and market teams to interrogate data and answer specific business questions. Qualifications Post Graduate Degree (MBA Preferred, Statistical background preferred) 8+ years of experience in data analytics, using custom quantitative - product, pack testing Must have experience. Additionally good to have brand equity background Experience with integrating multiple data sets and systems for integrating new incoming data efficiently Advanced Excel skills a must Excellent project management skills: can manage project delivery, including estimating timelines and identifying risks Comfortable with statistical modeling Comfortable with a broad range of data sources and metrics, such as economic data, social listening data, etc. Strong analytical thinking with proven ability to connect data & to digestible representations to generate insights Structured thinker / problem solver who works independently Excellent organizational skills and attention to detail Great Collaborator / Team Spirit Language: English Fluent Post Graduate Degree (MBA Preferred, Statistical background preferred) 8+ years of experience in data analytics, using custom quantitative - product, pack testing Must have experience. Additionally good to have brand equity background Experience with integrating multiple data sets and systems for integrating new incoming data efficiently Advanced Excel skills a must Excellent project management skills: can manage project delivery, including estimating timelines and identifying risks Comfortable with statistical modeling Comfortable with a broad range of data sources and metrics, such as economic data, social listening data, etc. Strong analytical thinking with proven ability to connect data & to digestible representations to generate insights Structured thinker / problem solver who works independently Excellent organizational skills and attention to detail Great Collaborator / Team Spirit Language: English Fluent Focusing on the Superior Proposition Capability, this individual masters the art and science of being chosen by consumers: Enhanced Product Development: The new Proposition Testing methodology provides comprehensive diagnostic insights that can lead to product reformulation capitalizing on market opportunities. Improved Brand Equity: By going beyond traditional CQA, the Proposition Testing methodology offer deeper insights into Brand Equity that can retrofit the way we recommend Marketing to strengthen brand connections. Optimized Product and Packaging Design: Insights gathered from external vendors and internal PepsiCo experts (e.g., R&D) through the Proposition Testing methodology can led to the redesign of product packaging, impacting on consumer preference. Additionally, this individual collaborates with Global Insights, CX, R&D and market teams to interrogate data and answer specific business questions, providing analysis and insights that inform strategic decisions. Develop and Deploy Insights Capabilities: Develop, deploy, and continually support Global and Market teams with core superiority capabilities. Elevate the broader Insights function by pushing it to new horizons of Insight capability. Enhance efficiency by streamlining, standardizing, and identifying connections across business needs. Ensure products worldwide meet and /or exceed consumer expectations. Proposition Testing Methodology: Implement the new Proposition Testing methodology to provide comprehensive diagnostic insights. Enhance understanding of Methodology and interconnections with Brand Equity. Performs analysis of business and user needs, documenting requirements. Mine and analyse the data from such company databases to drive optimization and improvement of product development, marketing techniques and business strategies Assess the effectiveness and accuracy of new data sources and data gathering techniques. Collaboration and Consultation: Collaborate with Global Insights, CX, R&D, and market teams to interrogate data and answer specific business questions.

Job Title: Internal Audit Analyst Management Level: 11 Analyst Location: Bangalore Must have skills: Chartered Accountant with 2 - 3 years of post-qualification experience in external or internal auditing, preferably in Big 4 or a global organization. Good to have skills: Internal Audit experience with Big 4 or a global organization Job Summary : An agile, highly motivated, innovative thinker with a background in audit, risk, or compliance looking to join a fast-paced, global Internal Audit department that has embraced transformative capabilities including advanced analytics, dynamic risk assessment, and automation to retain its role as a trusted advisor to the business. You are looking to build your career with a leading-edge Internal Audit department that enables you to work with advanced technologies, interact with senior levels of organizational leadership, work with multi-national and multi-cultural teams, participate in professional development activities, and receive global work exposure. Roles & Responsibilities: Participate in the execution of the risk-based audit plan, reporting results to Accenture Leadership and the Audit Committee of the Board of Directors Conduct a wide-ranging scope of audits with an emphasis on assessing emerging areas of risk including revenue recognition, contract accounting, compliance, fraud, operations, and outsourcing. Responsible for end-to-end audit execution including fieldwork, workpaper documentation, leading audit meetings, reporting, and follow-ups; ensuring that methodologies governing internal audits are followed. Leverage the power of advanced data analytics and automation techniques to achieve comprehensive risk coverage and deliver high-quality audit results. Through advisory services, work with our business partners to help them proactively identify and manage risk in new technologies, new go-to-market offerings, and critical corporate initiatives. Shape the future of the Accenture Internal Audit through involvement in operational excellence and best practice initiatives. Ensure technical skill set and business acumen stay current and relevant through participation in our robust training program. Through interaction with clients and team members, develop strong professional relationships that foster trust and collaboration. Keep abreast of company policies and procedures, current developments in accounting and auditing professions. Work with a multinational team and flexibility to work across time zones. Professional & Technical Skills: Chartered Accountant with 2 - 3 years of post-qualification experience in external or internal auditing, preferably in Big 4 or a global organization. Highly motivated and self-driven with limited guidance from the supervisor. Experience in leveraging advanced data analytics in all phases of the audit lifecycle. Excellent project management skills. Strong working knowledge of financial, operational, compliance, and systems auditing techniques. Strong verbal and written communication, report drafting, and presentation skills, and proficiency with the English language. Ability to think outside the box and challenge the status quo. Must be able to work in a dynamic and fast-paced environment with flexibility to adjust to time zones across APAC, Europe, and the U.S. Additional relevant professional or technical certifications (CIA or CFE) is preferred. Readiness for domestic and international travel, as and when required. Additional Information: The ideal candidate will possess a strong educational background along with a proven track record in Internal Audit . This position is based at our Bengaluru office. About Our Company | Accenture Qualification Experience: 2-3 Years of post-qualification experience Educational Qualification: Chartered Accountant

Authorized, Responsible and accountable for Analytical check in QC To Conduct In process Quality Assurance check for the Quality Control and follow up for the Corrective Actions. Review in process, finished product ADS and FP COA. Review and release of raw material and affixing of the the labels. Microbiology In process checks, review of water trends, EM trends. Chemistry water trends. Stability Protocol and report review. Regular monitoring of Stability and issuance of ADS. Back up review of Stability data. Review of protocols and reports and follow up for the closure. OOS, LIR, OOL & OOT Handling as per respective SOP. Audit Trial review SOPs/STPs/Specs: Preparation and review of SOPs for QA department, Review of other departments SOPs for correctness. Review of STPs and specifications. Documentation Room: Segregation of documents as per displayed room. And update the list of documents on regular basis. GMP and GLP compliance: Maintain GMP and GLP compliance in Quality Control. Labelling: Maintaining centralized label control. APQR: Compilation of data. Preparation and Closure of APQR. QRM Assigning the risk assessment number as per requirement. Preparation and review of the risk assessment. Audit and Compliance: Compliance to the external audits and internal gaps. Preparation for external and internal audits. Responsible for overall QA compliance activity. Co-ordination with RA for document sharing. Effective Co- ordination with inter and intra Department for carrying Trouble free operation. Responsible to follow cGMP & GDP for documentation. Perform task and activities assigned by HOD whenever required. Focus on QCD to establish effective process and systems for improving quality and reducing cost of Manufacturing. Review of the water system related documents. Computer system validation activity. Vendor Qualification activity. Preparation of controlled copy, uncontrolled copy and other copy as per the requirement and issue to the concern department / personnel Maintaining the soft copy of the document in the QA folder. Control of SOPs and Quality Documents. Issuance and retrieval of documents

Pupose:Deliver formulations in defined timeframe to meet product delivery goals for I&D Development of different formulations either as generic or differentiated generics. To demonstrate successful stability and scale up at manufacturing site. Core Job Responsibilities Development of formulation using scientific rationale in use of excipients to create a reproducible prototype formulation. Ensure Proper documentation of every trial in the log note books and then using the information for creation of the Product Development Report for use in dossier for filing. Use of QbD wherever required for Product and process optimization. Ensure proper upkeep, maintenance and calibration of the equipment. Ensure scale up of the developed formulation works at engineering batch level. Key Deliverables: Literature/Patent search to create drug profile Prototype development with rationale use of excipients Preformulation study as may be required for formulation development Conduct 6 months accelerated stability studies to ensure stable formulation Proof of concept studies to demonstrate BE or comparative PK as the case may be Scale up studies at 1/10th scale or engineering batch Technology transfer and manufacturing of Bio/Clinical batch Job Title: Jr Research Scientist Formulation Job Function: Innovation & Development Location: Mumbai (Andheri MIDC) Reporting to:Sr Group Leader Formulation Critical Success Factors: Functional/ Technical: Functional / Technical: 1. Formulation and Product Development a. Schedule and follow all the steps to deliver the drug as per QTPP b. Select the suitable polymers / excipients based on either properties or scientific rationale c. Evaluation of CQA of drug / excipients and estimate its implications for product development d. Designs the process which is reproducible and scalable with higher yield, cost effective, and environment friendly 2. Design of Experiments a. Executes the experiments as per DOE to optimize product and process 3. Pharmaceutical Development Report (PDR) a. Prepares PDR as per Common Technical Document (CTD) module 3 requirements b. Complies with regulatory requirements as defined in QTPP 4. Project Management a. Is able to plan and prioritize multiple project deadlines to meet product delivery goals Education & experience: M. Pharm/Ph. D. 5 to 7 yrs JOB FAMILY: Product Development LOCATION: India > Mumbai : BKC Building t SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

About The Role Kotak Mahindra Investments limited (KMIL) is a subsidiary of Kotak Mahindra Bank Limited and is involved in Corporate Real Estate Lending and Structured Finance Business. The KMIL Internal Audit department conducts risk based internal audit (RBIA) for various functions as per the audit plan. Job Role: Performing Internal Audit of Lending business functions and support functions including Compliance, Risk, Secretarial, Accounts, Treasury and Taxation departments as per risk based audit plan. Ability to demonstrate business understanding, assess process, risk and controls and drive improvements. Document audit findings and maintain quality audit paper work. Independently discuss and conclude audit finding with stakeholders Delivering on time quality audit reports Follow up on the recommendations with stakeholders and monitor the compliance for effective closure. Monitor compliance with Industry standards, laws and guidelines Working as a Team Player with a one team mind-set & commercial acumen Collaborating with staff of co-sourcing firms Job requirements: Knowledge about key Regulatory requirements and Internal Policies Professionally qualified CA, CIA would be an added advantage 3 to 8 years of exposure / experience to Internal Audit/ Internal risk control practices of a Financial institution Critical thinking, analytical skills, strong communication, efficient data handling skills High energy, Passion & Self starter attitude with good presentation skills Ability to work under pressure Willing to travel as needed

About The Role Kotak Mahindra Investments limited (KMIL) is a subsidiary of Kotak Mahindra Bank Limited and is involved in Corporate Real Estate Lending and Structured Finance Business. The KMIL Internal Audit department conducts risk based internal audit (RBIA) for various functions as per the audit plan. Job Role: Performing Internal Audit of Lending business functions and support functions including Compliance, Risk, Secretarial, Accounts, Treasury and Taxation departments as per risk based audit plan. Ability to demonstrate business understanding, assess process, risk and controls and drive improvements. Document audit findings and maintain quality audit paper work. Independently discuss and conclude audit finding with stakeholders Delivering on time quality audit reports Follow up on the recommendations with stakeholders and monitor the compliance for effective closure. Monitor compliance with Industry standards, laws and guidelines Working as a Team Player with a one team mind-set & commercial acumen Collaborating with staff of co-sourcing firms Job requirements: Knowledge about key Regulatory requirements and Internal Policies Professionally qualified CA, CIA would be an added advantage 3 to 8 years of exposure / experience to Internal Audit/ Internal risk control practices of a Financial institution Critical thinking, analytical skills, strong communication, efficient data handling skills High energy, Passion & Self starter attitude with good presentation skills Ability to work under pressure Willing to travel as needed

As a Product Development Scientist at our company, you will be responsible for executing lab batches for Solid Orals and liquid orals, which includes formulation strategy, process selection, drug excipients compatibility, lead formulation selection, stability studies, and tech transfer in accordance with applicable regulations and ICH guidelines. You will also play a key role in advancing new formulations from idea generation through development and scale-up. Your primary task will involve evaluating and implementing ICH and Quality by Design (QbD) concepts during the Product development phase. This includes considering elements such as Quality Target Product Profile (QTPP), Critical Quality Attributes (CQA), Critical Process Parameters (CPP), Critical Material Attributes (CMA), and Design of Experiments (DOE). To excel in this role, you should possess strong problem-solving, analytical thinking, and communication skills. Additionally, you should hold an M.Pharm degree in Pharmaceutical Sciences or Pharmaceutics and have 4 to 7 years of relevant experience in the field. If you meet the qualifications and are excited about this opportunity, please send your CV to hr@lyruslife.com with the position you are applying for mentioned in the subject line.,

Purpose of Job An agile, highly-motivated, innovative thinker with a background in audit, risk, or compliance looking to join a fast-paced, global Internal Audit department that has embraced transformative capabilities including advanced analytics, dynamic risk assessment, and automation to retain its role as a trusted advisor to the business Skill Required Participate in the creation and execution of the risk-based audit plan, reporting results to Intas Leadership and the Audit Committee of the Board of Directors. Conduct a wide-ranging scope of audits with an emphasis on assessing emerging areas of risk including revenue recognition, contract accounting, compliance, fraud, operations and outsourcing. Responsible for fieldwork, work paper documentation, audit meetings, reporting, and follow-ups; ensuring that methodologies governing internal audits are followed. Leverage the power of data analytics and automation techniques to achieve comprehensive risk coverage and deliver high-quality audit results. Through interaction with auditees and team members, develop strong professional relationships that foster trust and collaboration and set a solid example for others. Keep abreast of company policies and procedures, current developments in accounting and auditing professions. Roles and Responsibilites Highly motivated and self-driven with limited guidance from the supervisor. Knowledge of data analytics will be added advantage. Strong working knowledge of financial, operational, compliance, and systems auditing techniques. Strong verbal and written communication, report drafting, and presentation skills, and proficiency with the English language. Ability to think outside the box and challenge the status quo. Must be able to work in a dynamic and fast-paced environment with flexibility to adjust to time zones. Additional relevant professional or technical certifications (CIA or CFE) is preferred. Readiness for domestic and international travel. Highly motivated and self-driven with limited guidance from the supervisor. Knowledge of data analytics will be added advantage. Strong working knowledge of financial, operational, compliance, and systems auditing techniques. Strong verbal and written communication, report drafting, and presentation skills, and proficiency with the English language. Ability to think outside the box and challenge the status quo. Must be able to work in a dynamic and fast-paced environment with flexibility to adjust to time zones. Additional relevant professional or technical certifications (CIA or CFE) is preferred. Readiness for domestic and international travel. Qualification Required Chartered Accountant with 0 - 1 year of post-qualification experience in external or internal auditing.

Skill Required Chartered Accountant with 3 - 5 years of post-qualification experience (Assistant Manager), 1-3 years of post-qualification experience (Senior Executive) in external or internal auditing. Experience in Big 4 or a global organization will be preferred. Highly motivated and self-driven with limited guidance from the supervisor. Experience in data analytics in audit lifecycle. Strong working knowledge of financial, operational, compliance, and systems auditing techniques. Strong verbal and written communication, report drafting, and presentation skills, and proficiency with the English language. Ability to think outside the box and challenge the status quo. Must be able to work in a dynamic and fast-paced environment with flexibility to adjust to time zones. Additional relevant professional or technical certifications (CIA or CFE) is preferred. Readiness for domestic and international travel. Roles and Responsibilites Participate in the creation and execution of the risk-based audit plan, reporting results to Intas Leadership and the Audit Committee of the Board of Directors. Conduct a wide-ranging scope of audits with an emphasis on assessing emerging areas of risk including revenue recognition, contract accounting, compliance, fraud, operations and outsourcing. Responsible for fieldwork, work paper documentation, audit meetings, reporting, and follow-ups; ensuring that methodologies governing internal audits are followed. Leverage the power of data analytics and automation techniques to achieve comprehensive risk coverage and deliver high-quality audit results. Through interaction with auditees and team members, develop strong professional relationships that foster trust and collaboration and set a solid example for others. Keep abreast of company policies and procedures, current developments in accounting and auditing professions. Work with multinational auditees and flexibility to work across time zones. Qualification Required CA with 4-6 Years of experience in Internal Audit.

Purpose of Job 1. Preparation and Review of PQR. 2. Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software. Skill Required 1. Having basic knowledge on Microsoft Word and Microsoft Excell 2. Have knowledge of Minitab software for statstical evaluation of data. Roles and Responsibilites 1. Preparation and review of PQR schedule. 2. Planining of PQR compilation as per PQR schedule. 3. Collection of data from all the CFT teams for compilation of PQR. 4. Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software. 5. Based of the PQR data recommendation to be recommended to concern department and ensure implemenation of the same. Qualification Required B. Pharm or M.Sc. Relevant skills / Industry experience 1. Should have relevant experience in Regulatory approved plant.

Purpose of Job 1. Preparation of PQR. 2. Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software. Skill Required 1. Utilization of Microsoft Word and Microsoft Excell 2. Using of Minitab software for statstical evaluation. Roles and Responsibilites 1. Preparation of PQR schedule. 2. Planining of PQR compilation as per PQR schedule. 3. Collection of data from all the CFT teams for compilation of PQR. 4. Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software. 5. Based of the PQR data recommendation to be recommended to concern department and ensure implemenation of the same. Qualification Required B. Pharm or M.Sc. Relevant skills / Industry experience 1. Should have relevant experience in Regulatory approved plant.

The Internal Audit Department provides the Audit Committee of the Board of Directors with an independent and objective assessment of the reliability and integrity of financial and select operating information, the effectiveness and efficiency of Intas Pharmaceuticals Limited and its consolidated subsidiaries (the Company) systems and internal controls, and compliance with the Companys policies and procedures. Internal Audit also provides advisory services designed to add value and improve the Companys operations through bringing a systematic and disciplined approach to evaluate and improve the effectiveness of risk management, controls, operations, and governance processes. We are looking for an agile, highly-motivated, innovative thinker with a background in audit, risk, or compliance looking to join a fast-paced, global Internal Audit department that has embraced transformative capabilities including advanced analytics, dynamic risk assessment, and automation to retain its role as a trusted advisor to the business. Roles and Responsibilites Creation and execution of the risk-based audit plan, reporting results to Intas Leadership and the Audit Committee of the Board of Directors. Manage wide-ranging scope of audits with an emphasis on assessing emerging areas of risk including revenue recognition, contract accounting, compliance, fraud, operations and outsourcing. Managing the team, fieldwork, work paper documentation, audit meetings, reporting, and follow-ups; ensuring that methodologies governing internal audits are followed. Leverage the power of data analytics and automation techniques to achieve comprehensive risk coverage and deliver high-quality audit results. Through interaction with auditees and team members, develop strong professional relationships that foster trust and collaboration and set a solid example for others. Keep abreast of company policies and procedures, current developments in accounting and auditing professions. Work with multinational auditees and flexibility to work across time zones. Qualification Required Desired Skills and qualifications: Chartered Accountant with 6 - 12 years of post-qualification experience in external or internal auditing. Experience in Big 4 or a global organization will be preferred. Highly motivated and self-driven with limited guidance from the supervisor. Experience in data analytics in audit lifecycle. Strong working knowledge of financial, operational, compliance, and systems auditing techniques. Strong verbal and written communication, report drafting, and presentation skills, and proficiency with the English language. Ability to think outside the box and challenge the status quo. Must be able to work in a dynamic and fast-paced environment with flexibility to adjust to time zones. Additional relevant professional or technical certifications (CIA or CFE) is preferred. Readiness for domestic and international travel.

Division Department Sub Department 1 Job Purpose Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines Key Accountabilities (1/6) Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner Collect data from all SPOCs with respect to received work plan for review Escalate any delays in receiving response from unit with respect to work plan Review of collected data for work plan fulfilment Send data to HO for compilation of deficiency response Take follow up with HO to receive updated dossier for product updates Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to response for deficiencies Review master validation protocol and report within timeline Check major observation in other units documents also for improvement of validation documents at site Synchronize all units Validation documents for improvement of all units Review annual product quality review report at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readiness Collect APQR timely with units for review Review data with supporting documents for data authentication Check major observation with other units for improvement of documents at site Key Accountabilities (2/6) Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirement Review and compile received technical agreements for comments Provide guidance for execution of batches and handling events as per customer requirement Provide training in department to improve awareness in audit and compliance with licencing department Take follow up with HO for providing fresh TA and pending TAs for products Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of new products smoothly Receive and check approval certificate, dossiers (TDP & RAP) and development report for distribution at site Update site on receipt of documents for handling execution of customer or market specific batches Coordinate with auditors and site teams for regulatory and customer inspection/ audit at site to meet regulatory expectation and acquire GMP approvals Prepare final draft of compliance to audit observation and check whether it is in line with cGMP requirement to avoid regulatory action and continual improvements Inspect audit prerequisites to support and prepare for external audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Prepare and submit EPA annual production application for getting the establishment registration of unit V Key Accountabilities (3/6) Collect, compile and review raw data and finalise the same for timely submission of MHRA, UK interim update document to corporate as per agency requirement by tracking interim updates at a site level, for risk based inspection planning Coordinate with units for all the raw data, its review and finalization before submission to corporate Prepare pre-inspection compliance report after announcement of MHRA audit Key Accountabilities (4/6) Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP Review warning letters received by competitors, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Review audit observations received by other Cipla sites, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Participate in internal team for conducting self-inspection, report preparation, submission and compliance review, to evaluate adherence to cGMP Prepare and update procedures in line with current GMP requirements Key Accountabilities (5/6) Execute on time and errorless submissions by reviewing product license, all certificates for product registration and tender , staff approvals and other applications to adhere to legal requirements Collect, review and finalize applications for: Additional Product COPP Test License Renewal of drugs manufacturing license and WHO GMP certificate All certificates for product registration and tender Alcohol Quota FDA Staff Approval Site Layout Approval Submit and process above application to FDA (district, state, CDSCO) for time bound receipt of approval Communicate with FDA to resolve queries and follow ups to monitor status of application Review, maintain and distribute approved certificates to concerned stakeholders at site Track the consumption of alcohol quota allotted by state FDA under subsidized scheme as per the plan to manage optimum level of alcohol availability for smooth functioning of site Track the status of FDA approved staff at site to adhere to Drug and Cosmetic Act Track the status of quantity specific product license to monitor dispatch of such products and renewal of license in compliance to DCGI NOC condition Key Accountabilities (6/6) Support in CDSCO and state FDA inspection to be GMP compliant and getting product licence, FDA stall approvals by ensuring cross functional interaction Inspect audit prerequisites to support and prepare for CDSCO and state FDA audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Major Challenges Delay in receiving data for allotted work plans from units may impact whole process of deficiency response hence to overcome this situation we are in continue follow up with units for timely response Major observation handling in validation documents impact on registration batch execution, leading to delay in filing of product hence to overcome this situation we share and resolve each observation with units timely with resolving strategy Lack of detailed compliance with appropriate root cause from user department. Regular discussion and trainings is provided to unit Liaising with Government officials for availability and timely approvals of applications Key Interactions (1/2) SPOCs of process validation at site for timely review of master validation protocol and reports at the time document received for review (once or twice a month) SPOCs of APQR at site for timely review of APQR (monthly) SPOCs of RA at site for timely receiving of work plan response of deficiencies on (weekly) Unit QA heads in reference to audit readiness and preliminary draft response (need basis) CQA and A&C team for final draft response review (need basis) Key Interactions (2/2) FDA for processing and approval of application (need basis) Dimensions (1/2) Zero overdue compliance of deficiencies. 100% adherence to provided timelines for review of documents timely. Track and support in Top 07 projects. Timely and errorless review of APQR at site. Review should not exceeding 15 days from schedule. Ensure quality score minimum of 90% for each month. Timely and errorless preparation of tech transfer summary for site. Data submission to corporate should not go beyond 5th of every month Average 30 audits/ year 100% adherence to timeline of compliance for various regulatory and customer audits. No disruption is supply chain because of GMP approvals, product deficiency and product license For FDA: Approximately 150 additional product license 36 test license 40 certificates 290 COPP 5 staff approvals Dimensions (2/2) Key Decisions (1/2) Review observation provided for correctness and improvement of master validation protocol and report documents (To Unit QA) List of pending technical agreements with requirement of fresh TA to HO for regular execution of customer products. Review observation provided for correctness and improvement of APQRs and FDA product license applications at site (To unit QA) Recommend to update correct data provided for deficiency response (To HO) Process of identifying root cause for the observation in various inspection and audit (to CFT) Key Decisions (2/2) Education Qualification B. Pharma/ M.Sc. with minimum three/ four year of experience in quality assurance department Licensing and registration (0-2 years) Relevant Work Experience Sound knowledge of cGMPs and regulatory guidelines and basic knowledge of computer system

Job Roles and Responsibilities: Perform maintenance, review, and approval of company Standard Operating Procedures (SOPs) in compliance with ISO standards and applicable international and national regulations. Prepare and review Quality Management System (QMS) documents, CQA procedures, and assist in reviewing department SOPs as needed. Manage SOPs in mLMS, create users, review training records, and escalate non-compliance issues to the Head of CQA or relevant department heads. Maintain the CQA document repository and archive validation protocols and documents in line with regulatory requirements. Conduct internal audits of Clinical Research Department activities and ISO requirements, ensuring compliance with ICH-GCP and company procedures. Provide training to staff on ISO standards and local regulations when necessary. Control and manage documents, including maintaining master lists and issuing change controls, deviations, CAPAs, amendments, and notes to file. Update logs for change control, deviations, CAPAs, amendments, and NTFs. Prepare annual CQA reports and trend analysis, and assist with external audits from clients, certification bodies, or regulatory authorities. Requirements: Education: Bachelor's or Master's in Life Sciences (or related field). Experience: 2-3 years of experience in Clinical Quality Assurance or related roles. Familiarity with ISO regulations, ICH-GCP guidelines, and QMS. Experience in conducting internal audits and maintaining regulatory documentation. Note: Additional responsibilities may be assigned by the Head of Department (HOD).

The job involves working at KPMG, a professional services firm in India affiliated with KPMG International Limited. KPMG has been operating in India since August 1993, with offices located in various cities across the country such as Ahmedabad, Bengaluru, Chandigarh, Chennai, Gurugram, Jaipur, Hyderabad, Kochi, Kolkata, Mumbai, Noida, Pune, Vadodara, and Vijayawada. The professionals at KPMG leverage the global network of firms and possess knowledge of local laws, regulations, markets, and competition to serve national and international clients in India across different sectors. The primary focus of KPMG entities in India is to provide rapid, performance-based, industry-focused, and technology-enabled services that demonstrate a deep understanding of global and local industries and expertise in the Indian business environment. The job role may involve working in risk analytics. Qualifications required for the position include a B.com degree, CFA-level 2 certification, or CQA (Certified Quality Auditor) qualification. KPMG is an equal opportunity employer, providing a fair and inclusive work environment for all employees.,