Jobs
Interviews

71 Cqa Jobs

Setup a job Alert
JobPe aggregates results for easy application access, but you actually apply on the job portal directly.

4.0 - 6.0 years

10 - 20 Lacs

Ahmedabad, Gujarat, India

On-site

Job description Liase with relevant stakeholders (EHS, R&D, Clinical, Patent, CQA, CRA, Plant, SCM, Finance) for smooth progress of the projects. Support BD team for any queries on existing and new products. Monitor & escalation (if any) Project scope, budget and timelines for the allotted projects. Maintain project charter, stage gate, and action logs for each of allocated projects. Coordinate with other Piramal site for Tech transfer support. To support proposal preparation & finalization by consulting concern stakeholders. Send monthly status update for the allotted projects. Update presentations with respect to facilities & Facilitating the Client visit Regulatory support for ANDA submission & query response Invoicing for CDMO projects including pass through costs. Support site specific business case Support review and finalization of CDA s, MSA s , Quality Agreement and any other agreements on need basis Host and coordinate client meetings at site Coordinate project meetings with clients/ internal stakeholders based on agreed schedules Draft agenda and minutes of the meetings that are initiated by self. M. Pharm/M. Sc. /MBA

Posted 10 hours ago

Apply

10.0 - 15.0 years

9 - 13 Lacs

Hyderabad

Work from Office

What is the Internal Audit group responsible for? The Franklin Templeton Internal Audit group is an independent and objective function within the Franklin Templeton organization, designed to improve and protect organizational value by providing independent, dynamic risk-based assurance and advisory services. Internal Audit (IA) accomplishes its objectives by being a future-focused and sought-after business partner driven by our insight, knowledge and expertise. What is the Manager, Internal Audit, responsible for ? As our Manager, Internal Audit, you will play a key role in assessing risks, reviewing internal controls, and providing forward-looking insights into improving business processes. You will work closely with senior Private Market stakeholders and co-source partners to deliver high-quality internal audit reviews and help strengthen governance. Collaboration with teams across Internal Audit and the wider organization, while working under limited supervision, is key to supporting delivery of organizational strategies. Our global organization provides a stimulating environment and the opportunity to collaborate with knowledgeable colleagues and specialists around the world. What are the ongoing responsibilities of the Manager, Internal Audit? Planning and executing Private Market audits and special projects, including meeting with auditee management, documenting the control environment, documenting control weaknesses, inefficiencies, root causes, risks, and recommendations. Finalizing audits and special projects for Private Market areas, including conducting exit meetings and drafting and/or reviewing the audit reports. Meeting and interacting with key stakeholders (primarily Private Markets), overseeing our co-source partner of internal audit services, coordinating with other internal compliance/risk management functions. Attending and reporting to Boards and Audit Committees (ACs) as required. Interacting with external auditors and/or regulators as required. Training and developing Internal Audit personnel, working on department-wide initiatives including methodology enhancements, quality assurance, audit tool/system enhancements and procedural reviews What ideal qualifications, skills & experience would help someone to be successful? Bachelors Degree or equivalent in Business, Accounting, Information Technology, or a related discipline 10 to 15+ years of auditing experience and at least 4 years in a senior/supervisory position. 4+ years of top-tier public accounting firm experience Required to hold one or more professional certification/designations in the following: Auditing, e.g., CPA, CIA, CA, CISA, CFE Experience in the asset management industry (Private Markets Private Credit / Private Debt, Real Estate, Private Equity) Knowledge of regulations affecting asset management Demonstrated ability to perform both Assurance and Advisory reviews as well as collaborating with co-source partners Data analytics / data visualization experience (e.g., Tableau, Power BI, Business Objects) What are the other abilities of an Audit Manager? Knowledge of and ability to understand, adapt, respond to, and proactively seek changes and innovation in the technology business environment to improve the competitive advantage of an organization Drive critical activities to completion. Ability to work independently and as part of a team with minimal supervision Apply organizational acumen to identify and maintain focus on key success factors for the organization Knowledge of and ability to work and think alongside stakeholders to achieve stakeholders' current and future aspirations and successes Knowledge of effective influencing tactics and strategies; ability to impact decisions within and outside own organization Knowledge of and the ability to use summarization and simplification techniques to explain complex technical concepts in simple, clear language appropriate to the audience Work with minimal supervision and exercise independent judgment consistent with department guidelines Act as supervisor to lower-level staff Ability to interact with senior management on a regular basis Ability to maintain a professional image (e.g., demeanor, confidentiality, humbleness, maturity and confidence) Work Shift Timings - 2:00 PM - 11:00 PM IST

Posted 3 days ago

Apply

2.0 - 3.0 years

5 - 9 Lacs

Bengaluru

Work from Office

About The Role 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

Posted 4 days ago

Apply

10.0 - 15.0 years

10 - 17 Lacs

Ahmedabad

Work from Office

Role & responsibilities: To enhance the quality system by imparting cGMP knowledge and updating regulatory requirements to the sites. To provide new regulatory guidance and technical documents to the site. To maintain a quality intelligence database and inform the concerned site about current regulatory requirements, updates and changes as and when required. To prepare corporate quality policy, standard practices, and corporate directives for system harmonization across all sites. To evaluate and ensure continual improvement of the quality management system. To verify policy implementation at the site and extend the identified gaps to the site for compliance. To review and evaluate regulatory guidelines, other company 483s, warning letters and inspection reports as per current regulatory requirements and extend identified gaps into quality intelligence portal to sites for compliance. To inform the Zydus family about new quality issues, current regulatory inspection trends, forecasts and best possible practices. To impart policy training to the site as and when required. To initiate corporate change controls for preparation and revision of quality policies. To review, verify and monitor the implementation of extended Global CAPA, Policy implementation observations and quality intelligence observations at sites. To perform any other activity assigned by HOD, as and when required. Preferred candidate profile: 2 Vacancies: one is for QA OSD background and second is for QA Injectable background. Candidate must be from pharma QA (OSD or Injectable) background. Must have Good communication skill, drafting skill and interpersonal skills. Must ready to travel to site location for inspections and audit. Must be ready to work at Ahmedabad location.

Posted 1 week ago

Apply

10.0 - 12.0 years

10 - 12 Lacs

Bengaluru, Karnataka, India

On-site

Your key responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Identify opportunities in existing accounts to cross-sell other EY services. Planning and monitoring of the project deliverables from the team. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Regular status reporting to the Senior Managers, Partners, Directors and onsite coordinators. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Demonstrate flexibility to travel to the customer locations on need basis Conduct performance reviews and contribute to performance feedback for staff and senior staff Foster teamwork, quality culture and lead by example Understand and follow workplace policies and procedures Training and mentoring of project resources Participate in the organization-wide initiatives Lead practice initiatives and portfolios Market trend +Digital trends. Cross skill and cross train the team members as per the business requirements Skills and attributes for success Quality & Compliance managed services and Consulting experience in of Life Sciences Domain. Has worked in executing the Validation Deliverables in software implementation projects Strong knowledge of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Strong knowledge of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Versed with ICH guidelines, ISPE framework on Risk management, System Development Life Cycle concepts. Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization. Versed with SOP documentation, analysing the work instructions, user manuals Strong knowledge of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. as they relate to Computer Systems Strong understanding of Data Integrity requirements Governance and reporting Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures. Strong Knowledge on authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Has supported Audits / Inspections Sound domain knowledge in Pharmaceutical industry in the areas of Quality and Compliance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 10-12 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills At managerial positions within Information Technology (IT) and/or Quality Assurance (QA) for major organizations Experience in managing team and solution designing Ideally, you'll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications Project Management

Posted 1 week ago

Apply

7.0 - 12.0 years

15 - 30 Lacs

Vapi

Work from Office

Role & responsibilities Design and implement Quality Management System to ensure personal care & cosmetics are consist-ently made as per company, regulatory requirements, and consumer expectations Lead audit management process to ensure compliance as per company and regulatory requirements. Engage with cross functional team during NPD to proactively identify risks/challenges/ actions to ensure regulatory and quality system requirements. Lead investigations, corrective and preventive actions for issues that have/would impact on products/processes or compliance to regulations or company standards Continuously improve domain knowledge and build up skills and capability of team w.r.t Packaging, Auditing, Vendor auditing and Quality Management System Ensure manufacturing facility has an effective QMS in place by providing leadership and expertise to set up a systematic approach to quality improvement and adherence to Quality processes Implementation of Best Practices, Automation, Anti-Counterfeiting and Technology in Packaging Processes and Defects elimination Ensure Mould Quality & Health Management systems along with Plants, 3P and Vendors. Actively drive actions for Market Quality and consumer Quality complaints with Cross Functions. Ensure Packaging Materials and converters Vendor Quality Assurance and Audits by engaging with Procurement Preferred candidate profile Graduate/ P. Graduate in science /B.Tech having minimum 10 years of experience in quality management, NPD and proven track record of quality system implementation

Posted 1 week ago

Apply

1.0 - 5.0 years

4 - 8 Lacs

Gangtok

Work from Office

Division Department Sub Department 1 Job Purpose Execute analysis of allocated samples and Produce reliable and reproducible results in order to ensure their compliance to the microbiological quality parameters and predefined specifications and standards. Key Accountabilities (1/6) Analyse and review samples based on work allocation to meet the service level agreement Analyse samples as per priority and work allocation Review the data as per respective specification, Microbiological Methods and results obtained Prepare, review and submit reports to Team leader within stipulated timelines in order to support individual sample release within stipulated timelines to achieve SLA Key Accountabilities (2/6) Report errors, abnormal observations, non-compliances related to procedures, equipment and instruments, and deliver results promptly to facilitate timely action and avoid delay in releases Initiate investigations and take necessary corrective and preventive actions Investigate incidence & lab error on priority basis so that batch release timely and issues are not recurring Key Accountabilities (3/6) Document entries, raw data and findings concomitantly in relevant test data sheets so as to facilitate the lab QA to review the reports and avoid missed entries Review reports as per cGMP & GDP for compliance to GLP Ensure no GMP / regulatory concern are raised by adhering to SOPs and following procedures Key Accountabilities (4/6) Evaluate & document Instrument / equipment break down and suggest mechanisms to avoid the same Maintain equipment and instruments optimally to ensure no incidences or non-compliances occur due to malfunctioning of equipment/ instruments Key Accountabilities (5/6) Key Accountabilities (6/6) Major Challenges Availability of Validation records of analysis samples becomes a challenge in cases where validation is performed on other sites. Material and resource availability becomes a challenge due to conflicting priorities between labs and coordination between analysts which makes it tough to fulfil SLA Key Interactions (1/2) Units for receiving specification, documents, protocols, area availability etc. (daily) QA/QC for product sample release (daily) Stores for procuring materials (need basis) Communicate if any observation find on the specification. Key Interactions (2/2) CQA for procuring pharmacopial guidelines (need basis) Dimensions (1/2) Review and release approximate 15 MLT reports on daily basis to achieve the SLA. Review and release approximately 15 sterility batches on weekly basis and 15 bio load samples. 50 Water Samples analysis and release 10 Technical Information Sheets for swap analysis 6 Autoclave & DHS Operation 200 locations released on daily basis for Environmental monitoring Dimensions (2/2) Key Decisions (1/2) Daily Media and Plates requirement (to Team Leader Microbiology) Key Decisions (2/2) Education Qualification M. Sc (Microbiology) Relevant Work Experience 1-5 years experience for analyst and 3-7 years for reviewer in Microbiology Good knowledge of Microbiology, skill to perform assigned task, communication in English

Posted 1 week ago

Apply

15.0 - 25.0 years

50 - 60 Lacs

Mumbai

Work from Office

Job Description Managing the Distribution and Commercial functions of East zone covering the states of West Bengal, Orissa, Bihar, Jharkhand and North Eastern states. Receivables Management and Inventory Management Control DSO within 28 days for East zone (5 depots) Reviewing customer services, cold chain management and CQA compliances Monitoring the Regional Sales Office (RSM) administration located in these states Ensuring compliance of all statutory requirements such as licenses, assessments, filing returns, professional tax, GST etc for East Zone. Freight management identifying reliable Transporters and review of vendor performance Managing Nepal business through Patna depot Ensuring proper controls and compliances in East zone for audit Work Experience 15-25 years Strong knowledge of SAP MM & SD module. Education Graduation in Commerce or Accountancy Post Graduation Competencies Customer Centricity Strategic Agility Developing Talent Collaboration Result Orientation Stakeholder Management Innovation & Creativity Process Excellence

Posted 1 week ago

Apply

3.0 - 8.0 years

5 - 10 Lacs

Hyderabad

Work from Office

Job Area: Finance & Accounting Group, Finance & Accounting Group > Internal Audit General Summary: Job Overview Qualcomm is a company of inventors that unlocked 5G - ushering in an age of rapid acceleration in connectivity and new possibilities that will transform industries, create jobs, and enrich lives. But this is just the beginning. It takes inventive minds with diverse skills, backgrounds, and cultures to transform 5Gs potential into world-changing technologies and products. This is the Invention Age - and this is where you come in. 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. Job Overview Qualcomm is a company of inventors that unlocked 5G - ushering in an age of rapid acceleration in connectivity and new possibilities that will transform industries, create jobs, and enrich lives. But this is just the beginning. It takes inventive minds with diverse skills, backgrounds, and cultures to transform 5Gs potential into world-changing technologies and products. This is the Invention Age - and this is where you come in. 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. Applicants Qualcomm is an equal opportunity employer. If you are an individual with a disability and need an accommodation during the application/hiring process, rest assured that Qualcomm is committed to providing an accessible process. You may e-mail disability-accomodations@qualcomm.com or call Qualcomm's toll-free number found here. Upon request, Qualcomm will provide reasonable accommodations to support individuals with disabilities to be able participate in the hiring process. Qualcomm is also committed to making our workplace accessible for individuals with disabilities. (Keep in mind that this email address is used to provide reasonable accommodations for individuals with disabilities. We will not respond here to requests for updates on applications or resume inquiries). Qualcomm expects its employees to abide by all applicable policies and procedures, including but not limited to security and other requirements regarding protection of Company confidential information and other confidential and/or proprietary information, to the extent those requirements are permissible under applicable law. To all Staffing and Recruiting Agencies Please do not forward resumes to our jobs alias, Qualcomm employees or any other company location. Qualcomm is not responsible for any fees related to unsolicited resumes/applications. If you would like more information about this role, please contact Qualcomm Careers.

Posted 2 weeks ago

Apply

4.0 - 9.0 years

20 - 25 Lacs

Hyderabad

Work from Office

Job Area: Information Technology Group, Information Technology Group > IT Programmer Analyst General Summary: Qualcomm IT is seeking a Lead Conversational AI Developer for Intelligent Automation Center (IAC)Responsibilities include: Experience on designing and implementing Conversational AI solutions using Microsoft Azure and Copilot Stack in combination with GenAI Hands-on experience with Microsoft Copilot Studio, Microsoft Bot Framework, NLP, Azure AI Search and Azure OpenAI Extensive hands-on experience in implementing end-to-end projects utilizing Generative AI using Retrieval-Augmented Generation (RAG) or Agentic AI architecture Strong expertise in Python for building bot solutions Experience with Azure Cognitive Services (LUIS/CLU, QnA Maker/CQA, Spell Check,Speech API) for advanced NLP features. Knowledge of Power Automate, Azure Logic Apps, and APIs for extending Copilot Agent and bot functionalities. Experience in software development with a focus on Conversational AI and Machine Learning. Proficiency with tools and Frameworks such as LangChain, LlamaIndex, and Streamlit. Knowledge and implementation experience of chatbot technologies using Microsoft Azure Services and Power Platform. Ensure quality of coded components by performing thorough unit testing and develop reusable test cases Work collaboratively with test teams for supporting Product testing and UAT Report status, issues and risks to tech leads on a regular basis Improve skills in automation products through certifications Train and coach team members on Conversational AI related technologies Work independently with minimal supervision and good team management skills Excellent communication and collaboration skills Provide timely status on assignments, planned activities, issues, and dependencies Good knowledge on Conversational AI on Microsoft Stack (Copilot Studio, Azure AI Foundry, Azure AI Search, Azure OpenAI) Good understanding of Generative AI concepts and Frameworks like Langchain Hands-on programming experience on Python and any frontend technology like Angular Minimum Qualifications: 4+ years of work experience in programming, scripting, and/or automation or IT-relevant work experience with a Bachelor's degree. OR 6+ years of work experience in programming, scripting, and/or automation or IT-relevant work experience without a Bachelors degree. 2+ years experience with Database Design structures such as Mongo DB, MySQL. Good understanding of conversational AI and Intelligent Automation methodologies and associated tools & technologies Knowledge of Process Mining concepts and implementation expereience using Celonis inclusing data models and dasboards Experience in business process diagrams and process flow charts with Automation Anywhere Certification in Industry Leading Robotic Automation products is a plus. Experience in identifying the right processes for Automation and providing estimates for implementations Programming concepts and coding background in Python Understanding of RDBMS concepts and writing SQL queries Expereience in Cloud (preferrably AWS) and certifications is a plus Experience in Agile development using standard tools like Jira Bachelor's degree and 5+ years IT-relevant work experience Applicants Qualcomm is an equal opportunity employer. If you are an individual with a disability and need an accommodation during the application/hiring process, rest assured that Qualcomm is committed to providing an accessible process. You may e-mail disability-accomodations@qualcomm.com or call Qualcomm's toll-free number found here. Upon request, Qualcomm will provide reasonable accommodations to support individuals with disabilities to be able participate in the hiring process. Qualcomm is also committed to making our workplace accessible for individuals with disabilities. (Keep in mind that this email address is used to provide reasonable accommodations for individuals with disabilities. We will not respond here to requests for updates on applications or resume inquiries). Qualcomm expects its employees to abide by all applicable policies and procedures, including but not limited to security and other requirements regarding protection of Company confidential information and other confidential and/or proprietary information, to the extent those requirements are permissible under applicable law. To all Staffing and Recruiting Agencies Please do not forward resumes to our jobs alias, Qualcomm employees or any other company location. Qualcomm is not responsible for any fees related to unsolicited resumes/applications. If you would like more information about this role, please contact Qualcomm Careers.

Posted 2 weeks ago

Apply

1.0 - 6.0 years

14 - 18 Lacs

Hyderabad

Work from Office

Job Area: Finance & Accounting Group, Finance & Accounting Group > Internal Audit General Summary: Auditor, IT Internal Audit- Hyderabad Qualcomm is a company of inventors that unlocked 5G - ushering in an age of rapid acceleration in connectivity and new possibilities that will transform industries, create jobs, and enrich lives. But this is just the beginning. It takes inventive minds with diverse skills, backgrounds, and cultures to transform 5Gs potential into world-changing technologies and products. This is the Invention Age - and this is where you come in. 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 IT 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 the business and industry to assess impacts to 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 on their teams, and in the Company. One to three 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 Strong understanding of IT general controls, cybersecurity frameworks (e.g. NIST, COBIT), and ERP systems Fluent English; multi-lingual capability is a plus 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 Controls, risk assessment, risks, internal audit, IT Bachelor's degree in Accounting, Finance, Computer Science, cyber security, or related field. CPA, CA, CIA, CISA, CFE, or other credentials, a plus. Minimum Qualifications: Bachelor's degree. 1+ year of Finance, Accounting, or related work experience. *Completed advanced degree in a relevant field may be substituted for up to one year (Masters = one year) of work experience. Applicants Qualcomm is an equal opportunity employer. If you are an individual with a disability and need an accommodation during the application/hiring process, rest assured that Qualcomm is committed to providing an accessible process. You may e-mail disability-accomodations@qualcomm.com or call Qualcomm's toll-free number found here. Upon request, Qualcomm will provide reasonable accommodations to support individuals with disabilities to be able participate in the hiring process. Qualcomm is also committed to making our workplace accessible for individuals with disabilities. (Keep in mind that this email address is used to provide reasonable accommodations for individuals with disabilities. We will not respond here to requests for updates on applications or resume inquiries). Qualcomm expects its employees to abide by all applicable policies and procedures, including but not limited to security and other requirements regarding protection of Company confidential information and other confidential and/or proprietary information, to the extent those requirements are permissible under applicable law. To all Staffing and Recruiting Agencies Please do not forward resumes to our jobs alias, Qualcomm employees or any other company location. Qualcomm is not responsible for any fees related to unsolicited resumes/applications. If you would like more information about this role, please contact Qualcomm Careers.

Posted 2 weeks ago

Apply

4.0 - 6.0 years

5 - 8 Lacs

Gurugram

Work from Office

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.

Posted 2 weeks ago

Apply

7.0 - 12.0 years

9 - 14 Lacs

Gurugram

Work from Office

Corporate Quality Assurance (CQA) Sr. Executive Posted: July 2025 Coral Drugs Pvt. Ltd. is seeking a skilled and experienced professional for the role of Senior Executive / Assistant Manager Corporate Quality Assurance (CQA). This position is ideal for candidates with over 7 years of experience, particularly within the Active Pharmaceutical Ingredient (API) sector. The role involves document review, audit processes, quality compliance, and regulatory adherence to global standards such as USFDA, EU-GMP, and WHO-GMP. Read more and apply

Posted 2 weeks ago

Apply

0.0 - 2.0 years

2 - 3 Lacs

Gangtok

Work from Office

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

Posted 2 weeks ago

Apply

5.0 - 10.0 years

3 - 8 Lacs

Kolkata, Mumbai, New Delhi

Work from Office

Responsibilities & Key Deliverables As the Asst. Manager for PET Field Quality Analysis, your primary responsibilities will encompass a range of critical tasks aimed at enhancing product performance and quality assurance. You will: Monitor and analyse key performance indicators, particularly focusing on the reduction of important metrics such as R/1000, CPU, and aggregate replacements for both engine and after-treatment systems. Employ systematic problem-solving methodologies to address and resolve field concerns, ensuring that corrective actions are monitored for effectiveness post-implementation. Utilise diagnostic tools to diagnose common rail system issues and after-treatment system failures, maintaining an up-to-date knowledge of industry tools. Coordinate with internal departments such as Supplier Quality Engineering (SQE), Customer Quality Assurance (CQA), manufacturing, and customer care to facilitate timely resolution and closure of quality concerns. Engage in joint investigations at dealer or supplier locations to conduct thorough analyses of field failures. Study component designs and prepare insightful proposals aimed at enhancing design robustness, thereby reducing the likelihood of field failures. Actively contribute to new projects, ensuring that lessons learned from previous experiences are appropriately implemented in future developments. Prepare Management Information System (MIS) reports, including dashboards, PowerPoint presentations, cost impact approvals, and field intervention documents for senior management reviews. Utilise SAP effectively for warranty claims administration and maintain comprehensive records of warranty return parts, systematically releasing reports on warranty recoveries. Maintain a daily work management (DWM) framework for key performance indicators, ensuring transparency and accountability in reporting. Safeguard sensitive data while adhering to Quality Management Systems (QMS), Mahindra Quality Standards (MQS), and strict ISO TS16949 requirements. Experience The ideal candidate will possess 5 to 10 years of relevant experience post-Bachelors in Engineering (BE). Your experience should reflect a strong understanding of quality assurance processes within the automotive or commercial vehicle sectors. Familiarity with field quality assessments and the capacity to engage with multi-disciplinary teams will be paramount to succeeding in this role. Industry Preferred Experience in the commercial vehicles industry is heavily preferred. Candidates with a background in commercial vehicle systems, including their componentry and assembly processes, will have a noticeable advantage in this role. This industry experience will prepare candidates to effectively tackle the challenges faced within the field quality domain. Qualifications A degree in Mechanical Engineering or Automobile Engineering (BE) is required. A strong educational foundation in engineering principles is essential for diagnosing system failures and analysing performance metrics effectively. General Requirements The role requires candidates to embody a set of essential traits including: Assertiveness in decision-making and in engaging with various stakeholders. Agility and boldness in adapting to changing circumstances and problem-solving. Collaborative work ethic, fostering teamwork and cooperation across various departments. A systematic approach to data analysis and task execution. Insightful thinking, demonstrating the ability to predict potential challenges and opportunities. A good temperament, enabling effective communication and interaction with team members and management. Additionally, you should possess: Excellent analytical abilities, with a focus on data interpretation skills. Strong communication and presentation skills for effective stakeholder engagement. A collaborative team spirit with the capability to work both independently and as part of a team. Familiarity with business intelligence (BI) and statistical analysis tools. Proficiency in MS Office applications, particularly Excel and PowerPoint. A deep understanding of engine systems and after-treatment processes, along with related vehicle systems. Robust problem-solving skills, demonstrating a capacity to resolve complex issues efficiently.

Posted 2 weeks ago

Apply

3.0 - 10.0 years

3 - 7 Lacs

Pune

Work from Office

Responsible for ensuring manpower training, skill enhancement and allocation of work to associates as per their skills to produce first time right and every time right products Responsible for Paint shop Process Monitoring through statistical methods and Proactive actions Capable of Paint shop concern resolution using Advanced quality tools to deliver consistent results in First Time right ratio and Quality audits score Customer centric approach to deliver best quality product to internal (TCF & CQA) and Final customer Implementation of TPM standards for Paint shop process To Participate and lead contamination control CFT Capable of global benchmarking for process and product (PT-CED & Topcoat) knowledge of Paint shop lab equipment s and material standards Knowledge of SOP, SOS, kaizen, problem solving tools, DCP Cost control, paint consumption monitoring, energy management & consumables Knowledge of Paint shop Fire and safety FOS standardization Knowledge of QC Tools, Conversant with SPC, PFC, FMEA, DCP QMS & Daily Work Management Kaizens, Poka-yoke & 5S Basic knowledge of Materials - PT, CED, Sealers, Topcoat, wax Knowledge of Paint Technology and Paint shop equipment s Knowledge Manufacturing process & Supplier processes Statistical process Control Skill Experience 3-10 Years Industry Preferred Qualifications General Requirements

Posted 2 weeks ago

Apply

5.0 - 10.0 years

14 - 19 Lacs

Mumbai

Work from Office

: In Scope of Position based Promotions (INTERNAL only) Job Title - Principal Auditor Location - Mumbai, India Role Description The Lead Principal Auditor typically leads complex audits of a specific business/functional area/region, and evaluates the adequacy and effectiveness of internal controls relating to risks within those business areas. They typically act as coach for auditors and people managers as leads on the audit. They will proactively develop and maintain professional consultative working relationships within their function and with stakeholders inside and outside the bank. They will use a range of approaches to collect relevant information to assess key risks, resolve major issues or carry out tasks across a portfolio. The Lead Principal Auditor works in a co-operative manner with subject matter experts and other teams from across the function and outside the function to provide front-to-back audit coverage and will actively contribute to the delivery of team plans in support of the functional and business strategies. They may occasionally lead ad-hoc projects and special investigations and represent the division at committees and forums, both internally and externally. What well offer you 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Accident and Term life Insurance Your key responsibilities Leading complex audits for evaluating the adequacy and effectiveness of internal controls relating to the underlying risks. Executes and leads day-to-day operational audit work and lead delivery of audits (including risk assessment profiles and business monitoring). Completes all assigned audit work in line with agreed budgets, including ad hoc projects and special investigations. Proactively manages and executes day-to-day responsibilities with group audit deliverables on Concurrent Audit Planning and executing audit fieldwork in line with the agreed audit approach e.g. documenting Activity Flows, identification of key risks, testing of key controls to determine whether they are properly designed and are operating effectively and documenting work in accordance with divisional standards. Leading and undertaking audit assignments, drafting audit reports for review by audit management, writing and agreeing high quality findings, facilitating finding tracking and validating closure of findings (as required). Reviewing and providing expert opinions on action plans provided by stakeholders, helping them develop robust remediation plans. Acting as a challenger to finding owners in the findings closure process. Partnering with other divisional/teams during audit engagement to guarantee an integrated approach. Completing all assigned audit work in line with agreed budgets, including ad hoc projects and special investigations. Communicating openly with divisional management and internal stakeholders; keeping them informed of potential issues and escalate problems/delays accordingly. Presenting complex and sensitive messages (such as audit finding) comprehensively, professionally and reducing complex topics to simple statements. Proactively keeping abreast of pertinent industry, regulatory and business practices. Performing business monitoring and risk assessments for enabling the prioritization of audit delivery. Proactively developing and maintaining professional working relationships with colleagues across Group Audit Taking ownership for own career management, seeking opportunities for continuous development of personal capability and improved performance contribution. Reinforcing an environment where people management and development is a key priority. Prior people management experience is essential. Acting as a role model for new employees, providing help and support to facilitate early integration and assimilation of the new environment. Highlights performance issues within the team, where appropriate, to drive for high performance. Your skills and experience Audit/business knowledge and experience and an understanding of the risks and regulatory requirements in one or more of the following business/functional areasInvestment Banking, Transaction Banking, Retail & Corporate Banking, Asset & Wealth Management, Business Services (operations), Risk, Legal & Compliance, Finance and Information Technology. Familiarity with operational requirements of a global bank. Sound understanding of global banking control environment and compliance issues in the banking/finance industry. Solid communication skills, communicating with clarity, both orally and in writing, in a logical order and structured approach. Fluent in English (written and verbal) and local languages if necessary. Solid relationship management, analytical, problem solving, communication, influencing, planning and presentation skills. Good knowledge of auditing standards and concepts. Ability to work in a fast-paced business environment. Able to work in virtual, global teams in a matrix organization, transfer knowledge and develop capability of team members. Additionally, good people management skills for leading and nurturing teams. Education/Certification Professional/industry recognized qualification such as CA and CPA and CIA. Bachelor Degree (or equivalent) from an accredited college or university (or equivalent) and equivalent work experience. How well support you About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.

Posted 3 weeks ago

Apply

5.0 - 10.0 years

0 - 3 Lacs

Delhi, India

On-site

Assure compliance with software procedures, identify task dependencies, guide teams on appropriateness of the development life cycle, and assure development and maintenance efforts are effective and compliant. Provide software quality engineering principal expertise, both external (Regulations) and internal (MD&D and ASP standards and procedures), including leading both internal and external audits for software quality systems. Provide training to software development teams, staff, contractors and business partners on ASP software quality engineering procedures. Leverages software experience and technical knowledge to lead compliance and risk management activities for software projects or software portion of systems projects. Continually improve software quality engineering processes based on industry trends and best practices. Improve software technical expertise and understanding of regulatory requirements. Assure that robust, reliable and compliant systems are transferred to users with a prioritization on patient safety. Assure that project software change control is compliant with all quality procedures and work instructions. Implements systems to address changing regulations. Represents SWQE function during regulatory inspections. Recommends issue resolution to senior management for significant capability and compliance issues. Resolves and seeks consensus across affected business areas. The individual will ensure that all applicable Quality System Regulation, including FDA and ISO (i.e. QSR 21, CFR 820, ISO13485, IEC 02304, ISO 14971.), security, records retention, Sarbanes-Oxley laws and applicable statutory/regulatory (e.g. FDA and ISO) compliance are considered and emphasized in all computer Systems Validation plans and actions. Will ensure that documented evidence exists to provide a high degree of assurance that specific design and processes will consistently and continually produce a product that meets specifications and critical to quality attributes. Will establish and recommend changes to standard operating procedures in all areas related to Computer Systems Validation and be responsible for providing Quality System Regulatory interpretation, consulting, training, and assessment to ensure project teams are aligned with current regulatory requirements, standards, and current industry trends (FDA QSR 21 CFR 820 / ISO13485 quality system requirements). Will ensure and/or develop appropriate methodologies, policies and procedures to deliver business solutions consistent with the company and department Vision and Mission, will lead continuous improvement of the Software Development Lifecycle Management process and clarify business needs and turn them into solution designs and will serve as the technical subject matter and expert and communicates to auditors and investigators on Computer Systems Validation process. Will serve as the technical expert for the organization (worldwide) in the application of Software Development Lifecycle Management advanced theories, concepts, principles, and processes for an assigned area of responsibility (i.e., subject matter, function, type of facility, or equipment, or product). Responsible for communicating business related issues or opportunities to next management level. Performs other duties assigned as needed. Our Needs Bachelor s degree (or equivalent) in Engineering (software, computer, computer science or electrical) AND 5 or more years of relevant experience OR Graduate degree AND 3 or more years of relevant experience. ASQ CQE, CQM, CQA; Process Excellence yellow, green or black belt optional. Experience working in a regulated environment (Medical Device, Aerospace, etc.). This includes knowledge of, and experience with, applicable standards, GxP requirements and applicable regulations. Development experience with any or all: imbedded product software, ATE, customer/product data management, product connectivity. Strong knowledge of system development methodologies and software program metrics Experience with system/software Quality Engineering methods, techniques and principles. Thorough understanding of GxP standards and medical device regulatory and compliance environment including: ISO 13485, 21 CFR Part 820 and 21 CFR Part 11. Thorough knowledge of and in-depth experience with system development configuration management and change control processes, testing (V&V), issue tracking and defect management. Experience with cyber security and data integrity requirements, methods and implementation Experience managing projects, and demonstrating project leadership abilities. Experience with a proven track record of implementing appropriate risk mitigation w/in-depth knowledge of ISO 14971 Risk Management and IEC 62366 Software Development Processes Experience with GxP data collection. Demonstrated ability to perform hands on troubleshooting and problem solving. Working knowledge of failure investigation processes, computer code static analysis methods and tools. Clear and effective communicator (presentation, technical writing, verbal) Strong understanding of either embedded software systems or cloud applications (SaaS). Leadership ability in developing achievable high-quality computer Systems Validation in partnership with various departments, such as R&D, Operations, Service etc. and managing the implementation and execution of these SDLC goals is strongly preferred. Ability to effectively manage external development partners, consultants and contractors desired. Strong knowledge of Product Software Lifecycle Development process required. A working knowledge of Microsoft office products (MS Word, Excel) and other Testing Software tools is required. Strong working knowledge of FDA QSR 21 CFR 820 / ISO13485 quality system requirements and the ability to provide an expert knowledge of both regulatory requirements and other complianc3e areas to minimize risk across franchise required. Extensive Quality Engineering experience with working knowledge of product design verification, as well as product and project validation activities required. Excellent both written and verbal communication skills and capable of working independently and in a team setting. Strong Project Management and leadership skills required. Demonstrated competence in change management preferred. Project management methodologies required.

Posted 3 weeks ago

Apply

1.0 - 2.0 years

3 - 5 Lacs

Gurugram

Work from Office

Role & responsibilities Analytical testing( Salt%, Moisture%, Oxygen%, Defects %, Fat% & Oxidative rancidity check) Shelf life sample- Meenal performs analytical testing of Shelf life samples almost on daily basis for PC & Extrusion team along with Bangladesh samples. CQA samples- Meenal conducts detailed analytical testing of all CQA samples-Twice in a year for PC & Extrusion team. Samples include market as well ascompetitive samples. Because of very high no of samples it takes minimum 8-10 days every time. Gold & Reference samples- Meenal also conducts analytical testing of Gold & refence samples for PC(ASCO, STT, LMM & LCS) & Extrusion. Consumer research samples- All consumer research samples are analytically tested before going to the consumers- Almost on daily basis consumer researchsamples are being prepared at lab. Product monitoring event samples- On monthly basis PME samples are being analytically tested by Meenal. 2- Lab upkeeping- Lab inventory- Meenal is looking after all the lab inventories including- N2 Cylinders, all PPEs, critical lab equipment spares & all packaging materials used topack consumer research samples. Chemical- Inventory management of lab chemicals (Ordering consumption & stock management) 5S- Meenal is responsible for maintaining 5S at lab- This helps in minimizing time loss & prevents incidents. Equipment Calibration- Meenal is ensuring time to time calibration of all the equipments( Foods) Maintaining MSDS- Meenal is maintaining MSDS for all the chemicals being used in foods & Beverages lab, this helps us in quick traceability during Chemicalinjury. Quality & Food safety - Meenal insures that during preparation of consumer research samples, all quality & food safety practices should be followed. 3- Safety activities- As active member of safety committee team Meenal ensures time to time risk assessments at lab facility. Safety trainings- From last 2 years Meenal is leading Weekly safety Pep Talk with lab associates- Till YTD-24, 84 peptalks were completed. This year a bigger safety program has been rolled out globally- Lab safety management- Meenal is leading this along with one safety team member. Preferred candidate profile Research Development

Posted 3 weeks ago

Apply

7.0 - 13.0 years

12 - 16 Lacs

Nagpur

Work from Office

Job Description Experience: 7 to 13 years Qualification: B. Pharm / M. Pharm / M. Sc Budget: 12 to 16 LPA Designation: Sr. Executive Required Key Skills: Supply & Planning, Product Management, Should have worked on Kinaxis software, Should be well versed with system, Should have process knowledge of Tablet, Capsule & Injectables. Candidate from OSD/Inject unit is preferred. Should have good interpersonal and communication skills. Job Description: Should co-ordinate with PDL, R&D and quality for integrated plan for exhibit/ Pre-validation batches for next 3M , 12M. Should co-ordinate with Prod for planning execution and updating daily status. Should maintain R Vs C Vs A metrics with actuals and Gap and shall populate the data with all CFT in weekly meet. Should be able to handle procurement plan through SAP with good knowledge to carry out MRP process in SAP, knowledge of Kinaxis will be additional advantage. Should have good knowledge of inventory analysis and management of RM/PM/SFG/FG s with good excel working. Should have basic understanding about machines used in manufacturing processes and its output rate with material and capacity view during prod plan in finalization. Should have strong analytical skill, managing large data basis, excellent problem-solving mindset and inter-personal skill with effective communication and presentation, ready to accept new challenges in defined role. Efficient coordination with procurement, artwork development, CQA, and other relevant stake holders for effective operations. Timely review of all the responsible KRA s and ensure for strong adherence Candidate from Pharma background is preferred. Work Experience 7- 13 yrs experience in Pharma Supply planning Education Graduation in Production Management Post Graduation in Science Competencies Innovation & Creativity Strategic Agility Result Orientation Collaboration Stakeholder Management Customer Centricity Developing Talent Process Excellence

Posted 3 weeks ago

Apply

5.0 - 8.0 years

6 - 10 Lacs

Navi Mumbai

Work from Office

Executive-CQA Long Description 1. To perform and track the Vendor Qualification Compliance and review for all vendors & AVDs. 2. To review, approve, and extend the Q info for new alternate vendors. 3.To execute vendor Audits, CAPA tracking, and qualification documentation 4.To schedule and monitor the Vendor Audits 5.To work on VQ special projects in coordination with Project IT team 6.To track the project till its implementation and Go Live across all sites Competencies 1. Strategic Agility 2. Innovation & Creativity 3. Customer Centricity 4. Developing Talent 5. Result Orientation Work Experience 5 - 8 years

Posted 3 weeks ago

Apply

5.0 - 8.0 years

7 - 11 Lacs

Navi Mumbai

Work from Office

Executive-CQA-VQG 1. To perform and track the Vendor Qualification Compliance and review for all vendors & AVDs. 2. To review, approve, and extend the Q info for new alternate vendors. 3.To execute vendor Audits, CAPA tracking, and qualification documentation 4.To schedule and monitor the Vendor Audits 5.To work on VQ special projects in coordination with Project IT team 6.To track the project till its implementation and Go Live across all sites Competencies 1. Strategic Agility 2. Innovation & Creativity 4. Developing Talent 3. Customer Centricity 5. Result Orientation Education Masters in Chemistry Post Graduation in Pharmacy 5-8 YearsWork Experience

Posted 3 weeks ago

Apply

10.0 - 12.0 years

11 - 15 Lacs

Navi Mumbai

Work from Office

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

Posted 3 weeks ago

Apply

10.0 - 18.0 years

12 - 22 Lacs

Navi Mumbai, India

Work from Office

Job Responsibilities: 1. Monitoring and Assessment of QMS related activities for all API sites (Nerul, Chiplun and Ambernath) and Govandi (CPRL, PAN, BRL etc.). 2. Change Controls: Review and closure of change controls, approval and closure of actions childs, CQA Assessment etc., 3. Review of Customer Complaints, Risk Assessments, Deviations, CAPAs, Investigations, Recalls etc., 4. Handling of Customer Quality agreement and co-ordination with cross functional team till execution of the agreement. 5. Tracking of CQA SOPs as per the review date, by maintaining the SOP Periodic review tracker and master SOP list. 6. Preparation/Revision of CQA SOPs and making master, effective after completion of training. 7. Review of Master formula and technology transfer documents for API sites. 8. Master product label information update in Traces application as per the site requirement. 9. To provide training of SOPs, cGMP, or other modules as per the requirement. 10. Review of SOPs related to various departments of corporate functions (e.g. CPRL, PAN Lab, HR etc). 11. Scheduling and participation in self-audits (Sites and corporate functions). 12. Regulatory and customer audit support to sites. 13. Review of Specifications for raw material, intermediate, finished API, working standard, GTPs of API Sites in DocuSign. Master and making effective through DocuSign and distribution of controlled copies to site and CFTs. 14. Handling Customer Questionnaires, Regulatory Agencies Questionnaires and Customer queries as per the requirement. 15. Participation in Quality related meetings. 16. Shall perform any other related work/projects assigned by CQA HOD/Section head.

Posted 1 month ago

Apply

10.0 - 15.0 years

20 - 25 Lacs

Mumbai

Work from Office

We are looking for a highly skilled and experienced Deputy Head to lead our Small and Medium Business-Internal Audit team in Mumbai. The ideal candidate will have 10+ years of experience in internal audit, preferably in the banking or financial services industry. Roles and Responsibility Develop and implement effective internal audit plans to ensure compliance with regulatory requirements. Conduct risk assessments and audits to identify areas of improvement in business operations. Collaborate with cross-functional teams to design and implement process improvements. Provide expert guidance on internal controls, auditing standards, and regulatory requirements. Identify and mitigate risks associated with business operations. Develop and maintain relationships with key stakeholders, including senior management and external auditors. Ensure consistent application and documentation of internal audit methodology. Interface regularly with senior corporate and line of business management to identify control weaknesses and develop recommendations within all divisions and operations of the company. Pursue professional development opportunities, including internal and external training and professional association memberships, and share information gained and best practices with co-workers including team members. Job Chartered Accountant (CA) certification is required, along with Certified Internal Auditor (CIA) or Certified Information Systems Auditor (CISA). Possess strong knowledge of internal auditing standards, regulations, and industry best practices. Demonstrate excellent analytical, communication, and problem-solving skills. Ability to work effectively in a fast-paced environment and meet deadlines. Exhibit strong leadership and coaching skills, with the ability to motivate and guide junior team members. Maintain a high level of professionalism and integrity, with a commitment to excellence and quality. Strong interpersonal, communication, and team skills are essential, with the ability to work and communicate effectively with all levels of management and staff. Demonstrates leadership and credibility, capable of generating a high degree of respect and trust, building relationships rapidly with various operating units and corporate staff. Self-motivated with a strong commitment to quality. Age & DOB30+ years. Additional Info The selected candidate will be responsible for providing regular reports to the Business/Pre-Audit Committee/Audit Committee on the company''s system of internal controls and significant audit recommendations.

Posted 1 month ago

Apply
Page 1 of 3
cta

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.

Job Application AI Bot

Job Application AI Bot

Apply to 20+ Portals in one click

Download Now

Download the Mobile App

Instantly access job listings, apply easily, and track applications.

Featured Companies