118 Cqa Jobs - Page 2

The BP Cell Culture Sales Specialist will report to the BP Cell Culture India Leader and is part of the Cytiva India Commercial organization located in Ahmedabad will be working remotely to cover the assigned region . At Cytiva, our vision is, to advance future therapeutics from discovery to delivery. What you will do: Provide pre and post sales technical support to customers and sales teams on cell culture related product lines (Cell Culture Media and feeds, Process Liquids and Buffers, Serum, Custom services, Bioreactor and Microcarriers) Plan and achieve target assign (Order /sales/ Design in) Based on effective root cause analysis provide technical solution and troubleshooting the process to achieve customer goals. Design-In of cell culture products in customer process and achieve higher market share in the region Develop good long-term customer relationships, and high customer satisfaction utilizing optimum level resources. Collect customer and market feedback from the field and channel it to internal team and relevant departments Ensure exhaustive reporting of all on-field activities and customer contacts on SFDC. Maintain record of sampling. Conduct product/technical training programs for internal and external customers Who you are: Master s degree in biotechnology, Engineering degree in biotechnology or biochemical engineering 6-9 years of hand on experience in Biopharmaceutical industry in upstream process development (Mammalian). Proven skills in handling various cell lines/lineages, process optimization and CQA modulation Hand on experience in concentrated fed batch/perfusion process development is an added advantage Proficient in basic cell culture techniques and stable cell line development

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. Key responsibilities: Timely validation of analytical methods of the drug products and API (intermediates and key starting material) for the drug products I drug substances to be filed globally. This role necessitates understanding of cGMP requirements and good technical knowledge to validate analytical methods and establish their suitability for the intended use Documentation of data as per laid down procedures during execution of validation experiments Interaction with Internal compliance group/R&D quality-CQA to answer their queries during review of validation documents Transfer of analytical methods at different plant locations before exhibit batches. Ensuring cleanliness in GMP area at all times in terms of proper labeling at all designated places and arrangement of chemicals. The role requires continuous up gradation in terms of regulatory and GMP requirements pertaining to method validations and attending SOP / Compliance related trainings. Any other responsibilities assigned from time to time orally or in writing. Educational Qualification M. Sc / B. Pharm / M. Pharm

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 Key Accountabilities (2/6) 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 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 Key Accountabilities (3/6) 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 (4/6) 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 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

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

USV, a top-15 pharmaceutical company in India, excels in the diabetes and cardio sectors. We have a presence in over 65 countries with our dynamic team of over 7,000 across generations. Our commitment to brand building is evident in our popular products like Glycomet GP, Ecosprin AV, Jalra, Tazloc, Glynase, MVI and more. Join USV and be part of our journey as we continue to innovate, transform lives, and shape the future of healthcare. Job Title: Manager / Sr. Manager (Quality Assurance) - API Only Designation - Manager / Sr. Manager - CQA - API Direct Reportees: No Location: HO @ Govandi, Mumbai Working Days: 5 days from Office + Alternate Saturdays - 1st, 3rd & 5th Working (sometimes 2-3 days in a month to sites depends on work) Job Responsibilities: Must have audit handling experience for regulatory agencies audits like USFDA, EMA, ANIVSA, CDSCO etc Must have technical knowledge and well versed with regulatory & cGMP requirements Monitoring and Assessment of Quality Management System (QMS) for manufacturing sites and R&D functions. Hands on experience in industry software like TWD, SAP HANA, LIMS, DMS etc., Review of Customer Complaints, Risk Assessments, Deviations, CAPAs, Investigations, Recalls etc. - QMS Handling of Customer Quality agreement and co-ordination with cross functional team till execution of the agreement. Tracking of CQA SOPs as per the review date, by maintaining the SOP Periodic review tracker and master SOP list. Preparation/Revision of CQA SOPs and making master, effective after completion of training. Review of Master formula and technology transfer documents for API sites. To provide training of SOPs, cGMP, or other modules as per the requirement. Review of SOPs related to various departments. Scheduling and participation in self-audits (Sites and corporate functions). Regulatory and customer audit support to sites. Review of Specifications for raw material, intermediate, finished API, working standard, GTPs of API Sites. Handling Customer Questionnaires, Regulatory Agencies Questionnaires and Customer queries as per the requirement. Participation in Quality related meetings. Education: Min. Qualification Required - B.Pharm./M.Pharm/M.Sc. Experience: Minimum 13-17 years

Roles & Responsibilities: As a Senior Auditor, you will be a part of the Internal Audit team and responsible for: Independently managing delivery of the SOX engagements for multiple Business Processes - including scoping, test of design, test of effectiveness and reporting. Providing guidance to auditors to conduct effective assessment to comply to Sarbanes-Oxley (SOX) compliance Assisting Senior Manager in conducting SOX scoping, control rationalization and standardization for business processes Evaluating control gaps noted during design or operating effectiveness testing, partner with 2nd Line of defense, provide recommendations and track remediation Performing Design & Operating effectiveness testing & review for assigned Business Process Controls (Manual ITDM ITAC) while adhering to Internal Audit quality guardrails. Identifying & driving Automation opportunities in SOX controls testing Testing & Reviewing ITAC - configuration of standard SAP & Non SAP applications, reviewing variations, Interface Controls testing, building sample scenarios, source code reviews and key reports testing. Developing a strong understanding over Targets business & control environment and ensure control objectives are met during the course of your testing. Monitoring project progress, manage multiple assignments and related project teams, if needed Meet quality guidelines within the established turnaround time (or allotted budget) for assigned requests Provide regular status update on projects and controls in hand. Plan and execute operational audits in adherence to IA policies and procedures Managing relationships with key internal & external stakeholders and ensuring adherence to project timelines & deliverables. Identifying opportunities for use of Data Analytics & Automation to enhance Internal Audits ability to perform efficient testing/audit. Demonstrating a high level of engagement at work by closely interacting with HQ Internal Audit Team, participating in Internal Audit trainings, team building & community relations activities. Being independent, innovative & proactive in taking steps for your personal development by willingly taking on stretch assignments, cross-functional engagements & acquiring of new skills. *Job duties may change at any time due to business needs. About You. 3 or 4 year college degree (Accounting, Auditing, Analytics or related field preferred). 5 to 8 years of internal or external audit experience focused on SOX IFC & Operational Audit. Experience in SAP environment is preferred. Knowledge of IPFF Standards, Risk-Based Auditing, Three Lines Model Working Knowledge of auditing BP & ITAC Exposure to Risk Management and Governance Frameworks/ Systems & ERP systems Preferred Certifications CA/CIA/ACCA

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Key Accountabilities: Internal Controls over Financial Reporting Assist with risk assessment and audit scoping/planning for internal controls over financial reporting Plan and perform business process walkthroughs Develop and maintain internal controls documentation to assist management (e.g., narratives and control information in AuditBoard) Execute internal controls testing to accurately document design and operating effectiveness conclusions Prepare audit workpapers that are thorough, complete, and accurate Respond to review points in a timely and clear manner Identify and communicate audit findings to senior members of the Internal Audit team and/or management Support audit finding remediation efforts and closure Operational Risk & Compliance audit (ORC) Assist with risk assessment and audit scoping/planning across a variety of functional areas including operational risk and compliance Execute audit procedures to accurately document results and conclusions Prepare audit workpapers that are thorough, complete, and accurate Respond to review points in a timely and clear manner Identify and communicate explanations of audit findings to senior members of the Internal Audit team and/or management Support issue remediation and closure May assist with Informational Technology audits under the direction of the IT audit resources Business Partnership Interact with management to build strong, trust-based ongoing relationships Partner with Control and Process Owners to establish, maintain, and strengthen the global control environment Communicate with Control and Process Owners (control deficiencies, audit findings and/or results of operational/IT audits) Assist with ad-hoc initiatives and special projects as needed at the direction of any member of Internal Audit management/leadership Process understanding and monitoring Monitor processes for changes impacting risks and controls and support the business with control design and enhancement External audit support Work with the organization’s external auditors on substantive testing and internal controls audit requirements including other audit support via “use of others” or “direct assistance” Skills: Communication – Effectively communicates with most levels in the organization, both written and verbally. Project Management – Demonstrates the ability to execute multiple priority assignments concurrently and efficiently within established deadlines. Changes priorities as needed to meet business demands. Keeps more senior team members abreast of workload and availability. Judgment – Displays willingness to propose solutions and make decisions but seeks guidance in making key judgments or decisions. Teamwork – Works in partnership with team members to deliver expected results; seeks clarity on assignments as needed. Problem-solving – Identifies and resolves problems in a timely manner and gathers and analyzes information; strives for self-resolution of problems as the first course of action before asking more senior team members for help but doesn’t “spin his/her wheels” leading to inefficiency. Quality Management – Identifies opportunities to promote and improve quality and demonstrates accuracy and thoroughness. Knowledge and Experience : 0-2 years’ experience Experience with internal controls testing or operational audits is a plus. Education and Certifications: Chartered Accountant or Bachelor’s degree in Accounting or Finance required Certified Public Accountant (CPA) or Certified Internal Auditor (CIA) is accepted

Bachelors degree in Life Sciences, Engineering, or a related field. 3-5 years of experience in QA roles with strong focus ondocumentation and compliance in the medical device industry. In-depth knowledge of ISO 13485, FDA QSR, EU MDR, and risk management (ISO 14971). Proven experience with QMS documentation management and inspection/audit readiness. Familiarity with risk management tools (e.g., FMEA, Hazard Analysis). Strong attention to detail and high standards for documentation accuracy. Experience in a startup or fast-paced, resource constrained environment preferred. Excellent written and verbal communication skills. Preferred Qualifications: Certified Quality Auditor (CQA), Six Sigma, or similar certifications. Experience with software as a medical device (SaMD) is a plus. Familiarity with electronic QMS systems (e.g., MasterControl, Greenlight Guru, Qualio, SimplerQMS, ETQ, and Qualityze EQMS). Skill Required: Contribute to building and maintaining our QMS in line with ISO 13485, FDA 21 CFR Part 820, EU MDR and so on. Own and manage CAPAs, non-conformances, and change controls. Support risk management activities (ISO 14971) and product lifecycle management. Work cross-functionally with engineering, regulatory, and manufacturing teams to support design controls and risk management. Support and prepare for audits and inspections (internal and external). Assist in regulatory inspection readiness and participate as SME where needed. Develop, revise, and maintain quality documentation (SOPs, work instructions, protocols). Support the development and maintenance of Design History File (DHF) and Device Master Record (DMR). Help implement electronic QMS tools suitable for a growing organization. Monitor and analyze quality metrics and trends to identify improvement opportunities. Participate in supplier evaluations, audits and ensure ongoing quality compliance. Review and approve quality documents including SOPs, work instructions, protocols, and reports. Maintain document control and training systems per QMS requirements. Ensure quality-related training programs are current, effective, and fully documented. Support complaint handling and post-market surveillance activities (as applicable).

Role Description The Group Audit (GA) function comprises c. 880 staff who take a proactive, risk based and independent approach to assist the Bank's business and infrastructure functions to identify key control weaknesses. GA prides itself in ensuring the highest standard in professional delivery. Being DB's 'third line of defense GA have a high internal profile, acting as an independent and forward-looking challenger and adviser to Senior Management. We are strongly rem/lied upon by the Regulators. We are a diverse and inclusive global division where culture is at the core of our team dynamic; GA is inextricably linked to promoting strong corporate and ethical governance, a philosophy that it is the responsibility of each, and every person employed within DB. GA is about trust, excellence, people, and performance. Overview of the Role: The Country Head of India (Director, Principal Audit Manager (PAM)) is responsible for leading the country Group Audit team in India, delivering risk based and regulatory required audit coverage, managing local regulatory relationships, and facing off to local management Your key responsibilities The Principal Audit Manager (PAM) and Country Head of India leads a team of auditors based in Mumbai to execute a risk-based audit plan to evaluate the adequacy and effectiveness of internal controls relating to risks within the countries portfolio. Develops the audit team, providing coaching and support to enable success. Cascades SMART business driven objectives and ensures every team member receives continuous and constructive performance feedback. Works with GA leadership at the global and regional level to provide audit coverage to meet risk based and local regulatory requirements. Responsible for the planning, staffing, risk assessment and delivery of audits and finding validations especially with a focus on local regulatory requirements and also collaborating with GA SMEs to maintain oversight over coverage of regulatory required topics. Owns and drives the audit process, identifies, and escalates audit issues and quality controls audits and subsequent reporting. The PAM is responsible for reviewing all audit workpapers, findings and recommends audit grades and finding ratings for final approval. Acts as a primary relationship manager for local ciuntry management and represents the division at committees and forums both internally and externally. Responsible to manage relationships with local regulators and coordinates GA requirements during regulatrory inspections. Acts as a management role model for their team and the wider Function. Determine audit team involvement and responsibility for each audit and validation. Build and sustain networks and relationships across the organization and with external parties to enhance the function's performance, create buy-in and support for departmental/functional plans, aiming to form win-win alliances with others. People Management Create and reinforce an environment where people management and development are a key priority and personally demonstrate commitment to the immediate and wider Function. Manage direct reports, through empowering them to deliver on their objectives, providing coaching and support to enable them to be successful. Your skills and experience Minimum 15 years of Audit Business experience and an understanding of the risks and regulatory requirements in Retail, Corporate and Investment Bank set-up. Proven knowledge of the banking control environment and compliance issues in the banking/finance industry. Proven working knowledge of auditing standards and concepts. Proven track record in Direct Regulatory interactions Sound understanding of regulatory developments and of both the holistic risk environment and control best practice for their respective areas of responsibility including Asia Pacific. Outstanding operational and people management skills; the ability to operate a diverse team, appraise individual potential, motivate teams. Successful track record in communicating complex issues across different hierarchical levels in both local and global context Excellent project management and planning, problem solving, relationship management and presentation skills combined with the ability to work in virtual, global teams in a matrix organization, openness for occasional travel Able to work in virtual, global teams in a matrix organization, transfer knowledge and develop capability of team members. Excellent communication skills, communicating with clarity, both orally and in writing, in a logical order and structured approach. Excellent relationship management, analytical, problem solving, communication, influencing, planning and presentation skills. Education/ Qualifications: Educated to University degree level Additional qualifications/certifications CA, CIA, ACAMS will be an additional advantage

Post- Sr Customer Quality Engineer/Manager* *Bus canteen* *Location: Pune Chakan* *Experience* : 8-10 yrs *interview immediately arrangement* *Contact - 9356395439* *Education* - B.E./Diploma in mechanical *JD* *Sheet Metal automotive industry* Customer Quality Customer Quality Documentation Customer complaint handling Customer Quality rejection material technically resolution skills must. Customers and QMS and IATF related documentation experience must. Other day to day quality related work Quality tools.

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

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

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

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.

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

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

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

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

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.

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.

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.

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.

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

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

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.