118 Cqa Jobs - Page 3

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

: 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.

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.

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

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

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

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

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

Job 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.

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.

Ensure the effective deployment of the EV Quality Vision, Mission, and Policy across the plants by providing necessary resources and structuring quality systems. Establish a structured process to capture the voice of customers through dealers and customer care for Product Quality & Reliability improvement. Ensure outgoing quality of the product meets or exceeds customer requirements. Work towards ensuring product quality consistency and meeting critical parameters through the development of Product & Process using appropriate tools. Collaborate effectively with various teams such as PVT and SQE to drive Product Quality, Supplier Quality Improvement, and benchmark enhancements. Deploy quality management systems through structured product, process & component audits. Take the lead in organizing management reviews to provide updates on quality initiatives/goals and ensure timely escalations. Provide functional guidance to the quality assurance team and lead as a people manager for the team in terms of recruitment, setting KRAs, performance appraisals, and team development. Guide the team in enhancing functional excellence in Quality Systems and Quality Engineering to resolve quality issues effectively and efficiently. Education Qualification: Graduate in Engineering (Electrical, Mechanical, or Automobiles). ASQE/QMS certifications will be an advantage. General Experience: 15+ years in Quality Assurance in the EV Passenger Cars Vehicle segment. Thorough understanding of business operations, manufacturing, and quality assurance processes. Familiarity with various quality systems. High level of business acumen and process orientation. Ability to make strong decisions, possess analytical skills, and demonstrate resilience to pressure. Critical Experience: Exposure in deploying Quality Management Systems through structured audits. Experience in Quality Assurance function and manufacturing processes. Previous role handling CQA Head responsibilities for large plants. Experience in successful new product launches in automotive/passenger/commercial vehicle segments or Powertrain products. Experience in leading medium to large-sized teams.

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 Pharma/ M Licensing and registration (0-2 years) Relevant Work Experience Sound knowledge of cGMPs and regulatory guidelines and basic knowledge of computer system Show more Show less

Our Company Were Hitachi Digital, a company at the forefront of digital transformation and the fastest growing division of Hitachi Group. Were crucial to the companys strategy and ambition to become a premier global player in the massive and fast-moving digital transformation market. Imagine the sheer breadth of talent it takes to unleash a digital future. We dont expect you to fit every requirement your life experience, character, perspective, and passion for achieving great things in the world are equally as important to us. The role: This role reports to the Manager of Internal Audit and will perform and support diverse types of audits and consulting engagements, including but not limited to global end-to-end process reviews, sales office audits, J-SOX activities, operational reviews, and system implementation reviews. Act as J-SOX compliance coordinator for selected financial processes Understand organization objectives, structure, policies, processes, internal controls, and external regulations Prepare good quality work papers and other deliverables timely and professionally to adequately and clearly document testing, support conclusions, communicate findings and recommendations to line manager and stakeholders. Identify risks and improvement opportunities in the organization, exercise judgment while evaluating audit findings and provide meaningful, high impact recommendations for management to improve process and operational efficiencies, including reducing the possibility of fraud, and mitigate risks Influence process owners and stakeholders to improve operations and enhance controls. Validate the completion and closure of agreed remediation and management actions as needed Working on multiple priorities/projects for on-time delivery, proactively providing status of all activities to Internal Audit management and relevant business stakeholders Execute special assignments to support the wider needs of the Internal Audit team or other business functions What you bring to the team: Recent 2-3 years of experience in internal audit, internal control or accounting firm consulting/advisory is required (Big 4 background is desirable) Bachelor's Degree in Auditing, Accounting, Finance, Business Administration, or Information Technology Good knowledge of J-SOX or SOX requirements, internal audit, and accounting practices. The candidate should be able to work collaboratively across various departments, regions, and cultures. An accounting or audit qualification e.g., CIA, CISA, CPA, ACCA or equivalent preferred Ability to work independently and effectively with limited supports, have experience to lead small projects and have good time management and organizational skills. Experience of shared service centre environments is desirable Ability to convey under presence, professional image, and deal confidently with business problems while building and maintaining strong relationships with key stakeholders You are out-of-the box thinker with good analytical skills and the ability to adapt quickly to changing work environments, priorities, and deadlines Excellent verbal and written communication skills About us Were a global, 1000-strong, diverse team of professional experts, promoting and delivering Social Innovation through our One Hitachi initiative (OT x IT x Product) and working on projects that have a real-world impact. Were curious, passionate and empowered, blending our legacy of 110 years of innovation with our shaping our future. Here youre not just another employee; youre part of a tradition of excellence and a community working towards creating a digital future. #LI-RR1 Championing diversity, equity, and inclusion Diversity, equity, and inclusion (DEI) are integral to our culture and identity. Diverse thinking, a commitment to allyship, and a culture of empowerment help us achieve powerful results. We want you to be you, with all the ideas, lived experience, and fresh perspective that brings. We support your uniqueness and encourage people from all backgrounds to apply and realize their full potential as part of our team. How we look after you We help take care of your today and tomorrow with industry-leading benefits, support, and services that look after your holistic health and wellbeing. Were also champions of life balance and offer flexible arrangements that work for you (role and location dependent). Were always looking for new ways of working that bring out our best, which leads to unexpected ideas. So here, youll experience a sense of belonging, and discover autonomy, freedom, and ownership as you work alongside talented people you enjoy sharing knowledge with. Were proud to say were an equal opportunity employer and welcome all applicants for employment without attention to race, colour, religion, sex, sexual orientation, gender identity, national origin, veteran, age, disability status or any other protected characteristic. Should you need reasonable accommodations during the recruitment process, please let us know so that we can do our best to set you up for success.

About UKGHere at UKG, our purpose is people„¢. Our HR, payroll, and workforce management solutions help organizations unlock happier outcomes for all. And our U Krewers, who build those solutions and support our business, are talented, collaborative, and innovative problem-solvers. We strive to create a culture of belonging and an employee experience that empowers our people "“ both at work and at home. Our benefits show that we care about the whole you, from adoption and surrogacy assistance to tuition reimbursement and wellness programs. Our employee resource groups provide a welcoming place to land, learn, and connect with those who share your passions and interests. What are you waiting forLearn more at www.ukg.com/careers #WeAreUKG Job SummaryUKG is looking for a highly motivated, self-driven and detail-oriented Senior Internal Auditor for a hybrid-office based position out of our Noida, India office. The ideal candidate should be a self-starter and possess strong work ethics. This role will also support audit work focused on compliance with federal, state, and internal regulatory requirements. The ideal candidate will play a key role in ensuring effective risk management, promoting best practices, and providing insights to support organizational objectives. This position offers the opportunity to play a key role in ensuring the effectiveness of internal controls and compliance with organizational policies and regulations. The Senior Internal Auditor will join a Global Internal Audit Team and will be working closely Internal Audit leaders and team members across the world. Our Internal Audit team fosters a culture of collaboration and innovation and utilizes top of the line audit tools and systems. Key Responsibilitiesa) Internal Controls Evaluation and Enhancementˆ’ Conduct evaluations of internal controls and ensure they align with industry standards and regulatory requirements. ˆ’ Design and implement improvements in control processes to enhance efficiency, safeguard assets, and ensure compliance. ˆ’ Collaborate with process owners to develop and maintain control documentation, including narratives, flowcharts, and risk and control matrices. b) Compliance Audits and Controls Testingˆ’ Perform testing of controls related to compliance with federal, state, and internal regulations, such as SOX, and other applicable standards. ˆ’ Assess compliance with organizational policies and regulatory requirements, identifying gaps and providing recommendations for mitigation. ˆ’ Monitor the remediation of identified control deficiencies and ensure timely implementation. c) Reporting and Communicationˆ’ Prepare well-documented, clear, and concise audit reports, summarizing control deficiencies, risks, and improvement opportunities. ˆ’ Communicate findings and recommendations to senior management and stakeholders, ensuring transparency and fostering collaboration. d) Risk Assessment and Control Environment Monitoringˆ’ Participate in risk assessments to identify high-risk areas and prioritize audits focused on critical compliance and control issues. ˆ’ Develop a thorough understanding of the organization's control environment and contribute to the annual internal audit planning process. e) Otherˆ’ Work closely with business units, compliance, and risk teams to promote control awareness and support compliance initiatives. ˆ’ Serve as a trusted advisor on controls and compliance matters, providing insights and actionable recommendations to enhance business processes. Qualifications- Bachelor's degree in accounting, Finance, Business Administration, or a related field. Relevant certifications such as CPA, CIA, or CFE are highly preferred. 3"“6 years of experience in internal auditing, controls testing, or a similar field, preferably within a multinational organization. Strong understanding of internal control frameworks (e.g., COSO) and experience with compliance standards, such as SOX, HIPAA, or state-specific regulations. Proficiency in controls testing and compliance audit methodologies. Excellent communication and interpersonal skills, with the ability to present complex issues clearly to both technical and non-technical audiences. Strong analytical and problem-solving skills, with attention to detail and accuracy. Ability to work independently and as part of a team, with a proactive approach to managing multiple projects and meeting deadlines. Personal Attributes- High level of integrity and professionalism. Strong organizational and time-management skills. Ability to manage multiple tasks and meet deadlines.

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

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

About Us. At SentinelOne, we’re redefining cybersecurity by pushing the limits of what’s possible—leveraging AI-powered, data-driven innovation to stay ahead of tomorrow’s threats.. From building industry-leading products to cultivating an exceptional company culture, our core values guide everything we do. We’re looking for passionate individuals who thrive in collaborative environments and are eager to drive impact. If you’re excited about solving complex challenges in bold, innovative ways, we’d love to connect with you.. What are we looking for?. Reporting to the ManagerInternal Audit, this position is a highly visible and impactful role across the company. The Sr. Analyst – IT Internal Audit, based in India and will work with all levels of management to promote business integrity and robust internal control structures, compliance with Sarbanes-Oxley legislation, and recommendation for process improvements and IT internal Audit projects.. What will you do?. Assist in IT SOX 404 planning, scoping, and risk assessment process through close collaboration with external auditors and business process owners. Engage in Internal audit projects, ERM, operational and IT audits.. Participate in the IT risk assessment process and development of the audit plan for assigned entities. Conduct IT walkthroughs and controls testing according to established audit standards. Develop high-quality process and audit testing documentation for design effectiveness and operating effectiveness of ITGCs, ITAC, SOC1 restricted access controls. Perform testing of application controls, key reports, interfaces, integrations, and segregations of duties rules. Develop and maintain comprehensive documentation including flow charts, process narratives and risk and control matrices and any others required. Evaluate audit findings and coordinate remediation of deficiencies. Strong understanding of US GAAP, SOX requirements, and internal audit standards. Understanding of SDLC principles.. Develop business relationships and proactively interact with process owners to gather information, resolve problems, and make recommendations for improvement and optimization. Demonstrate initiative and provide timely updates to internal audit management. Manage multiple tasks effectively and deliver projects timely. Documentation and activities remain current and in compliance with the IIA’s IPPF Standards and are consistent with best practices. Develop metrics for ongoing operational activities and leverage technology and data analytics to enhance IA operations.. Help manage governance of the Internal Audit function and mature and evolve our audit methodology and operational audit program. Perform other tasks and projects as assigned in support of the internal audit team and corporate objectives. What skills and knowledge should you bring?. Bachelor’s degree in Computer Science, Accounting & Finance, Information Systems, or related field preferred CA/CPA/CISA/CIA/CISSP/CISM. Minimum of 5+ years of audit experience, preferably within the technology industry.. Experience with Big 4 accounting firms or global public companies is strongly preferred.. Ability to take direction, learn quickly, work independently, and maintain a level of professional skepticism. Ability to handle multiple priorities and deadlines, with high standards for quality, accuracy, and attention to detail. Working knowledge of data analysis and business intelligence tools is a plus (PowerBI, Tableau). Data Governance and Management. Business Continuity and Planning and Disaster Recovery. Systems Development Life Cycle (SDLC), Project Management Life Cycle (PMLC), and Application Change Management. Websites and Mobile Applications. IT Asset Lifecycle Management. IT Problem Management, Help Desk and Service Level Management. Enterprise Applications including the following control areas:. Application security architecture. Application access, Server-level access and controls, Database-level access and controls. Why us?. You will be joining a cutting-edge company, where you will tackle extraordinary challenges and work with the very best in the industry.. Industry leading gender-neutral parental leave. Paid Company Holidays. Paid Sick Time. Employee stock purchase program. Disability and life insurance. Employee assistance program. Gym membership reimbursement. Cell phone reimbursement. Numerous company-sponsored events including regular happy hours and team building events. SentinelOne is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.. SentinelOne participates in the E-Verify Program for all U.S. based roles.. Show more Show less

Must have knowledge of documentation (COA, MSDS, VQ Filings , APQR, MOA,DMF) COA/ Certificate of Analysis • MSDS • Specifications/ TDS • Method of Analysis • Stability Data • DMF/ Drug Master File • Declarations Required Candidate profile Intrested Candidate Can share your CV in Whatsapp : 91-9724346949 / 9327657730

Step into the role of Assistant Vice President at Barclays Internal Audit (BIA) in Mumbai, where you'll support the Audit Lead on audit executions to ensure timely and efficient delivery of audit results As an independent contributor, youll support collaborative audit reviews and guide junior team members in the completion of these reviews, You may be assessed on the key critical skills relevant for success in role, such as experience in either Global Markets and/or Corporate Banking business, as well as job-specific skillsets, Basic/ Essential Qualifications Experience in audit and business monitoring, Understanding of relevant regulatory and compliance environment in India, Relevant professional certifications, e-g CIA, CPA, or CISA, is preferred, Job Location is Mumbai, Purpose of the role To support the development of audits aligned to the banks standards and objectives by working collaboratively with colleagues, providing accurate information and recommendations, and complying with policies and procedures, Accountabilities Audit development and delivery support, including financial statements, accounting practices, operational processes, IT systems and risk management, Identification of operational risks to support the delivery of the Barclays Internal Audit (BIA) Audit Plan through risk assessments, Assessment of internal control effectiveness and their capability to identify and mitigate risk aligned to regulatory requirements, Communication of key findings and recommendations to stakeholders, including the Audit Owner, senior managers and directors, Identification of regulatory news and industry trends/developments to provide timely insight and recommendations for best practice, Assistant Vice President Expectations To advise and influence decision making, contribute to policy development and take responsibility for operational effectiveness Collaborate closely with other functions/ business divisions, Lead a team performing complex tasks, using well developed professional knowledge and skills to deliver on work that impacts the whole business function Set objectives and coach employees in pursuit of those objectives, appraisal of performance relative to objectives and determination of reward outcomes If the position has leadership responsibilities, People Leaders are expected to demonstrate a clear set of leadership behaviours to create an environment for colleagues to thrive and deliver to a consistently excellent standard The four LEAD behaviours are: L Listen and be authentic, E Energise and inspire, A Align across the enterprise, D Develop others, OR for an individual contributor, they will lead collaborative assignments and guide team members through structured assignments, identify the need for the inclusion of other areas of specialisation to complete assignments They will identify new directions for assignments and/ or projects, identifying a combination of cross functional methodologies or practices to meet required outcomes, Consult on complex issues; providing advice to People Leaders to support the resolution of escalated issues, Identify ways to mitigate risk and developing new policies/procedures in support of the control and governance agenda, Take ownership for managing risk and strengthening controls in relation to the work done, Perform work that is closely related to that of other areas, which requires understanding of how areas coordinate and contribute to the achievement of the objectives of the organisation sub-function, Collaborate with other areas of work, for business aligned support areas to keep up to speed with business activity and the business strategy, Engage in complex analysis of data from multiple sources of information, internal and external sources such as procedures and practises (in other areas, teams, companies, etc) to solve problems creatively and effectively, Communicate complex information 'Complex' information could include sensitive information or information that is difficult to communicate because of its content or its audience, Influence or convince stakeholders to achieve outcomes, All colleagues will be expected to demonstrate the Barclays Values of Respect, Integrity, Service, Excellence and Stewardship our moral compass, helping us do what we believe is right They will also be expected to demonstrate the Barclays Mindset to Empower, Challenge and Drive the operating manual for how we behave,

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

Senior Internal Auditor India, Chennai Hybrid, Office-Based ICON plc is a world-leading healthcare intelligence and clinical research organization Were proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development, Reporting to the Senior Manager of Internal Audit, you will join a fast paced and dynamic internal audit team supporting ICON's mission to help its clients accelerate the development of drugs and medical devices that save patient lives and improve their quality of life, As a key member of the ICON Group Internal Audit team, you will perform internal control, financial and operational audits for ICON plc, with emphasis on global project governance and risk assurance, What You Will Be Doing Manage various Sarbanes-Oxley (Sox) testing and reporting requirements across ICON's Divisions globally, Lead walkthroughs and risk assessments with process owners Review documentation and assess results to ensure adequate control design and identification of ?key? controls Serve as a main SOX contact for coordination with external auditors related to testing requirements/requests and issues Perform risk based internal audit assignments across ICON's Divisions globally, Consistently evaluate the adequacy and effectiveness of internal controls and compliance, relating to risks across all aspects of ICON, Co-ordinate & deliver quality audit reports containing realistic recommendations, agreed with Management ensuring they are achievable, cost effective and contribute to the business, Play an active role in ensuring any potential operational risk issues and matters, are monitored and communicated effectively, Collaborate with the Senior Manager of Internal Audit on relevant Audit Committee engagements, Analyse large amounts of data in an efficient and accurate manner, using your IT acumen, Familiarise yourself with the In-house SOX tool and look for ways of enhancing its use, Foster good working relationships with global cross-function teams in the business, Promote the Internal Audit brand internally and encourage stakeholders to engage with Internal Audit, Motivate, coach and develop more junior team members to excel in their roles and advance professionally, Your Profile Bachelor's degree in Accounting, Finance, or a related field (Relevant certifications such as CPA, CIA, or CISA are a plus), Must have extensive SOX experience to be considered for this role Big 4 trained preferred 3 years + Audit experience required Post qualification experience in industry preferred Strong Analytical Skills with Good IT Acumen, Strong report writing skills, excellent attention to detail and time management skills What ICON Can Offer You Our success depends on the quality of our people Thats why weve made it a priority to build a diverse culture that rewards high performance and nurtures talent, In addition to your competitive salary, ICON offers a range of additional benefits Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family, Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your familys needs, Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead, Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your familys well-being, Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others, Visit our careers site to read more about the benefits ICON offers, At ICON, inclusion & belonging are fundamental to our culture and values Were dedicated to providing an inclusive and accessible environment for all candidates ICON is committed to providing a workplace free of discrimination and harassment All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status, If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles, Are you a current ICON EmployeePlease click here to apply

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment If someone asks for payment on our behalf, it is a scam Please report the incident to the local police or cybercrime unit Your trust and safety are important to us, Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Sr Executive Quality Assurance Job Requisitions No : 13749 Job Description Purpose of Job Preparation and Review of PQR, Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software, Skill Required Having basic knowledge on Microsoft Word and Microsoft Excell Have knowledge of Minitab software for statstical evaluation of data, Roles and Responsibilites Preparation and review of PQR schedule, Planining of PQR compilation as per PQR schedule, Collection of data from all the CFT teams for compilation of PQR, Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software, Based of the PQR data recommendation to be recommended to concern department and ensure implemenation of the same, Qualification Required Pharm or M Relevant Skills / Industry Experience Should have relevant experience in Regulatory approved plant, Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: SEZ, Ahmedabad, GJ, IN, 382213 Travel: 0% 25% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 26 May 2025

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

Physical Walk-in Interview - CQA @ Chennai Role :CQA Experience : 10 years Qualification : BE , Diploma Skills : CQA,8D, SPC, DOE, Audits Interested candidates can share the profile to yamuna.k@harita.co.in

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