68 Regulatory Audits Jobs - Page 2

You will be responsible for initiating, reviewing, and approving various quality management systems such as Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints. In addition, you will handle Return Goods and ensure the proper functioning of the quality system by performing risk assessments as needed. Conducting regular internal audits will also be part of your duties. Reviewing and approving all documents including SOPs, Spec & STPs, Forms, protocols, and reports will be crucial to ensure compliance. You will also review annual product quality review reports and provide training on cGMP topics to employees at the site. Additionally, you will support customer audits/visits and regulatory audits, as well as provide necessary documentation for amendments, annual updates, regulatory filings, and CMC supporting documentation. Your role will also involve filling out questionnaires, declarations, and quality agreements. Finally, you will execute any additional responsibilities assigned by the Head of Department.,

As a Deputy Manager at Syngene International Ltd., your main responsibility will be handling QMS documentations like CC, CAPA, and Investigations, as well as managing EDMS documents, study protocols, and qualification protocols. You will be in charge of performing activities related to Engineering & maintenance at Biologics Unit 03 while ensuring GMP compliance and error-free operations. It will be crucial for you to follow all EHS requirements at the workplace to ensure individual and plant safety. Your role will involve completing all assigned mandatory trainings related to data integrity, health, and safety measures on time, and ensuring compliance to quality systems and current good manufacturing practices. You will play a key part in developing procedures and practices that promote safety operations compliant with company and regulatory norms, as well as adhering to Standard Operating Procedures and safety requirements. In terms of educational qualification, a Bachelor of Engineering degree is required for this position. You should have 9-12 years of experience in a relevant regulated environment. Technical skills such as handling QMS documentation, EDMS documents, system implementation, audit compliance, reviewing documents, and approvals will be essential for this role. Additionally, you will be responsible for performing preventive maintenance, equipment qualification, validation activities, equipment PM, utilities maintenance, SOP preparation, attending equipment breakdowns, maintaining critical spares, and more. Your behavioral skills should include good communication skills, both verbal and written, a high level of dedication, enthusiasm, motivation, and persuasive ability in a team and cross-functional environment. You should be able to work successfully in a dynamic, ambiguous environment, meet tight deadlines, prioritize workloads, and develop new ideas and creative solutions. Syngene International Ltd. is an equal opportunity employer dedicated to providing integrated scientific services to various industries globally.,

As a Process Head at Kavs Spectronova Technologies Pvt Ltd, you will be responsible for leading the process engineering aspects of pharmaceutical plant projects. Your role will involve overseeing optimal process design, ensuring regulatory compliance, and facilitating seamless coordination among internal and external stakeholders for both greenfield and brownfield facility projects within the pharmaceutical industry. Your key responsibilities will include leading the end-to-end process design for various types of pharmaceutical facilities such as OSD, Injectable, Vaccine, or Biotech. You will be required to develop and review essential documents including P&ID, Process Flow Diagrams, Mass Balances, Equipment Sizing, and Critical Design Parameters. Additionally, you will prepare and evaluate User Requirement Specifications (URS) and oversee various tests and validation protocols such as FAT, SAT, DQ, IQ, OQ, and PQ to ensure compliance with regulatory standards like GMP, WHO, USFDA, and EU. Collaboration with cross-functional teams such as R&D, Quality Assurance, HVAC, Utility, Electrical, Instrumentation, and Automation will be a crucial part of your role. Your technical expertise and leadership will be essential during project execution, commissioning, and regulatory audits. Client meetings, technical presentations, and troubleshooting activities will also be a part of your regular responsibilities, along with international travel for projects, site visits, audits, and technical review meetings. To qualify for this position, you should hold a Bachelor's or Master's degree in Chemical Engineering or Pharmaceutical Engineering with 8 to 12 years of experience in process design and execution of pharmaceutical plant projects. A deep understanding of regulatory requirements including GMP, WHO, USFDA, and EU is essential. Demonstrated leadership skills in managing diverse teams and external consultants/vendors, excellent communication, documentation, and presentation abilities, as well as the capability to handle multiple projects under strict timelines are required. A valid passport is mandatory for this role, and prior international exposure is highly desirable. In return, we offer you a challenging leadership role in global pharmaceutical projects, opportunities for international exposure and career advancement, a collaborative work environment that emphasizes innovation and compliance, as well as competitive compensation and benefits in line with industry standards. To apply for this position, please send your updated resume to suchita@spectronova.com with the subject line: Application for Process Head Pharma Projects.,

You will be joining HP & ASSOCIATES LLP, Chartered Accountants, a leading professional services firm specializing in Audit, Tax, and Advisory services. As a CA Articleship candidate based in Mumbai, you will play a crucial role in supporting audits, tax preparations, financial reporting, and compliance checks. Your responsibilities will involve handling direct and indirect taxes, corporate finance, IT advisory, and risk management services. Additionally, you will participate in regulatory audits and advisory services, demonstrating professionalism and precision in meeting diverse client requirements. To excel in this role, you should be enrolled in the CA Articleship program with IPCC certification and clearing both groups. This is a full-time position that offers a valuable opportunity to gain hands-on experience in a dynamic and innovative environment at HP & ASSOCIATES LLP.,

Ensure compliance with cGMP, ICH, and regulatory guidelines in API manufacturing. Review and approval of master batch manufacturing records (MBMR) and batch packing records (BPR). Conduct in-process checks and ensure batch release activities. Required Candidate profile Participate in internal and external audits (USFDA, EDQM, WHO, MHRA, etc.). Review of analytical documents, stability protocols, validation protocols & reports. Immediate to 30 days preferred

Panacea Biotec believes in providing opportunities for "Better Health to Live Well and Live Longer". As one of India's leading Pharmaceutical & Biotechnology Company, we have a strong foundation in Research, Manufacturing, and Brand Building. Our ultra-modern manufacturing facilities for Vaccines, Pharma & Nutrition are cGMP compliant, ensuring the production of high-quality products. Join us in making history by contributing to a company that introduces innovative brands that have positively impacted millions of lives worldwide! We are currently looking for a dynamic and experienced Head of Engineering and Projects to join our team. The ideal candidate will be responsible for overseeing all facilities and utilities to ensure a safe and compliant manufacturing plant that meets regulatory standards. Additionally, they will be tasked with developing, implementing, and tracking capital projects, equipment maintenance, and processes to ensure timely completion within budget. Key Responsibilities: - Demonstrate leadership in Good Engineering Practices (GEP) and knowledge of Pharma and Vaccine machinery. - Implement GMP principles, quality systems, and documentation in the engineering department. - Lead and build Empowered Engineering & Maintenance (E&M) Teams to achieve quality output. - Ensure consistent performance of plant & machinery throughout production cycles. - Manage capital projects, new technology assessment, and equipment retirement. - Conduct regular performance reviews, provide technical resolutions, and lead strategic change in Engineering. Qualifications: - B. Tech / M. Tech in Mechanical Engineering/ Automation Engineering / Process Engineering. Experience: - Minimum 20 years of engineering experience in pharmaceutical/biotech industry, with at least 5 years in supervisory roles. - Proven track record of successfully delivering complex projects on time and within budget. If you are passionate about engineering, have a strong background in project management, and are looking to make a meaningful impact in the healthcare industry, we encourage you to share your resume with Mr. Kulvinder Sarao, CHRO-Panacea Biotec at kulvindersarao@panaceabiotec.com. Join us in our mission of improving lives through innovation and excellence in healthcare.,

At ABB, the dedication is towards addressing global challenges with core values such as care, courage, curiosity, and collaboration. The focus on diversity, inclusion, and equal opportunities are key drivers in empowering everyone to create sustainable solutions. Take the opportunity to shape and influence the design and implementation of labor and employment strategies in the ABB Electrification business for the Middle East, India & Africa regions. As part of the ABB Electrification team of Labor and Employment lawyers, reporting to the VP Global Head of L&E lawyers, your responsibilities will include: - Serving as the Primary Point of Contact for Labor & Employment matters across the Middle East, India, and Africa regions. - Collaborating with Electrification Division Lead Counsels, Regional General Counsels, and HR to support Electrification goals and ensure compliance with labor laws. - Providing guidance on employee relations, investigations, employment agreements, and risk mitigation on a day-to-day basis. - Overseeing employment-related disputes and evaluating outside counsel law firms for dispute management. - Educating stakeholders, tracking industry trends, and supporting labor law projects across Electrification's footprint. To qualify for this role, you should be a qualified Labor & Employment law specialist lawyer with post-qualification experience in a major law firm or in-house, dealing with multi-jurisdictional projects. A proven track record in labor & employment law practice, bilingual proficiency in English and Arabic, resilience, adaptability, detail-orientation, and the ability to make executive decisions in a changing environment are essential. Being a collaborative team player with strong communication skills, work ethic, and ethical standards is crucial, along with a sense of humor being a plus. Join ABB and be a part of a diverse team. Apply today and take the next step in your career. Learn more about the impact of our solutions at www.abb.com. The preferred locations for this role are Riyadh, Saudi Arabia; Dubai, United Arab Emirates; or Cairo, Egypt. #MyABBStory,

Manage and execute internal audit assignments independently. Prepare Risk Based Internal Audit plan and define auditable scope Ensure compliance with ICFR (Internal Controls over Financial Reporting). Develop and maintain audit dashboards to monitor key metrics. Review of credit due diligence process, documentation, & post-sanction conditions. Conduct process mapping, identify control gaps, and build risk & control matrices. Evaluate operational efficiency and support in identifying leakages. Assess compliance with organizational policies, SOPs, and regulatory guidelines. Understanding of risk management frameworks and RBI regulations for NBFCs Collaborate and build strong relationships across various departments. Preferred: CA with 2-5 years of experience in NBFC audit.

Education Graduation in Pharmacy Long Description The person should have knowledge in Manufacturing equipments. He should have exposure in equipment’s such as FBE,Fette/KORSCH M/C & auto coater M/C He should be able to handle equipment trouble shoot in Manufacturing department. He should have exposure in regulatory organization . He must have faced the USFDA ,MHRA & other regulatory audits. He should have the exposure in Caliber QAMS, elog, track wise ,SAP ,WIND ,CDAS & other software. He should have the exposure in process simplification/optimization ,SABA ,elog & SCADA. Competencies Work Experience 3-6 years work experience in Fette compression machine

Oversee all QA activities related to API manufacturing in line with cGMP and regulatory standards. Review and approve manufacturing and analytical documents including MBMRs, BPRs, validation protocols and reports. Lead handling of QMS activities. Required Candidate profile Strong knowledge of QMS, cGMP, ICH, WHO guidelines,Audit handling and documentation expertise,Leadership and team coordination,Proficiency in handling TrackWise / MasterControl or similar systems

Participate in internal and external audits (USFDA, EDQM, WHO, MHRA, etc.),Ensure compliance with GMP, ICH, and regulatory guidelines in API manufacturing.Conduct in-process checks and ensure batch release activities are done per quality procedures. Required Candidate profile Experience of QMS software Exposure to regulatory audits and good Manufacturing practices. Strong communication and documentation skills. Sound knowledge of regulatory guidelines ICH, WHO, USFDA

Hiring Compliance Manager to handle regulatory circulars from SEBI, NSE, BSE, etc., and manage audits. Role ensures full compliance with exchange norms and keeps the company audit-ready at all times. Required Candidate profile Lead internal audits & regulatory inspections. Liaise wt auditors SEBI, exchange, statutory to ensure timely data submission. Address audit findings, close non-compliances, ensure inspection readiness

3 - 15yrs exp in IT & IT Security across various levels Certified in ISO 27001: 2013 /ISO 22301:2019 Preferred Enterprise IT Governance including knowledge of IT risk management & controls Strong PPT creation & design Func as SPOC for IT GRC & Audits Required Candidate profile Manage establishment of operate & tech decision-making process to ensure IT svc are align to organization priorities & risk appetite Prep sec dashboards with KPIs, sec metrics for CISO presentations Perks and benefits +++ Mediclaim + 10% perf bonus + 30% Company Bonus

Role & responsibilities Implement and maintain the Quality Management System as per regulatory and internal requirements. Internal audits and support external audits and inspection of Engineering. Should have knowledge of qualification of area, machines and validation activities. Should have the knowledge of calibration, validation and Preventive maintenance. Responsible to maintain self record files. Preferred candidate profile Sound knowledge pharma regulatory requirements. Hands-on experience with engineering audits. Experience in pharma engineering.

Head of Quality Assurance & Customer Service Excellence Gurgaon, India Permanent Role Role Summary The Head of Quality Assurance & Customer Service Excellence will lead the organization in developing and maintaining quality standards, achieving key accreditations, and managing audits across global business operations. This role demands a dynamic leader with a proven track record in establishing and maintaining compliance frameworks, driving customer-centric quality initiatives, and leading global accreditation efforts. The position will also require close collaboration with subject matter experts in various domains to ensure superior quality and service delivery. Key Responsibilities 1. Strategic Leadership Develop and implement the organizations quality and customer service strategy in alignment with business objectives. Establish and maintain a unified Quality Management System (QMS) across global operations, ensuring scalability and consistency. Act as a strategic advisor to senior leadership on quality and compliance matters. 2. Compliance, Accreditation, and Audit Leadership Lead the organization in achieving and maintaining global quality accreditations and certifications, such as ISO 9001, ISO 27001, SOC 2, COPC, and other relevant standards. Oversee the preparation, execution, and follow-up of internal and external audits to ensure compliance with international standards. Partner with subject matter experts to ensure all business units meet and exceed quality benchmarks. 3. Customer Service Excellence Design and implement customer service frameworks that enhance customer satisfaction and loyalty across all domains. Establish and monitor customer feedback mechanisms to identify areas of improvement and implement corrective measures. Leverage data analytics and innovative tools to drive customer service quality improvements and engagement initiatives. 4. Audit and Risk Management Create and oversee a robust audit mechanism that evaluates quality standards and service delivery across internal processes, external vendors, and partner organizations. Identify risks, implement corrective actions, and ensure preventive measures are integrated into operational workflows. Serve as the point of contact for external accreditation bodies and regulatory authorities during audits and inspections. 5. Team Leadership and Collaboration Lead, mentor, and inspire a high-performing quality assurance and customer service team. Foster a collaborative environment by working closely with cross-functional teams and business heads to align quality initiatives with organizational priorities. Streamline team structures to enhance efficiency while maintaining high-quality standards and service excellence. 6. Process Improvement Drive initiatives focused on operational excellence, customer-centricity, and process optimization. Implement advanced methodologies such as Six Sigma, Lean, or AI-based tools to improve quality and service outcomes. Promote a culture of continuous improvement and innovation across all business units. Required Qualifications Bachelors degree in Quality Management, Engineering, Business Administration, or a related field; a Master’s degree is preferred. Minimum of 15 years of experience in quality assurance, with a proven track record of leading organizations in achieving global accreditations, certifications, and audit compliance. Demonstrated expertise in compliance with international standards such as ISO 9001, ISO 27001, COPC, or SOC 2. Hands-on experience in managing global audits and regulatory inspections. Strong ability to align quality and customer service objectives with organizational goals. Preferred Qualifications Familiarity with healthcare-specific quality certifications (e.g., CAP, NABH, JCI) is advantageous but not mandatory. Expertise in data-driven quality monitoring and decision-making using AI-based tools. Experience in managing quality assurance and customer service teams across diverse industries and geographies. Exposure to working with multinational organizations and global compliance frameworks.

01 Managing the entire QA activities in the plant & Overall implementation of Quality Systems in all units. 02 Design, Develop and approve all Quality systems in all units. Monitoring, Documentation, and implementation of process development. 03 Responsible to handle regulatory audits USFDA ISO 9001-14001, EU,WHO, and their compliance in all units without any Major Non Compliance. Making sure that there is stability data to support retest or expiry dates and storage conditions on APIs and/or intermediates where appropriate; and Performing product quality reviews 04 Handling of statutory audits like Quality, EHS, KSPCB, -CDSCO, weight & scale inspector, Director of Factories & Boilers, Social audits etc and their compliance (Evaluated by No show cause notice and no complaints) 05 Making sure that critical deviations are investigated and resolved; 06 Approving all specifications and master production instructions, Test methods, Qualifications 07 Approving all procedures impacting the quality of intermediates or APIs 08 Making sure that quality related complaints are investigated and resolved 09 Adhering to QA budget. 10 To qualify company for various certifications. 11 Assuring QMS in all Units. Experience 15 - 20 Years Salary Not Disclosed Industry Pharma / R&D / Biotech Qualification B.Pharma, M.Sc Key Skills Quality Assurance Supervisor USFDA Compliance and Audits Pharmaceutical Quality Assurance

JOB OVERVIEW: To ensure regulatory compliance of LIMS at Global Piramal Pharma sites. Responsible to support in implementation of LIMS KEY STAKEHOLDERS: INTERNAL Business ( Site / Central functions) IT Team (e.g. Infra / PPS IT/Quality IT/SAP) KEY STAKEHOLDERS: EXTERNAL IT Vendors / OEM Vendors IT Contractors/Consultants REPORTING STRUCTURE: (Reports To/ Direct Reports Y/N) Will report to Associate General Manager - Quality eCompliance ESSENTIAL QUALIFICATION: Graduate in Science/Pharmacy/Engineering Post Graduation Science /MBA RELEVANT EXPERIENCE: 8 to 12 years of relevant experience. Must have experience in LIMS implementation. Key Role / Responsibilities : To have good understanding and knowledge on LIMS application functionalities and its integration with other systems. To provide SME support for the implementation of LIMS (Laboratory Information Management System) across sites and support the key decisions for the changes that required in the workflow of the system from Quality and e-compliance perspective. To support the validation of LIMS application (specifically). Additionally, to support the validation of Enterprise Systems, LMS (Learning Management System), VLMS (Validation Life Cycle Management Systems) and other applications systems to comply with regulatory guidelines. To define validation strategy and provide inputs to validation planning for projects; along with the review of validation/qualification deliverables of the assigned project/system in line with the organizational SOPs & adhering to company procedures and regulatory expectations. To ensure infrastructure (Network, Servers, Cloud, Database) are qualified as per required Quality standards and required documents are in place. To support the various phases of Computer System including Planning, Implementation, Maintenance, and Retirement activities by ensuring compliance with internal/external regulatory requirements. To review other QMS documents e.g. Change control/Deviation/ CAPA/Incidents-Discrepancy/User access forms in line with the organizational/site specific procedure. To communicate/discuss the identified gaps during the GxP computerized system assessment to responsible team. Coordinate with the relevant IT team for the compliance/closure of the identified gaps, incidents, deviations. To guide and train IT & Business teams at Site for CSV, relevant areas of Compliance and Validation for GxP IT and electronic systems, Data Integrity, and Regulatory Compliance activities. To perform periodic and audit trial review of the GxP application system as per defined frequency along with the relevant stakeholders. To support sites to ensure audit readiness and ability to represent the validation package of enterprise GxP application including LIMS during regulatory audits and can be able to perform DI Audits at site. To coordinate & build good working relations with Site/business users, Subject Matter Experts (SMEs) and IT operations team, Manage vendors / partners / support teams. Key Competencies :EY COMPETENCIES: KEY COMPETENCIES: To have in depth understanding of regulatory requirements and guidelines required to comply IT systems in Pharma industry DI, ALCOA+, Part 11, Annex 11, GAMP 5 etc. Knowledge and Experience of Pharma domain Quality (QA, QC) Understanding and exposure to Pharma CSV upcoming trends. A team player with good communication skills (verbal & written) Knowledge and experience on handling of CSV project related QMS e.g. Change control, deviation, CAPA and incidents. Responsibilities Qualifications Graduate in Science/Pharmacy/Engineering Post Graduation Science /MBA

Experience in pharma regulatory & QMS function, primarily in RLD / comparator sourcing, clinical trial supply chain management, and clinical packaging for USA and EU markets. The role includes supporting the end QMS function and regulatory affairs. Health insurance Provident fund Annual bonus

Arora.rajat@sammaancapital.com. Job Description Lead - IT Regulatory Compliance & Audit Location [Gurgaon] Key Purpose of the Role The Lead - IT Regulatory Compliance & Audit will be responsible for ensuring the organizations full compliance with applicable IT and Cybersecurity laws, regulations, and supervisory expectations, specifically those outlined by the Reserve Bank of India (RBI), including the Master Directions on Information Technology and Cyber Security Framework and IT Outsourcing guidelines. This role will also lead the IT Infra and cybersecurity audit management process, ensuring the timely closure of observations and proactive compliance monitoring. Key Responsibilities IT Regulatory Compliance (RBI & Other Regulatory Bodies) Ensure ongoing compliance with RBIs IT and Cybersecurity Master Directions, circulars, notifications, and guidelines. Track and analyze IT regulatory updates and assess their impact on IT operations, security, and governance. Implement a compliance monitoring framework specific to IT and cybersecurity, including regulatory checklists, gap assessments, and periodic testing. Ensure timely submission of IT-related regulatory returns, filings, and disclosures as required under various laws and RBI guidelines. Maintain a regulatory IT compliance register and evidence of adherence. Coordinate with IT, Information Security, Risk, and Legal teams to ensure regulatory alignment across technology and operations. IT Policy Management Draft, review, and update IT policies, processes, and internal control frameworks in line with regulatory changes. Provide guidance to IT and business units on the interpretation and implementation of IT regulatory requirements. IT Audit & Cybersecurity Review Management Lead and manage IT audits, assessments, statutory audits, and regulatory inspections. Liaise with IT auditors, statutory auditors, and regulatory examiners. Track and ensure timely closure of all IT audit observations and regulatory inspection findings. Prepare and present periodic reports to senior management and the Board on IT audit and compliance status. Stakeholder Reporting Prepare IT Compliance Risk Management Reports, Quarterly IT Compliance Reviews, and other Board-level presentations. Report material IT regulatory breaches or significant non-compliance incidents. Training & Awareness Conduct regular training sessions for employees on IT regulatory compliance requirements and updates. Promote a strong IT compliance culture across the organization. Desired Candidate Profile Education & Certifications Graduate/Post-Graduate in Information Technology, Computer Science, Cybersecurity, Law, or related fields. Certification in IT Compliance / Cybersecurity / Risk Management preferred (e.g., CISA, CISM, CISSP, ISO 27001 LA, IIBF Certified Compliance Professional). Experience Minimum 8-12 years of relevant experience in IT regulatory compliance and audit functions within Banking, NBFCs, or Financial Services. Hands-on experience with RBI IT compliance management. Hands on IT infra services specially VAPT, AD, Messaging etc.. Key Skills & Competencies In-depth understanding of RBIs IT and Cybersecurity regulations, circulars, and guidelines. Strong knowledge of IT compliance and IT risk management practices. Excellent analytical, communication, and stakeholder management skills. Strong leadership and team management capabilities. Proficiency in preparing IT regulatory and Board-level reports. Proficiency in managing the VAPT related to IT infra services Key Interfaces Internal IT - Infra Information Security Risk Management Legal & Secretarial Internal Audit External Reserve Bank of India (RBI) IT Auditors Cybersecurity Consultants Legal Counsel & Consultants Employment Type Full-Time / Permanent Thanks Rajat Arora 98735 66771

We are looking for a detail-oriented Audit Executive to join our Compliance & Documentation team. The candidate will be responsible for conducting audits on transactional, regulatory, documentation, ERP, and DLT processes, ensuring full adherence to SEBI regulations, Companies Act, and internal policies. Role & responsibilities: A. Transactional Audit Verify execution of all required documents for debt transactions. Check condition precedent documentation and timelines. Ensure Due Diligence Agreements (DTA) and certificates from empaneled professionals (CA, CS, Advocates, Valuers) are in place. Confirm In-Principle approval from the Stock Exchange and creation of securities within regulatory timelines. Check issuance of Due Diligence certificates (Annexure A & B) and their timelines. Validate execution of Debenture Trust Deed (DTD), receipt of ISIN letters, GID/KID availability, listing applications and approvals. B. Regulatory Audit Confirm all procedures for listed transactions comply with SEBI, Companies Act, and other regulatory frameworks. Review Preliminary Information Questionnaire (PIQ). C. Document Audit Review documentation for completeness: Proper signatures and stamps Blanks filled and counter-signed Proper dating and custody of originals D. ERP Audit Ensure proper execution and upload of documents into the ERP system. Validate accurate data entry including execution dates. E. DLT Audit Confirm necessary entries on the DLT platform by Issuers and Trustees. Check covenant entries and cash flow schedule compliance. Review deviation approvals (if Due Diligence is not issued via DLT). Verify SEBI has been informed in cases of issuer non-compliance. Preferred candidate profile: Good knowledge of SEBI regulations and Companies Act Familiarity with documentation and listing processes in capital markets Attention to detail and strong documentation audit skills Proficiency in MS Office and ERP systems Experience with DLT platform (preferred but not mandatory)

Skill Document Creation, Secondary Data Analysis, Regulatory Audits Minimum Qualification B.com Working Language English, Hindi, Marathi Job Description Receipt Entries in Oracle, Bank Reconciliation, Oracle entries for AP exps.& payment entries booking for cash & bank, JV for contra & other adjustment entries, AR for CM & DMLC documentation & follow up to bank for the same, MIS, PDC handling, Online Tax Payments, Accounts Reconciliations. Assisting to prepare reports for Assessment & Yearly Statutory Audit, Other Accounting Entries, Insurance Renewals processing. Handling & maintaning documents.

Role- Compliance Specialist Location: Mumbai / Noida Department: Compliance Experience Required: 6-8 years Role Overview We are seeking a seasoned compliance professional to join our Compliance Department at Paytm Payments Bank. The ideal candidate will have deep expertise in regulatory compliance specific to payment banks, including hands-on experience in compliance testing, advisory functions, and policy/SOP reviews. The role demands a strong understanding of key regulatory circulars and guidelines issued by the Reserve Bank of India (RBI). Key Responsibilities Regulatory Compliance & Advisory Interpret and implement RBI circulars including: - Master Direction on KYC (MD KYC) - Licensing Guidelines for Payment Banks - Master Direction on Prepaid Payment Instruments (MD PPI) - Compliance Function and Chief Compliance Officer (CCO) Circular Provide compliance advisory to business units on new products, processes, and controls. Review and update internal policies and SOPs to ensure alignment with regulatory expectations. Conduct periodic compliance testing and risk assessments across business units. Monitor Key Compliance Indicators (KCIs) and identify potential breaches or non-compliance. Support root cause analysis and remediation planning for compliance issues. Lead the dissemination of regulatory updates and circulars to relevant departments. Ensure timely implementation of regulatory changes and track compliance status. Prepare and present compliance reports to senior management, Board, and Audit Committees. Qualifications Postgraduate degree in Law/ Finance or Business Administration (MBA, CA preferred). Experience in banking compliance, preferably in a payment bank. Strong knowledge of RBI regulations and circulars applicable to payment banks. Excellent communication, analytical, and stakeholder management skills. Preferred Skills Experience with regulatory audits and inspections. Familiarity with digital banking products and services. Proficiency in drafting and reviewing policies and SOPs. Ability to work cross-functionally and manage multiple priorities.

Role & responsibilities Lead and manage the Quality Control team to ensure timely and accurate analysis of finished products (OSD & Injectables). Review and approve analytical reports, ensure compliance with GLP and cGMP standards. Oversee operations involving HPLC, GC, UV, IR , and other sophisticated instruments. Ensure proper implementation of MPCL and maintain all microbiological standards in compliance with regulatory guidelines. Handle all regulatory audits (USFDA, MHRA, WHO, etc.) and prepare necessary documentation. Manage OOS/OOT investigations and ensure CAPA implementation. Coordinate with cross-functional teams (QA, production, regulatory affairs) to ensure product quality. Train and mentor junior staff; ensure continuous skill development within the QC team. Manage documentation including SOPs, specifications, STPs, and logbooks. Preferred candidate profile B.Pharm / M.Pharm / M.Sc in Chemistry or equivalent. 12 15 years of relevant experience exclusively in the pharmaceutical industry (OSD & Injectables) . Strong knowledge of GLP, MPCL, and finished product QC . Proven team leadership and people management skills. Experience in handling regulatory inspections and audits. Good communication and documentation skills.

Job Description: Head of Quality Experience: 15 Years or more Location: Udaipur About Macsen Drugs: Macsen Drugs is a USFDA registered, WHO-GMP certified, TGA GMP certified, and EU GMP (Written Confirmation) certified manufacturer of active pharmaceutical ingredients or bulk drugs for varied therapeutic applications like antidote, urinary antiseptic, topical antiseptic, ophthalmic diagnostic, anti-dandruff, anti-acne, and several other applications. Job Overview: We are seeking an experienced and detail-oriented individual to perform research activities as designing and conducting scientific experiments, analyzing and interpreting results, leading to significant value to the process development. Efficient contribution to the overall success of the research & development team performance according to objectives and targets set by the Management. Responsibilities: 1. Quality Assurance (QA) Develop and implement a comprehensive Quality Management System (QMS) compliant with cGMP and ICH guidelines. Review and approve quality documents such as SOPs, batch records, deviations, and CAPA reports. Ensure the site is prepared for regulatory audits and inspections from the USFDA, EMA, WHO, and other agencies. Conduct internal audits and self-inspections to maintain quality standards. 2. Quality Control (QC) Oversee laboratory operations, ensuring raw materials, intermediates, and finished products meet established quality specifications. Manage analytical method validations and stability studies. Monitor calibration and maintenance of laboratory instruments. 3. Regulatory Affairs Prepare and submit regulatory documents, including DMFs, for US and international markets. Address regulatory queries and implement corrective actions for observations from audits or inspections. Stay updated on global regulatory trends and ensure compliance with evolving requirements. 4. Production Oversight Collaborate with production teams to ensure manufacturing processes align with quality standards. Oversee cleaning and process validation for a multi-product facility to prevent cross-contamination. Troubleshoot production and analytical challenges in coordination with R&D. 5. Data Integrity and Security Ensure compliance with 21 CFR Part 11 for electronic records, signatures, and data integrity. Establish protocols for data security and governance across all quality operations. 6. Cross-Functional Coordination Work with R&D and Analytical Development Labs for seamless technology transfer and method development. Collaborate with Stores and Maintenance teams to ensure proper inventory management and equipment validation. Coordinate training programs for team members to maintain high-quality standards. 7. Leadership Lead and mentor teams across QA, QC, Regulatory, Production, and Maintenance departments. • Foster a culture of quality, accountability, and continuous improvement. 1. Educational Qualifications Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or a related scientific field. Additional certifications in Quality Management Systems (e.g., ISO 9001, Six Sigma) are preferred. 2. Experience Requirements Minimum 15 years of experience in API manufacturing, with at least 5 years in a leadership role managing QA, QC, and Regulatory Affairs. Proven experience in handling audits and inspections by regulatory agencies such as USFDA, EMA, WHO, or PICS. Hands-on experience in managing multi-product facilities with cleaning and process validation expertise. How to Apply: Send your updated resume to hrd@macsenlab.com

Continuously update knowledge of relevant regulations, guidelines, and industry standards. Ensure that products and processes adhere to all applicable regulations throughout the lifecycle, from development to post-market surveillanc Required Candidate profile Prepare, review, and submit regulatory documentation, including applications, reports, and amendments, to regulatory agencies. Prepare for and participate in regulatory audits.