68 Regulatory Audits Jobs

As a Corporate Quality Assurance (QA) professional at Alembic Pharmaceuticals in Mumbai, your primary responsibility will be to ensure the effective implementation of Quality Management System (QMS), adherence to regulatory standards, efficient vendor management, and maintenance of product quality standards across various sites. Your key responsibilities will include managing QMS processes such as deviations, change control, investigations, and Corrective and Preventive Actions (CAPA). You will be entrusted with handling FDA and market complaints, ensuring their timely closure. Additionally, you will oversee the qualification/requalification of vendors for raw materials and packaging materials, as well as address any vendor-related complaints. You will be required to review laboratory QA compliance issues like Out of Specification (OOS) and Out of Trend (OOT) results, oversee technology transfer activities, and ensure the accuracy of product documentation. Furthermore, you will play a crucial role in supporting regulatory audits and ensuring compliance with Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP). To excel in this role, you should possess a Bachelor's or Master's degree in Pharmacy (B. Pharm / M. Pharm) and have a minimum of 12 years of experience in pharmaceutical Quality Assurance, with a preference for exposure to corporate QA and QMS. A strong understanding of GMP standards, QMS principles, vendor management practices, and regulatory requirements is essential. Effective communication skills, proficient documentation abilities, and the aptitude for cross-functional coordination are also key requirements for this position. Your top skills should include expertise in Quality Management System (QMS), GMP Compliance, Corrective and Preventive Actions (CAPA), Vendor Management, and the ability to handle Regulatory Audits effectively.,

As a Quality Control Technician III at TAPI, you will be an integral part of the leading international supplier of active pharmaceutical ingredients (APIs). TAPI boasts the industry's broadest portfolio, which includes over 350 API products. With a rich history spanning over 80 years, we are recognized as one of the most trusted API suppliers globally, catering to 80 PERCENT of the top 50 pharmaceutical companies. At TAPI, our commitment to excellence is driven by our experience, expertise, cutting-edge technologies, and unwavering dedication to exceptional customer service. Your primary responsibilities will include maintaining 24/7 audit readiness, possessing expertise in Wet Chemistry, and being flexible to work in different shifts. You will actively participate in internal, external, and regulatory audits, ensuring full compliance with CAPA trainings. Additionally, you will be responsible for initiating and investigating LIR, OOS, OOT, and borderline results, promptly reporting them to the designated authority. Collaborating with various departments, you will facilitate the sharing of necessary documents from Quality Control to Regulatory Affairs and other relevant areas. In your role, you will play a crucial part in determining team priorities aligned with the plant's requirements, while coordinating effectively with team leaders and managers. Upholding stringent quality standards, you will adhere to housekeeping practices, cGMP, GLP, and Safety Guidelines within the laboratory. Your duties will encompass sampling and analyzing raw materials, finished goods, intermediates, and cleaning samples as per specific requirements, meticulously documenting results in analytical sheets, QA forms, LIMS, and online systems to ensure data integrity. Furthermore, you will conduct analytical tests following established monographs and SOPs, oversee the calibration and verification of instruments, and manage the reserved samples room along with chambers, autoclaves, and incubators. Your support will also be essential in preparing department-related documents such as STPs, SOPs, and more. Ensuring the timely sampling, approval, and rejection of labels for various products and maintaining accurate stock records of chemicals will be among your key responsibilities. To excel in this role, you should hold a Bachelor's or Master's degree in Chemistry and possess a minimum of 3 years of relevant experience in a similar capacity. Your dedication to upholding Teva's Equal Employment Opportunity commitment, which includes supporting diversity and providing equal opportunities to individuals with disabilities and veterans, is paramount in our inclusive work environment.,

To perform in-process quality assurance (IPQA) activities on the shop floor throughout all stages of manufacturing and packing. Conduct quality assurance oversight for clean room behavior and activities. Review batch processing records to ensure compliance with quality standards. Inspect all documents related to manufacturing, packaging, and analysis reports before batch release. Assess documents and logbooks in respective areas for adequacy and completeness. Monitor the receipt of materials from the warehouse to production area. Conduct IPQA for dispensing, manufacturing, packaging, and dispatch activities. Manage and control Standard Operating Procedures (SOPs), specifications, Batch Production Records (BPR) issuance, Master Formulae, and records. Prepare and review process validation protocols and reports. Execute validation and revalidation activities in the absence of an authorized person. Perform any job activity assigned by the Head of the Department (HOD). Responsible for regulatory audits and possess exposure equivalent to USFDA standards.,

As an Audit Assistant at our organization, you will play a crucial role in supporting audit engagements in the United States. Your primary responsibility will be to collaborate with the audit team to ensure the accuracy and completeness of financial statements and related documentation. This is an excellent opportunity for you to gain exposure to audit processes, financial regulations, and client interactions. Your key responsibilities will include: Planning and executing audits by establishing audit plans, performing risk assessments, executing audit procedures, and reviewing documents and transactions. Evaluating internal controls by assessing control systems, identifying weaknesses, and testing internal controls. Conducting compliance and regulatory audits to ensure adherence to federal, state, and industry regulations, preparing compliance reports, and staying updated with changing laws. Analyzing financial statements, verifying financial data accuracy, identifying discrepancies, and reporting findings. Documenting audit procedures, preparing audit reports, and communicating results to stakeholders. Conducting forensic and investigative audits to identify fraudulent activities, provide litigation support, and develop fraud prevention strategies. Adhering to auditing standards, maintaining confidentiality, and upholding ethical standards in audit procedures. Coordinating with external auditors by supporting external audits, resolving audit queries, and collaborating effectively. Providing recommendations for operational improvements, implementing corrective actions, and monitoring follow-up actions. Collaborating with departments, leading or mentoring junior auditors, and enhancing audit processes. Engaging with clients and stakeholders by maintaining effective communication, understanding client business models, and delivering tailored audit services. To be successful in this role, you should have a Bachelor's degree in Accounting, Finance, or a related field, knowledge of GAAP and auditing standards, strong analytical skills, proficiency in Microsoft Office Suite, excellent communication skills, and the ability to work independently and as part of a team. Prior experience in auditing or accounting, familiarity with audit software or tools, and CPA or CPA candidate status are advantageous. This position is based in Ahmedabad, and the work mode is from the office. Join us and be part of a dynamic team that values integrity, professionalism, and continuous improvement in audit practices.,

Job Description We are hiring a Senior Regulatory Affairs Executive with around 5 years of experience in regulatory submissions for international markets, especially USFDA and EDQM . This role involves end-to-end regulatory dossier preparation and submission, technical data coordination, and maintaining compliance with global regulatory standards in an API manufacturing environment. Key Responsibilities Prepare, compile, and submit regulatory dossiers (DMFs, CEPs, ASMFs) to international authorities, focusing on EDQM and USFDA. Coordinate cross-functionally with R&D, QA, QC, and Production teams for document and data collection. Maintain submission timelines and follow-up systems for timely responses and approvals. Provide regulatory intelligence, evaluate changing guidelines, and ensure compliance for ongoing projects. Handle deficiency responses and audits with strong documentation and archiving practices. Act as a regulatory liaison with internal and external stakeholders. Job Location : Innov8 Suman Business Park Kalyani Nagar Pune Apply to: recruitment@dnplfactory.com Contact No: 8956760759

Walk-In Drive for Development Quality Assurance - Formulation Department @ MSN R&D Center Pashamylaram on 02.08.2025 (Saturday ) Roles & Responsibilities 1. Issuing of Batch Manufacturing Records, Analytical Raw datas and maintaining the respective log books. 2. Issuing of registers and formats for all departments and maintaining of records for issuance and reconciliation. 3. Issuance approval, Issuance and Retrieval of the documents in eDMS. 4. Receiving, Issuing and reviewing the bio batches related executed Batch Manufacturing Records, Analytical raw datas and archiving. 5. Responsible for review of product development documents and analytical documents related to technology transfer. 6. Preparation and review of departmental SOPs 7. Reviewing of Equipment qualification protocols and Reports. 8. Review of supplier qualification documents. 9. Review of calibration documents 10. Receiving and reviewing of executed raw datas & ATRs and archiving for bio batches. 11. Reviewing of analytical method validation protocols & reports. 12. Maintenance, Retrieval and Archiving of all GMP related documents and records. 13. Preparation & review of department Schedules 14. Responsible for document distribution to the user departments. 15. Responsible for Document control activities. 16. Responsible for preparation, review and submitting License Applications. 17. Handling of Change controls (Permanent and Temporary), OOS and Incidents. 18. Responsible for approval of documents in absence of Head FDQA. 19. Responsible for performing job assigned by Head FDQA or his authorized designee. Note : Formulation R&D Candidates also eligible Position : Executive / Senior Executive Qualification : M Pharma / B Pharma Only. Work Location : MSN R&D Center, Pashamylaram. Department : Development Quality Assurance - Formulation Department. Experience : 2 to 8 Years Date of Interview : 02.08.2025 (Saturday ) Interview Time : 9.00 AM to 3.00 PM Venue Details : MSN Laboratories Pvt Ltd. MSN R&D center, Pashamylaram , Isnapur, Patancheru, Sangareddy - 040-30438786

Sr Internal Auditor with Data Analytics to lead & execute audits across India & Asia supporting the global internal audit team. This role will be based from our Technology Center in Bangalore but will call for both national & international travel. Required Candidate profile Certified Internal Auditor CIA 5+ years of experience in internal auditing, with a focus on data analytics. Proficiency in data analytics tools such as ACL, IDEA, SQL, or Python. financial principles

You will be responsible for liaising between various departments such as Planning, Production, Technical Services, Marketing, and Exports. Your roles and responsibilities will include the preparation, review, and implementation of SOPs and STPs. You will be checking all QC related records like analytical reports and logbooks. Additionally, you will be involved in planning and distributing samples for the analysis of Raw Materials, Intermediates, and finished products. You will design and conduct Stability studies as per ICH Guidelines and develop and validate analytical testing methodology used to control raw materials, production intermediates, and final products. Your tasks will also include the preparation and maintenance of working standards with documents, as well as the operation and calibration of laboratory instruments like HPLC, GC, and Spectrophotometer. You will review and approve Raw material, finished product, and Packaging material specifications. Furthermore, you will be responsible for handling customer audits and regulatory authority audits and preparing compliance reports. Troubleshooting of HPLC, GC, and other instruments will be part of your responsibilities. You will manage the laboratory and work towards analytical laboratory improvement, cGMP and GLP compliance, and problem resolution. As the QA/QC Manager, you will be solely responsible for exports and quality-related issues for the unit. You will supervise QC chemists to ensure the smooth working of the department and to guarantee the best quality of products from the production. This is a Full Time position located in Byrathi, Bangalore.,

The Quality Assurance (QA) Executive API (Bulk Drugs) role based in Savli, Gujarat requires a candidate with 2-5 years of experience and a qualification of B.Sc / M.Sc. As a QA Executive, your responsibilities will involve ensuring compliance with cGMP, ICH, and regulatory guidelines in API (bulk drug) manufacturing. You will be responsible for preparing, reviewing, and controlling SOPs, BMRs, BPRs, change controls, deviations, and CAPAs. In addition, conducting in-process checks for manufacturing and packaging activities, handling investigations for deviations, OOS/OOT results, and supporting root cause analysis are key components of this role. You will also be involved in participating in internal audits, regulatory audits (USFDA, EU, WHO, etc.), and vendor audits. Maintaining documentation for batch release, validation protocols, and quality systems, ensuring adherence to data integrity and good documentation practices (GDP), and supporting qualification and validation activities are crucial aspects of this position. Collaboration with cross-functional teams such as Production, QC, and R&D is essential for ensuring smooth operations. This is a full-time, permanent position with benefits including health insurance and Provident Fund. The work schedule is day shift with additional perks such as performance bonus and yearly bonus. The work location is in person.,

Role & responsibilities Asst. Manager (Regulatory Affairs) 1. The Candidate must be M.Sc or B.Pharma or M.Pharma with 7-12 years of experience out of which minimum 3-4 years in regulatory affairs in EU, US markets, WHO GMP certified pharmaceutical formulation company. He will be responsible for all regulatory functions- domestic as well as exports. He will coordinate with other departments on regular basis. He will provide documentation support required for regulatory submission independently, including preparation and submission of dossiers for product and plant registrations in different countries as per latest guidelines. Exposure to Regulatory Audits & QMS system. Knowledge of Drug & Cosmetic Act, DPCO & All other guidelines related to pharmaceutical industries Responsible for monitoring of critical processes for R&D in compliance of operations, Quality Management and regulatory affairs. Preparation or Review of SOPs, BMRs, MFRs, PVP, PVR, PDR, Chemical compatibility of drug product/Drug substance specifications, MOA and change control to ensure compliance. To ensure new products registration and license renewal compliance to local regulations, as well as GMP, GDP and ISO requirement. Review of formulation development protocols, and technology transfer dossier (TTD) Performing literature reviews and staying up-to-date with the latest advancements in pharmaceutical research to contribute to the development of new products. Ensure compliance with regulatory requirements, including FDA and global regulations, and maintain up-to-date knowledge of industry regulations and guidelines. Oversee R&D tasks, ensuring proper documentation of records and prepared of reports submitted to regulatory authorities. R&D document and their findings to support quality assurance, and regulatory affairs processes. Co- ordination with Quality assurance, Quality control, Production, Warehouse & Engineering department, ensure GMP and EHS related to R&D functions. Establish operational, analytical and documentation standards aligned with industry best practices. Preferred candidate profile

You should have over 15 years of experience in Warehouse operations, including at least 7 years in a supervisory role within injectable manufacturing. Your role will require a strong understanding of regulatory requirements, cGMP, and industry best practices. You should possess proven leadership abilities and excellent communication skills to effectively work cross-functionally and resolve quality-related challenges efficiently. Previous experience in successfully facing regulatory audits, including USFDA, EU-GMP, and ANVISA is mandatory. In terms of Material Receipt and Storage, you will be responsible for ensuring that all materials are stored and handled in compliance with cGMP and regulatory requirements. Regular recording of temperature, RH, and DP in designated logbooks is essential to maintain optimal storage conditions. Warehouse Maintenance and Cleanliness will also fall under your purview. You must ensure the cleanliness and organization of the warehouse at all times. Your duties will also involve Material Handling and Dispensing, where you will be required to dispense raw materials and issue packing materials following the FIFO (First In, First Out) system. Proper handling, storage, and distribution of materials in alignment with company procedures and safety standards are vital. Compliance and Documentation are key aspects of the role. You will need to ensure compliance with cGMP standards and regulatory requirements in all warehouse operations. Maintaining up-to-date inward registers, following good documentation practices (GDP), and participating in audits and compliance assessments are crucial responsibilities. Safety and Hygiene protocols must be strictly adhered to. This includes ensuring that safety protocols and hygiene standards, including personal hygiene and gowning procedures as per SOPs, are followed by the warehouse team during work operations. Quality Risk Management is another critical area where you will be involved. Handling rejected materials, coordinating their disposition, participating in Quality Management System (QMS) activities, and conducting regular quality risk assessments are all part of maintaining quality standards in warehouse processes. Your role will require you to ensure that warehouse processes, documentation, and operations are audit-ready at all times.,

As Manager 2 in the Corporate Quality department at SUN Pharma, you will be responsible for overseeing the quality aspects of contract manufacturing organizations (CMOs) involved in manufacturing site transfer products for the US market. Your primary focus will be to ensure compliance with SUN Pharma Quality and Compliance Standards as well as global regulatory requirements. Your essential job functions will include monitoring and overseeing activities at CMO sites to ensure adherence to SUN Pharma standards and regulatory guidance. You will conduct regular oversight visits, prepare visit reports, and serve as the main point of contact for coordination between SUN site, commercial team, corporate quality audit, and CMO site on manufacturing and technical matters. Additionally, you will be involved in authoring and reviewing quality agreements, ensuring the use of qualified service providers, participating in process validation batches, reviewing quality system documents, conducting visits based on market complaints/recalls/CAPA, reviewing batch records, stability data, and analytical reports, as well as preparing and reviewing SOPs. Your role will also include participation in the initial evaluation of CMOs, supporting regulatory audits at CMO sites, engaging in critical investigations, initiating QMS documents, preparing for regulatory agency inspections, participating in product release site audits, maintaining audit-related documents, preparing monthly reports, staying updated on regulations through training, and following Corporate Quality Policies/Global Quality Standards and Regulatory Guidelines. To be successful in this role, you should have an M.Sc./B.Pharm/M.Pharm or equivalent degree along with a total of 10 years of industrial experience and knowledge. You will also be expected to participate in and execute project work assigned by your reporting authority. If you are looking for a challenging opportunity to ensure quality compliance in contract manufacturing organizations and contribute to the overall quality standards of SUN Pharma, this role is ideal for you. Join us in our mission to maintain high-quality standards and regulatory compliance in the pharmaceutical industry.,

Role & responsibilities Lead Audit Engagements: Lead and execute complex internal audit engagements in accordance with the annual audit plan and professional auditing standards (e.g., IIA standards), ensuring timely completion and high-quality deliverables. Risk and Control Assessment: Rigorously review and evaluate financial, operational, and compliance processes, identifying critical risks and assessing the design and operating effectiveness of internal controls across various business units. Procure-to-Pay (P2P) Process Review: Oversee and conduct in-depth reviews of end-to-end Procure-to-Pay (P2P) processes, including purchase requisitions, orders, goods receipt notes (GRNs), and vendor payments, identifying control gaps and areas for optimization. Audit Recommendation Follow-up: Drive the follow-up process on audit recommendations, actively engaging with stakeholders to ensure timely and effective implementation of corrective actions and process enhancements. Statutory Compliance Review: Ensure comprehensive review of adherence to statutory and regulatory requirements, including Goods and Services Tax (GST) and Tax Deducted at Source (TDS), proactively identifying potential compliance gaps and proposing remedial actions. Documentation and Reporting: Maintain meticulous and comprehensive audit documentation and working papers, ensuring compliance with internal and external audit standards and best practices. Prepare detailed audit reports and present findings and actionable recommendations to senior management and relevant stakeholders. External Audit Support: Act as a primary point of contact and provide comprehensive support to external auditors, facilitating their reviews with accurate and timely documentation and information. Advanced Risk Assessment: Lead and conduct advanced risk assessments of key business processes and controls, contributing significantly to the development of the annual audit plan and identifying emerging risks. Tax Compliance & Exposure: Proactively assess compliance with applicable tax laws, identifying and evaluating potential areas of exposure or risk, and recommending robust strategies for mitigation. Brand Performance Control Evaluation: Evaluate the effectiveness of internal controls related to brand performance tracking and reporting against established criteria, ensuring data integrity and reliable insights. Strategic Collaboration & Feedback: Collaborate strategically and proactively with business units to gain a deep understanding of their processes, providing expert, constructive feedback and actionable recommendations for process improvement and control enhancement. Methodology Enhancement: Contribute to the continuous improvement of the internal audit methodology, tools, and processes, driving efficiency and effectiveness within the department. Mentorship and Guidance: Mentor and guide junior audit staff, fostering their professional development and ensuring adherence to audit standards and best practices. Continuous Learning: Stay abreast of industry best practices, regulatory changes, and emerging risks relevant to internal audit and the organization's operations. Technical Skills: Strong understanding of internal control frameworks (e.g., COSO). Proficiency in auditing principles, practices, and standards. In-depth knowledge of financial processes, operational controls, and compliance requirements. Experience with ERP systems (e.g., SAP, Oracle, Microsoft Dynamics) and data analytics tools is highly desirable. Solid understanding of GST, TDS, and other relevant statutory requirements.

Title: Block Head (Parenteral Production) Job Grade: G8 Deputy General Manager Educational Qualification: B.Pharm / M.Pharm Location: Baska, Gujarat Experience: Knowledge of parenteral manufacturing operations Understanding regulatory guidelines Leadership & Team Management Skills Problem Solving & Decision-Making Proficiency in handling production documentation & compliance Min. 15 years of experience working in sterile manufacturing plant or Block In-charge experience Position Summary Responsible for plant operations from material procurement to product dispatch along with operational activities, manufacturing actions, lean management, training, regulatory compliance, cross functional coordination, new product projects, new CAPEX projects, safety and administrations. Monitoring and control of the manufacturing environment, plant hygiene, compliance to requirement of current Good Manufacturing Practice, EHS, local and international regulatory norms. To coordinate for external/regulatory GMP audits at plant and to ensure timely compliance of audit observations. Optimum utilization of man, material and machinery of pharmaceutical products and assuring adequate resource arability with focus of safety and quality first. Ensuring lean management, operation excellence, GEMBA, yield improvement and waste reduction etc. with action plan and its implementation. Responsible to review and approve the qualification related documents as URS, DE, FAT, SAT, IQ, OQ, PQ etc. To coordinate with FDD/PDD (R&D)/ MSTG for execution of trial/ exhibit/ process validation batches and trouble shooting. Implementation of effective control on budgetary provisions and cost reduction measures. Supervision of proper production planning, plan execution as per schedule and ensure that products are produced and stored according to appropriate safety, cGMP requirement. Ensuring protection of the product from contamination and maintain quality as required. Participate in management reviews of process performance, product quality and of the quality management system and advocating continual improvement.

As a Manager-II in the MSTG department at Sun Pharmaceutical Industries Ltd, your primary responsibility will be to provide support for the execution and monitoring of trial, scale up, exhibit process qualification batches. You will be involved in preparing and reviewing new product documents such as material requirement sheet, master formula card, bill of material, master formula, risk assessment reports, sampling protocol, reports, exhibit batch manufacturing record, and exhibit protocols. Additionally, you will be required to prepare regulatory responses and share process knowledge with cross-functional departments through presentations for smooth technology transfer. You will play a key role in reviewing and evaluating product history and process parameters for technical remediation and improvement of product robustness. Your duties will also include preparing and submitting investigation reports for OOS, OOT, and any failure during exhibit/validation/commercial batch manufacturing and stability testing. Furthermore, you will be responsible for tracking activities related to change control, CAPA, planned deviations, unplanned deviations, and more. Your role will involve preparing and reviewing product containment approaches, risk assessment reports for new products, elemental impurities, Nitrosamine impurities, and residual solvent. You will also be tasked with arranging placebos for quality control testing, change part development, and evaluating the feasibility of products. Statistical evaluation for process assessment, preparation and review of standard operating procedures, training schedules, conducting training sessions, and participating in regulatory audits to support the plant will also be part of your responsibilities. Overall, as a Manager-II in the MSTG department, you will be at the forefront of ensuring the quality and compliance of processes and procedures while contributing to the continuous improvement and development of new products within the organization.,

Role & responsibilities 1. Laboratory Management Lead & supervise all QC lab functions include chemical, instrumental, microbiological testing. Ensure timely and accurate analysis of raw materials, intermediates, APIs, packaging materials. Maintain and calibrate analytical instruments (HPLC, GC, FTIR, UV-Vis, etc.). 2. Compliance and Regulatory Ensure full compliance with cGMP, ICH guidelines, and all relevant regulatory requirements. Prepare for and lead regulatory and customer audits (USFDA, MHRA, EDQM, WHO, etc.). Manage CAPA, OOS, OOT, deviations, and change control processes. 3. Documentation and Quality Systems Oversee preparation and review of all QC-related SOPs, protocols, reports, and test records. Ensure proper documentation practices and data integrity in line with ALCOA+ principles. Maintain LIMS or other digital lab systems. 4. Method Development & Validation Supervise and review analytical method validation and method transfer activities. Support R&D and manufacturing with analytical troubleshooting and investigations. 5. People Management & Training Lead, mentor, and train QC staff to build technical capability and GMP awareness. Set performance objectives, conduct appraisals, and support employee development. 6. Stability and Environmental Monitoring Oversee stability study program for APIs per ICH guidelines. Ensure appropriate environmental monitoring of QC labs. 7. Budget and Resource Management Manage the QC lab budget, procurement of lab reagents, consumables, and capital equipment. Optimize resource utilization and lab efficiency. Preferred candidate profile The Head of Quality Control is responsible for overseeing all aspects of Quality Control operations in an API manufacturing facility in Chennai & Vizag . This includes managing the QC laboratory, ensuring compliance with regulatory standards (e.g., cGMP, ICH, FDA, EMA), method validation, raw material and finished product testing, stability studies, and continuous improvement initiatives. The incumbent will lead a team of QC professionals, collaborate with cross-functional teams, and drive quality excellence across the plant.

You should have an ITI or Diploma in Electrical Engineering or equivalent qualification. Additionally, you should possess at least 3 years of experience working as an industrial electrician in a pharmaceutical or GMP-regulated manufacturing environment. Your role will require a strong understanding of industrial wiring, control panels, and basic PLC operations. It is essential that you can read and interpret electrical drawings and schematics proficiently. Knowledge of GMP standards is mandatory, and you should be willing to work in shifts if required. Preferred skills for this role include basic knowledge of automation systems, familiarity with cleanroom operations, and pharma-grade equipment. You should also have a quick problem-solving ability and be capable of working efficiently under pressure. As an industrial electrician, your key responsibilities will involve carrying out preventive and corrective maintenance of production machinery, electrical systems, and control panels. You will be expected to diagnose and repair electrical faults promptly, ensuring all electrical work complies with GMP and safety standards. It is crucial to maintain detailed documentation of maintenance and repair work, assist in equipment calibration and validation, and provide support during regulatory audits. Collaboration with production and QA/QC teams to minimize equipment downtime and managing inventory of electrical spare parts and tools are also part of your responsibilities. This is a full-time, permanent position with benefits including Provident Fund and a yearly bonus. The work schedule may include day shifts, rotational shifts, day shift availability, and night shift availability. The work location is in person.,

Requirement Experience in API Regulatory Affairs Routine job skill: Good conceptual, analytical, problem solving, reasoning and organizational skills. Should be change agile and have ability to work in highly matrixed environment. Attention to detail and accuracy required. Must be able to prioritize with independently/minimal guidance. Ability to handle multiple projects with good prioritization skills. Willingness to complete the work as per the committed timeline. Technical Skills: Sound understanding of drug development regulatory processes and requirements for defined market(s) and able to interpret and apply to projects. Ability to identify inconsistencies and deficiencies in technical data and escalates for resolution. Thorough knowledge and experience of drug development practice, rules, regulations, and guidelines. Demonstrates knowledge of key processes, procedures and tools. Regulatory Skills: Strong knowledge on the Regulatory requirements during both development and life-cycle management phases for US, Europe and other major markets and has expertise to oversee preparation and submission of complex regulatory submissions. Knowledge on current regulations and filings requirements for post approval. Competency in understanding and interpreting regulatory requirements and emerging regulatory landscape. Adequate level of knowledge on general standards SOP, processes and policies of Pharma industry. Leadership Skills: Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format. Ability to comprehend and summarize complex technical data. Ability to utilize flexible approaches to negotiate skillfully in tough situations with both internal and external groups. Gains trust quickly with cross functional team to the negotiations.

Hiring for RA Executive / AM For Pharmaceutical-Formulation Qualification: Bsc/B.PHARMA Experience: 7 to 15 Years CTC: 10.0 LPA Send CV on sdpbharuch@gmail.com sub With : RA Vadodara Free Job Share with your Friends & Colleagues!! Required Candidate profile Join Our WhatsApp Group: https://chat.whatsapp.com/EMLcH2RoVs1AzcbRKmZkjZ Follow Our WhatsApp Channel: https://whatsapp.com/channel/0029VaDwTZoHgZWddec9BL0y

You will be joining HP & ASSOCIATES LLP, Chartered Accountants, a professional services firm that specializes in Audit, Tax, and Advisory services. As part of our dynamic team, you will have the opportunity to work on a wide range of projects that aim to create, preserve, and transform value for our clients. We take a sector-first approach to ensure that our clients receive high-value solutions that help them adapt seamlessly to industry changes. In this full-time, on-site role based in Mumbai, you will be participating in a CA Articleship program at HP & ASSOCIATES LLP. Your main responsibilities will include assisting in audits, tax preparations, financial reporting, and compliance checks. You will be involved in a variety of tasks such as working on direct and indirect taxes, corporate finance, IT advisory, and risk management services. Additionally, you will be working on regulatory audits and providing advisory services to clients, all while maintaining a high level of professionalism and accuracy. To be considered for this role, you should be enrolled in the CA Articleship program with IPCC certification and have cleared both groups. This is an excellent opportunity for you to gain valuable experience in the field of Chartered Accountancy and work with a team that is committed to delivering top-notch services to our clients.,

You will be responsible for initiating, reviewing, and approving various quality management systems such as Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints. You will also handle Return Goods and ensure the smooth functioning of the quality system by performing risk assessments as required. Conducting regular internal audits and reviewing/approving all documents including SOPs, Spec & STPs, Forms, protocols, and reports will be part of your duties. Additionally, you will review annual product quality review reports, provide training on cGMP topics to employees, and support customer audits/visits as well as regulatory audits. You will assist in providing necessary documents for amendments, annual updates, regulatory filings, and CMC supporting documentation. Other tasks may include filling out questionnaires, declarations, quality agreements, and executing any additional responsibilities assigned by the Head of Department.,

As a Senior Manager - Stores at Dishman Carbogen Amcis Limited, located in Bavla, Gujarat, IN, you will be responsible for overseeing API & Formulation Stores functions. Your duties will include managing RM/PM receipt, storage, material issuance, dispatch, as well as ensuring compliance with regulatory audits such as USFDS, EDQM, PMDA. You will also be in charge of maintaining QMS related documents, statutory requirements of MA-1, MA-2, RS-2, AC-2, DS-5, and handling monthly, quarterly, and yearly returns. Additionally, you will be responsible for inventory planning, stock requirements, material movement, hazardous material handling, and tanker unloading. This role requires a strong understanding of compliance, law, and management practices.,

Role & responsibilities - Develop and execute a risk-based internal audit plan in alignment with IRDAI regulations and business priorities. Lead the internal audit team and manage relationships with external auditors and consultants. Conduct audits across operational, financial, IT, and regulatory domains. Present audit findings and risk insights to Senior Management and the Audit Committee . Monitor implementation of audit recommendations and ensure timely closure of control gaps. Drive automation and continuous control monitoring using data analytics and audit tools. Provide advisory support to business units on control design and risk mitigation.

This Opportunity is with a leading NBFC company for their office in Chennai location Role: Compliance Manager Experience: 5 - 10 Years Job Description: Roles & Responsibilities: Assist in conducting process reviews and identifying gaps in risk and compliance controls Monitor and interpret relevant RBI regulations, circulars, and guidelines for applicability Support the preparation and maintenance of compliance-related documentation and internal policies Collaborate with internal departments to ensure understanding and implementation of regulatory requirements Coordinate with auditors during internal and regulatory audits Required Skillset: Understanding of RBI regulations for NBFC or banking Industry General understanding of process review, risk, and compliance requirements in finance company Quick learner with a proactive approach to regulatory changes Hands-on with compliance monitoring tools and Excel-based reporting Must have good communication skills (verbal and written) Must have strong knowledge of MS Excel and MS Office. Qualification: CA/CA-Inter or CS/CS-Inter Interested Candidates can share their CV's at priyal@topgearconsultants.com

As a Senior Compliance Manager at Suncrypto, a top 5 Crypto Exchange in India, you will be responsible for leading the compliance and AML functions of the company. With 5-7 years of experience in Regulatory Compliance, AML, and Financial Crime Risk Management, you will play a crucial role in ensuring Suncrypto's adherence to all compliance frameworks applicable to Virtual Digital Asset Service Providers (VDASPs) in accordance with FIU-India guidelines, PMLA, FATF recommendations, and other regulatory requirements. Your key responsibilities will include developing and implementing AML, KYC, and Transaction Monitoring policies, overseeing FIU-India reporting, and handling compliance obligations for crypto transactions. You will lead and mentor the compliance team, collaborate with internal stakeholders, and act as the primary point of contact for FIU, Law Enforcement Agencies (LEA), and regulatory authorities. Additionally, you will oversee AML transaction monitoring processes, implement KYT solutions, and ensure a robust fraud risk management framework. You will also manage internal and external audits related to AML compliance and regulatory frameworks, and prepare responses to regulatory inquiries and audit requests. To excel in this role, you should have a strong understanding of PMLA, FIU-India guidelines, FATF, I4C, RBI, SEBI, and AML/CFT frameworks. Technical expertise in AML tools and transaction monitoring processes, as well as proven experience in drafting and implementing KYC, AML, and Transaction Monitoring policies, are essential. Possession of CAMS, CAME, IIBF AML certification, or any equivalent compliance certification is mandatory. If you are a seasoned professional with experience in team management, regulatory interaction, and compliance enforcement, and possess strong communication skills to liaise effectively with regulatory authorities, FIU, and senior management, we encourage you to apply for this full-time Senior Compliance Manager position at Suncrypto in Jaipur.,