40 Regulatory Audits Jobs

Role & responsibilities 1. Shall responsible to review implementation & maintain of the Quality Management system with the regulations. 2. Determining, negotiating, and agreeing on in-house quality procedures, standards and specifications 3. Checking & Maintaining of Master Documents related to the QMS system. 4. Shall responsible to review filled Batch Production control record & analysis report for batch release. 5. Responsible for coordinate validation activity and validation protocols. 6. Responsible for control and approve deviations whenever raised in the concerned department and record the deviations. 7. Review and approval of the standard operating procedures for other concerned departments. 8. Responsible to plan and carry out internal audits & MRM. 9. Responsible for Coordinate with QC/Production for handling and investigation of Market complaints. 10. Responsible for conducting on-going training programs for new recruits and retraining for existing employees of concern department on the topic of SOP, GTP, GLP cGMP, WHO, ISO, etc. whenever required or as per schedule & Responsible for verifying the effectiveness of training programs system. 11. To check and approve artworks in coordination. 12. Verification and approval of the change control whenever the change in the document, facility, process, and equipment. 13. Verification and approval of documents concern to the production process, analysis including quality system. 14. Responsible for verifying the effectiveness of corrective action and preventive action systems. 15. Responsible to review & maintain system represent in QA department SOPs like OOS, OOT, (document record, storage & retention), Document control, APQR, Calibration, Trend data, etc. 16. Should have better co-ordination with QA, Production, QC, Engineering & Maintenance, for implementation of cGMP and also the electrical department. 17. Responsible for complying with all regulatory queries during any inspection and audit. 18. Responsible for application to FDA, FSSAI, Kosher, Halal, ISO, and others for any approval like Technical person, License/Renewal License, and additional Product, GMP. 19. Also responsible to work on time and to ensure TAT (Turn Around Time) given by Directors, any other job assigned by Superior. 20. Ensuring the manufacturing processes comply with standards at both the national and international levels. Job Type: Full-time

10+ yrs exp IT & IT Security Certified in ISO 27001: 2013 Enterprise IT Governance including knowledge of IT risk management and controls Strong power point presentation creation and design Func as SPOC for IT GRC & Audits Team Leading Exp preferable 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 + additional 10% performance bonus

KEY SKILLS & COMPETENCIES: In-depth knowledge of RBI regulations applicable to NBFCs, including the RBI Master Direction for NBFCs, Digital Lending Guidelines, KYC norms, and Outsourcing Guidelines. Strong understanding of NBFC-LSP operating models, co-lending arrangements, and digital lending ecosystems. Experience in managing internal compliance controls for an NBFC and LSPs. Legal and contractual acumen to review lending and outsourcing agreements. Ability to interface with external partners. QUALIFICATIONS & EXPERIENCE: Bachelor s degree in law. Master s degree in law will be an additional advantage. Minimum 4 years of relevant experience in an NBFC, Bank or FinTechs operating in Digital Lending. Familiarity with NBFC regulatory matters, digital lending platforms is preferred. PRIMARY RESPONSIBILITIES : - Ensure provision of legal advice in framing/ review of policies and on all documents, contracts and agreements relating to the lending business to protect the organization against any legal exposure and minimize liability. Draft and review partnership agreements for NBFC and Banking partnerships and outsourcing arrangements with LSPs. Scan the regulatory environment, identify, interpret and analyze existing & new legislations/amendments & notifications that impact; bring to the notice of the appropriate functions about their implications and applicability. Advise and assist all stakeholders on both ongoing legal risks and anticipate on new legal risks, arising by virtue of new laws or regulations. Liaise and coordinate with partner NBFCs and Banks to structure new and existing products in compliance with applicable regulatory environments pertaining to lending and co-lending partnerships. Conduct regular internal diligence and risk assessments related to LSP operations and digital lending processes along with compliance function and partner lenders Coordinate with internal tech, product, and business teams to ensure compliant implementation of customer journeys and product features. Maintain documentation, SOPs, and MIS required for compliance, contractual requirements and internal/external regulatory audits.

Prepare, submit regulatory dossiers for new product registrations Coordinate and manage the submission of regulatory documents Facilitate communication with health authorities, responding to queries Required Candidate profile M. Pharm (Female Candidate Preferred) 1 year of experience in Regulatory Affairs in Pharmaceutical Formulations unit desired. Excellent communication skills.

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.

QA Senior Executive / Quality Assurance Manager CTC UPTO 6 LPA, Contact: 09990842892 Email: info@wellgen.in We are a 30-year-old Medicine Manufacturer Company is located in Baddi Experience : Minimum 7 years of Pharmaceutical Experience Qualification : B.Pharm You will also be responsible for identifying and resolving quality-related issues and ensuring that the company's products and services meet the requirements of customers Conduct regular quality audits to identify and resolve quality-related issues Develop and maintain quality metrics to track performance and identify areas for improvement Manage the documentation process for quality assurance procedures, including the creation and maintenance of standard operating procedures (SOPs)Role & responsibilities Preferred candidate profile Male candidate

Job Overview To perform quality control testing of raw materials, intermediates, and finished products as per approved specifications, ensuring compliance with cGMP, regulatory, and company standards. Roles and Responsibilities: Conduct chemical and instrumental analysis of raw materials, intermediates, and peptide APIs using HPLC, GC, UV-Vis, IR, Karl Fischer, and TOC. Execute peptide-specific analytical techniques including reverse-phase and ion-exchange HPLC, amino acid analysis, and peptide mapping where applicable. Perform method validation, verification, and transfer in line with ICH guidelines. Maintain and review analytical documentation such as SOPs, STPs, specifications, and validation protocols. Ensure compliance with cGMP, GLP, and data integrity practices in all laboratory operations. Support OOS/OOT investigations, perform root cause analysis, and assist in CAPA implementation. Monitor calibration, maintenance, and qualification of analytical instruments as per the approved schedule. Prepare samples and documents for regulatory submissions and audits (e.g., DMF support, ANDA filings). Coordinate with QA, RA, Production, and R&D for timely resolution of issues and release of batches. Participate actively in regulatory audits (USFDA, EUGMP, WHO, etc.) and internal quality audits. Experience 14 years of experience in QC in pharmaceutical / chemical / API manufacturing industry Competencies Hands-on experience with instruments like HPLC, GC, UV-Vis, and others. Sound understanding of cGMP, GLP, and regulatory guidelines Strong documentation and communication skills. Ability to work in shifts and under pressure. Team player with problem-solving and analytical skills. Responsibilities Qualifications 2-5 years of experience in the QC department of a USFDA / EUGMP-approved peptide/API manufacturing company

KRA's: Quality check of all raw materials, in-process and finished goods on a FIFO basis QMS Implementation Audit Documentation Internal/ external as well as 3rd party/ regulatory audit compliances Required Candidate profile 5+ years of experience in Quality [quality inspection, auditing, testing, reporting] in a medical device/ pharmaceutical manufacturing co. Should be ready to travel or relocate to Taloja Navi Mumbai

Supervision of cleaning and calibration processes for equipments like electronic weighing balances, dispensing accessories, deep freezers, temperature sensors. Ensure the proper cleaning of packing materials, raw materials and Finished Goods storage areas. Ensure the cleaning procedures for various items like empty drums, hose pipes, flycatchers, Weighing Boxes, Standard Weights etc., Supervision of the receipt, storage, issuance, dispensing of raw materials, solvents, packing materials, and intermediate materials. Ensuring that FIFO/FEFO systems is followed during issuance, dispensing & storage of materials and specific requirements for hazardous or temperature / Humidity sensitive materials. Maintaining records for all raw materials received and issued, ensuring proper documentation like MRNs (Material Receipt Notes), logbooks, registers etc. Supervision of scrap/waste disposal activities in compliance with Standard procedures. Ensuring timely removal of waste from the warehouse and segregation of expired materials or those due for retesting. Supervising inventory management, including accurate weighing of materials, storage and issuance to production department as per material requisition slip. Preparing and maintaining dispatch records and performed the activity as per SOP procedures. Ensuring the stored material as per prescribed condition and maintain storage manual and records. Monitor the inspection activity of outdoor storage solvent drums, handling of retest/expiry material, handling of rejected material procedures, Return material, Intermediate Storage room, Temperature Mapping, EHS aspects. Provide the induction to joining the new employees. To ensure and provide the training to new employees as well as contract workers for handling & storage of materials. Implementing and ensuring the adherence to SOPs related to handling of materials, equipments and cleanliness. Reviewing and overseeing the implementation of corrective actions for deviations, incidents etc. Ensuring compliance with Regulatory Requirements and Quality standards in Inventory Management. Participating in investigations of complaints, deviations, Out of Specifications, incidents or any non-conformances, performing the root cause analysis and implementing corrective actions to prevent recurrence. Involve in mock recall procedures provide the list of customers/agents, contact details, reconciliation of materials of API batches / recalled batches and managing the recall of APIs, including documentation, labelling and storage etc. Leading a team to ensure the smooth operation of warehouse activities. Supervising the activities of various teams, including cleaning, material handling, storage and inventory management. Ensuring effective communication and timely execution of tasks within the team and cross-functional departments. Change Control reviewing and assessing the impact of proposed changes on standard practices whether in process, equipments or issuance of material to ensure that changes are appropriately executed. Evaluating repetitive deviations and taking steps to address systemic issues. Ensuring that data integrity is maintained in all warehouse activities, highlighting any potential data issues for further investigation. Participating the customers and Regulatory Audits and providing the compliances as per guidelines. Knowledge of GMP inventory management Good documentation practices Dispatch and logistics coordination Attention to detail, team coordination skills

QMS Implementation Audit facilitation: will represent the company during regulatory/ 3rd party audits: MHRA, USFDA, MCC, WHO, etc. Products: temperature-controlled packaging & temperature monitoring systems used for storage & transit of medicines Required Candidate profile Any science graduates 10-15 years' experience in quality, ideally in pharma/ medical devices/ equipment manufacturing industry International Audit Experience mandatory Should be open for global travel

KRA's: Ensure SOPs are followed & quality standards are met Quality check of raw materials, in-process & finished goods on a FIFO basis QMS Implementation Audit Documentation Audit facilitation - Internal/ external & 3rd party/ regulatory audits Required Candidate profile 5+ years of experience in Quality [quality inspection, auditing, testing, reporting] in a pharma/ medical device mfg. co Ready to relocate to Medchal, Hyderabad Accommodation & food will be provided Perks and benefits Accommodation and Food provided

Role & Responsibilities: As a QA Manager , you will lead the Quality function across multiple departments, including Quality Assurance (QA), Quality Control (QC), and Microbiology. This critical role ensures that manufacturing operations are fully compliant with international regulations and consistently meet high-quality standards. You will drive continuous improvement initiatives, manage audits, and oversee the development and implementation of strategies to enhance product quality. Key Responsibilities: Leadership & Quality Culture: Lead, mentor, and inspire the Quality teams, promoting a culture of quality across the organization. Ensure audit readiness at all times and foster a proactive, quality-driven environment. Regulatory Compliance & Audits: Ensure strict adherence to international regulatory requirements such as WHO GHP, Revised Schedule M, and other relevant standards. Manage successful audit outcomes to maintain compliance. Manufacturing Operations: Oversee cGMP-compliant operations, focusing on the production of Oral Solid Dosage (OSD), Small Volume Parenteral (SVP), Beta Lactam, and External Preparations. Manage scale-up processes, new product development, and product lifecycle. SOPs & Documentation: Ensure all Standard Operating Procedures (SOPs) align with WHO GHP, Revised Schedule M, and regulatory guidelines. Work closely with cross-functional teams on new product registrations and updates. Quality Management Systems (QMS) & Continuous Improvement: Strengthen and enhance the QMS across the organization. Drive continuous improvement initiatives, ensuring that quality is maintained and improved at all levels of operation. Risk Management & Compliance: Conduct regular compliance reviews, facilitate facility and equipment qualifications, and manage quality risk assessments to mitigate potential risks to product quality. Dossier Filing for Exports: Oversee and manage the preparation and filing of dossiers for export markets, ensuring that all documentation meets regulatory and quality standards. Key Skills & Experience: Experience in Regulated Environments: Extensive experience in manufacturing environments, particularly in the production of injectable products, with a deep understanding of regulatory standards and compliance processes. Audit & Compliance Management: Strong background in audit management, ensuring successful audit outcomes while maintaining the highest standards of compliance. Leadership & Team Management: Proven leadership ability to manage cross-functional teams, mentor staff, and build a cohesive and effective Quality function. Analytical & Negotiation Skills: Strong analytical skills to assess compliance and quality issues, with the ability to negotiate and resolve challenges effectively. Communication & Collaboration: Excellent verbal and written communication skills, with the ability to collaborate effectively with internal teams and external regulatory bodies. Travel Flexibility: Open to travel up to 50% of the time, managing various scheduling requirements across different sites.

Job Title: FDA & International Pharma Compliance Consultant (Excipients, API & Ingredients & Formulations) Location: Kutch, Gujarat (Remote advisory with periodic on-site presence) Experience: 2025 years in pharmaceutical manufacturing and regulatory compliance Salary: Competitive Education: Bachelors or Master’s in Pharmacy, Pharmaceutical Sciences, Chemistry or related discipline Kindly get in touch for career advancement opportunities with us at rupsha.saha@antal.com Roles & Responsibilities Guide the upgrade and development of plant infrastructure and systems to achieve compliance with: WHO-GMP Regulatory requirements of Russia, Australia/New Zealand, African authorities Ultimate readiness for UK MHRA and US FDA audits Provide expert support on: WHO-GMP and GLP compliance for excipients, APIs, and formulation ingredients Equipment qualification (DQ/IQ/OQ/PQ) and cleanroom classification Process and cleaning validation Quality Management Systems (QMS), documentation (SOPs, BMRs, BPRs) and change control protocols Advise on regulatory documentation strategy for DMF and CTD/ACTD filings, including supplier qualification Assist in product selection and formulation pipeline development, identifying high-potential excipients and formulations for domestic and export markets Train and mentor QA, QC, production, and R&D teams on global pharmaceutical standards and best practices Desired Profile 20–25 years’ experience in excipients, API or formulations manufacturing, with a top-tier pharmaceutical company Proven track record of preparing and leading facilities through US FDA, MHRA or TGA audits Deep working knowledge of: ICH Q7/Q8/Q9/Q10 WHO GMP and EU GMP Annexes Indian D&C Act & Schedule M Hands-on experience supporting DMF submissions and familiarity with USP, EP, BP and IP Prior consulting or leadership roles serving regulated export markets Strong grasp of product lifecycle management, export documentation and quality risk management for emerging markets Tech-savvy, with exposure to digital QMS or e-BMR systems (desirable) Awareness of sustainability and EHS standards for global audit readiness Excellent cross-functional collaboration skills spanning production, QA/QC, R&D and supply-chain teams About Antal Antal International is a 30-year-old global executive search and placement firm with a network of over 800 people across 35+ countries, originally based out of the UK.

Roles and Responsibilities Prepare dossiers, variations, renewals, and amendments for regulatory submissions to FDA and other global health authorities. Coordinate with cross-functional teams to ensure timely submission of regulatory documents. Maintain accurate records of all regulatory correspondence, reports, and audit findings. Ensure compliance with regulatory guidelines and requirements by reviewing documentation and conducting internal audits. Provide support during regulatory audits by gathering necessary information and preparing responses. Desired Candidate Profile 1-4 years of experience in Regulatory Affairs or related field (pharmaceutical industry). Bachelor's degree in Pharmacy (B.Pharma) or Science (B.Sc), preferably in a relevant specialization. Strong understanding of FDA regulations, regulatory operations, compliance, submissions, documentation, guidelines, issues, reports.

Roles and Responsibilities Ensure compliance with regulatory requirements from USFDA, GMP, WHO, and other relevant authorities. Conduct internal audits to identify areas of improvement and implement corrective actions. Develop and maintain relationships with regulatory agencies to ensure smooth operations. Provide guidance on Good Manufacturing Practices (GMP) and Current Good Manufacturing Practice (cGMP) guidelines. Collaborate with cross-functional teams to resolve regulatory issues. Desired Candidate Profile 5-10 years of experience in Regulatory Affairs or related field. Strong knowledge of Allopathy or homeopathy regulations and guidelines. Proven track record of handling regulatory audits successfully. homoeopathy

Dispatch Achievement Verification of all Inwards & Outward material with correct documents, material code & qty etc. Stock Management Slow & non moving stock management 5s & Kaizan though implementation in ground operation Labor Management SOP compliance Minimum stock planing of Material & Packing material Working Language : - Hindi,Marathi,English

Help in Day To Day Production Of Pharmaceutical Products Manpower Allocation For Smooth Working In Shift Supervision Of Production Activity BMR And BPR Report Preparation Data Preparation For Internal And External Audit -IE. US FDA - EU GMP Etc Required Candidate profile B. Pharm - M. Pharm - B.Sc - M. Sc Experience In Production Or Packaging Working Experience US FDA Approved Plant is Desirable FDA Approval in Tablet - Capsule Or Any will be an added advantage

Help in Day To Day Production Of Pharmaceutical Products Manpower Allocation For Smooth Working In Shift Supervision Of Production Activity BMR And BPR Report Preparation Data Preparation For Internal And External Audit -IE. US FDA - EU GMP Etc Required Candidate profile B. Pharm - M. Pharm - B.Sc - M. Sc Experience In Production Or Packaging Working Experience US FDA Approved Plant is Desirable FDA Approval in Tablet - Capsule Or Any will be an added advantage

Role & Responsibilities Assist in API/intermediate manufacturing as per SOPs. Monitor production processes and ensure GMP & quality compliance. Maintain batch records, logbooks, and related documentation. Handle raw materials, samples, and finished goods safely. Operate equipment such as reactors, centrifuges, dryers, and filters under supervision. Collaborate with QA, QC, and Engineering teams. Maintain workplace hygiene and follow EHS guidelines Preferred Candidate Profile B.Sc. / M.Sc. in Chemistry or related discipline. 04 years of experience in API or intermediate manufacturing (Freshers can apply). Willing to work in rotational shifts. Good knowledge of GMP, safety protocols, and documentation practices. Strong attention to detail, willingness to learn, and teamwork attitude.

Role & responsibilities Candidate should be from API industry having knowledge of handling sophisticated Analytical Instruments. He should be able to work, adopt and guide subordinates and juniors in following Good Laboratory Practices. He should be well versed with various regulatory & Statutory requirements. Experience in facing regulatory and customer audits. Preferred candidate profile Should have minimum 10 years experience including minimum 3 years as Deputy Manager. He should be able to guide the team for completing the task assigned.

Role & responsibilities Well experience in reviewing product development related activities Good knowledge in quality and regulatory requirements Hands on experience in handling paperless documents and electronic data review Experience in handling customer and regulatory audits Good knowledge in MS office, power point and excel Interested Candidates can share there CVs to dinesh.baratam@msnlabs.com

Role & responsibilities - Understanding and applying regulatory requirements in line with MDR 2017/745. Identifying and determining specific regulatory requirements for each product. Implementing a proactive approach for planning and conducting Clinical Evaluation (CER), Post-Market Surveillance (PMS), and Post-Market Clinical Follow-up (PMCF) activities. Ensuring compliance with regulatory guidelines and conducting CER, PMS, and PMCF activities in accordance with established procedures and EU regulatory requirements. Monitoring regulatory updates, ensuring continuous compliance, and making necessary updates to documentation and processes. Preparing regulatory dossiers and managing all documentation to ensure that regulatory submissions meet the standards and deadlines. Collaborating with cross-functional teams to ensure that regulatory affairs are effectively integrated into product development, marketing, and post-market activities. Experience in regulatory documentation, regulatory compliance , and ensuring that products meet applicable standards. In-depth knowledge of medical device regulations and standards , particularly those required under EU regulatory frameworks. Qualifications: Masters degree or equivalent in Regulatory Affairs, Life Sciences , or a related field.

Review & process applications for accreditation Maintain documentation of the process for audit Conduct assessments & evaluations of the applicants with SEBI Generate invoices for the applications processed Prepare periodic reports of applications Required Candidate profile Fluent communication skills Hands on experience on Excel, word and PowerPoint Should have good presentation skills Document verification of Clients

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.

Job Purpose Help team for IT GRC Knowledge of applicable Information Security management, Governance, and Compliance principles, practices, laws, rules, and regulations. Risk assessment and management methodology. Independent assessment/audit as per ISO Standards. Audit/assess IT General Controls. Professional experience in Audit Management Systems, Vendor Risk Management, User Access Management, Environmental Social and Governance solutions implementation. Exposure of working across internal audit departments of Banks, Small Finance companies and Insurance, Mobile Tower. Developed Business Requirements Documents, Technical Customization, Gap Documents and Functional Specifications. Previously worked end-to-end Banks Projects, Small Finance companies' projects. Rendered strategic advisory for prompt & effective resolution of critical development Functional issues; delivered projects at highest standards of quality by effective coordination with multiple team members. Proficient in managing service operations with key focus on defining SLAs, Contracts by ensuring optimal utilization of resources as well as handholding of business partners & key stakeholders. Leveraged skills in liaising with administration, account department for obtaining sanctions, approvals, and others clearance. Skilled in people management, maintaining healthy employee relations & resolving employee grievances Key Skills : Risk, Governance, Compliance, Regulatory audit. Candidate aware about Information security regulatory requirement. Good in soft skills and communication skill with internal stake holder. Looking for team player.