28 Regulatory Audits Jobs

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.

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