59 Dmf Jobs

Paytm is India's leading mobile payments and financial services distribution company. Pioneer of the mobile QR payments revolution in India, Paytm builds technologies that help small businesses with payments and commerce. Paytm’s mission is to serve half a billion Indians and bring them to the mainstream economy with the help of technology. About Team The Statutory Audit Team is responsible for ensuring the accuracy and compliance of our company's financial statements with relevant laws and regulations. This team conducts thorough audits to identify areas of improvement, mitigate risks, and provide assurance on the financial health of the organization. With expertise in financial reporting, auditing standards, and regulatory requirements, the Statutory Audit Team plays a critical role in the system. About the role: 1. Oversee and manage the general accounting functions, including, but not limited toaccounts payable, accounts receivable, general ledger, and taxes 2. Help with quarterly and year-end financial audit activities and the annual corporate financial controls audit 3. Assess current practices and procedures, and make recommendations for improvements 4. Prepare, review, and analyze financial statements to ensure accuracy and completeness 5. Perform ad hoc analysis and projects as requested 6. Supervise and/or manage general ledger accounting functions 7. Develop staff by managing performance, setting goals, providing ongoing training, and maintaining strong employee relationships 8. Work with auditors to ensure correct and timely closing and reporting at year-end Expectations/ : 1. Creative and dedicated individual who will fit with our collaborative culture 2. Cohesively work with a lot of people, across functions and teams every day 3. Coordinate with other departments for compatibility of all aspects of each project 4. Develop comprehensive project plans along with key stakeholders 5. Program manage initiatives that are driven centrally for Technology improvements 6. Track Program/Project performance, specifically to analyze the successful completion of short- and long-term goals 7. Engage with various Business & Technology Teams within Paytm to identify common bottlenecks esp. on Technology front 8. Enable and encourage use of common services to increase the speed of development and execution 9. Smart thinking and clear communication 10. Use and continually develop leadership skills Superpowers/ Skills that will help you succeed in this role: 1. 2 to 4 years of progressive accounting experience, with a portion of it being in a supervisory role 2. Thorough knowledge of Ind AS GAAP 3. Excellent verbal and written communication abilities across all level of an organization 4. Strong leadership skills with a dedication to driving and achieving results 5. Knowledge of employee relationship building and performance management techniques 6. Advanced Microsoft Excel skills. Experience with other financial systems. Education Chartered Accountant. Why join us: 1. A collaborative output driven program that brings cohesiveness across businesses through technology 2. Improve the average revenue per use by increasing the cross-sell opportunities 3. A solid 360 feedbacks from your peer teams on your support of their goals 4. Respect, that is earned, not demanded from your peers and manager Compensation: If you are the right fit, we believe in creating wealth for you With enviable 500 mn+ registered users, 21 mn+ merchants and depth of data in our ecosystem, we are in a unique position to democratize credit for deserving consumers & merchants – and we are committed to it. India’s largest digital lending story is brewing here. It’s your opportunity to be a part of the story!

Preparation of DMFs for different markets in CTD and eCTD formats. Coordination with cross-functional dept to manage the documents. Supporting marketing team & QC/QA/R&D in various capacity. Preparation of Declarations and other supporting docs.

What you will do Let’s do this. Let’s change the world. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality, and countries. In this vital role you will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Potential to oversee or manage staff Act as a primary point of contact for specific submission execution or annual reporting tasks, including but not limited to, developing, documenting and maintaining process documents, training and onboarding new staff, and/or coordinating with impacted cross functional teams Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, postmarket supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 1 to 3 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industryOR Master’s degree and 4 to 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 6 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Experience managing or overing staff members Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Roles and Responsibilities Should Have Formulation Experience. 1. Responsible for product registration in ROW (AFRICA, ANZ, ASIA, LATAM, CIS &, MENA). 2. Responsible and involving in the regulatory audits and coordinating with the auditors/customers. 3. Preparation, compilation and review of dossiers for RoW region in CTD /country specific format. 4. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities. 5. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. 6. Responding to queries with in the time lines received from client/agency. 7. Preparation of check list as per country specific requirements in RoW region. 8. Review of documents like specifications/ MFC/ BMR/ PV/ Stability/ PDR/ DMF/ CoAs/Artworks and other quality related documents for their suitability for registration in RoW region. 9. Co-ordinating for CoPP, GMP, License and other required documents/certificates legalization activity required for dossier compilation and registration. 10. Maintenance of the dossiers, renewal files and variation approvals along with supporting documents in regulatory data base. 11. Identifying gaps in approved dossier, compiled and submit the post approval changes (Minor variations) to agent/agency. 12. Compilation and circulation of product approval package up on receipt of product approval/Minor variation approvals to concern departments. Desired Candidate Profile Should Have Regulatory Affairs Relevant Experience Perks and Benefits

Role & responsibilities We are hiring for the role of Executive - Regulatory Affairs department (API Industry ) Preferred candidate profile Candidate with 3 to 6 years experience in the Regulatory Affairs (API Industry) can apply for the job . Please drop relevant cvs to ramya_n@hikal.com

Dossier Power House

Urgent job opening for Senior Quality Assurance Executive at Dombivli. Qualification : B.Sc., M.Sc. Experience : 6 to 8 years Description of Job Responsibilities 1) Responsible for Preparation and review of master documents of QA department and review of all master documents and formats of respective departments other than QA. 2) Responsible for review of technical documents such as Technology Transfer, MPCR, BPCR, Specification and Standard test procedure, stability data, etc. 3) Responsible for preparation of training schedule and provide training on QA-related topics, guidelines, regulatory and cGMP requirements to all concerned employees. 4) To evaluate Quality and stability of finished APIs. 5) Responsible for organizing and execution of internal audit program, review of observations, follow ups and closures. 6) To investigate & approve Deviations, Out of Specification 7) Responsible for preparation, review of MSDS and approval 8) Responsible for preparation, review & approval of annual product quality review. 9) Responsible for providing effective CAPA procedures, tracking completion and implementation of the same. 10) Responsible for validation activities as per validation master plan 11) Responsible to investigate & approve customer complaints and provide responses to customers regarding complaints. 12) Ensure handling, effectiveness and continuous improvement of the QMS System. 13) Initiates Follow-Up Audit activities in order to verify Audits and record the implementation and effectiveness of the Corrections & Corrective Actions 14) To organize & performed vendor audits for critical raw materials/ packing materials & testing labs. 15) Initiates Follow-Up Audit activities in order to verify Audits and record the implementation and effectiveness of the Corrections & Corrective Actions 16) Responsible for updating and maintaining Quality management system documents 17) To ensure that the preparation, submission of Drug Master Files to customers/ authorities 18) To ensure that responsible & provide the audit compliances, DMF query responses, market complaints/ queries related to documents or products 19) To organize and participate in MRMs and to monitor actions of the same 20) Responsible for procedures of approval/rejection/release/dispatch for commercial batches and documents. 21) Responsible for the preparation DMF (Close & Open part), replying to the QA / RA related queries of Marketing, Exports, Customers, Regulatory authorities & all work related to Regulatory Affairs (RA) functions. 22) Responsible for maintaining and handling of vendor qualification activities. If you are interested for the above referred position, kindly revert back with your Updated Resume with Photograph along with following details: 1) Current salary 2) Expected salary 3) Notice period 4) Total experience 5) Relevant experience 6) Current location 7) Reason for job change Contact no.:- Sakshi - 8591939527 Mail ID:- sakshi@jobsearchindia.in

Role & responsibilities Responsible for Drug Master Filing submissions to various regulatory agencies like USFDA, European Agencies, Brazil, and other semi-regulatory countries. Review and submission of Response to queries raised on DMF by USFDA, and other agencies. Review and submission of Amendments and revisions of Drug Master Files. Review and ensuring the regulatory compliance of CMC information and manufacturing facilities of advanced intermediated through regular visits, which are intended to submit to regulatory markets. Evaluation of cost reductions processes in regulatory point of view and submitting to different regulatory agencies. Review of OOS, BPR, process validation, and other quality assurance documents required for regulatory submissions. Markets Handled: USA, Europe, Canada, Brazil, other ROW etc. Preferred Candidate Candidate must have experience working in Regulatory Affairs in Pharma API Industry.

Role & responsibilities 1. Preparation of DMFs for regulated (US, EU) & ROW markets. 2. Preparation of lifecycle management submissions (amendments / revisions) for the filed DMFs. 3. Preparation of response to deficiencies from regulatory authorities & customers. 4. Review of the data for DMF preparation received from mfg. site and R&D and ensuring required corrections. 5. Coordination with cross functional teams for data / documents. Review of the DMFs & other submissions prepared by the team. Preferred candidate profile 1. Candidate should be M.Sc. Chemistry with 6-8 years experience OR B.Sc. - Chemistry with 8 years plus relevant work experience in a reputed pharma industry, preferably in API RA. 2. Should possess good knowledge of ICH guidelines and regional regulatory requirements for US, EU, Brazil & other ROW markets. 3. Should have individually handled DMF & deficiency response submissions. Should have strong analytical & interpersonal communication skills.

Dear Candidate, We have a Job Opening for FLO-ETP /WTP in Reputed Industry at Harihar, Karnataka. Requirement Details: Location : Harihar, Karnataka Designation: Assistant Manager/Engineer Experience: 3 to 7 Years Qualification: BE /B. Tech Chemical Engineering Regular Expected Notice Period : Immediate to 30 days Responsibilities: Ensure supply of Filter, DM and Soft water to Pulp plant, fibre plant, Energy Centre and Colony Achieving First Pass Yield (FPY) and Up time (UT) Ensure treatment of effluent If you are interested, kindly share your updated CV to cg12@convate.com with below details. Kindly fill the below details: 1. Reason for job change: 2. Current Salary: 3. Expected Salary: 4. Joining Time needed Request you to kindly refer any of your friends or colleagues relevant and interested to the opportunity shared. About Convate Consultancy Recruitment Firm: Estd in 2004, Convate (team of 60 recruiters) is a leading International Recruitment Company having operations in Bangalore and Dubai. We specialize in the recruitment of IT/Healthcare/Engineering in India and the Middle East. Convate provides a learning-based work culture with a strong opportunity to grow in the years to come. Thanks and Regards, Snigdha Jha Recruitment Specialist Cg12@convate.com 9172215407 Convate Consultancy Services Pvt Ltd

Accountable to develop, implement and communicate the regulatory strategies to support registration activities for all Products for all global markets such as US, EU, Canada, Gulf and ROW Market. Lead, manage and develop leading edge regulatory strategies leading to successful regulatory filings and approvals for Generics for Global markets. implement changes required to comply with new regulatory requirements and to effectively lead and direct the creation of required data packages and facilitate knowledge for drug development. Collaborate with development and other cross functional teams during the product development activities to provide appropriate CMC as well as regulatory strategies. critical regulatory requirements to meet the quality submission and timely approvals. Responsible for all queries received from Agency or customers. Post-approval changes and Post approval compliance. communicate critical aspects of ongoing project activities and influence internal/external stakeholders to meet the regulatory requirements.

Accountable to develop, implement and communicate the regulatory strategies to support registration activities for all Products for all global markets such as US, EU, Canada, Gulf and ROW Market. successful regulatory filings and approvals for Generics for Global markets. implement changes required to comply with new regulatory requirements and to effectively lead and direct the creation of required facilitate knowledge for drug development. Collaborate with development and other cross functional teams during the product development critical regulatory requirements to meet the quality submission and timely approvals Responsible for all queries received from Agency or customers Post-approval changes and Post approval compliance communicate critical aspects of ongoing project activities and influence internal/external stakeholders to meet the regulatory requirements.

Roles and Responsibilities Manage ANDAs (Abbreviated New Drug Applications) for US market approval. Coordinate with DMF (Dossier Management Facility) team for dossier compilation and submission. Prepare dossiers, variations, renewals, and amendments according to FDA guidelines. Ensure timely review of documents by internal teams and external agencies. Maintain accurate records of all regulatory correspondences. Desired Candidate Profile MS/M.Sc(Science) or M.Pharma degree from a recognized institution. Strong understanding of formulation research development principles. Excellent communication skills with ability to work effectively with cross-functional teams. 0-3 years of experience in Regulatory Affairs - Formulations with expertise in drug regulatory affairs.

Roles and Responsibilities Prepare dossiers for DMF (Dossier Management Facility) submissions to US FDA, including eCTD structure preparation, data compilation, and review. Coordinate with cross-functional teams to ensure timely submission of regulatory documents. Review and compile technical documentation for various global markets, ensuring compliance with regulations. Manage change controls, variation applications, renewals, variations, extensions, and post-approval changes. Provide guidance on regulatory requirements to internal stakeholders. Desired Candidate Profile 6-10 years of experience in Regulatory Affairs or related field (API industry preferred). MS/M.Sc(Science) in Chemistry or equivalent qualification. Strong understanding of emerging markets' regulations (US FDA). Excellent communication skills with ability to work effectively across functions.

Preparation & implementation of SOPs related to the concerned department & Specification Handles the Regulatory & Customer audit and its compliance Responsible for ensuring that all necessary documentation is completed accurately Required Candidate profile Must to have exp into DMF Filling Good in Audit Must be from API

About The Role : Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality and countries. The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, post-market supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams Basic Qualifications: Master’s degree OR Bachelor’s degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Associate’s degree and 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR High school diploma / GED and 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: BS degree in Life Science Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms

Knowledge on Regulatory guidelines for API & Finished product registration. Preparation, Review and submission of Technical documents/Dossiers (CTD/ACTD) for Regulatory and Non Regulatory Markets. Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling of customer and MOH queries. Coordination with cross-functional teams & Reviewing of Documents (Specification, MOA, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge on EAEU, ICH and EMEA guidelines. Re-registration (Renewal) procedures. Should have hand on experience in handling ODLS, FSSAI, Sugam Portal for Licensing of Drug & Food Products. Prior knowledge on Administrative document applications (COPP, GMP, Free sale and Import License). Registration information management system updates on regular basis. Requirements Bachelors/Masters degree in Biotechnology/ Microbiology/ Pharmacy/ Regulatory Affairs. 1-4 Years of experience as Regulatory Affairs Executive in Pharmaceuticals. Interpersonal and communication skills Planning and organizing skills

To prepare Standard Operating Procedures of all departments. To review batch manufacturing records protocols and reports of all Active Pharmaceuticals Ingredients and Intermediates to support DMF / FILING. Follow quality assurance systems as per cGMP guidelines. To ensure that all manufacturing operations at the location comply with ICH Q7 system, documentation and records. To follow a system for releasing or rejecting all APIs. To follow up a system for releasing or rejecting intermediates for use outside the control of the manufacturing company. To follow a system to release or reject RM, Intermediates, packing and labeling materials. To perform product quality review. To prepare product labels and establish a system to control issuance of labels. To review raw data of analysis before release of the batch. To support Asst. Manager / Officer for Q.A activities like qualification, validation, calibration, and area monitoring. To prepare documents for customer questionnaires and support. To prepare, review and respond to the Regulatory Query. To fill the customer vendor questionnaire as per customer requirement & provide VQ related declaration. To prepare & review the DMF as per the pharmacopeia & customer requirement. To Submit the DMF to the Regulatory Authority as per the Regulatory requirement. To prepare & review declaration as per customer vendor questionnaire requirement. To perform Nitrosamine risk assessment as per the guideline requirement. To perform Genotoxic risk assessment as per the guideline requirement.

Kamla Homes is looking for Officer- RA to join our dynamic team and embark on a rewarding career journey Prepare regulatory submissions for product approvals Ensure compliance with domestic and global regulations Monitor regulatory changes and update dossiers Coordinate with QA and production for alignment

Sodexo Food Solutions India Pvt. Ltd. is looking for Operator - Stp & Wtp to join our dynamic team and embark on a rewarding career journey Responsible for coordinating all work requests coming in through e mail, phone or any other form of communication regarding the services provided to the client by Sodexo Key Responsibilities Collaborate with other members of the Sodexo on site team, to dispatch as well as collect the work orders established after receiving a request through mail/phone/paper. Collect all closed work orders to close the calls. Produce reports based on the data collected, through produced work orders, for Sodexho and the Client Receive and answer all incoming calls/mails/papers reporting complaints or work requests Log in the call through the software, which in term generates work orders Set up reports with all collected data coming from the work orders for the Client as well as for Sodexo for controlling, transparency and information purposes Maintain the helpdesk work area and equipment in a clean and orderly condition following all prescribed regulations Maintain the confidentiality and security of all data and information relating to the facility Maintain professional appearance at all times

Sodexo Food Solutions India Pvt. Ltd. is looking for Operator - Stp & Wtp to join our dynamic team and embark on a rewarding career journey Responsible for coordinating all work requests coming in through e mail, phone or any other form of communication regarding the services provided to the client by Sodexo Key Responsibilities Collaborate with other members of the Sodexo on site team, to dispatch as well as collect the work orders established after receiving a request through mail/phone/paper. Collect all closed work orders to close the calls. Produce reports based on the data collected, through produced work orders, for Sodexho and the Client Receive and answer all incoming calls/mails/papers reporting complaints or work requests Log in the call through the software, which in term generates work orders Set up reports with all collected data coming from the work orders for the Client as well as for Sodexo for controlling, transparency and information purposes Maintain the helpdesk work area and equipment in a clean and orderly condition following all prescribed regulations Maintain the confidentiality and security of all data and information relating to the facility Maintain professional appearance at all times

Sodexo Food Solutions India Pvt. Ltd. is looking for Operator - Stp & Wtp to join our dynamic team and embark on a rewarding career journey Responsible for coordinating all work requests coming in through e mail, phone or any other form of communication regarding the services provided to the client by Sodexo Key Responsibilities Collaborate with other members of the Sodexo on site team, to dispatch as well as collect the work orders established after receiving a request through mail/phone/paper. Collect all closed work orders to close the calls. Produce reports based on the data collected, through produced work orders, for Sodexho and the Client Receive and answer all incoming calls/mails/papers reporting complaints or work requests Log in the call through the software, which in term generates work orders Set up reports with all collected data coming from the work orders for the Client as well as for Sodexo for controlling, transparency and information purposes Maintain the helpdesk work area and equipment in a clean and orderly condition following all prescribed regulations Maintain the confidentiality and security of all data and information relating to the facility Maintain professional appearance at all times

Sodexo Food Solutions India Pvt. Ltd. is looking for Operator - Stp & Wtp to join our dynamic team and embark on a rewarding career journey Responsible for coordinating all work requests coming in through e mail, phone or any other form of communication regarding the services provided to the client by Sodexo Key Responsibilities Collaborate with other members of the Sodexo on site team, to dispatch as well as collect the work orders established after receiving a request through mail/phone/paper. Collect all closed work orders to close the calls. Produce reports based on the data collected, through produced work orders, for Sodexho and the Client Receive and answer all incoming calls/mails/papers reporting complaints or work requests Log in the call through the software, which in term generates work orders Set up reports with all collected data coming from the work orders for the Client as well as for Sodexo for controlling, transparency and information purposes Maintain the helpdesk work area and equipment in a clean and orderly condition following all prescribed regulations Maintain the confidentiality and security of all data and information relating to the facility Maintain professional appearance at all times

Guide the upgrade and development of plant infrastructure and systems to meet the requirements of: WHO-GMP, Russia, Australia/New Zealand, and African regulatory authorities, Ultimately UKMHRA and USFDA. Provide expert support on: WHO-GMP and GLP.

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.