161 Fda Jobs

Primary Function of Position: The Senior Quality Systems and Compliance Staff will provide leadership for ISI's quality systems function to ensure the overall quality management system (QMS) align with domestic and global regulatory requirements. Collaboration with business partners and management will be key to create and sustain a QMS infrastructure that is compliant, effective, efficient and agile to support a rapidly growing international business model with complex and diverse product lines. The Senior Quality Systems and Compliance Staff will have strong leadership skills to support established customer-focused quality initiatives plus maintain and improve the health of QMS. The leadership skills will serve to manage projects that identify and drive continuous improvements for a robust and agile QMS. Roles & Responsibilities: Provides leadership for Quality Systems and Compliance projects and personnel to ensure the fulfillment of company quality goals and objectives Mentors others for the development and maintenance of a robust quality systems and compliance team Leads and facilitates projects for the development, maintenance and improvement of the company's quality management system with a focus on maintaining robust processes and optimization where feasible Support facility inspections and audits required by government and regulatory agencies on a global basis. Shares responsibility with Regulatory Compliance on maintaining audit readiness for internal and external audits; provides backroom leadership during external audits Provides guidance to business partners and the QSC group in the interpretation of FDA regulations and external regulations/standards pertaining to processes within the quality management system Performs assessments, develops action plans, and drives/facilitates implementation activities to address new requirements from global standards or regulations Supports business partners and QSC group in determining risk-based actions and decisions to ensure quality system issues are appropriately escalated and addressed Develops, maintains and improves processes and procedures for various processes within the quality management system and where necessary, provides training Collaborates with OUS ISI sites in the harmonization of primary quality system processes and where appropriate, leads primary quality initiatives within the quality systems Qualification Minimum Bachelor Degree - BS degree in Engineering, Physical or Biological Science, or other technical field Ten plus (10+) years' experience in quality systems, quality engineering, or compliance (or combined experience) in the medical device or other regulated industry Five plus (5+) years' experience in a leadership role with direct management experience strongly preferred Demonstrated strong leadership and partnership in working with diverse teams for improvements, issue resolution, or projects Applied understanding of applicable US medical device regulations (e.g., 21 CFR Part 820, 21 CFR Part 11), international standards (e.g., ISO 13485, ISO 14971), India regulations Experience with computer software validation (CSV) regulations/standards and methodologies Experience in developing and implementing processes and procedures to comply with regulations and standards across the organization; and providing training Strong organizational, written, and verbal communication skills; plus critical thinking skills and proficient in constructive dialogue Effective at prioritizing tasks and responsibilities within a fast-paced, dynamic environment Effective in collaborating and partnering with all levels of management and displaying an appropriate level of assertiveness Good understanding of product development lifecycles; design control through post-market surveillance Applied knowledge of risk management, CAPA, and internal/external audit methodologies Practiced in presenting to various levels of management Experience working directly with regulators such as CDSCO, FDA, Notified Body, or other governmental agencies (preferred) Applied knowledge of validation methodologies pertaining to computer system, process and equipment (preferred) Six Sigma Greenbelt certification or other professional certification (e.g., ASQ certification) (preferred) Additional Information Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

As a Research and Development (RD) Asst. Manger in Hair Care, you will play a pivotal role in the creation and testing of new hair care. You'll work closely with scientists, chemists, and other team members to ensure the smooth operation of lab processes and the development of innovative hair care range. This role requires a keen eye for detail, a passion for cosmetics, and the ability to adhere to strict quality and safety standards. Responsibilities: Lab Operations: Execute laboratory experiments and procedures. This includes preparing hair care product, conducting/monitor stability tests, and performing quality control checks. Formulation Development: Create formulation basis product brief from the scratch to the finalization. Follow established protocols and document all experimental procedures and outcomes accurately. Ingredient Selection: Collaborate with RD team members to research and evaluate cosmetic ingredients for efficacy, safety, and regulatory compliance. Contribute insights on ingredient functionality and compatibility in formulations. Testing and Analysis: Conduct various tests and analyses to assess the performance, stability, and safety of cosmetic products. This may involve viscosity measurements, pH testing, microbial analysis, and sensory evaluations. Documentation and Reporting: Maintain detailed records of experimental procedures, formulation recipes, test results, and other relevant data. Prepare reports and presentations summarizing RD activities and findings for internal review and regulatory purposes. Equipment Maintenance: Operate and maintain laboratory equipment and instrumentation, ensuring proper calibration and functionality. Notify appropriate personnel of any equipment malfunctions or maintenance needs. Compliance and Safety: Stay updated on industry regulations, guidelines, and best practices related to cosmetic formulation and testing. Follow safety protocols and procedures to minimize risks in the laboratory environment. Qualifications: Bachelor's degree in Chemistry, Chemical Engineering, Cosmetology, or a related field. Previous 4-6 years of experience in a hair care division, preferably from Loreal or Unilever. Strong understanding of cosmetic science, formulation principles, and ingredient functionality. Familiarity with laboratory techniques and instrumentation used in cosmetic analysis and testing. Excellent organizational skills and attention to detail. Effective communication and collaboration skills, with the ability to work well in a team environment. Knowledge of regulatory requirements for cosmetics, such as FDA regulations and EU Cosmetics Regulation, is a plus. Attributes: Passion for cosmetics and beauty products. Analytical mindset with a problem-solving orientation. Adaptability and willingness to learn new techniques and technologies. Commitment to quality, safety, and compliance. Creative thinking and innovation in product development.

Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose the relentless pursuit of a world that works better for people – we serve and transform leading enterprises, including the Fortune Global 500, with our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI. Inviting applications for the role of Regulatory Engineer! In this role - The team developing industry leading X-ray generation subsystems is looking for highly motivated regulatory engineers to join them in ensuring compliance and availability of these subsystems for CT scanners to all the global markets of interest. Regulatory Engineer will be working on compliance activities for various medical devices global regulations. Responsibilities Collaborate with cross functional teams (engineering, manufacturing, regulatory, sourcing, etc ) to lead or support compliance activities to medical device regulations. Review regulatory compliance change notifications and drive associated actions to be compliant by the effective date Lead compliance efforts to various global regulations (Eg. REACH, ROHS, etc) in alignment with the quality management system Lead or support product regulatory documentation updates (eg NRTL reports, tech file, etc) Support regulatory audits and inspections to ensure post-market surveillance compliance. Qualifications we seek in you! Required Qualifications Bachelor’s degree in engineering, Science or related area Minimum of 2 years of experience working with medical devices regulations and quality management system. Tools and Technologies Knowledge of medical regulations including FDA, EU MDR, NMPA/CFDA, and other applicable international regulations Knowledge of regulatory standards such as IEC 60601, ISO13485, 14971 and other applicable standards and substandard. Proficiency in interpreting, applying complex regulations, and preparing associated documentation. Excellent interpersonal communication and collaboration skills Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values respect and integrity, customer focus, and innovation. For more information, visit www.genpact.com . Follow us on Twitter, Facebook, LinkedIn, and YouTube. Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a 'starter kit,' paying to apply, or purchasing equipment or training.

Key Responsibilities: Project Delivery & Oversight Lead end-to-end delivery of MedTech projects, including software platforms, connected devices, and digital health tools. Define project scope, goals, and deliverables in collaboration with stakeholders. Manage timelines, budgets, and resource allocation. Stakeholder Management Act as the primary liaison between clinical teams, IT, vendors, and regulatory bodies. Translate clinical and business requirements into technical specifications. Compliance & Quality Ensure all solutions comply with healthcare regulations (e.g., FDA, MDR, HIPAA). Oversee validation, testing, and documentation processes. Team Leadership Lead cross-functional teams including developers, QA, clinical informaticists, and product managers. Mentor junior team members and foster a culture of continuous improvement. Risk & Issue Management Identify project risks and develop mitigation strategies. Resolve delivery issues and escalate when necessary. Qualifications: Bachelor's or Master's degree in Engineering, Computer Science, Biomedical Engineering, or related field. 5+ years of experience in project or delivery management within the MedTech, HealthTech, or Life Sciences sector. Strong understanding of medical device lifecycle, software development (SDLC), and regulatory frameworks. Experience with Agile, Scrum, or hybrid project methodologies. Excellent communication, leadership, and stakeholder management skills.

JD @ QC Executive will ensure that products meet quality standards & regulatory requirements with analyzing samples, conducting tests, maintaining documentation & more Accommodation, Meals & Transport from client side Saturdays are Half day

Testing of food samples(frozen/solid/liquid/breverages) as per IS/ISO/FDA/EPA methods Maintenance of NABL documents Media and sample preparation, media performance and method validation test.

Company Name: A wholly owned subsidiary of Alkem MedTech Private Limited. Purpose of the role: The Engineering and Facilities Lead is responsible for overseeing and managing all engineering and facilities operations within the organization. This includes ensuring the safe, efficient, and compliant operation of the companys facilities, including shopfloor, laboratories, and office spaces. The role involves leading a team to maintain and improve facilities systems, equipment, and infrastructure, ensuring that all operations meet regulatory standards, safety requirements, and operational efficiency targets. Roles & Responsibilities: Facilities Management & Operations: Oversee the day-to-day operations of all company facilities, ensuring compliance with safety, environmental, and regulatory standards (e.g., FDA, GMP, OSHA). Manage facility maintenance programs, including preventive and corrective maintenance schedules, to ensure the smooth operation of all systems (HVAC, electrical, plumbing, etc.). Ensure the integrity of all infrastructure (e.g., building structures, equipment, utilities) and coordinate repairs or upgrades as needed. Maintain a clean, safe, and efficient work environment, ensuring facilities are compliant with regulatory standards and industry best practices. Engineering Support & System Optimization: Provide engineering expertise and support to optimize facility systems, equipment, and processes. Identify opportunities for process improvement, energy savings, and cost reduction across engineering and facilities operations. Ensure the proper functioning and calibration of critical equipment used in manufacturing and testing processes, aligning with the companys quality control and regulatory requirements. Lead engineering projects related to facility upgrades, new construction, or equipment installations, ensuring timelines and budgets are met. Regulatory Compliance & Safety: Ensure that all facilities, equipment, and systems comply with relevant regulatory guidelines (e.g., FDA, GMP, environmental regulations). Implement and maintain safety protocols to ensure a safe working environment for all employees, including hazardous material management and emergency response plans. Lead risk assessments and implement corrective actions to mitigate any safety or operational risks within the facilities. Prepare and support internal and external audits and inspections, ensuring all necessary documentation is in place for regulatory compliance. Capital Projects & Budget Management: Lead and manage capital projects related to facility improvements, expansions, or new installations, ensuring adherence to project plans, timelines, and budgets. Develop and manage the facilities and engineering budget, ensuring cost-effective use of resources and identifying cost-saving opportunities. Evaluate and recommend investments in new technologies or infrastructure improvements to increase efficiency and meet business objectives. Sustainability & Environmental Initiatives: Develop and implement sustainable practices for energy use, waste management, and resource conservation in the facilities. Work with environmental health and safety teams to ensure compliance with local environmental laws and regulations. Drive initiatives to reduce the companys environmental footprint and improve overall sustainability within engineering and facilities operations. Emergency Preparedness & Crisis Management: Ensure the implementation of robust emergency response plans and procedures, including power outages, system failures, or facility incidents. Lead the crisis management team during any facilities-related emergency, coordinating response efforts and ensuring timely resolution.

Role & responsibilities Liaison with Food & Drugs Control Administration, Gandhinagar/circle offices/CDSCO for various applications including but not limited to Product Permissions for manufacturing COPPs Various certificates for tender (FSC, Performance certificate, Non-conviction certificate) Inspections for WHO GMP/Schedule M GMP certification Technical persons approval Technical person application verification. Liaison with CDSCO, West Zone, Form 29 Export licenses Loan license Manufacturing licence renewal for all plants Wholesale licences Submission of commercial batches to CDL Kasauli for testing Submission of quarterly returns to NCB/CBN Handling NSQs Experience in submissions through Sugam, NSWS and ONDLS portals

Role & responsibilities To establish the quality, health & safety policies, procedures, standards and specifications Maintain Certificate of Conformity for all our Products To work with the procurement team & production team to ensure quality standards To look at ways to reduce waste and increase efficiency; To set audit/ inspection procedures, protocol and checklist To conduct periodical inspections at the supplier location & also our warehouse for quality control, evaluate problems and suggest corrective action Focus on Continuous Improvement Preferred candidate profile Women candidate with Graduate in BSC Chemistry / B Pharma

Regulatory Submissions Publisher – Mumbai/Bengaluru (Night Shift). Prepares & QC’s regulatory dossiers (IND, NDA, CTA, BLA, IMPD, MAA) for US, EU, Canada, ANZ. Handles EDMF, COS/CEP, MRP/DCP/CP filings Required Candidate profile Requires 2+ yrs pharma publishing exp, Documentum/Liquent Insight skills, MS Office proficiency. Must have international BPO exp, grad degree, and be based in Mumbai/Bangalore. No ex-TCS candidates.

Role & responsibilities Review and approve product test license, Import license for RLD and API. Review and approve standard operating procedures (SOPs) of equipment, instruments & facilities. Plan and execute reverse engineering of RLD and marketed products. Conduct Pre-formulation and formulation studies to evaluate the physical and chemical properties of drug substances and drug products. Plan and optimize formulation for Injectable dosage forms. Compile, review and approve technical documents, including Formulation Development and Stability study protocol reports. Plan and perform stability studies to ensure formulation meets stability requirements. Compile, review and approve API, Formulation stability reports. Ensure compliance with regulatory documents and company quality standards. Coordinate with Analytical, Regulatory, Stores, Purchase, Project management and Development Quality Assurance teams to support product development and regulatory submissions. Maintain laboratory equipment and ensure proper calibration and maintenance. Participate in technology transfer activities to manufacturing sites. Prepare FD lab for agency audits and customer visits. Other roles and responsibilities assigned by the FD Manager and R&D Head. Preferred candidate profile Master's degree in Pharma or related field Must have 06 - 08 years of Experience in Formulation Development Must have 04 - 06 years of team handling role in R&D Centre

Responsibilities: Review of formulation development documents like trade dress for new product, feasibility report, justification for specification, scientific study protocol and report and pharmaceutical development report. Health insurance Provident fund

Role & responsibilities Responsibilities: - Oversee and manage quality control processes and procedures within the organization - Develop and implement quality control standards and guidelines - Conduct regular inspections and audits to ensure compliance with quality standards - Analyze data and trends to identify areas for improvement and implement corrective actions - Collaborate with cross-functional teams to address quality issues and drive continuous improvement - Train and mentor QC staff to ensure adherence to quality control protocols - Prepare and maintain documentation related to quality control activities - Participate in regulatory inspections and audits as needed

* Urgent job opening for Production Chemist for reputed Chemical Manufacturing Company with B.Sc. / M.Sc. ( Chemistry) near Vadodara Location. * Experience in FDA Approved in Bulk Drugs Manufacturing

: Job Title Regulatory Advisory Analyst Location Bangalore, India Corporate TitleAssociate Role Description The Regulatory & Exam Management ("R&EM) team is responsible for not only coordinating the Bank's relationships with its regulators but also overseeing any external party engagement or exam administration related to regulatory assigned monitors, consultants and/or auditors for all CAO related matters, from inception through field work and ultimately report generation, distribution and findings upload in GFMS. The team's success is rooted in following these four main principles: Drive consistent communication to our regulators; Organize staff based on residing location and functional areas supported, encouraging specialization by subject matter; Standardize exam management process-including reporting templates-and apply same rigor for regulatory exams, enforcement monitorships and statutory audits; and Set forth interaction protocols to define the operating model with those parties outside R&EM's umbrella such as Litigation & Regulatory Enforcement, Anti-Financial Crime, Compliance, COO and the businesses What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy Best in class leave policy Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities Scheduling of meetings on behalf of examiners and/or regulators Tracking, collection and submission of documentation requests, including maintenance of document request log; hosting of Sharepoint sites for easy storage and access to documents; and production of relevant exam statistics for key stakeholders Overseeing onsite review logistics such as scheduling office space, arranging building access and requesting technology access Reviewing and prioritizing emails received in group mailboxes for assignment and escalation and uploading report submissions to the respective regulators Overseeing monthly, quarterly and ad hoc reporting process which includes chasing stakeholders for updated content and compiling final document(s) ensuring consistent format and language used Preparing briefing documents including relevant participants, timing, bios, agendas, etc. Managing the interaction tracking centrally in GFMS (RFIs, meetings, notification and letters) Performing general administrative support to global R&EM colleagues Your skills and experience Bachelor's degree with 1-2 years of relevant experience in project management, consulting, and/or remediation analysis Ability to multi-task and work in a fast-paced environment Ability to proactively and professionally engage with multiple stakeholders Ability to prepare status reports, including the synthesis and tracking of multiple initiatives, activities and programs of work Self-motivated, proactive and resourceful, with ability to identify solutions to issues Strong attention to detail required Strong problem solving, analytical, organizational and interpersonal skills Excellent (oral and written) communication and presentation skills Ability to work independently with minimum supervision and collaborate as necessary with team members Strong MS Excel / Word / Powerpoint skills required How we'll support you Training and development to help you excel in your career Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.

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 : ISO 9001/ISO 13485. Manage the Quality Management System. To provide QA support in all quality related matters and to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements. Risk Management & CAPA. Establishing procedures and records as per requirement of standards and regulatory authorities. Responsible for establishing, managing, and implementing Records Management policy, Records. Retention and retrieval procedures are in place. To manage and execute internal and external audit schedules and follow up on action plan, Quality Auditing of External suppliers - maintain an annual auditing program. Regular Internal Quality Audit and maintain the company anytime audit ready. Participate in and/or lead audits, manage action plans and follow up on agreed upon CAPAs & NCs. To monitor & handle market complaints. Conduct Management review at site. Conduct Calibration of instrument & Maintain Calibration Matrix . Ensure that a respective Change Control procedure is in place and adhered to . Process validation protocol preparation & implementation. Provide leadership and expertise on all aspects of product regulatory compliance to ensure that products are successfully introduced and maintained domestically and globally pursuant to regulatory compliance. Must be capable to handle all types of Audit. To Lead and face the regulatory audits and close all queries and NC in stipulated time. To maintain all documents related to compliances. Create Maintain & update Device Master/ Product Technical File. Preferred candidate profile: Graduate in Science or Engineering . Post Graduation preferred. Thorough Experience in quality and regulatory areas. Thorough experience in ISO 13485, GMP, US FDA, EU MDR, CDSCO, ISO 9001. Regulatory functions throughout the organization including monitoring , improvement , audits, and team building. Thoroughly conversant with technical documentation requirement and preparation. Excellent MS office skills. Should have faced multiple audits from multiple agencies Should have thorough knowledge of the applicable standards Perks and benefits: Medical Insurance for Spouse , 2 Kids Below 18 years upto Rs. 3lac.

Urgent : Assistant Manager / Manager {Regulatory & Food Safety} @ Shirwal , Near Pune / Satara Our client is leading Ice Cream Manufacturer of India , UAE & UK They are a professionally managed global conglomerate with traditional values of the 70-year-old family business. They directly employ over 2000 people across several regions of operations & includes the ownership & management of the boutique hotel in Mumbai, Banquets & Catering services, Indias largest ice-cream store chain , extremely delicious lower-calorie ice cream brand , the leading ice cream & food brand of the Middle East offering traditional Indian packaged foods such as paneer, frozen vegetables, rice & more a chain of modern Indian family dining restaurants in India & other sub-brands. They are urgently looking for Assistant Manager / Manager {Regulatory & Food Safety} Department: Regulatory & Food Safety Location: Shirwal , Near Pune / Satara Reported By : Sr. Executive / Executive Regulatory & Food Safety Job Objectives: To ensure full compliance with applicable food safety & regulatory requirements (FSSAI, FDA , etc.) for all ice cream & ice cream cake products manufactured at the facility. The role is responsible for driving quality assurance, food safety initiatives & regulatory compliance while supporting new product development & leading cross-functional improvement initiatives. Qualifications & Skills: Bachelor’s degree in food science/food technology or related discipline (Master’s preferred) Minimum 7-10 years of experience in food safety & regulatory roles in the ice cream or dairy industry Certifications in HACCP, FSSC 22000, BRC, or similar standards preferred Strong knowledge of FSSAI regulations , food labelling laws, & international standards Excellent leadership, analytical, & interpersonal skills Proficient in regulatory documentation, SAP systems & quality reporting tools. Primary Responsibilities: Strategic & Planning Monitor & interpret changes in local, national & international food safety regulations. Develop & implement regulatory compliance strategies aligned with business goals. Lead regulatory audit preparedness & strategic initiatives for continuous compliance. Core Functional Ensure product compliance with applicable laws & customer requirements. Manage documentation & approval of product labels, artworks & declarations. Lead the implementation & review of HACCP plans & food safety systems (e.g., FSSC 22000). Oversee supplier quality management, audits & ongoing performance evaluation. Coordinate sensory evaluations, shelf-life validation, & microbiological testing protocols . Internal Processes Maintain robust document control systems to ensure traceability & audit-readiness. Handle regulatory inspections & ensure timely closure of non-conformances. Develop SOPs, work instructions, & process flows to standardize operations. Manage & investigate food safety incidents, implementing effective CAPA processes. People Development Conduct regular food safety & GMP training sessions for shop floor & QA teams. Provide mentorship & technical guidance to team members. Promote a culture of quality, accountability, & continuous improvement across departments. Key Result Areas Internal Interfaces Production Quality Assurance Research & Development Procurement Supply Chain Marketing Training External Interfaces Regulatory Authorities (FSSAI, FDA, LM, FDA, HALAL etc.) External Auditors & Certification Bodies Raw Material & Packaging Suppliers Private Label Partners External Laboratories Key Interfaces Regulatory documentation & licenses Product specification & compliance verification HACCP & GMP records & validation files Food safety risk assessment & mitigation plans as per GFSI standards. Customer complaint investigations & reports Audit reports & improvement action trackers You are requested to Email updated resume with following details Current Location Please confirm you are ready to work in Shirwal , Near Pune / Satara Relevant experience in food safety & regulatory roles in F&B Industry (In years) Relevant experience in food safety & regulatory roles in the ice cream or dairy industry(In years) Can you ensure full compliance with applicable food safety & regulatory requirements (FSSAI, FDA , etc.) for all ice cream & ice cream cake products manufactured at the facility? Do you have certifications in HACCP, FSSC 22000, BRC, or similar standards? Do you have strong knowledge of FSSAI regulations , food labelling laws & international standards? Can you lead the implementation & review of HACCP plans & food safety systems (e.g., FSSC 22000) ? Can you oversee supplier quality management, audits & ongoing performance evaluation & coordinate sensory evaluations, shelf-life validation, & microbiological testing protocols ? Can you interact with Regulatory Authorities (FSSAI, FDA, LM, FDA, HALAL etc.) & External Auditors & Certification Bodies? Can you comply with Product specification & compliance verification , HACCP & GMP records & validation files , Food safety risk assessment & mitigation plans as per GFSI standards. Languages known Please self-rate : your English Communication skills on a scale of 1 to 10 (10 being highest) Team Size Managed ( Direct & Indirect) Current Salary (Fixed + Variable) Expected Salary Minimum period required for Joining Contact Details, Residence & Mobile No What’s App No./ Skype ID In case you are not interested, we would appreciate, if you can refer us, suitable matching profiles from your rich contacts [[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[ Best Regards Pradeep Kumar / Mumbai Email: pradeep@intellectualcapital.co.in Cell: 8828181917 [[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[[

Review SOP Support quality system Familiar with process/cleaning validation Assist internal & external audits Assist specification settings, OOS investigation, change controls, regulatory submission/update, annual product reviews, other investigation Required Candidate profile Must have min. 2 yrs experience & must be familiar with cGMP requirements. Candidate should have good knowledge of computer & ability to effectively interact with individuals at all levels.

Work collaboratively with regulatory, quality, package engineering, document control, and product development team(s) to develop new product labelling (Label/IFU/User documentations) Understanding country specific regulatory needs Labelling design as per regulatory & business requirements Review of all labelling based on the various domestic and international requirements – including product labels, instructions for use, e-labelling, website, advertising, and promotional materials Understands impact(s) of labelling design and development as part of overall product and packaging development. Effectively engages with the project team and seeks out support when appropriate. Manages change controls for labelling release and updates. Assist in development of labelling processes and policies. Standardize labelling printing technology software and labelling formatting/templates across sites; as well as labelling content development. Fosters a collaborative environment and gains support and cooperation for ideas proposals projects and solutions to accomplish goals. Continuously builds knowledge keeping up to date on the technical or procedural aspects of labelling and labelling regulations. Utilizes good documentation practices (i.e. revision control red lining Agile release) All other essential related duties as required. Experienced with label/graphic design tools - Codesoft, Adobe Illustrator, InDesign preferred Qualification : Education - B.E/B.Tech 4 to 8 years of industrial experience in Pharma or medical device environment Relevant labelling experience, preferably within a regulated environment an advantage but not essential Knowledge of RA/QA and FDA, EU MDR requirements for packaging and labelling Knowledge of ISO 7001, ISO 15223 Strong organizational and project coordination skills PC literate and strong knowledge of Microsoft office tools are essential

Job Title: Quality and Regulatory Manager (Medical Devices) Reports to: Director of Quality / Head of Operations Job Summary The Quality and Regulatory Manager is responsible for ensuring that all medical device products comply with global regulatory requirements (e.g., US FDA, EU MDR, ISO 13485), maintaining effective quality management systems, and facilitating successful regulatory submissions. The role involves leading internal and external audits, managing documentation, and supporting cross-functional teams to ensure the safety, efficacy, and compliance of medical devices throughout the product lifecycle. Key Responsibilities Quality Management System (QMS): Develop, implement, and maintain the QMS in accordance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulations. Lead internal and external audits, and manage corrective and preventive action (CAPA) processes. Ensure proper documentation, control, and retention of quality records and regulatory files. Oversee product nonconformance investigations and ensure timely closure of deviations. Regulatory Affairs: Prepare, compile, and submit regulatory filings (510(k), CE Mark Technical Files, etc.) for new and existing products in global markets. Monitor and interpret global regulatory changes, ensuring the company remains in compliance. Serve as primary contact for regulatory agencies and notified bodies during inspections and audits. Develop and maintain product registration dossiers and technical documentation. Risk Management: Lead risk management activities in accordance with ISO 14971, including hazard analysis and post-market surveillance. Support product recalls, field safety corrective actions, and complaint investigations. Training & Continuous Improvement: Train and mentor staff on quality and regulatory requirements. Drive continuous improvement initiatives for product and process quality. Cross-Functional Support: Collaborate with R&D, Manufacturing, Supply Chain, and Marketing to ensure compliance in product design, labeling, packaging, and advertising. Support new product development teams with regulatory strategy and submission pathways. Qualifications & Requirements Bachelors or Master’s degree in Engineering, Life Sciences, Pharmacy, or related field. Minimum 2 years’ experience in quality and/or regulatory roles in the medical device industry. Strong knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR/IVDR, and related standards/regulations. Experience preparing regulatory submissions (510(k), PMA, CE Mark, etc.). Lead Auditor certification for ISO 13485 (preferred). Excellent written and verbal communication skills. Strong organizational and project management abilities. Key Competencies Detail-oriented and analytical. Problem-solving and decision-making skills. Ability to work cross-functionally and lead teams. Up-to-date with global regulatory trends and requirements. Location: [Insert location] Employment Type: [Full-time/Part-time/Contract] Let me know if you want to add anything about company culture, reporting structure, or specific product lines!

Job Title: Senior Regulatory Publishing Specialist Responsibilities:Technical Document Preparation: Lead the preparation, review, and submission of Technical documents/Dossiers (CTD/ACTD) for both Regulatory and Non-Regulatory Markets.eCTD Publishing: Proficiently handle the electronic regulatory submissions (eCTD), ensuring accuracy and compliance with regulatory standards. Submission Build Activities: Execute submission build activities, including creating inter-document links, conducting quality checks, validating compiled submissions, and ensuring timely dispatch.Collaboration with RA - Ops Team: Coordinate and engage with the Regulatory Affairs Operations team to facilitate on-time submissions and publishing tasks. Manufacturing Document Review: Review critical manufacturing documents such as MFC, BMR, process validation Protocol/report, stability protocol/report, sampling protocol, process validation protocol, and PDR.Response to Agency's Queries: Prepare and review responses to regulatory agencies' queries, ensuring timely submission within stipulated deadlines.Regulatory Submissions Development: Develop and deliver comprehensive regulatory submissions within agreed-upon timeframes, providing crucial regulatory support to project teams for assigned projects. Qualifications:Education: Bachelor's/Master's Degree (preferably in B Pharm/ M Pharm) or Any Life Science field. Experience: Minimum 3-6 years of hands-on experience within the CRO/Biotech/Biopharma industry. Expertise: Demonstrated expertise in gap analysis, publishing, and knowledge of CTD compilation.Communication Skills: Excellent communication and interpersonal skills, both written and spoken, with the ability to effectively interact with sponsors and internal stakeholders at all levels. Location - Madhapur, Hyderabad, Telangana, India 500081

Define product positioning, pricing, and promotion strategies in collaboration with marketing teams. Develop product roadmaps aligned with company goals and market demands.Monitor product performance post-launch and recommend adjustments as needed

Role & responsibilities Manage timely delivery of feed tank to HCM with compliance to IPQC parameters and supervises all resources (raw material, equipment, manpower) and activities in a shift. This will be in-line with the schedule prepared by the In-charge for that day. Execute the shift activities (MM Charging, review FT planning, shift manpower deployment) allocated to him as per the plan Ensure shift handover/takeover on the shop floor and hold accountability for any failures/challenges in the previous shift. Review the dipping schedule daily to prioritize the FT preparation schedule, color change, ZMICs for specific requirements for all upcoming batches and highlight the necessary corrections to FT Chemist/operator Monitor various parameters such as shade, bubbles, viscosity, solution temperature & SCADA monitoring at regular intervals as per defined Verification of dip bath and FT cleaning as per SOP to avoid non-compliance wrt GMP Preferred candidate profile Education : B.Pharmacy/M.Pharmacy, B.sc/M.sc (Microbiology), (Chemistry) Experience : Atleast 4 years in capsules/pharma industry Preferred Industry : Capsules Manufacturing Preferred Qualification : FDA Approved Perks and benefits

Manager Data Management,FSP(MDM,FSP) is responsible to support the Sr.Manager, Data management FSP in providing leadership, direction, and operational management operation. MDM FSP is responsible for line managing, developing CDM team withing the FSP