224 Fda Jobs - Page 7

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

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

Job Description Candidate shall manage projects from concept to commercialization, ensuring projects stay on time, within budget, and meet regulatory requirements. • Develop project plans, manage resources, monitor progress, and handle changes to achieve project goals, while also ensuring compliance with relevant regulations, like FDA and EU guidelines • Communicate effectively with stakeholders, including clients, management, and internal Cross-functional teams Roles & Responsibility Demonstrated proficiency in the following areas: • Strong understanding of product development lifecycle, design controls, and regulatory requirements. • Experience in managing medical device development projects or related fields. • Knowledge of relevant regulations and standards in the medical device industry. • Excellent communication, interpersonal, and leadership skills • Ability to manage multiple projects simultaneously and meet deadlines • Project management certifications (e.g., PMP, Scrum) is preferred • Proficient in project management tools (e.g., MS Project, Jira). General Skills • Self-motivated and able to work independently with minimal supervision. • Must be a good team player and able to adapt to the work environment. Must have good verbal and written communication and interpersonal skills with good working attitude.

The Regulatory Compliance Change Assessor will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams, as well as Amgen Operations, Quality, and/or Supply Chain for specific strategies or activities that impact a product. The Change Assessor will be responsible for varying levels of product support, including global reportability assessment of single or cross-product changes, based upon their experience level. Roles & Responsibilities: Key responsibilities of the Regulatory Sr Associate include: Reviews change records to evaluate impact of the change with respect to reportability and product restrictions for any product in scope. Defines and documents the reporting and product distribution restriction requirements for the change within the change control management system. Liaise with other functions, including Process Development, Operations, Quality and Supply Chain to ensure alignment of regulatory strategies What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a type of person with these qualifications. Basic Qualifications: Master’s degree OR Bachelor’s degree and 2 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Associate’s degree and 6 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Diploma and 8 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Degree in Life Science discipline Regulatory CMC specific knowledge & experience Understanding and application of principles, concepts, theories and standards of scientific/technical field Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services. Employees under this span will be a part of one of the sub-offerings - Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory affairs tasks of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components. Veeva Regulatory Suite experienceCollect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for Life Sciences Regulatory ServicesAbility to handle disputesAbility to manage multiple stakeholdersAbility to meet deadlinesAbility to perform under pressureAbility to work well in a teamLife Sciences Automation Enablement Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification Master of Pharmacy

IVL India Environmental RD is looking for Quality Expert to join our dynamic team and embark on a rewarding career journey. Develop and implement quality assurance policies and procedures. Conduct quality audits and inspections. Analyze data to identify areas for improvement. Provide training on quality standards and processes. Ensure compliance with regulatory requirements.

Quality Control Dept, ensuring Timely testing & quality check of Raw Materials and Finished Products. Analysis on equipment like HPLC, FTIR, GC etc, all other Q.C. related matters Required Candidate profile Experience in handling HPLC, FTIR, GC etc, for 3 to 7 yrs, Experience in Quality Control dept. of Pharma Company. FDA Approval Required. Perks and benefits Apply with Salary Drawn & Expected Salary

Role & responsibilities QA Documents Preparation, review, & revision (such as Work Instructions, Flowcharts, SOPs, Inward Quality Plan, Technical Data Sheet, Formats, etc.) Document Control (Soft copy & Hard copy) Coordinate with QC, Production, Design team & management. Maintain master copy & distribute control copy of documents to respective departments. Gain knowledge regarding medical device applications. Developing and implementing quality systems: Including policies, procedures, and guidelines, to ensure that products or services meet the required quality standards. Conducting audits and monitoring processes to ensure that they comply with quality systems and standards. Handling Customer Complaints Handling Corrective Action & Preventive Action (CAPA). Suggest & implement new document/ process/ system. Preferred candidate profile Should be a Graduate of Biological Science. (Bsc & Btech Biotechnology) Minimum 1 to 2 years of relevant experience required Certified internal auditor for ISO 13485;2016. Experience working with 3D printers in the healthcare segment. Strong organisational skills that reflect the ability to perform and prioritise multiple tasks seamlessly with excellent attention to detail.

Key Responsibilities: Manage pharmacy operations, staff, and inventory. Ensure CDSCO, PCI, and NABH compliance. Optimize medication therapy for pediatric and maternity patients. Drive budgets and tech-driven efficiency. Collaborate with doctors and nurses for patient care. Requirements: B.Pharm/PharmD with 8+ yrs hospital exp. (5+ yrs leadership). Maharashtra Pharmacy Council registration. Expertise in clinical pharmacy, GMP, and regulations. Strong leadership & communication skills.

Experienced in pharmaceutical RA labeling, cGMP/FDA/CFR compliance, SPL creation, proofreading, and DSCSA. Skilled in MS Office, Adobe, TrackWise, SharePoint, and graphic design. Knowledge of label lifecycle, drug listing, and patent carve-outs.

Lead the design and development of innovative digital health products Oversee product lifecycle management from ideation to commercialization Collaborate with healthcare providers and tech teams to ensure compliance with medical regulations Must have experience in telemedicine, wearable tech, or AI-driven healthcare solutions Strong project management and UX design skills are required Knowledge of FDA and HIPAA regulations is a plus

Lead the design and development of innovative digital health products. Oversee product lifecycle management from ideation to commercialization. Collaborate with healthcare providers and tech teams to ensure compliance with medical regulations. Must have experience in telemedicine, wearable tech, or AI-driven healthcare solutions. Strong project management and UX design skills are required. Knowledge of FDA and HIPAA regulations is a plus.