397 Fda Jobs - Page 8

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 throug...

Position: Production Head Experience: 10 To 20 Yrs Location: Bangalore Department: Manufacturing Industry: Medical Devices / Healthcare Technology Role Summary We are looking for an experienced and strategic Production Head to lead our manufacturing operations in the medical device domain. The ideal candidate will have deep knowledge of regulated production environments, strong people management skills, and a passion for driving quality, safety, and efficiency. This role is critical to ensuring that our products meet global standards and are delivered on time and within budget. Key Responsibilities Lead and oversee all daily manufacturing activities, ensuring production targets, timelines, a...

Job Summary We are looking for a persuasive and knowledgeable Pharmaceutical Telesales Representative to promote and sell our clinically proven testosterone replacement therapy (TRT) products. In this role, you will engage healthcare professionalsincluding primary care physicians, endocrinologists, and urologistsvia phone and digital channels to educate them on the benefits, safety, and appropriate use of our testosterone treatments. The ideal candidate has experience in pharmaceutical or medical sales, with a passion for men’s health and wellness. Key Responsibilities Make high-volume outbound calls to targeted healthcare providers to promote testosterone therapy solutions. Deliver compelli...

Job Responsibilities Operations Build successful relationships with Life Sciences (LS) client stakeholders to promote confidence in quality and compliance, as well as forward planning. Provide management and leadership direction for the development and implementation of quality and compliance programs. Collaborate with other Life Sciences accounts to proactively accumulate, share and reapply all learnings, successes as well as best practices. Collaborate with Global Life Sciences Quality Vertical for development, revision and implementation of QMS and quality documents. Responsible for ensuring Lide Sciences facilities teams adhere to the required training and ensuring in compliance to clien...

You'll make a difference by The work involves System Testing of Products based out of Batch Products of PCS 7. Responsible for Designing, writing, reviewing, and executing test cases, and Test case automation for Products based out of PCS 7. Responsible for writing bug reports and verifying them after fixes. In Addition, responsible for carrying out Performance Tests. Performs Test Automation of existing Test cases Involves in interacting with Business Partners for technical clarifications. You'd describe yourself as A graduate with 4-5 years of total experience in DCS with experience in Batch process like Pharma, F&B, Oil & Gas, etc. (experience in PCS 7 SIMATIC Batch is an added advantage)...

Provide outstanding editorial services for all designated projects, including editing, fact-checking, and proofreading on assigned brand(s) Follow established procedures/guidelines to ensure consistent work quality Develop and maintain style guides for any assigned brands Understand the product and the clients objectives, including product information, visual aids, pivotal trials, journal articles, and related promotional materials Prioritize work appropriately, while meeting all deadlines Collaborate effectively and communicate proactively to enhance dynamics within and among teams Adhere to AMA and brand style requirements Attend kickoff, hot-sheet, and status meetings related to assigned ...

Role & responsibilities Architect and implement a lean, auditready ISO13485:2016 Quality Management System and drive certification. Own all designcontrol documentation (SRS, DHF, Risk Management File, DMR, Technical File, etc.) in collaboration with engineering teams. Define and execute regulatory strategies: first CDSCO (ClassII/III), then FDA 510(k), and EU MDR CE Mark. Prepare, review, and submit regulatory dossiers; interact with authorities and notified bodies. Plan and conduct internal audits, manage CAPA investigations, and lead continuousimprovement initiatives. Qualify and monitor suppliers/CMOs; establish incoming and inprocess quality controls and batchrelease records. Train cross...

Job Title: Labelling Specialist - Medical Devices Location: Sanand, Ahmedabad Department: Quality Assurance Employment Type: Full-Time (On-Site) Reports To: Quality Manager Job Summary: We are seeking a detail-oriented and knowledgeable Labelling Specialist to manage the creation, review, and maintenance of labelling content for our medical devices. The ideal candidate will have a strong understanding of medical device regulations and be well-versed in labelling standards, particularly ISO 15223. This role is critical to ensuring our product labels are compliant, accurate, and aligned with global regulatory requirements. Key Responsibilities: Develop and maintain medical device labels artwor...

Job Summary A detail-oriented and results-driven Adobe Campaign Technical Consultant with experience in the banking or financial services domain The ideal candidate will have 4+ years of experience designing, executing, and optimizing data-driven marketing campaigns using Adobe Campaign The role requires strong proficiency in SQL and experience with ETL tools such as SSIS to manage end-to-end campaign workflows, including data extraction, transformation, and loading from complex data environments The candidate will work closely with marketing, data, and compliance teams to deliver targeted communications, enhance customer engagement, and ensure regulatory adherence Key Responsibilities 1. De...

You will be responsible for reviewing and conducting chemical testing of raw materials, finished products, cosmetics, Ayurveda, Sidha & Unani products. You will need to accurately enter the test results into the LIMS software. Additionally, you will be required to handle instruments like HPLC, GC, FTIR, Dissolution, etc. Technical documentation in compliance with FDA, CDSCO & Ayush standards for audits will also be part of your responsibilities. The position is based in Gurugram and requires a minimum qualification of B.Pharma, M.Pharma, MSc. Chemistry or a related field. The ideal candidate should have 2 to 15 years of relevant experience.,

Required Qualifications: Bachelors or master’s degree in mechanical, electrical, or Systems Engineering , or a related technical field. 3+ years of experience in V&V for medical devices , ideally with complex systems involving fluidics, embedded systems, or renal therapy technologies . Hands-on experience designing and executing verification tests for software-controlled electromechanical systems. Strong knowledge of systems engineering principles , including the V-model , requirement validation, and test traceability. Proficient in using lab instrumentation (e.g., flow meters, pressure sensors, data acquisition systems).

Greetings, Hope you are doing fine! NOTE: We apologize if any inconvenience is caused or if this job opening is irrelevant / not of interest to you and request you to ignore this mail. We have an job opening with a leading HealthTech company Position: Head of Compliance Location: Bangalore JD: Need a candidate having experience in Compliance, HIPAA, SaMD, and FDA. If interested in the profile, kindly send us your updated CV to debraj.bhattacharya@connexio.asia and ankit.kumar@connexio.asia Also, it would be great if you could help me with the following details Current Fix CTC: Expected CTC: Notice Period: Current Location: Thanks, Mona Shah Recruitment Team Email: mona.shah@connexio.asia

Role & responsibilities Shall be take care of process Equipments ( preventive Maintenance , Breakdown , QMS ) Preferred candidate profile Candiate should have very deep knowledge about preventive maintenance and breakdown activities pertaining process equipments. Also shold velwersed with QMS GMP activities.

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.

Company: Yash Technology Location: Bangalore Experience: 6+ years Mode of work: Work from Office Type of employee: Full Time Employee Shift Timings: 12PM - 9PM Interested and relevant candidates share your profile to padma.ashwitha@gmail.com Essential Duties and Responsibilities: • Possesses solid understanding of overall vision and business needs and utilize specialized expertise to collaborate with Quality and Operations to define detailed User Stories for D&T enablement of business needs. This includes interpreting any issues and recommending solutions or best practices. • Utilizes knowledge of best practices to help define strategic direction, help determine business needs and design & d...

(We are looking fo the Immediate joining candidates or willing to leave early for their current company) Role & responsibilities HPLC Analysis of Solid Orals/Nasal hands on experience on QC activities, RM, Packing, In Process and Finished Products Compliance with GMP/GLP Practices Preferred candidate profile 2-7 years of experience Prior experience of working in Regulated plants (USFDA/MHRA Approved) Perks and benefits Working in a state-of-the-art fully automated world class manufacturing. Opportunity to work on diverse dosage forms in a multi-product facility. Attractive attendance bonus & Special Allowances Unmatched opportunities to learn and grow Thanks & Regards Dhivakar D BVR People C...

As a Regulatory Affairs Coordinator at Cipla, your primary responsibility is to ensure timely approvals from the FDA (Loan License units) by effectively coordinating with internal stakeholders and FDA teams for the submission of various applications. Your role also involves developing strong relationships with external stakeholders and advocating for licensing approvals for Cipla LL products. Your key accountabilities include: - Securing timely regulatory approvals from State FDA and CDSCO offices for loan license units, which includes obtaining approvals for various applications such as fresh loan licenses, additional product permissions, test licenses, India Business Tender Certificates, W...

About ValGenesis ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelligence across their product lifecycle. Learn more about working for ValGenesis, the de facto standard for paperless validation in Life Sciences: https://www.youtube.com/watch v=tASq7Ld0JsQ About the Role: ValGenesis is excited to invite applications for the position of Senior Validation Engineer. In this role, you will be pivotal in ensuring the compliance and quality of our innovative software soluti...

You will be working in the Operations department of Pharma Solution business located in Lexington. Your role as a Manufacturing Operator will involve performing various production activities such as component preparation, filling, capping, autoclaving, terminal sterilization, compounding, and lyophilization production. You will report directly to the Manufacturing Supervisor. Your key responsibilities will include complying with all relevant policies and procedures, performing line clearances and cleaning/sanitization, operating and maintaining production equipment, ensuring proper ingredients and quantities of batches, executing validation protocols, maintaining records, and following Good ...

Role Summary: As Deputy Manager Automation (Pharma Process Validation & Documentation) , you will lead validation strategy, customer interfacing, and cross-functional coordination to ensure seamless project execution and regulatory compliance. This role demands strong technical acumen, leadership capability, and the ability to drive results across departments in a regulated pharmaceutical environment. Key Responsibilities: Lead project documentation and automation activities, ensuring timely execution and alignment with customer requirements. Manage end-to-end coordination for CRMs and KOMs preparing agendas, driving discussions, and capturing actionable outcomes. Define and implement valida...

Medical R&D Team Lead-Chennai-10+years-NPD Job Category: TEAM LEAD Job Type: Full Time Job Location: chennai Years of Experience: 10+ years Position Overview This is an excellent opportunity to work for the global leading company in the field of gas control equipment. The focus of this role is managing our R&D team based in Chennai who are focused on Healthcare products and covering mechanical, electrical, electronics and software disciplines. Duties & Responsibilities Managing the teams actions to delivery New Product development projects. This is an end to end responsibility of successful project delivery from gate 0 to post project audit. Manage the R&D budget, timelines, and resources ef...

• Facilitate the implementation and support of SAP Public Cloud- 2 SL System and 3 SL System • Experience in Cloud Transport Management process related to FICO part • Good Knowledge in Business Process Tiles • Have good exposure of the Data Migration Cockpit • Good exposure on Banking • Bank Master Data • House Banks and Account Ids • EBS • DME • Facilitate the implementation and support of SAP Financials with expertise and focus on FICO Controlling Cost Center Accounting, Profit Center Accounting, Product Costing, Month End process and Treasury. • Expertise in Process, Configuration & Customization of SAP FICO sub-modules: FI-New GL, FI-AP, FI-AR, Asset Accounting. • Perform detailed analys...

S4HANA Finance for Group Reporting Job Description Should have experience 8-10 years end to end implementation experience of SAP S/4 HANA for Group reporting. Interactions with various client functional teams to understand the requirements and to finalize the design of each model in SAP Group reporting CA/ICWA candidates are preferred but otherwise should be a Postgraduate as minimum educational qualification like MBA / M. Com etc. SAP FICO (S/4HANA 1809 & above) experience is preferable. Good hands-on experience in AO (Analysis for Office) reports experience Balance sheet, Profit & Loss, Cash flow reports and Custom analytic queries. Should have sound knowledge/configuration experience on t...

Key Responsibilities: Greenfield S/4HANA Implementation •Lead and manage greenfield S/4HANA implementation projects within the life sciences/pharma industry. •Design and configure the SAP CO module to meet specific business requirements and regulatory standards. •Oversee system integration, testing, validation, and data migration activities. Client Interaction and Workshops : •Conduct client meetings to gather requirements, present solutions, and provide project updates. •Facilitate workshops to engage clients, understand their operational challenges, and deliver tailored solutions. •Build and maintain strong client relationships, serving as the primary point of contact throughout the projec...

Note: Qualification: B.Tech / B.E. in Biomedical Engineering, Biotechnology, or related Medical Engineering field (Pharma background (B. Pharma / M. Pharma) profiles will not be considered) Mandatory Skills: Regulatory Affairs Medical Devices EU MDR compliance Design History File (DHF) Risk Assessment & Risk Management Familiarity with ISO 13485 and other applicable standards Key Responsibilities: Prepare, review, and manage regulatory submissions for medical devices (India and international markets) Ensure compliance with EU MDR (Medical Device Regulation) and local regulatory requirements Maintain and update Design History Files (DHF) , Technical Files, and Risk Management documentation Co...