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8.0 - 12.0 years

9 - 13 Lacs

Gurugram

Work from Office

Sr. Core Business Support Engineer II Job Details | Hollister Incorporated Search by Keyword Search by Location (City, State, Country) Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Sr. Core Business Support Engineer II May 29, 2025 Gurugram, HR, IN, 122002 Hollister Global Business Services India Private L work mode: hybrid work location: gurgaon SUMMARY The Sr.Core Business Support Engineer II will lead and contribute to product and process change projects for existing Hollister products and processes in both our Ostomy Care and Critical Care businesses. The projects will be primarily related to Technical Transfer, Process Change, Material Change, Supply Security (stay in business), and Cost Savings. This is a permanent position based at the Gurugram facility. Live the Hollister Immutable principles, Develop test plans, analyze test data and interpret result Generate original ideas based on professional knowledge of product design for both ostomy and critical care products. Develop realistic action steps, timetables, and resource estimates for technical projects. Identifies potential challenges and proactively work to address them. Actively participate on cross-functional teams (international) and supports the completion of team deliverables. Validate plans within the team and acts on suggestions for improvement. Establishes a rapport with their working teams which allows them to identify key resources and network efficiently. Supports technical management in establishing goals and strategies. Communicate effectively and review project outcomes with internal customers. Completes written reports on technical activities carried out. Prepares and updates a range of technical documents including drawings and specifications. Provides technical support to Manufacturing, Engineering, Quality and Supply Chain. ESSENTIAL FUNCTIONS OF THE ROLE General office environment - position may require sitting at a desk / computer for extended periods of time . The position also will require travel to other Hollister facilities and various suppliers ( 10%). Talking, walking, vision, hearing, fine motor skills, writing, lifting up to 30 lbs.(occasionally), and pushing Some, but not all aspects of this job could be modified to accommodate the physical abilities of a handicapped person WORK EXPERIENCE REQUIREMENTS 8 to 12 years experience in a similar position, preferably in the medical devices sector Proven track record in project management and project leadership; capable of working independently Uses problem solving techniques such as DMAIC to resolve issues as they arise Demonstrates working knowledge of standard techniques, procedures, and criteria in accomplishing well-defined tasks Strong communication skills, with ability to articulate relevant technologies and processes to others in the technical group and provide project updates to non-technical key stakeholders Solves technical issues using alternative or unique approaches Recognizes value-added product features and integrates them into product designs Demonstrates awareness of current technological trends, especially within their specific discipline Previous knowledge or experience in field of Ostomy, Continence care would be added advantage (not mandatory) Previous knowledge or experience in polymer films, bonding technology would be added advantage (not mandatory) Ability to create, read, edit, and interpret 2D and 3D drawings as well as product specifications (with minimal oversight). EDUCATIONAL REQUIREMENTS Bachelor of Science / Engineering degree or higher preferably with Mathematics or Statistics as a subject PMP Certification is desirable (not essential) SPECILIZED SKILLS/ TECHNICAL KNOWLEDGE Experience with the FDA Quality Systems Regulations and an ISO 13485 environment at a medical device manufacturer (preferred) Project management training and experience (preferred) Experience with product development, design controls, change controls and risk management for medical devices. Advanced statistics training and experience with plastic proicessing and/or automated assembly processes (nice to have) LOCAL SPECIFICATIONS (Work Environment / Language) Hybrid work environment with 3 days in the office and 2 days at home performance based Two days per week will require flexible work hours to accommodate international project work with the USA and Europe R&D, Facilities, Project Manager, Risk Management, Supply Chain, Research, Operations, Technology, Finance

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6.0 - 11.0 years

14 - 16 Lacs

Pune

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Job Title Regulatory Affairs Specialist Job Description Minimum required Education: Bachelors Degree in any Engineering, Biomedical Engineering. Minimum required Experience: Bachelors Degree with 6+ years of experience in Regulatory Affairs, Quality Compliance, Product Development in Medical Devices Industry or equivalent. Minimum required Certification: N/A Job title: Regulatory Affairs Specialist Your role: Be recognized as a key talent in International Regulatory filings and procedures. Be considered a key regulatory point person in Centralization of Regulatory Operations and enable the regulatory compliance in Markets where Philips products are commercialized. Be an impactful member of the Regulatory Affairs (RA) team and trusted by management as an independent regulatory team member on multiple projects simultaneously. Assist in building center of excellence for RA operation with purpose to centralize regulatory operations to enhance compliance, efficiency, and global market readiness. Function on a multi-geography basis, prioritize, conduct team meetings, and meet project deadlines. Youre the right fit if: (4 x bullets max) 1. Experience- 6+yrs of experience in international regulatory affairs 2. Skills- Regulatory Affairs, Dossier Preparation, experience in Class, I, II. 3. Education- Any Engineering Degree, prefer in Biomedical Engineering 4. Anything else- Good Interpersonal skill, holding strong communication skills. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company s facilities. Field roles are most effectively done outside of the company s main facilities, generally at the customers or suppliers locations. Indicate if this role is an office/field/onsite role. If you re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here .

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1.0 - 3.0 years

4 - 6 Lacs

Mumbai, Navi Mumbai, Mumbai (All Areas)

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Customer evaluation to identify selling possibilities and evaluate customer needs Actively seeking out new sales opportunities through cold calling and networking. Setting up meetings with potential clients, Key Account Management, Sales & Marketing Required Candidate profile Candidate must have medical device/ Surgical items sales experience Proven experience as a Product Specialist or a relevant role Proficiency in English Science graduate or Tech graduates preferred

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4.0 - 9.0 years

3 - 5 Lacs

Hyderabad

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Experienced Candidates in QA as per ISO 13485 review batch records, handle deviations, CAPA, and audits; support validations; write and maintain SOPs; coordinate with cross-functional teams, documentation, and Compliance with regulatory standards. Required Candidate profile Graduate / Post Graduate in biotechnology / bio medical / Microbiology / Chemistry with strong hands on experience in QA operations in any Pharma or medical devices company.

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0.0 - 1.0 years

3 - 3 Lacs

Vadodara

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Role & responsibilities Handling of sugam portal for various applications like BE NOC, form 8, Dual use NOC, Written confirmation, medical devices application etc Handling of NSWS portal for various applications like CT-12, CT-13, CT-16, MD-16, CT-10 applications Handling of Change control Preparation and revision of SOPs and Guideline Handling of SAP software

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0.0 - 1.0 years

3 - 3 Lacs

Vadodara

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Role & responsibilities Handling of sugam portal for various applications like BE NOC, form 8, Dual use NOC, Written confirmation, medical devices application etc Handling of NSWS portal for various applications like CT-12, CT-13, CT-16, MD-16, CT-10 applications Handling of Change control Preparation and revision of SOPs and Guideline Handling of SAP software

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8.0 - 13.0 years

5 - 11 Lacs

Chennai

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Responsible for business development and management for the entire state/region through sales team recruitment/development, distribution management and product promotion of our rapid tests, blood banking & point of care range (Glucose meters). Required Candidate profile Previous experience in medical diagnostics, medical devices or surgical products is a prerequisite.

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5.0 - 8.0 years

8 - 18 Lacs

Hyderabad / Secunderabad, Telangana, Telangana, India

On-site

Bachelor's or Master's degree in Radiology, Medical Imaging,Pharmacy, Biomedical Engineering, or a related field, statistical background is a plus. Expertise in medical imaging modalities (CT, MRI, X-ray, ultrasound) and proficiency with medical annotation tools (e.g., ITK-SNAP, 3D Slicer, Labelbox, V7 Labs). Strong understanding of clinical anatomy, pathology, and medical terminology Proven experiencein medical image annotation, quality assurancewith deep familiarity with DICOM, PACS, and other medical imaging systems, or a similar role within data-driven environments. Strong analytical skills and meticulous attention to detail. Effective communication and collaboration skills for cross-functional teamwork. Familiarity with annotation tools and quality control software. Knowledge of regulatory requirements, including HIPAA and GDPR compliance, for handling medical data.

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4.0 - 9.0 years

5 - 9 Lacs

Pune

Work from Office

Technical writing expert, preferably healthcare experience, with below expertise. •Schema ST4 •FrameMaker tool •Technical Writing Course completion •Simplified Technical English course completion •Style Guide knowledge •Understanding of Medical regulatory and compliances •Understanding of service and maintenance activities

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15.0 - 20.0 years

15 - 22 Lacs

Faridabad

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Production Mgr- Surgical Blades, Medical Device mfg., micro precision items, quality, manpower, modern training - ISO 9001, hands-on work exp. in press engineering, applications, operation, product design, industrial engineering, QA, PMS, QMS

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3.0 - 8.0 years

3 - 4 Lacs

Kota, Visakhapatnam, Nashik

Work from Office

institutional sales, pharma/medical devices, interact with doctors, hospitals, govt institutions, chemists, distributers, Kota, Amritsar, Nasik, Vishakhapatnam, Mangalore, Kanpur, Ahmedabad , Bhatinda , Hyderabad ,Vadodara, Calicut, Bareilly, Mumbai

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6.0 - 10.0 years

5 - 8 Lacs

Faridabad

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medical device / pharma - Exposure in QMS & implementation, Calibration/Validation & QA regulations (National & International). knowledge in medical devices responsible for ensuring process controls - corporate standards, prevent outflow of defects

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5.0 - 10.0 years

3 - 5 Lacs

Bengaluru

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Role & responsibilities Drive sales of medical equipment and consumables to hospitals, clinics, and diagnostic labs. • Achieve sales targets through effective territory management and client servicing. • Conduct product demonstrations and training for healthcare professionals. • Maintain detailed records of client interactions, feedback, and orders. • Stay updated with industry trends and new product launches. Preferred candidate profile Sales experience in medical equipment or consumables preferred. • Strong interpersonal and communication skills. • Willingness to travel within the assigned territory.

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15.0 - 22.0 years

14 - 24 Lacs

Sonipat

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Design, develop & document components 2D/ 3D drawings Create, analyze, & test product designs Conversant & apply DFM/ DFMA Optimize the application of GD&T Manage team of highly fast paced 20+ Design Engineers with sense of ownership & responsibility Required Candidate profile BTech Mech., 15+ Yrs exp in Design & Development in Medical Devices/ Aerospace. Sound knowledge of Product design, 2D and 3D drawings, DFM, DFMA, Design Verification and Design Validation (ISO 13485).

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10.0 - 18.0 years

15 - 30 Lacs

Bengaluru

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1. Manual Tester Medical Devices (Ultrasound Focus) Location: Bengaluru, Karnataka Company: L&T Technology Services Limited Experience: 10–18 years Key Responsibilities: Conduct manual testing of medical devices, specifically ultrasound equipment. Design and execute test cases based on software requirements. Ensure adherence to the Software Testing Life Cycle (STLC). Document test results and report defects. Collaborate with cross-functional teams to understand device functionalities. Qualifications: Bachelor’s or Master’s degree in Engineering or related field. Proficiency in manual testing techniques. Strong communication and time-management skills. Experience in healthcare domain, particularly with ultrasound devices.

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9.0 - 14.0 years

0 - 0 Lacs

Bengaluru

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Job Description: • Identify and develop new business opportunities in the medical equipment and consumables sector. • Build strong client relationships with hospitals, diagnostic centers, and healthcare providers. • Lead the sales team in executing strategies to increase market share and revenue. • Conduct market research to identify trends and customer needs. • Prepare and deliver business presentations to prospective clients and stakeholders. • Monitor competitor activities and suggest improvements to product positioning and pricing. • Collaborate with product, logistics, and marketing teams for seamless execution. Preferred candidate profile Proven track record in business development, preferably in medical devices/consumables. Strong network in healthcare institutions. Excellent communication, negotiation, and leadership skills.

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0.0 - 3.0 years

2 - 3 Lacs

Patna, New Delhi, Bengaluru

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A Service Engineer in the medical field, often referred to as a Service Engineer or Medical Equipment Field Service Engineer, has a role cantered on the installation, maintenance, troubleshooting, and repair of medical devices and equipment used in healthcare settings such as hospitals, clinics, and diagnostic centers. Job Description is as follows: Must have experience in Medical Equipment Service (preferred Surgical, Neuorolgical & Audiological equipment) Demonstration, Install, maintains, and troubleshot biomedical equipment Conduct on-site and on time training for medical staff on the use medical equipment Provide technical support to medical personnel Perform preventive maintenance and calibration of medical equipment Document service activities and maintain customer records Skills: Excellent technical and problem-solving skills Ability to work independently and as part of a team Proficiency in using computers and related diagnostic software Good communication and customer service skills Experience: Fresher or 2-3 Years experience for Service Engineer Location: Bangalore(Chennai), Patna, Delhi Based Salary: Service Engineer (20K for Fresher and 25-27K for experienced per month); and can be negotiable depends upon person ability. (+ travelling allowance + incentives)

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2.0 - 7.0 years

4 - 9 Lacs

Mumbai

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CORE JOB RESPONSIBILITIES Achieve Division wise primary target and ensure it to be equal to or greater than Secondary. Generate maximum prescriptions increase market share. Ensure zero cases of expiry on Stockist shelf by timely liquidation of stocks by prescription generation. Timely sharing of competitor and market information with the ABM and Division. Relationship building with customers and Stockist. Timely Stockist visit as per the defined frequency without deviation. Ensuring doctors are appropriately prioritized and met with the right frequency. Leverage managerial as well as marketing and support functions for engaging appropriately with important customers and to strengthen relationships. Plan and monitor new product introduction, stocking as per plan and sales progress. Provide information in a timely manner about the new product to the Stockist. Report field work on daily basis in the assigned online system. Organizing Camps (CME) as per the division strategy and customer needs. Generate POBs for Abbott brands as per the business plan REQUIRED EXPERIENCE Experience 2+ years of experience Fresher with good communication skills and analytical skills may also consider Required Qualification B.Sc. / B.Pharma. LOCATION: India > Mumbai : Unit 3 Corporate Park t

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2.0 - 7.0 years

4 - 9 Lacs

Ahmedabad

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CORE JOB RESPONSIBILITIES 1. To analyse and prepare working plan for the territory basis the data provides/ market research 2. To be able to follow up, monitor and achieve targets of the territory 3. Implementation execution of all strategies 4. Stakeholder engagement- doctors, stockist, retailers, chemists and institutions pharmacy 5. Discipline and punctual with set timelines for multiple internal processes 7. Basic computer skills- excel working, word email exchanges 6. Fast learner and adaptable to change in market 7. Strong communication skills (verbal)- English and local language 8. Effective in-clinic performance 9. Basic understanding and ability to explain anatomy physiology and product portfoli0 10. Organizing Camps (CME) as per the division strategy and customer needs 11. Prescription audit for Abbott brands and other competitors brands 12. Generate POBs for Abbott brands as per the business plan REQUIRED EXPERIENCE Experience 2+ years of experience Fresher with good communication skills and analytical skills may also consider Required Qualification B.Sc. / B.Pharma. LOCATION: India > Ahmedabad : Indraprasth Corporate Park t

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4.0 - 6.0 years

6 - 8 Lacs

Chennai, Bengaluru

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Sales Strategy Execution Achieve territory sales targets by managing Dental Clinics, Institutions (colleges hospitals), and reseller channels. Identify and convert new sales opportunities; maintain updates on CRM. Execute marketing and sales campaigns aligned with directions from the Sales Supervisor and Marketing team. Customer Engagement Relationship Management Build strong relationships with existing customers to increase repeat business and upsell new products. Collaborate with Clinical Specialists and Scientific Affairs Education team for customer workshops and training programs. Operational Excellence Monitor and resolve sales operations issues within the team, escalating to RSM where required. Track and ensure daily/weekly/monthly customer calls, opportunity pipeline updates, and program execution. Reporting Feedback Provide timely performance updates, competitor insights, and key account developments to the Regional Sales Manager. Qualifications Skills Bachelors degree in Science, Pharmacy, Dental, or a related field (preferred). 4-6 years of sales experience in the healthcare, dental, or medical devices industry. Strong communication, interpersonal, and leadership skills. Familiarity with CRM systems and sales reporting.

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2.0 - 5.0 years

3 - 7 Lacs

Bengaluru

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Design, develop, and maintain efficient, reusable, and reliable C# code for medical software applications. Collaborate with business analysts and domain experts to translate functional requirements into robust software solutions. Integrate third-party APIs , medical devices , and HL7/FHIR -based interfaces into the system. Ensure compliance with regulatory standards including HIPAA , GDPR , and FDA guidelines . Work closely with cross-functional teams such as QA, DevOps, and UI/UX for end-to-end product delivery. Optimize performance and ensure high responsiveness and availability of applications. Troubleshoot, debug, and upgrade existing systems. Maintain comprehensive documentation of code, architecture, and workflows.

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10.0 - 15.0 years

7 - 11 Lacs

Mumbai, New Delhi, Hyderabad

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About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About the role We have a opportunity for a Medical Device Assessor/ Auditor to join our India Team. The successful candidate will be responsible for, planning and conducting audits/ assessments, in accordance with ISO 13485, EU MDR, and MDSAP standards and related (eg IMDR). Key Accountabilities: Technical Compliances, Accreditation Requirements and collaborating with a Team of Auditors/ Assessors. Conduct audits (either desk-based or on client s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. Conduct Technical File reviews specific for products being authorized. Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business. Complete specific projects in relation to medical device procedures, processes, systems and documentation. If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements. Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. To be considered for this role, you ll require about 10 years of professional experience in relevant field of healthcare products or related activities e.g.: work in medical devices industry such as research and development, manufacturing, quality management, regulatory affairs: work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies. work in the application of device technology and its use in health care services and with patients. testing devices for compliance with the relevant national or international standards. conducting performance testing, evaluation studies or clinical trials of devices. 5 + years relevant professional experience in quality management is essential. In addition to the above you ll also need to demonstrate the following. An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques Good knowledge of ISO 13485, MDD 93/42/EEC/ Indian Medical Device Regulations and their application Knowledge of MDR 2017/745, MDSAP, IMDR Work experience in positions with significant QA, Regulatory or management systems responsibility Experience with Harmonized medical device standards and for active non active devices. Experience with Risk Management EN ISO 14971 Experience auditing against recognized standards Experience of working under own initiative and in planning and prioritizing workloads Solid knowledge of non-active devices Solid knowledge of sterilization processes The following attributes are essential: Work actively with a Team of Assessors/ Auditors. Experience of reviewing audit packs Review of technical documentation Registered IRCA lead auditor, or equivalent registration under other recognized body What we offer Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share. *Benefits may vary based on position, tenure/contract/grade level* About you University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Computer Software Technology, Engineering, Nursing, Quality Management. Qualified MDR Assessor from a reputed EU Notified Body, desirable. Experience with scientific literature searches or peer review in the medical context. Fluent in written and spoken English. Experience working with Various Digital Tools. Excellent organizational and professional communication skills.

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1.0 - 6.0 years

1 - 2 Lacs

Dispur, Guwahati

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Any Degree or B.E. in Mechanical, ECE, EEE, Bio-Medical Engineering, or IT About the Role: As a Field Service Engineer, you will be the technical face of our company, playing a critical role in the installation, servicing, and maintenance of life-saving medical equipment. This is a field-based position that requires hands-on work, strong problem-solving skills, and a customer-first mindset. Key Responsibilities: Install, test, and calibrate medical devices (Syringe Pumps, Infusion Pumps, Blood Fluid Warmers, Thalassemia Pumps) at customer sites Provide timely and effective troubleshooting and repair services Conduct preventive maintenance visits as per service schedules Deliver technical training and support to hospital staff and end-users Maintain service documentation and reports accurately Coordinate with internal teams for spare parts and service updates Ensure minimal downtime and maximum customer satisfaction Travel across assigned territory (within Assam) for service support we're Looking For: Fresh graduates passionate about medical technology and field service Experienced candidates (1+ year) in service roles, especially in medical equipment or similar industries Strong communication skills and ability to build rapport with hospital staff Basic understanding of electronics/mechanical systems Willingness to travel and work independently on the field Problem-solving attitude and a drive to learn new technologies What you'll Get: Hands-on training and onboarding on advanced medical devices Opportunity to make a real difference in the healthcare sector Career growth and skill development in a supportive environment Be a part of a stable, fast-growing, and respected medical device company

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8.0 - 13.0 years

11 - 15 Lacs

Mumbai, Tarapur, Pune

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A Graduate or Post-Graduate degree. 8+ Years of Industrial experience in IR and Admin. Knowledge of Factory Act, Labor laws, Safety, Legal and Statutory requirements Good English and Marathi communication skills with emphasis on listening. You will be responsible for: Managing day-to-day operations of IR, Admin & HR function. Developing and maintaining positive relationships with workmen, management, and labor union. Ensure compliance with Factory Act, Labor laws, Safety, Legal and Statutory requirements. Key Deliverables Manage the IR, Admin & HR routine activities at factory (except activities related to Talent Acquisition of management grade) to ensure a healthy work atmosphere and culture in the organization. Compliance with Factory Act, Labor laws, Safety, Legal and Statutory requirements. Liaison with Government authorities & external agencies. Compensation and benefits management. Administering online payroll system, annual Increments, Mediclaim and other benefits. Coordinating employee related insurance renewals with the Purchase team. Handle employee grievances, discipline issues, industrial relations and assist in Union wage settlements. Coordinate with the Utility Team to maintain company owned residential buildings (Torpac House, Capsule House, and Millennium Park) and bachelors accommodation. Plan, Supervise and track the evaluation of employee engagement activities and events in the organization. Identify and coordinate for CSR projects that support our company s interests and the local community. Provide Accounts with data for Company Annual Budget related to payroll, statutory compliance and administration expenses. Ensure maintenance of IR, Admin & HR data for various audits like Directorate of Industrial Safety and Health (DISH), FDA, ISO etc D1. Functional Competencies: Knowledge of Labor law, Legal and Statutory Compliance. Knowledge of Compensation and Benefits. Proficiency in administrative activities Good English and Marathi communication skills with emphasis on listening. D2. Behavioural Competencies: Relationship-building skills with internal and external stakeholders. Quality and service orientation. Delivering consistent results. Timely Decision Making. Reporting & Responsibility: Position Reports to: HR Head Number of Direct Reports to this position 1 Tarapur MIDC. Tarapur MIDC, Boisar, Dist. Palghar, Maharashtra. Tarapur- Railway station Boisar takes 1.5 hrs. by train from Borivali Station or by road via Western Express Highway. Suburban local trains direct from Churchgate to Boisar Railway station. For outstation bachelors, Company provides a subsidized bachelors flat with a cook. For outstation families, Company provides subsidized accommodation in company owned Buildings. It is a requirement to be based in Tarapur/Boisar area. Relocation allowance is available as per company policy. What s in it for You: Opportuning to work at Head Office location. Intimate small company culture. Company value programs TrANSSCEnD. Employee events like festival celebrations, family fun events etc Five days working (alternate weeks). Medical Insurance for spouse and children. Housing accommodation for Bachelors & family within a travel distance of 10 minutes from the factory.

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8.0 - 10.0 years

11 - 15 Lacs

Mumbai

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B. Pharma, B.Sc./M.Sc. (Chemistry/Microbiology) 8 10 Years of experience in QA process in Pharmaceutical / food processing / cosmetics / chemical industries. C1. Principal thrust area: You shall be responsible for maintaining and improving all QMS activity, GMP and GLP across the company. Key Deliverables Ensure manufacturing practices as per cGMP and GLP standards. Handling QMS activities like change control, validations, stability, qualifications, APQR and Risk assessment etc Applications for AHC to AQCS, EIA and Capexil and coordinate related activities. (AHV/SPD: This is exclusive knowledge related to Capsule and companies manufacturing animal origin products. We have mentioned this as the candidate on joining will be responsible for this work though he/she may not be having exposure to same.) Organize internal and external audits for ISO, GMP+, FDA, Capexil, GMP+, EIA and others. Maintain the documents required for those audits. Ensure all personnel are trained on requirements for GMP, GLP, GDP, applicable regulatory issues and other procedures related to their work area. (SBG) Evaluation and approval of Suppliers for RM, PM, testing labs and service providers. Assisting HOD in customer complaint analysis and preparation of customer complaint report. Investigation of incidents, deviations, OOS and ensure corrective actions in place. Reviewing the daily availability of operators and allocating work to them. Maintaining and review BMR documents, guide for relevant changes if required. Label artwork review and management. D1. Technical Competencies: a) Analytical skills (spotting trends and patterns) b) Report writing skills c) Problem solving abilities d) GMP and GDP knowledge e) Good English communication skills (verbal & written). D2 . Behavioural Competencies: a) Quality and Service Orientation b) Delivering consistent results c) Ability to prioritize, organize, manage work and time. d) Customer Centric e) Cross Functional Team Working . Reporting & Responsibility: Position Reports to: Plant Head (M03) Reportees to this position: Assistant Officer QA M12 (2 nos) Your Job Location: Tarapur MIDC. Tarapur MIDC, Boisar, Dist. Palghar, Maharashtra. Preference will be given to candidates in Tarapur/Boisar area or willing to relocate. For outstation bachelors, Company provides a subsidized bachelors flat. For outstation families, Company provides subsidized accommodation in company owned buildings. Relocation allowance is offered. 3.Tarapur- Railway station Boisar takes 1.5 hrs. by train from Borivali Station or by road via Western Express Highway. Suburban local trains direct from Churchgate to Boisar Railway station available. What s in it for You: Opportunity to be part of a growing organization offering niche products to Pharma industry. Opportunity to work at Head Office location. Intimate small company culture with MNC professionalism. Company value programs TrANSSCEnD. Employee events like festival celebrations, family fun events etc Five days working (alternate weeks). Medical Insurance for your immediate family. Housing accommodation for Bachelors & family.

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