Johnson & Johnson Looking for QC Executive at Greater Aurangabad Area

Johnson & Johnson; Aurangabad; On-site; INR 4,00,000 - 8,00,000; Full time

Job summary

An established industry player is seeking a dedicated professional to manage LIMS implementations and ensure compliance with regulatory standards. This role focuses on enhancing laboratory processes, supporting data management, and collaborating with cross-functional teams to deliver high-quality healthcare solutions. If you are passionate about improving health outcomes and have a solid background in laboratory information management systems, this opportunity will empower you to make a significant impact in the medical devices sector. Join a team that values innovation and commitment to quality in a dynamic environment where your contributions matter.

Qualifications

• Minimum 2-3 years of experience in LIMS implementation and master data management.
• Knowledge of chromatography is preferred.

Responsibilities

• Manage LIMS Labware data and execute implementations for various modules.
• Conduct testing of finished products and maintain compliance with regulations.

Skills

LIMS implementation

Chromatography

GxP Documentation

Data Analysis

Instrument Operation

Quality Management Systems (QMS)

Cross Functional Coordination

Problem Solving

Education

Graduate or Postgraduate in Chemistry

Bachelor's in Engineering

Bachelor's in Pharmacy

Tools

Empower Software

Laboratory Instruments

Job description

Job Description

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science — bringing creative ideas, products, and services to advance the health and well-being of people. Every day, our more than 130,000 employees across the world are blending heart, science, and ingenuity to profoundly change the trajectory of health for humanity.

At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale, and experience to reimagine the way healthcare is delivered and help people live longer, healthier lives.

In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, vision, and interventional solutions with the big ideas of others to design and deliver physician and patient-centric products and solutions.

As pioneers in medical devices, we continually focus on elevating the standard of care—working to expand patient access, improve outcomes, reduce health system costs, and drive value. We create smart, people-centered healthcare to help the patients we serve recover faster and live longer and more vibrantly.

Under General Direction and in accordance with all applicable Federal, State, and Local laws/regulations and corporate Johnson & Johnson procedures and guidelines, this position includes:

1. Management of LIMS Labware static and dynamic data.
2. Execution of Labware LIMS implementation for various modules.
3. Knowledge of developing analyses, product specifications, environmental monitoring, lot manager, project manager, stability manager, storage location manager, standard and Reagent, and instrument manager.
4. Design, create master data, and execute dry runs for verification.
5. Validation and implementation of LIMS modules such as Lot management, Instrument management, Batch manager as per 21 CFR requirements.
6. In-depth understanding of the analytical test method, procedures, and raw data generated by the instruments.
7. Ability to do process mapping of a procedure.
8. Gap identification in the existing process flows.
9. Effective communication with end users, CFTs, line QA regarding the master data.
10. Design logics and verification through dry runs.
11. STP/SOP’s revision as per the LIMS requirements.
12. Investigation, addressing master data revisions, and acknowledging the changes through QMS system.
13. LIMS basic experience to build or update component calculations and format calculations is required.
14. Experience with System Development Life Cycle (SDLC) and validation requirements ensuring compliance with regulatory requirements.
15. Ability to write test scripts and support execution of validation protocols adhering to SDLC.
16. End user training & support.
17. Performing with competence, upon training, routine testing and review of laboratory test methods, test reports, and procedures.
18. Developing competence, upon training, in the use of laboratory instruments and equipment.
19. Performing calibrations and annual maintenance of laboratory instrument life cycle management according to current SOPs.
20. Working in compliance with current GxPs regarding documenting, testing, and maintaining accurate laboratory logbooks and test data sheets.
21. Initiation and participation in laboratory investigations of non-conforming lab incident laboratory test results.
22. Collecting and preparing laboratory records for evaluation following good documentation practices.
23. Ensuring personal compliance with all local and company regulations, policies, and procedures for Health, Safety, and Environmental compliance.
24. Performing other related duties as assigned by the management.
25. Testing of finished product, raw material, packing material, stability, validation, and in-process samples.
26. Support to test method validation and test method life cycle management for chemical test methods.
27. Chromatographic analysis and review.
28. Act as a reviewer role for finished good testing, in-process, validation.
29. Raw material and packing material testing as and when required.
30. HPLC & GC column usage and maintenance. HPLC, GC, and UPLC calibration/validations and test method validations. Support in new analyst qualification.
31. Testing of all FG’s as per instruction of supervisor and support in timely releases of FG.
32. Responsible for timely testing and release of FG, e.g., HPLC tests, GC test, UPLC test, and all other FG tests.
33. Destruction of samples.
34. Communicating business-related issues or opportunities to their immediate supervisor. Perform work/activities as assigned by supervisor.
35. Operation of Empower, maintain audit trail. Timely submission of reports and audit trails for review.
36. Preparedness for announced and unannounced audits.
37. Responsible for communicating business-related issues or opportunities to the next management level.
38. For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety, and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
39. Responsible for ensuring personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures.

Performs other duties assigned as needed.

1. Education: Graduate or Postgraduate in Chemistry, bachelor’s in engineering, bachelor’s in pharmacy.
2. Experience: Minimum 2 to 3 years of relevant experience in LIMS implementation, LIMS Master data management is a must, and experience in chromatography is preferred.

Technical Skills / Behavioral Skills Functional Competencies

1. Knowledge of GxP Documentation and of following areas like Test Method and Specification, Instrument operation procedure, current regulations, Departmental SOPs, Report writing/Data analysis, OOS/OOT NC procedures, and Data Integrity issues.
2. QMS: In-depth knowledge of tools for investigation of OOS/NC, Audit trail reviews, and capabilities of analyzing its impact assessment.
3. Cross Functional coordination: Coordination skills with all stakeholders.
4. Instrumentation and Analysis: Overall knowledge of Instrumentation and analysis.

Professional Competencies

1. Operational Excellence: Analytics & Problem Solving, Technology & Data Management, Decision Making, Knowledge Management.
2. Quality & Compliance: Quality Mindset, Compliance Orientation, Environment Health & Safety.
3. Business Fundamentals: Financial Management & Budgeting, Project Management, Business Case Development, Business Orientation.
4. Business Partnering: Influencing, Change Management, Time Management, Global Mindset & Management.

Are you ready to impact the world?

Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

This description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.

Primary Location

Asia Pacific-India-Maharashtra-Aurangabad

Organization

Johnson & Johnson Private Limited (8080)

Job Function

Quality Control

Job Qualifications

EXPERIENCE AND EDUCATION*