QC Executive Job J&J – Chemistry Candidates Apply Online
QC Executive Job J&J – Chemistry Candidates Apply Online. Interested and eligible applicants can check out all of the details on the same below:
JOB TITLE: QC Executive
SUB FUNCTION: Quality Control
LOCATION: Aurangabad, Maharashtra, India
DATE POSTED: Sep 29 2023
REQUISITION NUMBER: 2306143929W
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 standardof 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.
- Management of LIMS Labware static and dynamic data.
- Execution of Labware LIMS implementation for various modules.
- Knowledge of developing analyses, product specifications, environmental monitoring, lot manager, project manager, stability manager, storage location manager, standard and Reagent, and instrument manager.
- Design, create master data and execute dry runs for verification.
- Validation and Implementation of LIMS modules such as Lot management, Instrument management, Batch manager as per 21 CFR requirements.
- In-depth understanding of the analytical test method, procedures, raw data generated by the instruments.
- Ability to do process mapping of a procedure.
- Gap identification in the existing process flows.
- Effective communication with end users, CFT’s, line QA regarding the master data.
- Design logics and verification through dry runs.
- STP/SOP’s revision as per the LIMS requirements.
- Investigation, addressing master data revisions, and acknowledging the changes through QMS system.
- LIMS Basic experience to build or update component calculations and format calculations is required.
- Experience with System Development Life Cycle (SDLC) and Validation requirements ensuring compliance with regulatory requirements.
- Ability to write test scripts and support execution of validation protocols adhering to SDLC.
- End user training & support.
- Performing with competence, upon training, routine testing and review of laboratory test methods, test reports and procedures.
- Developing a competence, upon training, in the use of laboratory instruments and equipment’s.
- Performing calibrations and annual maintenance of laboratory Instrument life cycle management according to current SOPs.
- Working in compliance with current GxPs regarding documenting, testing and maintaining accurate laboratory logbooks and test data sheets.
- Initiation and participation in laboratory investigations of non-conforming, lab incident laboratory test results.
- Collecting and preparing laboratory records for evaluation following good documentation practices.
- Ensuring personal compliance with all, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
- Performing other related duties as assigned by the management.
- Testing of Finished product, raw material, packing material, stability, validation and In -process samples.
- Support to test method validation and test method life cycle management for chemical test methods.
- Chromatographic analysis and review.
- Act as a reviewer role for Finished good testing, In-process, validation.
- Raw material and packing material testing as and when required.
- HPLC & GC column usage and maintenance. HPLC, GC and UPLC calibration /validations and test method validations. Support in new analyst qualification.
- Testing of all FG’s as per instruction of supervisor and support in timely releases of FG.
- Responsible for timely testing and release of FG, e.g. HPLC tests, GC test, UPLC test and all other FG tests.
- Destruction of samples.
- Communicating business related issues or opportunities to their immediate Supervisor. Perform work/ activities as assigned by supervisor.
- Operation of Empower, maintain audit trail. Timely submission of reports and audit trails for review.
- Preparedness for announced and unannounced audits.
- Responsible for communicating business related issues or opportunities to next management level.
- 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.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
- Performs other duties assigned as needed.
EXPERIENCE AND EDUCATION*
Education: Graduate or Postgraduate in Chemistry, bachelor’s in engineering, bachelor’s in pharmacy.
Experience: Minimum 2 to 3 years of relevant experience in LIMS implementation, LIMS Master data management is must and experience in chromatography is preferred.
Technical Skills / Behavioral Skills Functional competencies:
- Knowledge of GxP Documentation and of following areas like Test Method and Specification, Instrument operation procedure, current regulations. Departmental SOP’s, Report writing / Data analysis, OOS /OOT NC procedures, and Data Integrity issues.
- QMS: In-depth knowledge of tools for investigation of OOS / NC, Audit trail reviews and capabilities of analyzing its impact assessment.
- Cross Functional coordination: Coordination skills with all stakeholders.
- Instrumentation and Analysis: Overall knowledge of Instrumentation and analysis.
- Operational Excellence: Analytics & Problem Solving, Technology & Data Management, Decision Making, Knowledge Management.
- Quality & Compliance: Quality Mindset, Compliance Orientation, Environmental Health & Safety.
- Business Fundamentals: Financial Management & Budgeting, Project Management, Business Case Development, Business Orientation.
- Business Partnering: Influencing, Change Management, Time Management, Global Mindset & Management.
For more information, please visit the official job posting.
Keywords: QC Executive, Quality Control, Chem & Pharma, Johnson & Johnson, Job Posting, Maharashtra, India, LIMS implementation, Chromatography. QC Executive Job J&J – Chemistry Candidates Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.