Johnson & Johnson looking for Quality Control Officer

Janssen India, the pharmaceutical division of Johnson & Johnson India, is dedicated to addressing and solving some of the most important unmet medical needs of our time in India, in oncology, immunology, neuroscience and analgesia, dermatology, infectious diseases and metabolic diseases. Driven by a strong dedication to the health and well-being of patients, Janssen India brings innovative products, services and solutions to people throughout the world.

Post : Officer, Quality Control

Job Description
Plans, coordinates and perform routine and complex testing in compliance with laboratory test methods and procedures to support the manufacturing and timely delivery of product to customers.
• Plan, co-ordinate and execute activities of Quality Control, Instrumentation Section including HPLC, GC , UPLC, . Finished Goods activities to ensure continuous production of products consistent with established Quality & Regulatory standards by performing the assigned duties and responsibilities
Responsible for the day to day management of the quality laboratory tests, log book review, compliance to applicable procedure. The Analyst will ensure that product testing is completed in a timely and compliant manner and support in troubleshoot instrument issues, investigate nonconforming data as well as review and issue Certificates of Analysis as required. In addition, the Analyst will support and execute in collecting, collating and documenting laboratory metrics for presentation to management.

DUTIES & RESPONSIBILITIES
Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
• Performing routine and complex testing in compliance with laboratory test methods and procedures to support the manufacturing & timely delivery of product to customers.
• Applicable Compendia testing.
• Quality Control testing, reports review when thorough training has been completed under the guidance of supervisor.
• Knowledge and experience in Empower system.
• Initiation and participation during investigations for non-conforming laboratory test results.
• Collecting and preparing laboratory records for evaluation following good documentation practices.
• Troubleshooting methodology or instrument problems
• Communicating business related issues or opportunities to their immediate Supervisor
• Operating in accordance with current GxPs with regard to documenting, testing and maintaining accurate laboratory records.
• Support in QC lab Projects, Change Controls, Actions and Effectiveness Monitoring.
• Performing calibrations and annual maintenance of laboratory Instrument life cycle management according to current SOPs.
• Assisting in various other duties which contribute to the organization and function of the laboratory, and as assigned by supervisor
• Ensuring personal and company compliance with all local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
• QC test Data Timely Archival and retrieval.
• Ensure all time audit readiness and 5S in Quality Control Lab.
• Test method validation and test method life cycle management for Chemical test methods.

Handling and support for Audit.
• Chemical -safety, Chemical-hazard management
• Assures that all QC tests activities run in a safe, clean and environmentally sound Manner.
• Ensure timely validation & Calibrations of Instruments in QC laboratory under the guidance of supervisor.
• Formulates and meets QC objectives and coordinates objectives and priorities with operations.
• Trending and analysis of statistical data related to QC activities to determine
• present standards and establish proposed quality and reliability expectancy
• Carries out duties in compliance with all regulations and guidelines including MDR and Food & Drug
• Administration (FDA). Complies with all company and site policies and procedures
• Follows all applicable aspects of the site environmental management system

Compliance & Training
• Observes & promotes all regulatory requirements as defined per applicable regulations, rules & procedures established by the Company, and notified any violation or deviation to the immediate supervisor or appropriate authority.
• Complies with all training requirements to perform duties of the job.
• Ensure adherence/compliance to Records Management policies and procedures, as applicable.
Accountability:
• Maintained 5S in laboratory, GLP in laboratory.
• Instrument spare management. Gas cylinder inventory & management.
• Status Labelling.
• Overall Instrumentation of lab Accountability

Candidate Profile
• Education: Graduate or Postgraduate in Chemistry / B. Pharm / M. Pharm or Life Science.
• Experience: Minimum 2 to 5 years of experience in QC function/ Instrumentation Section.
• 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 / 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 stake holders.
• Instrumentation and Analysis: Overall knowledge of Instrumentation and analysis.
• Qualification and Certification: Process experience. Overall knowledge of Product / Business priorities / Projects. Authority of decision making base on facts. Overall expertise in elements of one section of Technical Competency, leading in Fundamental skills, Professional skills & Behavior skills. Must be expert for Supervision & process knowledge.

Additional Information
Qualification : Graduate or Postgraduate in Chemistry / B. Pharm / M. Pharm or Life Science
Location : Maharashtra-Aurangabad
Experience : 2 to 5 years
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Quality
End Date : 30th August, 2021