Company Profile:

: Caring for the world, one person at a time, inspires and unites the people of Johnson & Johnson. We welcome innovation—bringing ideas, products and services to life to advance the health and well-being of people around the world. We believe in collaboration, and that has led to breakthrough after breakthrough, from medical miracles that have changed lives, to the simple consumer products that make every single day a little better. Our over 125,000 employees in 60 countries are united in a common mission: To help people everywhere live longer, healthier, happier lives. In India, J&J operates as a single legal entity and consists of the 3 strategic business units: Consumer Products, Pharmaceuticals and Medical Devices, which are independently handled and report into their respective Global business segments

Job description:

 

Main Responsibilities

 

• Maintain oversight for status of individual batches, including sampling, testing, deviations, and target release timelines; communicate status accurately and succinctly.
• Review batch documentation provided by external manufacturing site for compliance with cGMPs, Janssen standards, and product specifications.
• Ensure all required testing and documentation is provided and meets release requirements.
• Perform batch disposition in accordance with Janssen Supply Chain (JSC) procedures 
• Manage/track OMCL/CBER samples from EM to final shipment to government facility 
• Generate OMCL/CBER protocols for lot release 
• Enter data into eLIMS 
• Alert Supervision of any nonconforming results, out of trend, or out of specification results 
• Support supply chain logistics for on time shipment from CMO to Warehouse 
• Support all Quality and Compliance activities and strategy to support the Internal and External
• Manufacturing (EM) of COVID-19 Vaccine DS and DP product release
• Manages quality metrics, release cycle times, and drives improvements as needed
• Assure adequate strategy for Quality Systems: Event and CAPA Management System,
• Document Management System, Learning Management System, Change Control System & new technologies as needed
• Draft, edit and approve department procedures as needed and ensure document hierarchy is
• maintained in a logical state
• Manages/facilitate awareness of investigations, Corrective Actions, Change Controls (e.g.,
• tracks open records and assures closure) in support of Covid-19 vaccine release
• Escalates issues to quality management in timely manner and works with management to
• address and remediate issues
• Communication and presentation of project updates to all levels of the organization
• Remain current with international Health Authority regulations, guidelines, and quality practices associated with the pharmaceutical industry
• Continued development of knowledge and expertise as needed in order to perform job duties      

 

 

Requirements

 

Experience expectation

• Bachelor Degree in a scientific function, or equivalent degree level, with minimum of 4+ yr healthcare industry experience

• Experience in quality function in Biologics or Vaccine industry preferred
• Previous experience in work environment under cGMP regulation highly desirable, 

• Must have strong ability to maintain high efficiencies and accuracy in data entry
• Strong proof-reading skills to validate complex information and detect errors

• Strong quantitative and analytic abilities to analyze and validate data
• Ability to maintain and organized record file is essential
• Strong computer skills in Excel, Word, Sharepoint
• Ability to follow standard operating procedures and work instructions. 
• Good interpersonal, communication and organization skills. Ability to manage multiple and changing priorities required. 
• Detail oriented, dependable and motivated
• Willingness to initiative to alert supervision when encountering aberrant data. 
• Fluency in English.