Applications are invited from eligible candidates for the post of Batch release coordinator at Johnson & Johnson for its office in Hyderabad.
About the Company
Johnson & Johnson is one of the world’s most valuable companies and is one of only two U.S.-based companies that have a prime credit rating of AAA, higher than that of the United States government. Johnson & Johnson had worldwide sales of $70.1 billion during the calendar year 2015. Johnson & Johnson’s brands include numerous household names of medications and first aid supplies.
About the Post
The company 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.
- 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.
- 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
How to Apply?
Interested candidates can apply for the post through the link given below.
Click here to view the official notification for the post of Batch Release Coordinator by Johnson & Johnson, Hyderabad
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