Require Assistant Scientist at Johnson & Johnson | B.Pharm, B.Sc
Caring for the world, one person at a time, inspires and unites the people of Johnson & Johnson. We embrace 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 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.
Post : Assistant Scientist
• Responsible for performing the Microbiological analysis, method development, method validation, release testing and Stability Studies of samples (Drug substance, Drug Product, Intermediate, Excipient) received at Microbiology lab from sites across the world and ensure quality level for the same.
• Responsible for carrying out activities such as Microbiological method transfer, Microbiological method validation, Microbiological method development and developmental stability studies.
• Responsible for receipt, storage and disposition of samples received at Microbiology lab.
• Microbiological analysis of samples, environmental Monitoring.
• Repacking of samples received for stability studies.
• In-use study for stability samples.
• Responsible for Timely deliverables of projects.
• Responsible for indenting (purchase request) and management of stock (Microbiological Media, cultures, reagents and consumables) required for Microbiology Lab.
• Responsible for coordinating with suppliers for timely delivery of Materials (Microbiological Media, cultures, reagents and consumables).
• Responsible for ensuring the cleanliness & sanitization of Microbiology Lab as per applicable procedure.
• Responsible for ensuring the decontamination and disposal of Biological wastes generated from Microbiology Lab as per applicable procedure.
• Responsible to get trained / qualified on applicable techniques and procedures and to keep the training records up to date
• Responsible for continuous improvements within area of responsibilities
• Responsible for the activities assigned by the supervisor
• To be aware of the technological development under laboratory.
• Responsible to ensure that Microbiology Lab equipment’s & accessories are operated & maintained as per applicable Procedure.
Computerized / Computer system – Validation
To execute software validation activities as per J&J procedures and current guidelines
Facilities and Utilities
• Ensure optimal utilization of work hours & prioritization of activities to meet departmental commitments.
• Optimum utilization of the materials like Media, reagents and consumables required for Microbiological testing.
• To comply with respect to J&J procedures
Handling of Events & Deviations
• Responsible to inform supervisor immediately but not later than 1 business day from identification of any nonconformance, atypical observation or failure.
• Responsible to generate and maintain raw data / records as per applicable procedures
• Responsible for preparation of lab related protocols and other quality documents as required
• Perform and document the analysis with regard to the physicochemical and instrumental analysis carried out for samples of APDC-PDMS-Group according to protocol, analytical methods, specifications and procedure
Internal Auditing Program
• Responsible for supporting Internal/External audits.
Management of External Contract Laboratories and Service Providers
• Collect and share the data with the external contract laboratories for the projects handled within group.
• To support in sending samples to external contract laboratories for testing.
• Responsible for self-development and training
• Ensure to provide best support in terms of quality and speed of completion of the work of control.
• Planning and completion of tasks as per the business requirement
• Responsible to follow the set up measures intended to improve the productivity of the laboratories and cost control initiatives.
• Practice and follow standards of leaderships with respect to
* Customer’s needs
* Mastering complexity
* Maintaining successful team relationships
* High sense of responsibility regarding professional activities
* Customer satisfaction
* Adequate and timely communication to different groups
* Knowledge sharing within the area
Employee safety and health
• Ensure to follow the health & safety related guidelines, procedures and company policies
• Ensure to follow the Environmental care related guidelines, procedures and company policies
• Follow applicable J&J Quality Policy requirements.
• Follow and implement current pharmaceutical regulations and pharmacopoeias in the laboratory.
• Should comply with all applicable current Good Manufacturing Practices (GMP).
• Should follow the data integrity principles in all activities carried (ALCOA++).
• Ensure that respective guidelines / practices are observed.
• Identify cost saving opportunities.
• Follow all applicable company business policies.
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