Johnson & Johnson is the world’s most comprehensive and broadly based manufacturer of health care products.In India, Johnson & Johnson operates as a single legal entity and consists of the 3 strategic business units: Consumer Products, Pharmaceuticals and Medical Devices which are independently managed and report into their respective Global business segments.
Post : OFFICER - QUALITY CONTROL
Job Responsibilities
- Perform and document stability analyses and investigations on drug substance and drug product for various techniques (HPLC, Dissolution, Titiration, CE, etc) according to protocol, specifications, analytical methods and procedures
- Ensure proper planning for execution of analysis within window so as to ensure first pass analysis avoiding human errors.
- Adequate knowledge on regulatory requirements for stability testing
- To ensure immediate escalation of issues not in conformity with applicable procedures /policies etc.
- Results reporting into the LIMS or any other applicable system
- Maintenance and qualification/calibration of lab equipment
- Technical/scientific support to other labs within the premises
- Participate in project teams as analytical technical team member
- Comply with the analyst responsibilities according to various procedures Training of colleagues
- Initiate, document and coordinate deviations and events in applicable Event Tracking System
- Implement CAPAs
- Compilation of work instructions and standard operating procedures Initiate applicable change requests according to the procedures
- Execute the tasks according to the cGMP guidelines.
Functional competencies (Skills, Knowledge and Attributes):
Experience with sample analysis (Formulations and bulk drugs)
Expertise with a variety of analytical techniques e.g. HPLC, GC, UPLC, dissolution, KF, DSC, etc.
Exposure to empower software for HPLC data processing preferred
Experience of working in a regulated
Behavioral Competencies (Leadership Imperatives):
Analytical thinking capability
Problem solving skills
Good team player
Accuracy of results generated
Ethics and values
Potential leadership skills
Communication skills
Self confidence
Additional Information:
Experience: 0-2 years
Qualification: B.Sc/M.Sc
Location: Mumbai
Department: Stability Operations
Job Function: QC
Requisition ID: 1600122718W
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