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 : Asst. officer QC
Position Summary: Janssen Supply Chain (JSC) is a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus, this group strives to provide access to and affordability of medicines through innovation and strong collaboration with their R&D and commercial partners to deliver life changing solutions for patients in need. Stability Operations is a department within the JSC, responsible for the management of stability testing of pharmaceutical products and active pharmaceutical ingredients manufactured in the different manufacturing sites.
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
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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:
Location: Mumbai
Department: Pharma
Job Function: QC
Requisition ID: 1700160265W
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