Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. Johnson & Johnson strives to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life. The organization is comprised of more than 250 operating companies with over 127,000 employees located in some 60 countries. With Global sales of USD 71.3 billion in 2013, Johnson & Johnson is recognized as one of the most admired and respected companies in the world. Johnson & Johnson companies are equal opportunity employers.
Post : OFFICER - QUALITY CONTROL
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
Education & Certifications: Bachelors / Masters in Science (Analytical chemistry or equivalent). At least 2-4years of experience in a Pharmaceutical Industry (Quality Control).
Additional Information:
Experience: 5-8 years
Location: Mumbai, India
Industry Type: Pharma
Functional Area: QUALITY CONTROL
Last date : 15th June, 2017
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