Hospira is the world's leading provider of injectable drugs and infusion technologies. Through our broad, integrated portfolio, we are uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs.
Through our offering of high-quality, lower-cost generic medications, we continue to help reduce the overall costs of healthcare — to improve both the affordability of care for patients and the financial strength of the global healthcare system.
Post: Executive, Analytical Stability
Job Description
The Stability Coordinator will coordinate stability operations activities and ensure quality products and systems. Activities to include protocol development, equipment management, internal and external testing coordination, scheduling, stability data compilation and analysis.
- Coordinate stability operation activities and ensure quality products and systems
- Determine stability sample requirements, develop stability protocols and oversee execution of stability protocols;
- Monitor stability chambers and chart recorders on a daily basis to confirm environmental conditions for acceptance with established specifications;
- Responsible for performing routine QC Stability testing of all active substances, excipients, finished dosage forms and complaint samples.
- Verifies / validates US CPO Quality Control data, while monitoring for trends and abnormalities. Reports and acts on data results.
- Responsible for writing and updating applicable SOP's
- Assist with compilation of QC laboratory documentation metrics.
- Individual may provide internal training to other individuals.
- Responsible for Performance evaluations / reviews of team members
- Individual is capable of independently troubleshooting analytical and instrument problems.
- Individual is responsible for assuring adherence to Federal (FDA, DEA, EPA), OSHA regulations, cGMP's, SOP's, company policies and procedures.
- Work independently on and lead projects.
Candidate Profile
Education: Master in science (Chemistry) or Pharmacy graduate
Experience: 5- 6 years in analytical Laboratory,
Expertise in analytical instruments Like HPLC, GC, KF and IC etc.
Experience in Method validation and Stability studies
Worked in GMP environments
Individual must possess a thorough knowledge, understanding and ability to apply typical chemical analysis techniques
Understand and practice c GMPs and industry methodologies as it applies to quality assurance.
Strong computer, scientific, and organizational skills
Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
Ability to learn new techniques, performs multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
Requires intermediate to advanced Excel skills;
Knowledge of and ability to work with equipment, supplies, components and technical areas that are utilized in the pharmaceutical industry, i.e., weighing equipment and controlled environmental chambers;
Knowledge of FDA guidelines on Stability requirements is a plus
Must have program management skills and scheduling abilities;
Able to develop and implement efficient functional systems;
Quality minded with ability to perform work with detailed accuracy and in accordance with established procedures
Must be able to analyze data and work with a high degree of accuracy;
Organized and able to perform duties in a timely manner;
Must be flexible and able to handle multiple activities;
Additional Information:
Auto req ID: 18894BR
Qualification: M.Pharm, M.Sc, Graduation
Location: Chennai, Tamil Nadu
Functional Area: R&D
Employment Type: Full Time
Job Type: Regular
End Date: 30th September, 2015
See All D.Pharm Alerts B.Pharm Alerts B.Sc Alerts Bangalore Alerts
See All Other Jobs in our Database
.png)
