QA Data Reviewer
Sun Pharma, one of the world’s largest specialty generic companies, operating in over 150 markets worldwide, has been present in the U.S. since 1996, focusing on generics, branded generics and over-the-counter (OTC) products. We are a vertically integrated company and valued supplier to the largest wholesalers, distributors, warehousing, non-warehousing chain drugstores as well as leading managed care providers.
This position is located at OHM LABORATORIES Inc., (A Sun Pharma Company) in New Brunswick, NJ and is one of the nation’s leading manufacturer of pharmaceuticals. A long standing history of superior product and a steadfast reputation for excellence has positioned OHM LABORATORIES as an integral partner of choice by many leaders in industry. Rigid quality control, quality assurance, versatility, personalized service and the expertise of our team have continually attributed to the success of OHM LABORATORIES Inc. for over two decades.
IND123
Position Title: QA Data Reviewer
Job Summary:
The QA Data Reviewer is accountable for reviewing analytical data critically per current in-house and compendial requirements.
Area of Responsibility:
• Data Review of Raw Material, Finished Product, Packaging Material, and Stability
• Comply with GDPs, GLPs, and cGMPs
• Adhere to the Safety and Health Program and associated plans
• Educate analytical chemists to improve analytical data reporting
• Audit lab on a routine basis and report directly to department head
• Continuously improve documentation system to increase efficiency and GLP compliance
• Completion of work within the assigned time frame
• Coordinate and discuss with other team members for continuous improvement of review
• Discussions and provide suggestions to QC analysts for continuous improvement of the documentation process within cGMP requirements and applicable written test procedures and methods
• Interaction with QC Analysts and Group Leaders as well as managers of other departments as needed
• Able to work as a team member in QC Lab environment
• Any other responsibilities which are assigned by the manager or department head.
Requirements:
Bachelor’s degree in Chemistry, Pharmacy, Biochemistry, or a related field is required
Experience:
• 5+ years experience within a Quality Assurance/Quality Control environment
• Knowledge of QC laboratory test procedures, cGMP requirements, ICH/USFDA guidelines, raw material analysis, method validation guidelines, analytical method transfers, finished products and stability testing procedures
• Review of standard operating procedures, test procedures, and validation protocols Work Conditions:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job in an office, lab, or manufacturing environment. The noise level in the work environment is usually moderate.
Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to use hands to handle and feel and talk and hear. The employee is frequently required to stand, walk, sit, stoop, crouch, push, bend, climb stairs, and perform repetitive motion.
Must be capable of bending and lifting, moving and/or carrying up to 50 pounds.
Ability to navigate office, lab, and/or plant floor working environments, stands, ambulates, and reaches.
Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes.
Must have English language fluency, both written and verbal, with the ability to communicate at all levels within the organization.
