R&D QA Associate
Sun Pharmaceuticals Industries Inc. is the fifth largest generic pharmaceutical company in the world, and rapidly building brand presence. We manufacture, market and distribute pharmaceuticals to the nation’s largest wholesalers, distributors, warehousing and non-warehousing chain drugstores as well as managed care providers. Our goal is to continue to develop and market quality products that bring value to our customers and ultimately the patient. Current manufacturing capabilities allow Sun Pharma to develop products across most therapeutic categories.
At Sun Pharma we believe our people are an invaluable asset. Our culturally diverse workforce is one of our biggest strengths, along with the rich experience they bring across varied skill-sets. We are proud that our global workforce is bound by our common values:
Humility. Integrity. Passion. Innovation.
IND123
Position Title: R&D QA Associate
Job Summary:
This position consists of reviewing analytical data generated in the R & D and AR & D laboratories per current in-house and compendial requirements.
Area of Responsibility:
• Ensure that all products are tested under strict cGMP conditions and are documented accordingly.
• Ensure compliance with cGMP requirements, ICH/USFDA guidelines, and internal SOP requirements.
• Actively participate in the development of other Data Reviewers and Chemists by providing training, mentoring, and guidance.
• Participate in laboratory investigations when required.
• Ensure adherence to Safety and Health programs and associated plans.
• Review instrument logbooks on a routine basis.
• Participate in the improvement of the documentation system to increase efficiency and cGMP compliance.
• Ability to travel up to 10%
• Any other responsibilities which are assigned by the manager or department head.
Requirements:
A Bachelor’s degree in Chemistry, Pharmacy, Biochemistry, or a related field is required.
• An advanced degree in Chemistry, Pharmacy, Biochemistry, or a related field is preferred.
Experience:
• 7 years experience (with a Bachelor’s degree) or 3 years experience (with a Master’s degree) in a pharmaceutical company within a Quality Assurance and/or Quality Control environment is required.
• 2 years experience reviewing analytical data generated in an analytical laboratory is required.
• Strong attention to detail skills with the ability to communicate effectively with others.
• MS Office Suite skills
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.
