Production Operator Job Vacancy in USA

Granules Pharmaceuticals Inc., (GPI) is a subsidiary of Granules India LTD. Granules India LTD is a vertically integrated pharmaceutical company, headquartered in Hyderabad, India. Over the past 34 years, Granules has worked towards strengthening its core through its five products, and is, today, an integrated player with a strong market presence. With our focus on forward and backward integration, we are sowing seeds in new areas, segments and divisions to reach our targets. GPI is location in Chantilly, VA. We manufacture dosage forms with specific release capabilities like pulsatile drug release in tablet and capsule dosage form, orally disintegrating modified release tablets (XR, MR, ER), modified release suspension and controlled substances capabilities in an abuse deterrent technology platform, all supported by their New API business.

We are dedicated to excellence in manufacturing, quality and customer service. We are an innovative company empowering our employees to focus on excellence in developing, manufacturing and commercializing generic drugs to give customers reliable and affordable options. We invest in employee learning and development at work and beyond. 

Multiple vacancies available

Join Granules Pharmaceuticals, Inc. for an opportunity to work in the United States for 18 months through our J1- Visiting Trainee program! Our J1 program offers an excellent opportunity to further develop your career in your field while gaining US Workplace and Cultural experience. Once the program is coming to an end, you will have the opportunity to secure a role at Granules India Limited prior to your return to India. Please submit your application directly if interested.

(Must have valid passport)

JOB DUTIES OVERVIEW

The Visiting Trainee Pharmaceutical Manufacturing Operations and Improvement will be responsible for identifying, developing, and implementing improvement initiatives for manufacturing processes in assigned areas of work. The individual will work closely under the guidance of production managers, interact with manufacturing and quality assurance and quality control and engineering professionals to drive compliance and right first-time practices in our operations at Chantilly.

Through direct participation and contribution towards improvement projects, individuals will develop strong leadership skills, and the ability to collaborate and drive change in a cross-functional environment.

The individual will support manufacturing of drug products, by ensuring product compliance to established current Good Manufacturing Practices (cGMPs), to meet customer requirements and in adherence to Standard Operating Procedures (SOPs). Based on products and strengths, tasks assigned may vary in scope, sequence, complexity, and timing. Individuals will be trained to and will have an opportunity further develop their knowledge of science and experience in regular pharma manufacturing operations to ideate, develop, execute and deliver results through improvement projects. These projects could primarily be about increasing efficiency, throughput, and quality.

Responsibilities:

1. Responsible to deliver day to day targets (batch) in assigned process area and / or equipment while ensuring quality adherence throughout the process and in documentation.
2. Will be trained on how to identify and communicate continuous improvement opportunities to the Production Manager and VP Operations
3. Responsible for setup, upkeep and maintenance, monitoring, troubleshooting of assigned process and /or equipment and related spare parts
4. Conduct gap assessment of current standard operating procedures of manufacturing equipment
5. Opportunity to work cross functionally to develop approach and solve complex problems by utilizing Lean, Six Sigma, or other continuous improvement tools and methodologies
6. Develop documentation skills and will receive guidance on how to develop metrics that provide data for process measurement, identifying indicators for future improvement opportunities.
7. Create, review, and/or revise Master Batch Records and reconciliation, Standard Operating Procedures, forms, and other supporting documentation.
8. Perform in-process audits to ensure compliance of regulations and written instructions.
9. Deliver on any special projects or assignments from Manager of Production relating to process improvement.
10. Responsible for the safe and efficient execution of job duties and abiding by established quality standards.

Goals:

Towards the end of the program, the individual is expected to work independently on a project and deliver to satisfaction of the functional head. Individual will be presented an opportunity to present their work to the leadership during their last month on the program.

Summary of Knowledge/Skills /Techniques to gain:

1. Hands on experience in US FDA approved plant in the US
2. Multi-cultural experience and exposure to enrich business management, analytical and presentation skills
3. Gain international exposure by working in the US
4. Develop process improvement skills by delivering kaizens and improvement projects
5. Training and development of leadership, communication, and planning skills. Opportunity to train entry level operators.

Knowledge & Skills Required:

• Current Good Manufacturing Practices (cGMP) Food and Drug Administration (FDA) and other regulatory requirements
• Awareness of all aspects of OSD manufacturing and ability to work hands on is essential.
• Standard Operating Procedures for process rooms and manufacturing area
• GMP compliance in a regulated work environment
• Manufacturing processes and equipment procedures

Experience & Education Required:

• At least an Associate degree or equivalent in chemistry or pharmaceutical sciences or related field
• Knowledge of Good Manufacturing Practices (cGMP)
• Prior hands on experience in pharmaceutical manufacturing for at least 5 years across at least one unit operation (i.e. Pharmaceutical Glatt, Compression, Pan coating equipment essential)

Physical Requirements/Working Environment:

• Plant environment with lab coats, safety glasses and PAPR
• 8 hours per day
• 6-8 hours standing while performing the task
• Must be able to lift 50lbs

Email: careers.gls@granulesindia.com, Shilpa.nookaraju@granulesindia.com