3 GC Jobs

**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 Analytical Laboratory Operations and Improvement will be responsible for identifying, developing, and implementing improvement for Analytical testing in assigned areas of work. The individual will work closely under the guidance of Quality control managers, interact with Quality Assurance and technical services team professionals to drive compliance and right first-time practices in our Quality control lab operations at Chantilly.

Through direct participation and contribution towards improvement projects, individuals will develop hands on experience working in routine testing of raw materials, finished product and stability samples. Involved in equipment calibration/qualification and method validation of raw material and finished dosage forms. Improve the analytical capabilities and skills working independently on HPLC, GC, dissolution and other lab instruments. Improve time management skills including the ability to support process validation and product commercialization.

The individual will support Quality control lab activities, 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 to apply their knowledge of science and prior experience in Analytical laboratory operations to ideate, develop, execute and deliver results through improvement projects. These projects could primarily be about increasing efficiency, throughput, and quality.

Responsibilities:

1. Perform routine release tests of raw material, in-process, finished product and stability samples, such as content uniformity, blend uniformity, Assay, Related compounds, particle size distribution, density, water determination by KF, residual solvents, LOD, ROI, viscosity, and other tests according to the in-house specifications and methods and USP monographs.
2. Perform dissolution testing for in-process, finished product and stability samples.
3. Perform tests for determination of residual active substance and cleaning agent in swab samples.
4. Execute method transfer activities for raw materials and finished dosage forms.
5. Perform / coordinate qualification, preventive maintenance, and calibration of laboratory instruments.
6. Perform instrument repair and troubleshooting, monitor instrument performance lifecycle, work with outside vendors to facilitate repairs as needed.
7. Execute cGMP operations in the QC Laboratory in compliance with applicable guidelines and regulations.
8. Ensures compliance with SOPs, policies and procedures as required by the Company and regulatory agencies.
9. Document experiments accurately and complete all associated documents (Instrument, Standard and Column usage logbooks) in compliance with internal SOPs and FDA guidelines.
10. Evaluate test results against standards and timely reporting of any deviations, OOS, OOT and atypical results to the supervisor/department head.
11. Maintain work area and laboratory with good housekeeping practices and in compliance with cGMP.
12. Assist other chemists with trouble shooting of general laboratory instrumentation, analyses, and methodologies.
13. Identify and communicate continuous improvement opportunities to the Analytical manager and Director.
14. 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.

Knowledge/ Skills / Techniques to gain:

1. Hands on experience working in routine QC release and stability testing.
2. Exposure to enhance skills to develop and validate analytical methods for complex finish dosage forms (Immediate Release, Delayed release and Extended release) using different analytical techniques.
3. Improve the efficiency to plan, manage and execute analytical laboratory activities.
4. Gain international exposure by working in the US.
5. GMP compliance in a regulated work environment

Knowledge/ Skills:

1. Proven knowledge of HPLC
2. Proficient in documentation as per Good Documentation Practice.
3. Troubleshooting abilities
4. Computer skills including Microsoft and Excel
5. Excellent verbal and written communication and skills

Experience & Education:

• Bachelors/masters in chemistry or related scientific field
• Minimum 2-year hand on laboratory experience in pharmaceuticals industry.
• Knowledge of Good Manufacturing Practices (cGMP)

Physical Requirements/Working Environment:

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

Disclaimer

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.