Third Party - Intern QA

Job Title

Third party QA Intern

Organization Name

InvaGen Pharmaceuticals, Inc.

Location

Central Islip, NY location

Employment Type

Full Time

Salary Range

(Base/salary)

Based on education 19 to 27/hr

Benefits

Paid holidays that fall within the session

Work Hours/ Shift/ Remote

8:30 am - 5pm Mon- Fri

Responsibilities/ Accountabilities

• Coordination with different vendors/ Customers/ Service providers for arranging the documents as required.

• Documentation of vendor qualification documents. Compilation of the documents received from the vendors/CMO.

• Drafting of the agreements with vendors.

• Managing the schedules for the inspections and execution of activities as per instructions from manager.

• Following good documentation practices. Handling of change control documents for coordination with different cross functional teams.

• Perform in-process testing (e.g. weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions.

• Perform room and equipment checks (where applicable) prior to each stage of manufacturing following detailed written procedures.

• Perform AQL sampling and inspections as required.

• Prepare in-process and finished product samples (where applicable) for QC lab, following detailed documentation procedures and delivering them to QC lab.

• Maintenance of standard weights and perform daily verification of balances.

• Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record.

• Monitor facility and product environmental operating conditions.

• Review of engineering records (temperature and humidity data calibration and PM records, Pest control records and contractor related functions).

• Review of online batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing step.

• Verification of functionality of all the equipment and associated controls during the batch run.

• Perform applicable testing and prepare report for customer complaints.

• Identify and report any non-conformances/discrepancies to management if applicable.

• Other duties that management may assign from time to time.

• You will be required to attend a volunteer event and professional development seminar as part of your internship experience. You will also be assigned a ten (10) to fifteen (15) minute presentation at the end of the internship to express what you learned throughout your time working at Cipla and what you are taking away from the experience

Education Qualifications

• BS degree Pharmacy, Regulatory affairs or related field

Experience

• 0 - 1 year

Skills/ Competencies

• Knowledge of good manufacturing practices and good documentation practices preferred.

• Ability to read, write and communicate effectively.

• Self-motivated, with the ability to work in fast-paced manufacturing environment and handle multiple tasks simultaneously.

• Excellent organization skills with the ability to focus on details

• Basic computer skills (Word and Excel) - Intermediate

• Good basic math knowledge and excellent attention to details.

• Degree in Quality Assurance or related fields.

• A focus on vendor qualifications and management.

About Cipla

Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Driven by the purpose 'Caring for Life', Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world. In the last 85 + years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Cipla is a fast-growing pharmaceutical company with a continued focus on the expanse of our strong legacy. Over the last five years, Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division.

InvaGen Pharmaceuticals, Inc.

InvaGen Pharmaceuticals is a Cipla subsidiary engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. In October 2020, InvaGen established its project site in Fall River, Massachusetts to support the launch of Cipla's respiratory business in the United States.

Equal Opportunity Employer

Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Cipla, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require reasonable accommodation to make your application or interview experience a great one, please contact the recruiter.

About the Salary/ Pay Range: The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location. In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.