QA Inspector II - DPI

About the role

The QA Inspector II is responsible for monitoring and ensuring product quality is maintained through all phases of manufacturing or packaging in compliance with established specifications.

Responsibilities/ Accountabilities

- Verification of raw materials during the dispensing process. - Dispensing printed packaging materials to packaging. - Performing in-process checks during batch manufacturing and packaging, as per manufacturing & batch packaging record instructions. - Collection of in-process blend, finished product, validation samples for analysis, sample collection as per protocols. - Specifically, to perform blend uniformity (BU) sampling. - Cleaning and maintaining the samplings rods/dies/sample boxes used for BU sampling. - Performing IPQA testing on the manufacturing floor specifically LOD, Bulk Density, Tapped Density, Leak Test, Weight Variation test. - Ensuring cleaning of manufacturing and packaging equipment, area and providing line clearance. - Posting of dispensed materials and samples into SAP system (ERP system) and performing other transactions in SAP. - Involved in investigation of Deviations, OOS, OOT, or any other non-conformances. - Ensuring completion of individual training assigned and following company policies, safety requirements, cGMP and SOP’s. - Reviewing online batch records, area/equipment logbooks, calibration/PMP records etc. - Ensuring the proper isolation of rejected material generated during batch process and accountability in the batch record. - Reviewing engineering records (temperature and humidity data, calibration reports and PMP records). - Taking daily Quality rounds at shop floor to ensure shop floor is maintained in state of compliance and per GMP requirement. - Reporting, escalating to Manager quality assurance about daily shop floor activities and any discrepancy during batch manufacturing and packing. - Additional support duties as assigned by management.

Education Qualifications/Experience

- Minimum Science Graduate. - A minimum of 1-2 years of pharmaceutical experience (DPI, MDI or Injectables) preferred. - Preference will be given to candidates with experience in generic pharmaceutical manufacturing.

Skills/ Competencies

- Knowledge of Good Manufacturing Practices and 21 CFR Part 820. - Ability to read, write and communicate effectively. - Basic computer skills (Microsoft Word, Power and Excel). - Self-motivated, with the ability to work in fast-paced manufacturing environment and handle multiple tasks simultaneously. - Excellent organization skills with strong attention to details skills. - Strong fundamental mathematical skills and knowledge.

Physical Requirements

- Work standing or walking unassisted for 75% or greater of an 8-hour period. - Unassisted lifting up-to 35 lbs., may be required. - Able to wear appropriate personal protective equipment at all times, when required.

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.

About 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

Cipla is an 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.