Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider &

experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Quality Control Chemist I

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility (Ash Stevens, LLC), located in Riverview, Michigan, is seeking a qualified Quality Control Chemist I to join our Quality Control team.

The Quality Control

Chemist II is responsible for providing analytical chemistry support for the facility.

Requirements To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required:

- Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.

- Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values.

- Identify and protect the original technical information as part of the company property.

Key Responsibilities.

- Support manufacturing operations through the testing of raw materials and starting materials as required to meet production timelines.

- Perform cleaning verifications on multi-use equipment using approved methods.

- Test reference standards and stability samples.

- Document sample preparation, equipment set-up, and test results in laboratory notebooks or other appropriate test record forms. Verify data with second quality team member as required. Maintain all records as required to maintain compliance.

- As required, test intermediates and final products to meet production timelines/client requirements.

- Assist in the revision of documentation as required.

- Participate in quality unit projects, including but not limited to supplier certification, methods development, methods validation and training of both quality unit members as appropriate.

- Provide support in the maintenance and calibration of laboratory analytical instrumentation.

- Assist in the maintenance of the QC laboratory through routine housekeeping, as well as keeping personal bench area and desk organized.

- As required, perform routine testing on the water system (DI, ice, potable, and QC water), and prepare reports as needed.