Chemist (Manufacturing Associate)

Penn Life Sciences • Langhorne, PA

280d

About The Position

The Chemist (Manufacturing Associate) will be responsible for preparing, reviewing, and approving certification of all validation protocols including IQ, OQ, PQ, and PV to ensure compliance with validation and regulatory requirements in accordance with ANDA. The role involves evaluating the impact on production quality and monitoring the change control systems for all changes related to Process, Facility, Equipment, and other systems or Procedures. Additionally, the position requires the preparation of departmental SOPs and training, initiating and supporting investigations associated with qualification activities using CAPA, and analyzing and optimizing Production Equipment Qualification, Utility Equipment Qualification, and Air Handling Unit. The Chemist will also validate and execute SAP modules, MasterControl, and TrackWise.

Requirements

• Master's degree in Chemistry, Biochemistry, Pharmaceutical Science, or Pharmaceutical Technology.
• 2 years of experience in the job offered.
• Working knowledge of IQ/OQ/PQ, PV, CAPA, SOPs, MasterControl, and Change Control System.

Responsibilities

• Prepare, review, and approve certification of all validation protocols IQ, OQ, PQ, and PV.
• Evaluate the effect on production quality and monitor change control systems.
• Prepare departmental SOPs and training.
• Initiate and support performance of investigations associated with qualification activities using CAPA.
• Analyze and optimize Production Equipment Qualification, Utility Equipment Qualification, and Air Handling Unit.
• Validate and execute SAP modules, MasterControl, and TrackWise.

What This Job Offers

• Education Level: Master's degree
• Number of Employees: 11-50 employees