Qa Executive

ARKRAY Healthcare Pvt. Ltd. Surat, India

• Ensuring that all raw materials (ROH), packing materials (VERP) are tested in time (as per TAT) and release as per the approved quality specs/documents.
• Ensuring that all the in process (IPQC) and semi-finished products (HALB) are tested in time (as per TAT) and release as per the approved quality specs/documents.
• Ensuring that all the finished products (FERT) are tested in time (as per TAT) and release as per the approved quality specs/documents.
• Ensuring periodic conduction of calibration, testing and measuring instruments/equipment as per schedule in the section.
• Prepare and standardize the lab use reagents.
• Assisting Asst. Manager/Section Head in adherence to the regulatory and FDA audit process (internal and external).
• Ensuring for timely completion of different types of stability (Real Time, Accelerated Transport Stability/In use Stability) for various stages of materials/reagents/finished product in the section.
• Assisting Asst. Manager/Section Head for new vendor or alternative vendor development activity in the section.
• Ensuring of QC area (cold rooms, deep freezers, incubators, laboratory) as per GMP compliance.
• Ensuring records are filled properly, stored properly and easily retrievable.
• Assisting Manager QC/Asst. Manager/Section Head for microbiology work like sterility test and work related to prepare before sterility test. Identification of organisms.
• All other activities as and when required by superior.

Job Authority

• Authorized to do Various Types of sampling, Testing and Releasing (ROH / VEPR / INP / HALB / FERT / HAWA) as per std. TAT (SQ/TR/023).
• Authorized to do Lab use Reagent / Buffer preparation (SQ/TR/026).
• Authorized to use Different Types Incubators / Oven / Water Bath and Freezers Handling (SQ/TR/028).
• Review of plan, protocol and report of study conducted by QC.

Candidate Requirements

• Should have good knowledge about product.
• Good communication skills verbal as well as written.
• Good Team Player with proactive approach and experience of working in Cross Functional Teams (CFT).

(Prepared By)