Junior Executive, Quality Control
Amneal Pharmaceuticals
Department: Analytical Quality control
Role: QC (Raw Material/Packing Material)
Responsibilities
Roles & Responsibilities
- Sample management, including sample in/out, Entry/Exit of samples, Test sample requests, and management of sample request forms for QC laboratory activity.
- Ensure that all raw material and packing material testing and method verification activity is carried out per schedule and per GMP. Ensure that records are maintained to appropriate requirements.
- Sampling of Raw material, packing material and Physical verification of consumable as per priority of production and release in accordance with quality standards and procedures.
- Preparation of Raw material/ Packing material specifications and DRS. Analysis of Packing material (Primary, Secondary and Tertiary packing materials).
- Support laboratory operations including but not limited to method verification, equipment qualification, calibration, cleaning and maintenance, purchase and receipt of reagents and consumables and document management.
- Responsible for analysis of samples, following test methods, generation and compilation of results, data packets preparation and submission for review of results in a timely manner.
- Reading and understanding the test procedure and the requirements per USP, EP, JP and IP.
- Participate in inspection and ensure that the laboratory and documents are in a constant state of regulatory compliance and inspection readiness.
- To assist in writing SOP documents, change plan or change records (document revisions) supporting continuous improvement of test procedures.
- To carry out completion and review of GMP Documentation of data sheets or LIMS software.
- To carry out QC sample receipt, assay and release procedures.
- Support Audit preparation and any audit related activity
- Responsible for maintaining and Training records for the QC laboratory in accordance with GLP compliance and any other work assigned by the Supervisor or Head of Department.
- Qualification: Master’s degree in science
- Good verbal and email communication skills
- Attention to detail and strong compliance mindset
- Curiosity to read, learn and working across cross-functional teams
- Basic MS Office: Word, Excel, PowerPoint
- Flexible to work in shifts as per operational requirements.
QUALIFICATIONS
Qualification: Masters in Science( Chemistry/ Analytical/ Biotechnology)