Job Description

Department: Analytical Quality control

Role: QC (Raw Material/Packing Material)

Roles & Responsibilities

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.

Basic Requirements:

Qualification: Masters in Science( Chemistry/ Analytical/ Biotechnology)