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
Positive verbal and email communication skills
Attention to detail and robust compliance mindset
Curiosity to read, learn and working across cross-functional teams
Basic MS Office: Word, Excel, PowerPoint
Adaptable to work in shifts as per operational requirements.
Basic Requirements
QUALIFICATIONS
Qualification: Masters in Science( Chemistry/ Analytical/ Biotechnology)