Quality Control Specialist

1. Preparation, execution, review, and approval of Analytical method validation/ analytical method transfer protocol / report. 

1. Analytical Method Validation (Partial) of assay and related substances, dissolution in drug and drug substances by HPLC & GC method.

1. Audit arrangements and readiness. 

1. To work according to working standard, inhouse reference standard, official pharmacopeia standards, and impurity standard maintenance.

1. To work and guide the team in accordance with cGMP, and pharmacopeia and regulatory requirements for testing and validation procedures.

1. To handle and manage analytical instruments like HPLC, GC, TLC, dissolution apparatus, FTIR, UV-VIS spectrometer, and KF coulometer, wet chemistry techniques. 

1. To understand and provide reports on stability studies of drug product.   

1. To handle independently and communicate with method transfer units, prepare review, and execute Transfer Analytical procedures. 

1. To manage team of 2-3.

Competencies: 

1. Industry Knowledge - Relevant experience in the regulated pharmaceutical industry, specifically Quality Control.

1. Leadership. 

1. Health authority inspections and third-party audits. 

1. Understanding of manufacturing processes and / or quality systems element.

1. Decision Making & Judgment

1. Problem Solving 

1. Coaching 

1. Business Acumen /Understanding the Organisation