QC Analytical Methods Lifecycle Lead

GSK

About The Position

QC Analytical Methods Lifecycle Lead Manages the analytical aspects of product lifecycle collaborating with external supply quality, R&D, MSAT, the rest of Global QC and all Vx manufacturing sites. This role consists in supporting difficult analytical investigation, LICs and PIRCs, review analytical submissions source documents and support to audits. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

Requirements

Masters degree in Chemistry, Microbiology, Biological Sciences, Analytical Science, Pharmaceutical Sciences, bio or Chemical Engineering
5+ years of experience in Quality function or managing Quality Related activities in pharmaceutical industry with quality control experience.
Demonstrated knowledge of QC environment with extensive knowledge of GMPs, and of quality and regulatory compliance requirements.
Familiarity with FDA/EU/ICH regulations and guidance, particularly as they relate to Analytical Testing.
Applies technical knowledge to provide DMAIC support
Excellent written/verbal communication, presentation and effective influencing skills, with the ability to make persuasive recommendations based on rational technical analysis.
Strong leader in communication and influencing at key stakeholders and sites level

Responsibilities

Provide SME support to methods lifecycle issues collaborating with all the functions involved in analytical space
Provide Quality oversight in QC Methods robustness for NPI and Lifecycle products
Support LICs, PIRCs and difficult investigations
Provide support to sites during audits
Provide SME support for analytical transfer, methods troubleshooting, specs settings and analytical methods definition, submission files
In specific cases write or review dossier filing and HAQs