Job Description

Purpose

To lead and provide technical support to routine testing teams in the frame of the Analytical Science and Technology (ASAT) team around method development/ qualification/ validation/ verification and equipment qualification.

Key Responsibilities Area

Technical responsibilities

Manages and implements method development/ qualification/ validation/ verification and equipment qualification required by routine testing team, including but not limited to new equipment, material and method introduction and compendial updates.

Keeps up-to-date on regulations/ development of biopharmaceutical QC activities to ensure QC operations are in compliance to applicable corporate, regulatory and external agency regulations

Leads/ manages investigation of non-conformities (events and deviations) and complex tasks (e.g. continuous improvements, department/ site projects and initiatives)

Knowledge management on knowledge retention and effective training to ensure methods/ knowledge are effectively transferred to routine testing team Writes/ reviews/ approves change controls, events/ deviations, CAPAs and GMP documents (e.g. SOP, protocols, reports)

Provides technical expertise and consultation to routine testing team on technical matters to ensure compliance to applicable corporate, regulatory and external agency regulations

Subject-Matter-Expert (SME) audit fronter for assigned topics

Manages local compendium system

Co-ordinates and ensures review is timely and accurate.

Performs review of compendium updates timely and accurately.

Manages investigation system in QC

Reports trends for invalids, atypical results and OOS

Performs trends for invalids, atypical results and OOS

Problem Identification and Solving: Identifies and reports problems in QC.

Recommends and coordinates appropriate corrective actions with other departments. This includes managing non-conformities (lab, facility etc.), local CAPAs and leading investigations as necessary

Presents in a timely manner major issues to the management with strategies on their resolution

Organization and Management Responsibilities

Assist QC Manager in the management and operation of the team to create strong team morale and a culture of accountability, ownership and continuous improvement.

Supports QC manager to define objectives for the team Works with QC manager to align the priorities of the team with those of the department

Supports QC manager to ensure knowledge retention and effective training within team so that each team member is equipped with the required knowledge and competencies Supports

QC manager to ensure appropriate staffing of team to assume assigned workload and future development

Provides leadership, guidance and technical expertise / support to the team.

Ensures expenditures are within budget

Respects all safety and security polices, laboratory policies and practices on site and ensures policies and SEHSS are deployed and respected

Able to lead a small team of QC Specialists/Chemists & provide guidance to them.

Provides coaching/mentoring to Snr/Specialists/Chemists/ Associates.

Works across boundaries across departments and/or sites

Skills, Knowledge & Experience

Professional

University degree in a relevant science discipline with at least 4 years of relevant working experience

Or diploma with at least 8 years of relevant working experience

Preferably with laboratory experience in pharmaceutical industry (advantage)

Technical

Competent technical skills in the followings:

Common laboratory techniques (advantage)

Laboratory equipment qualification

Method validation

Computer system validation

Knowledge of cGLP & cGMP

Good knowledge in ASAT

Preferably with knowledge of statistics (advantage)

Preferably with knowledge of compendium (advantage)

Preferably with knowledge of QC laboratory investigation (advantage)

#Li-GSK

GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. \xe2\x80\x8b

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves \xe2\x80\x93 feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.\xe2\x80\x8b

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GlaxoSmithKline