Job Description

Purpose

To ensure that the manufacturing facilities, processes, analytical methods and systems are validated in full compliance with current Good Manufacturing Practices (cGMP) and regulatory requirements so as to meet the stipulated product quality standards in line with the established specifications of the organization.

Key Responsibilities Area

Participate / lead in the conduct of audits on equipment / system, and internal cross-functional departments involved in the manufacture of bulk drug substances to ensure full GMP and regulatory compliance

Draft, compile, review and update appropriate policies and procedures in support of the validation activities on site

Assess, review and approve changes that may have an impact on the validation status of the facility, processes or systems on site

Review and approve / authorise validation protocol documents and reports

Participate as an audit team member and/or as a subject matter expert in the preparation of site audits by internal corporate groups and external regulatory agencies to ensure GMP and regulatory compliance

Participate in the conduct of investigations relating to customer complaints, returned / recalled goods, investigations of failure, etc to assess root causes of the complaints, and evaluate the impact of corrective actions on the validation status

Act as a Validation Co-ordinator in projects that are deemed to have product quality impact, chair the Validation Working Party meetings and lead the conduct of validation activities to ensure that validation / regulatory requirements are met.

Perform the QA role in New Product Introduction (NPI) projects to ensure that the manufacture complies with GMP requirements

Lead the cleaning validation programme to ensure that all cleaning methods used are validated in compliance with regulatory requirements

Ensure that validation review of systems or processes are conducted on a periodic basis to ensure that the validation status is maintained, and make recommendations for re-validation as required, pending outcome of the validation review

Take on Validation Co-ordinator role for Method Validation to assess, review and approve changes that may have an impact on the method validation status on site. (As required)

Skills, Knowledge & Experience

Professional

At least a honours degree in the relevant science / engineering discipline

Senior Quality Validation Officer

At least 5 years of relevant experience in the pharmaceutical industry

Quality Validation Officer

Fresh graduates or preferably with 1-2 years of industry experience

Technical

Senior Quality Validation Officer

Extensive knowledge of GMP and validation

Extensive knowledge of quality and manufacturing processes

Good knowledge of corporate management systems

Good audit skills

Detailed knowledge of regulatory processes

Quality Validation Officer

Good knowledge of GMP and validation

Good knowledge of quality and manufacturing process knowledge

Basic knowledge of corporate management systems

Good audit skills

Good knowledge of regulatory processes

#Li-GSK

Why Us?

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. \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