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.Responsibilities:

• 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 \xef\x82\xb7 Consistency with agreed criteria and quality system

• 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 documentation

• 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.

Decision MakingProposals & Recommendations:

• Recommends validation approach for new systems and modified systems
• Recommendations on follow-up action for audits / investigations
• Recommendation for re-validation as required from the outcome of validation review

Decisions:

• Approval of the deliverables of each qualification phase before proceeding to the next phase
• Approval of change control requests
• Jointly decide with the NPI & Validation Manager the outcome of the validation status of each validation project and validation review

Skills, Knowledge & Experience:

• At least an honors degree in the relevant science/ engineering discipline
• At least 5 years of relevant experience in the pharmaceutical industry
• 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
• 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
• Good interpersonal skills
• Good oral and written communication skills
• Good investigating skills

Why GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, its 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 - 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.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

GlaxoSmithKline