Senior / Quality Validation Officer

GlaxoSmithKline

  • Singapore
  • Permanent
  • Full-time
  • 13 days ago
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 complianceDraft, compile, review and update appropriate policies and procedures in support of the validation activities on siteAssess, review and approve changes that may have an impact on the validation status of the facility, processes or systems on siteReview and approve / authorize validation protocol documents and reports  Consistency with agreed criteria and quality systemParticipate 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 complianceParticipate 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 statusAct 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 metPerform the QA role in New Product Introduction (NPI) projects to ensure that the manufacture complies with GMP requirements documentationLead the cleaning validation programme to ensure that all cleaning methods used are validated in compliance with regulatory requirementsEnsure 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 reviewTake 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.Skills, Knowledge & Experience:Minimum honors degree in the relevant science/ engineering disciplineAt least 1 to 2 years’ industry experience orAt least 5 years of relevant experience in the pharmaceutical industryExtensive knowledge of GMP and validationExtensive knowledge of quality and manufacturing processesGood knowledge of corporate management systemsGood audit skillsDetailed knowledge of regulatory processesGood knowledge of GMP and validationGood knowledge of quality and manufacturing process knowledgeBasic knowledge of corporate management systemsGood audit skillsGood knowledge of regulatory processesGood interpersonal skillsGood oral and written communication skillsGood investigating skillsTo learn more about Singapore GSK and our people, please click on this link:Why GSK?
Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.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