SKILLS, KNOWLEDGE & EXPERIENCE:

• Minimum honors degree in the relevant science/ engineering discipline
• At least 1 to 2 years’ industry experience or
• 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
  To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore

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
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  Draft, compile, review and update appropriate policies and procedures in support of the validation activities on site
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  Assess, review and approve changes that may have an impact on the validation status of the facility, processes or systems on site
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  Review and approve / authorize validation protocol documents and reports  Consistency with agreed criteria and quality system
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  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
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  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
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  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
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  Perform the QA role in New Product Introduction (NPI) projects to ensure that the manufacture complies with GMP requirements documentation
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  Lead the cleaning validation programme to ensure that all cleaning methods used are validated in compliance with regulatory requirements
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  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
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  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.