QA Project Validation Senior Specialist

Basic qualifications:

To provide quality oversight for project related validation activities and to ensure that the execution of qualification and validation is conform to established standards, applicable cGMP and regulations, and GSK QMS.

Preferred qualifications:

  • Responsible for ensuring quality and regulatory compliance of Tianyuan remediation and integration project related Validation and Qualification:
  • Provide input for all project related validation documents, e.g., risk assessment, gap assessment, deployment plan, Protocol and report, etc.
  • Accountable for the evaluation of remediation and integration related validation and study practices to ensure compliance with regulatory requirements.
  • Provide guidance and directive on validation practice to keep continuous improvement and make sure compliance in QA perspective.
  • Ensure all operations are documented in compliance with GMP requirements as applicable.
  • Ensure validation activity follow implemented quality systems and GSK QMS
  • Ensure all projects validation activities are performed according to current validation management system, e.g., Protocols numbering, Document preparation and approve, etc.
  • Provide oversight to quality systems related to validation events (Deviations, CAPA, Change Control, gap analysis, risks) related to remediation and integration project validation activities and ensure timely escalation when required.
  • Participate in the investigation of validation activities event in order to support the timely resolution of investigations. Ensure the appropriate corrective actions and preventive actions are being taken.
  • Ensure records are reviewed during the related activities, and that potential deviations or discrepancies are addressed and documented in a timely manner, so as to try and prevent deviations, and potential impact on product quality and system.
  • Ensure validation documents and records archived on time.
  • Verify validations activities related to project and make sure are compliant.
  • Make sure validation activities are implemented under EHS requirement.
  • Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, GSK standard operating & safety procedures, and industry practice.
  • Acquire and maintain knowledge of current local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality/compliance related matters is provided.

Minimum 最低要求 : Minimum of 5 years experience in a Pharmaceutical or Biologics industry – with at least 3 years in a Quality Assurance or Manufacturing role. Strong validation, sterile product manufacturing knowledge and biopharmaceutical experience required. Quality management experience in biological Pharmaceutical company preferred. Project management experience preferred.

Desired 有以下经验更佳: Minimum of 8 years experience in a Pharmaceutical or Biologics industry – with at least 5 years in a Quality Assurance or Manufacturing role and in People Management or matrix leadership. Good knowledge and understanding of GSK QMS and Policies, as well as the requirements, approach and perspectives of regulatory agency and Good Manufacturing Practices. Very good understanding of manufacturing of vaccines, including sterile manufacturing knowledge. Ideally with exposure to a multinational environment.

Skills (e.g. IT)) 工作技能 (如IT技能等) :

  • Provide leadership to generate options, resolve problems, prioritize solutions, select optimal solutions and implement decisions.
  • Drive execution and results, motivate others and foster collaboration.
  • Demonstrated interpersonal, communication (excellent written and oral communication) and leadership skills. The ability to function and influence within team based organization.
  • Ability to identify emerging trends in internal controls, by maintaining knowledge of the internal and external business and risk environment
  • Behave with integrity, transparency, respect for people and patient focus

Details:

  • Responsible for ensuring quality and regulatory compliance of Tianyuan remediation and integration project related Validation and Qualification:
  • Provide input for all project related validation documents, e.g., risk assessment, gap assessment, deployment plan, Protocol and report, etc.
  • Accountable for the evaluation of remediation and integration related validation and study practices to ensure compliance with regulatory requirements.
  • Provide guidance and directive on validation practice to keep continuous improvement and make sure compliance in QA perspective.
  • Ensure all operations are documented in compliance with GMP requirements as applicable.
  • Ensure validation activity follow implemented quality systems and GSK QMS
  • Ensure all projects validation activities are performed according to current validation management system, e.g., Protocols numbering, Document preparation and approve, etc.
  • Provide oversight to quality systems related to validation events (Deviations, CAPA, Change Control, gap analysis, risks) related to remediation and integration project validation activities and ensure timely escalation when required.
  • Participate in the investigation of validation activities event in order to support the timely resolution of investigations. Ensure the appropriate corrective actions and preventive actions are being taken.
  • Ensure records are reviewed during the related activities, and that potential deviations or discrepancies are addressed and documented in a timely manner, so as to try and prevent deviations, and potential impact on product quality and system.
  • Ensure validation documents and records archived on time.
  • Verify validations activities related to project and make sure are compliant.
  • Make sure validation activities are implemented under EHS requirement.
  • Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, GSK standard operating & safety procedures, and industry practice.
  • Acquire and maintain knowledge of current local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality/compliance related matters is provided.

Contact information:

You may apply for this position online by selecting the Apply now button.

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