Purpose:

• To lead and manage Site validation activities (as assigned) to ensure that validations are in compliance with company procedures, regulatory requirements, and cGMP expectations.

• To provide QA compliance oversight over IT and Technical Services (as assigned)

Responsibilities:

1. Ensure site validation activities are compliant with Site procedures, regulatory requirements, and cGMP expectations

·Author and maintain the quality system SOPs for validation.

·Define validation approach that is technically sound and are compliant.

·Author Validation Plans and Reports, including Continuous Validation Plan

·Review and approve validation deliverables

·Provide solutions to achieve validation requirements

·Collaborate with Operations to define the validation schedule and support the timely completion of activities as per schedule

·Drive efficiency, improvement and robustness in site validation systems and processes

·Be the link with Global Validation for technical information, and standards roll out

·Assess impact to validation and validation status during change management, and define appropriate validation requirements and approach to maintain validated status of systems

·Assess impact to validation for incidents/deviations and ensure appropriate CAPAs are in-place to resolve issues and prevent recurrence

·Perform Periodic Review and prepare the review report for systems and processes

·Oversee Periodic requalification and Continued process verification to maintain the validated status of systems and processes

·Conduct GSK internal audits and front as SME in external regulatory inspections

·Provide support for all activities related to GPS (e.g. Tiers, Gemba, DMAIC etc) for continuous improvement

2. Provide QA Oversight to IT operations in areas of:

·QA consultation to review and approve SOPs

·Review and approve changes, deviations and CAPAs

3. Provide QA compliance oversight to Technical Services

·Interact with TS personnel in day-to-day operations to ensure cGMP compliance

·Be the QA approver for TS activities including but not limited to:

-LSOPs, Deviation/Event, CAPAs, Change Controls,
-Quality Tag-Outs
-Calibration & maintenance programmes

-Pest control reports

4. Interface with Internal & External stakeholders

• Effective interfaces with internal and external stakeholders to ensure effective communication with and cascades from Global functions

5. EHS

• Comply with company requirements on EHS

Knowledge, Skills, and Experience:

Professional

• At least University basic degree in a Science or Engineering discipline

• At least 2 years' experience in pharmaceutical industry or related regulatory fields

• At least 5 years for Senior QA Validation Specialist role

Technical

• A good understanding of cGMP regulatory and legal requirements as applied to quality assurance and validation of pharmaceutical manufacturing

• Good understanding of regulatory inspection requirement

• A good working knowledge of validation, preferably with hands-on experience

• Computer skills in MS Office and familiar with web-based e-learning resources

• Potential or developing project management skills

Business

• Ability to apply optimal quality assurance standards to promote a business edge

• Ability to facilitate business activities compatible to international regulatory environment

• Ability to communicate effectively within site organization and across network

• Potential or developing planning and organizational skills

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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, it’s 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.

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