Operational Quality Manager

Purpose

To plan, co-ordinate and manage the manufacturing quality operations within the Quality Department in order to ensure that all activities are performed in full compliance with cGMP and regulatory requirements that meet the defined quality standards.

Responsibilities

• Ensure shift-based quality oversight of facilities, equipment and personnel to ensure real-time compliance to procedures, instructions, contemporaneous data integrity and other cGMP requirements.  This includes participation in Rapid Response approach to address deviations, with Operations, Engineering and Technical.

• Responsible for the review and approval of documentation supporting material release and ensure that all attributes / elements contributing to product release decisions have been fulfilled promptly in accordance with cGMP and regulatory requirements

• Responsible for plant inspection and release of facilities during plant turnaround and ensure that all attributes / elements contributing to the plant release decisions have been fulfilled promptly in accordance with cGMP and regulatory requirements

• Review, evaluate and approve changes that have / could have an impact on product quality, these include changes to incoming materials, product specification, method of analysis, process, plant etc.

• Support investigations arising from supplier, customer, returned goods or product failure etc, and accurately assess the impact of the complaints / failure so as to make appropriate recommendations on remedial actions for follow-up

• Draft, compile, review and update appropriate procedures and listing relating to cGMP and operational quality.

• Inspection readiness for corporate quality inspections and external regulatory inspections - actively participate in the preparation for site audits by corporate quality groups and external groups such as the Food and Drug Administration (US), HSA etc to ensure GMP and regulatory compliance.

• Lead team resources in support of site’s production schedule to ensure that operational quality activities such as life to re-testing, production records review, batch / plant release, investigations, change controls, reduced testing, stability, MERP DM etc. are adequately supported.

• Mentor and train Quality Officers / OQ Technicians to ensure staff competency in operational quality activities. Manage, develop, and motivate Quality Officers to help realize their maximum potential so as to contribute towards achieving the objectives of the department

• Provide coverage for the non-shift Quality Officers on an as-need basis in relation to red-lane activities

• Responsible for the implementation of the quality oversight program for production and QC

Requirement

Professional

• At least a degree in chemistry, pharmacy or related science discipline

• At least 8 years of relevant experience in a scientific/quality environment in the pharmaceutical industry

Technical

• Extensive knowledge in cGMP, compliance and group requirements

• Extensive knowledge of manufacturing processes, quality systems, operations, supplier management and outsourcing activities.

• Good audit skills

• Detailed knowledge of operational quality

• Good knowledge of value stream operations

• Good communication skills

• Knowledge of business process within GSK

• People management skills

• Risk management skills

• Basic financial management

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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