An exciting career opportunity has risen for an individual with scientific approach to products and processes as a guide to decision making to join our Product Assurance department team within the Global CH business as a Process Capability Technologist (PCT).
This role reports to the Site Technical Lead
The successful candidate’s principal role will be to ensure that the site products and process capability is appropriate to maximize the efficiency of GSK process operations (i.e. manufacturing and packaging operations). The PCT is also responsible for New Product Introduction and source change Management for API and Recipients used in the product manufacture.
Essential Job Responsibilities
Developing validation protocols and performing respective validation & qualification of the site systems (Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification/ Validation (PQ/V) Cleaning Validation (CV) and retrospective system reviews for new and/or modified existing systems. Advising and supporting the Manufacturing operations in the product development technology, and support delivery of product innovation. Leading team in proactive analysis of potential gaps that could result in product defect and implementing mitigation for the same. Providing suitable and adequate technical training to raise staff competency levels to ensure manufacturing processes in control and audit ready at all times. Ensuring systems and components are in compliance with guidelines set by GSK Quality and External Legislative and Regulatory agencies Working alongside with the other site functions to deliver site growth plans and strategic objectives and to meet service, quality, safety and financial standards Supporting and driving the waste and cost reductions in the business through value engineering projects, defects management and systems assurance. Ensuring changes with potential impact on product quality and/or other QMS/GMP compliance requirements are appropriately assessed before implementation through the site change control process.
Qualifications & Knowledge
University degree in Chemistry, Chemical Engineering or related sciences.
Minimum 3 years significant experience in equivalent role, with extensive knowledge in Validation Life cycle Management, in a multi-product operation, with proven track record in achieving positive results
Excellent communication skills, both verbal and written.
Demonstrated Scientific approach to decision making in previous role/ experience.
Strong ability to influence and support team members with respect to process improvement in FMCH organization
