R&D Quality and Compliance Senior Associate

The role reports to the Regional Head of R&D Quality-Health and shall ensure the safety and compliance of all Reckitt products in all markets by overseeing that the local QMS is developed by the local SME’s in line with Reckitt Global and local policies, the Global R&D QMS and in compliance with required regulations and that they are deployed and trained out as part of the relevant trainee records, whilst also providing support for standards specific for the Global Business Units commensurate with the product classification.

Responsibilities:

• Ensure local QMS meets current regulatory requirements, primarily as applicable to cosmetics, Biocides, Skin and Personal Care products as well as Reckitt internal standards and ensures that Quality policies are implemented within local SOPs 
• Quality oversight and approval of documents such as BMR's, SOP's, Quality One Records and other quality related records Develops + manages an annual internal audit program for the site to verify and improve the effectiveness of the of the operational quality management system to ensure compliance to required regulatory standards.
• Proactively monitors and ensures the facility has plans in place to respond to changes in guidance and legislation issued by Regulatory Authorities 
• Local R&D Vendor Quality management (assessments, audits, TA's etc..) in accordance with regulatory requirements/ Reckitt internal standards + maintaining approved lists 
• Provide quality input and helps to lead approval of equipment qualification and computer software validation, including major systems impacting R&D 
• Maintain and communicate performance of the QMS via the agreed Quality metrics – to ensure deviation, change controls and out of specifications are handled to a high standard in appropriate timeframes 
• R&D Quality management representative, scheduling and leading the Quality Management review for the site.
• Manage the local quality release function supporting Consumer studies locally as appropriate. Ensure that the systems that in place locally are consistent with the R&D Global quality release processes.
• Manage for the site the any GMP quality improvement action plans resulting from audits and proactive assessments and ensures initiatives are assessed and implemented promptly and effectively
• Ensure a system is in place to deliver Quality & Data integrity Inductions + refresher training
• Ensure that QMS documents are kept up to date by SME’s in compliance with Reckitt requirement.
• Host any external and Corporate Quality audits as the quality and compliance lead onsite
• Lead the Quality audit readiness and the improvement actions arising from inspections

Requirements:

• Degree in a relevant scientific discipline e.g. Pharmacy, Biology or Chemistry or relevant working background.
• Minimum of 5 years’ experience within Healthcare/FMCG multidisciplinary environment, preferably within a Quality or related discipline.
• Broad knowledge of regulatory requirements at an international level
• Knowledge of validation processes with experience of computer systems validation beneficial
• Good understanding of the product life cycle including R&D, Manufacture and Distribution
• Results oriented, entrepreneurial and self-motivated, with solid planning and organisational capabilities, a bias for action, and the capability to define and evaluating and communicating risks
• Good influencing, motivational and interpersonal skills
• Global mindset, agile thinking and a passion to change the norm
• Excellent communication skills, both written and oral